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Central Drugs Standard Control Organization (CDSCO), Government of India has a mandate for approval of drugs to be manufactured and imported for sale in India. The drugs approved by CDSCO can only be further licensed by State Licensing Authorities to various manufacturers in India. CDSCO often publishes the list of approved drugs/ new drugs on its website but the updation of the drugs are year wise and department wise. Also, there are numerous lists which a manufacturer has to go through to find the status of the drug which he intends to manufacture. There is no single list available mentioning the complete list of CDSCO approved drugs in India.
Looking at this scenario, we at Vaayath has taken this onus onto ourselves to compile and organize the list of approximately 5000 products. We are hereby publishing the complete list of new drugs at one place in an easy searchable format. We are committed to update this list as and when the list of new approved drugs are issued by CDSCO. This initiative has been taken after successful and widely applauded list of ban drugs and list of solubility of Active Pharmaceutical Ingredients has been published on our website.
About Vaayath: Vaayath is a one-stop destination for all pharma regulatory services. In a short span of time, we have created a niche for ourselves as regulatory consultants having expertise in a wide array of regulatory activities. Our services include but are not limited to new drug approval, medical device registration and licensure, FDC approval, Cosmetics Licensure, GMP Layouts preparation, Auditing, Training, etc. With a 100% success record, Vaayath boasts of a team, who not only help you with the filing process but performs the complete technical and administrative review of the data submitted to us. This helps to reduce the concerns raised by the regulators and helps to expedite the approval process. The transparent and supportive approach have helped us won accolades among our clients.
| Drug Name | Composition | Indication | Date of Approval |
|---|---|---|---|
| Pegaspargase injection 3750 IU per vial | Each vial contains: Pegaspargase 3750 IU per vial | As a component of multi agent chemotherapeutic regiment for the treatment of patients with acute lymphoblastic leukaemia who are hypersensitive to L-Asparaginase. | 04.01.2018 |
| Cefditoren Pivoxil dry powder for suspension 100mg/5ml (Additional Indication) | Each 5ml reconstituted suspension contains: Cefditoren Pivoxil equivalent to Cefditoren 100mg | For the treatment of mild to moderate infection also in children’s of (2 months to 12 years of age) which are caused by susceptible strains of the designated microorganisms in the condition listed below: Acute Bacterial Exacerbation of Chronic Bronchitis Community-Acquired pneumonia Pharyngitis/Tonsillitis Uncomplicated Skin and skin –structure infection | 04.01.2018 |
Tenofovir Alafenamide Hemifumarate Bulk | Tenofovir Alafenamide Hemifumarate Bulk | 10.01.2018 | |
Emtricitabine 200mg/200mg +Tenofovir Alafenamide 10/25 mg Tablets | | In combination with other antiretroviral agents for treatment of Human Immunodeficiency Virus type1 (HIV-1) infections in adults and adolescents with aged 12 years and older. | 10.01.2018 |
| Clofarabine Bulk & Injection 20 mg/20ml vial | Clofarabine Bulk & Injection 20 mg/20ml vial | For the treatment of patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based upon response rate | 16.01.2018 |
| Denaverine Hydrochloride Injection (Vet.) | Denaverine Hydrochloride Injection (Vet.) | cattle : Facilitation of parturition in heifers; activation of interrupted parturitions; insufficient opening of the soft birth canal; narrowness of the cervix of first and second degree after corrrection of uterine torsions; improvement of the conditions for foetotomy; regulation of labour contractions of the utreus Dogs: Activation of Interrupted parturition | 16.01.2018 |
| Eltrombopag olamine tablets 12.5mg (Additional strength & indication) | Each film coated tablet contains: Eltrombopag olamine equivalent to Eltrombopag olamine as free acid 12.5mg | 1. Chronic ITP : for Adults For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) Thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). For Paediatric patients aged 1 year and above: Thrombocytopenia in paediatric patients 1 year and older with immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy (lt should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). 2. For the treatment of patients with chronic Hepatitis C virus (HCV) infection for the treatment of thrombocytopenia to: Enable the initiation of interferon based therapy, optimize interferon based therapy. With the condition: to be sold by retail on the prescription of Haematologist only | 06.02.2018 |
| Fipronil 6.1 % m/v + Permethrin 54.5% m/V spot on solution for Dog (Vet.) | Fipronil 6.1 % m/v + Permethrin 54.5% m/V spot on solution for Dog (Vet.) | In dogs, to be used against infestations with fleas and/or ticks when repellant (anti feeding) activity is necessary against sand-flies and/or mosquitoes | 20.02.2018 |
| Paziquantel 0.0065 g + Abamectin 0.00025 g tablets for cat (Vet) | Paziquantel 0.0065 g + Abamectin 0.00025 g tablets for cat (Vet) | In infestation of cats with endoparasites tapewoms (teniae), flukes, roundworms (nematodes); with ectoparasites - lice, fleas, pasture ticks, notedric mange (feline scabies), "walking" dandruff (cheyletiellosis) and other mange, and particularly in cases of complex endo and ectoparasitic invasion. | 20.02.2018 |
| Cadexomer Iodine Bulk & Powder 100 % w/w (contain 0.9 % w/v Iodine) or cadexomer Iodine Ointment 500 mg (contains 0.9% w/v iodine) | Cadexomer Iodine Bulk & Powder 100 % w/w (contain 0.9 % w/v Iodine) or cadexomer Iodine Ointment 500 mg (contains 0.9% w/v iodine) | For the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetes ulcers infected traumatic and surgical wounds | 05.03.2018 |
| Alectinib Capsules 150mg (Additional Indication) | Each hard gelatin capsule contains: Alectinib 150mg equivalent to Alectinib hydrochloride 161.3mg | First-line treatment of patients with Anaplastic Lymphoma Kinase (ALK) - positive locally advanced or metastatic non-small cell lung cancer (NSCLC). With the condition: to be sold by retail on the prescription of Oncologist only. | 05.03.2018 |
| Each film coated tablet contains: Dolutegravir sodium equivalent to Dolutegravir ……………… 50mg Lamivudine IP……………. 300mg Tenofovir Disoproxil Fumarate IP ……. 300mg eq. to Tenofovir Disoproxil …… 245mg | Each film coated tablet contains: Dolutegravir sodium equivalent to Dolutegravir ……………… 50mg Lamivudine IP……………. 300mg Tenofovir Disoproxil Fumarate IP ……. 300mg eq. to Tenofovir Disoproxil …… 245mg | For the management of Human Immunodeficiency Virus (HIV) infections in adults weighing more than 40kg. | 08.03.2018 |
| Methotrexate injection prefilled syringe 15mg/0.3ml, 20mg/0.4ml and 25mg/0.5ml (Additional strength & indication) | Each 0.3ml prefilled syringe contains: Methotrexate 15mg Each 0.4ml prefilled syringe contains: Methotrexate 20mg Each 0.5ml prefilled syringe contains: Methotrexate 25mg | It is indicated in treatment of 1. Active rheumatoid arthritis in adult patients. 2. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drug (NSAIDs) has been inadequate, 3. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids and severe psoriatic arthritis in adult patients. 4. Mild to moderate Crohn's disease either alone or in combination with corticosteroids in adult patie | 09.03.2018 |
| Each film coated tablet contains: Abacavir Sulphate USP eq .to Abacavir………………..600mg Dolutagravir Sodium eq. to Dolutagravir……………50mg Lamivudine USP……….300mg | Each film coated tablet contains: Abacavir Sulphate USP eq .to Abacavir………………..600mg Dolutagravir Sodium eq. to Dolutagravir……………50mg Lamivudine USP……….300mg | For the treatment of Human Immunodeficiency Virus (HIV) infection in adults weighing more than 40kg. | 12.03.2018 |
| Dalfampridine Bulk & Film coated extented release tablet 10 mg | Dalfampridine Bulk & Film coated extented release tablet 10 mg | For treatment to improve walking in patients with multiple Sclerosis (MS) | 12.03.2018 |
| Ulipristal Acetate 5 mg tablets | Ulipristal Acetate 5 mg tablets | For the pro-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age | 14.03.2018 |
| Sildenafil power for oral suspension 10mg/ml (Additional dosage form) | Each ml of reconstituted suspension contains: Sildenafil citrate equivalent to 10mg, Sodium benzoate 4.375mg | Adults: Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population: Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease. With the condition: to be sold by retail on the prescription of Cardiologist only. | 20.03.2018 |
| Fulvestrant 250mg/5ml injection (Additional Indication) | Each 5ml pre-filled syringe contains: Fulvestrant 250mg ethanol (96%)-10% w/v | For the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy With the condition: to be sold by retail on the prescription of Oncologist only. | 20.03.2018 |
| Each ml cutaneous solution contains: Chlorhexidine gluconate solution IP Eq. to Chlorhexidine gluconate ……. 20 mg Isopropyl Alcohol IP …………… 0.70 ml | Each ml cutaneous solution contains: Chlorhexidine gluconate solution IP Eq. to Chlorhexidine gluconate ……. 20 mg Isopropyl Alcohol IP …………… 0.70 ml | For disinfectant of the skin prior to invasive medical procedures and maintenance of device insertion sites. | 22.03.2018 |
| Bendamustine hydrochloride injection 90mg/ml (0.5ml vial & 2.0 ml vial) (Additional Indication) | Each ml contains: Bendamustine hydrochloride 90mg ethanol 4.33% w/v | Front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment. With the condition: to be sold by retail on the prescription of Oncologist/Specialist only. | 23.03.2018 |
| Each film coated tablet contains: Canagliflozin + Metformin HCL (50mg+500mg, 50mg+850mg, 50mg+1000mg, 150mg+500mg, 150mg+850mg, 150mg+ 1000mg) . | Each film coated tablet contains: Canagliflozin + Metformin HCL (50mg+500mg, 50mg+850mg, 50mg+1000mg, 150mg+500mg, 150mg+850mg, 150mg+ 1000mg) | Indicated as an adjunct to diet and exercise to improve glycaemic control in adult with type 2 diabetes mellitus when treatment with both Canagliflozin and metformin is appropriate. Limitation of use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. | 27.03.2018 |
| Ulipristal Acetate bulk | Ulipristal Acetate bulk | - | 02.04.2018 |
| Dydrogesterone tablet 10mg (Additional Indication) | Each film coated tablet contains: Dydrogesterone 10mg | Luteal support as part of an Assisted Reproductive Technology (ART) treatment. With the condition: to be sold by retail on the prescription of Gynaecologist only | 06.04.2018 |
| Febuxostat tablet 60mg & 20mg (Additional Strength) | Each film coated tablet contains: Febuxostat 60mg & 20mg | For the treatment of chronic hyperuricemia in conditions where urate deposition has already occurred (including a history, or presence of tophus and / or gouty arthritis) | 06.04.2018 |
| Posaconazole injection 300mg/16.7ml (18mg/ml) (Additional Strength & Dosage Form) | Each injection contains: Posaconazole 300mg/16.7ml | For prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. With the condition: to be sold by retail on the prescription of Specialist only. | 13.04.2018 |
| Riociguat bulk & 0.5mg/1.0mg/1.5mg/2.0mg/2.5 mg tablet | Riociguat bulk & 0.5mg/1.0mg/1.5mg/2.0mg/2.5 mg tablet | For the treatment of persistent/ recurrent chronic Thromoembolic pulmonary Hypertension (CTEPH) WHO Group 4) After surgical treatment or imoperable CTEPH to improve exercise capacity and WHO function | 16.04.2018 |
| Each ml contains: i) Bupivacaine Hydrochloride IP 1.25mg Eq to anhydrous Bupivacaine Hydrochloride 1.185mg Fentanyl Citrate IP Eq to Fentanyl 2.0mcg Injection ii) Bupivacaine Hydrochloride IP 1.0mg Eq to anhydrous Bupivacaine Hydrochloride 0.948mg Fentanyl Citrate IP Eq to Fentanyl 2.0 mcg Injection | Each ml contains: i) Bupivacaine Hydrochloride IP 1.25mg Eq to anhydrous Bupivacaine Hydrochloride 1.185mg Fentanyl Citrate IP Eq to Fentanyl 2.0mcg Injection ii) Bupivacaine Hydrochloride IP 1.0mg Eq to anhydrous Bupivacaine Hydrochloride 0.948mg Fentanyl Citrate IP Eq to Fentanyl 2.0 mcg Injection | For maintaining the analgesia postoperatively. For maintaining analgesia during labour | 17.04.2018 |
| Baricitinib 2mg/4mg film coated Tablets | Baricitinib 2mg/4mg film coated Tablets | For the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modification anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate | 07.05.2018 |
| Teriflunomide tablet 7mg (Add. Lower strength) | Each film coated tablet contains: Teriflunomide 7mg | For the treatment of patients with relapsing form of multiple sclerosis. With the condition: to be sold by retail on the prescription of Neurologist only. | 07.05.2018 |
| Apremilast film coated tablet 10/20/30mg (Additional Indication) | Each film coated tablet contains: Apremilast-10mg, 20mg,30mg | For the treatment of adult patients with Active psoriatic Arthritis. | 11.05.2018 |
| Aripiprazole tablet 2mg (additional strength) | Each uncoated tablet contains: Aripiprazole-2mg | For the treatment of Schizophrenia in adolescent patients (13 to 17 years of age) With the condition: to be sold by retail on the prescription of Psychiatrist only. | 11.05.2018 |
| Dextromethorphan HBr Lozenges 10mg (Add. dosage form & strength) | Each lozenges contains: Dextromethorphan HBr-33.33% Complex 30mg eq. to Dextromethorphan HBr 10mg | Cough suppressant for the relief of acute non-productive (dry, tickly) cough associated with respiratory tract infection in adult patients only. | 11.05.2018 |
| Voglibose Orally Disintegrating Strips 0.2mg (Modified dosage form) | Each Orally Disintegrating Strips contains: Voglibose 0.2mg & 0.3mg | For improvement of parandial hyperglycaemia in diabetes mellitus, when only diet and/or exercise or oral hypoglycaemic drugs or insulin preparation in addition to diet and/or exercise do not result in adequate glycemic control. | 11.05.2018 |
| Vortioxetine Hydrochloride 5 mg/10mg/15mg/20mg | Vortioxetine Hydrochloride 5 mg/10mg/15mg/20mg | for the treatment of major depressive disorder in adults | 14.05.2018 |
| Tranexamic acid tablet 1000mg (Additional strength) | Each film coated tablet contains: Tranexamic acid-1000mg. | For the treatment of menorrhagia | 21.05.2018 |
| Eltrombopag Olamine Tablet 75mg (Additional strength) | Each film coated tablet contains: Eltrombopag Olamine as free acid-75mg | 1. For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.(It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). 2. Indicated in patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia to: a. Enable the intiation of interferon based therapy. b. Optimize interferon based therapy 3. For the treatment of patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy 4. For the treatment of thrombocytopenia in paediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). With the condition: to be sold by retail on the prescription of Hematologist only. | 29.05.2018 |
| Thyroxine Sodium Tablet 37.5 mcg (Additional strength) | Each uncoated tablet contains: Thyroxine Sodium eq. to Anhydrous Thyroxine Sodium. 37.5 mcg. | 1. As replacement or supplemental therapy in patients of any age or state (including pregnancy) with hypothyroidism of any etiology except transient hypothyroidism during the recovery phase of sub-acute thyroiditis resultng from thyroid dysfunction, primary atrophy or partial or total absence of the thyroid gland or from the effects of surgery, radiation or drugs with or without the presence of goiter, including sub-clinical hypothyroidism; secondary (pituitary) hypothyroidism and tertiary (hypothalamic) hypothyroidism. 2. As a pituitary TSH suppressant in the treatment or prevention of various types of euthyroidgoites, including thyroid nodules, sub-acute or chronic lymphocytic thyroiditis (Hashimoto's) multi-nodular goiter and in conjuction with surgery and radioactive iodine therapy in the management of thyrotropin-dependent well differentiated papillary or follicular carcinoma of the thyroid. | 08.06.2018 |
| Dabrafenib Hard Gelatin Capsule 50mg,& 75mg (Additional indication) | Each Hard Gelatin Capsule contains: Dabrafenib Mesylate eq. to Dabrafenib 50mg & 75mg | Dabrafenib in combination with Trametinib for the treatment of adult patients with advanced non-small cell lung cancer with BRAF V600 mutation. With the condition: to be sold by retail on the prescription of Oncologist only. | 08.06.2018 |
| Trametinib Tablet 0.5mg & 2mg (Additional indication) | Each Film coated tablet contains: Trametinib 0.5mg & 2mg | Trametinib in combination with Dabrafenib for the treatment of adult patients with advance non-small cell lung cancer with a BRAF V 600 mutation. With the condition: to be sold by retail on the prescription of Oncologist only. | 08.06.2018 |
| Vardenafil Hydrochloride Trihydrate Bulk and 2.5mg/5mg/10 mg/20 mg tablets | Vardenafil Hydrochloride Trihydrate Bulk and 2.5mg/5mg/10 mg/20 mg tablets | Treatment of erectile dysfunction in adult men | 11.06.2018 |
| Trientine Hydrochloride Bulk and 250 mg capsule | Trientine Hydrochloride Bulk and 250 mg capsule | For the treatment of Wilson's disease (hepatolenticular degeneration) in patients intolerant to Penicillamine. It should be used when continued treatment with Penicillamine is no longer possible because of intolerable or life endangering side effect. | 11.06.2018 |
| Each film coated tablet contains : Daclatasvir Dihydrochloride Eq to Daclatasvir………..60 mg Sofosbuvir……………....400 mg | Each film coated tablet contains : Daclatasvir Dihydrochloride Eq to Daclatasvir………..60 mg Sofosbuvir……………....400 mg | For the treatment of patient with chronic Hepatitis C virus (HCV) genotype 3 infection | 12.06.2018 |
| Azacitidine for injection 50mg/vial (Additional strength) | Each vial contains: Azacitidine….... 50mg Lyophilized powder for injection (for Subcutaneous or Intravenous use) | For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome. With the condition: to be sold by retail on the prescription of Oncologist only. | 22.06.2018 |
| Nilotinib Capsules 50mg (Additional strength & add. indication) | Each Capsule contains: Nilotinib 50mg | 1. Paediatric patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukaemia (CML) in the chronic phase. 2. Paediatric patients with chronic phase Philadelphia Chromosome Positive (CML) with resistance or intolerance to prior therapy including imatinib. With the condition: to be sold by retail on the prescription of Oncologist only. | 22.06.2018 |
| Gadoteridol injection | Gadoteridol injection | To visualise lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients over 2 years of age, lesions in the head and neck in adults. | 25.06.2018 |
| Fipronil 50mg/134 mg/268mg/402mg spot on solution for cats and dogs | Fipronil 50mg/134 mg/268mg/402mg spot on solution for cats and dogs | For treatment of flea and tick infestation in cats and dogs (for veterinary use only) | 25.06.2018 |
| FDC of Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg tablets | FDC of Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg tablets | In combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight atleast 35 kg) infected with Human Immunodeficiency Virus type-1 (HIV-1) | 25.06.2018 |
| Each vial contains: Meropenam IP eq. to Anhydrous Meropenam……..1gm Sodium Carbonate IP Eq. to Sodium ……90.2 mg Sulbactum Sodium USP Eq. to Sulbactum………1gm Injection | Each vial contains: Meropenam IP eq. to Anhydrous Meropenam……..1gm Sodium Carbonate IP Eq. to Sodium ……90.2 mg Sulbactum Sodium USP Eq. to Sulbactum………1gm Injection | For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only. | 25.06.2018 |
| Imidacloprid and Flumethrin i) Each 38 cm Seresto Collar Contains: (For Cats less than or equal to 8 Kg of body weight) Imidacloprid…..1.25g Flumethrin….0.56g ii) Each 38 cm Seresto Collar Contains: (For Dogs less than or equal to 8 Kg of body weight) Imidacloprid…..1.25g Flumethrin….0.56g iii) Each 38 cm Seresto Collar Contains: (For Dogs more than or equal to 8 Kg of body weight) Imidacloprid…..4.5g Flumethrin….2.03g | Imidacloprid and Flumethrin i) Each 38 cm Seresto Collar Contains: (For Cats less than or equal to 8 Kg of body weight) Imidacloprid…..1.25g Flumethrin….0.56g ii) Each 38 cm Seresto Collar Contains: (For Dogs less than or equal to 8 Kg of body weight) Imidacloprid…..1.25g Flumethrin….0.56g iii) Each 38 cm Seresto Collar Contains: (For Dogs more than or equal to 8 Kg of body weight) Imidacloprid…..4.5g Flumethrin….2.03g | For the treatment and prevention against fleas, Ticks & Lice and For reducing the risk of Vector-Borne Disease transmission. | 26.06.2018 |
| Each Film coated tablet contains: Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Chlorthalidone IP (40mg+25mg,40mg + 12.5mg) | Each Film coated tablet contains: Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Chlorthalidone IP (40mg+25mg,40mg + 12.5mg) | For the treatment of mild to moderate hypertension | 09.07.2018 |
| FDC of Azilsartan + chlorthalidone (40 mg + 12.5 mg) and Azilsartan + chlorthalidone (40 mg + 25 mg) tablet | FDC of Azilsartan + chlorthalidone (40 mg + 12.5 mg) and Azilsartan + chlorthalidone (40 mg + 25 mg) tablet | For the treatment of mild to moderate hypertension in adults | 09.07.2018 |
| Fulvestrant 250mg/5ml injection (Additional indication) (for IM use only) | Each 5ml pre-filled syringe contains: Fulvestrant USP 250mg Ethanol (96%) BP-10% w/v | In combination with Palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy”. With the condition: to be sold by retail on the prescription of Oncologist only. | 13.07.2018 |
| Ganciclovir Sodium powder for Infusion 500mg (Additional indication) (for IV use only) | Each vial contains: Ganciclovir 500mg (In the form of the sodium salt) | For the treatment of cytomegalovirus (CMV) disease in immunocompromised individuals and for the prevention of CMV disease in patients with drug-induced immunosuppression following organ transplantation or cancer chemotherapy. With the condition: to be sold by retail on the prescription of a Specialist only. | 13.07.2018 |
| Nepafenac Ophthalmic Suspension 0.3%w/v (Additional strength) | Each ml contains: Nepafenac 3.0mg | For the treatment of pain and inflammation associated with cataract surgery. With the condition: to be sold by retail on the prescription of Ophthalmologist only. | 13.07.2018 |
| Tadalafil Orally Disintegrating Strip 5mg (Additional strength) | Each Orally Disintegrating Strip contains: Tadalafil 5mg | For the treatment of Erectile Dysfunction | 13.07.2018 |
| Each capsules contains: Glycopyrronium (As Glycopyrrolate USP)…… 25mcg Formoterol Fumarate Dihydrate IP Eq. to Formoterol Fumarate……….6mcg (Capsule for inhalation) | Each capsules contains: Glycopyrronium (As Glycopyrrolate USP)…… 25mcg Formoterol Fumarate Dihydrate IP Eq. to Formoterol Fumarate……….6mcg | For the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema | 16.07.2018 |
| For the treatment of Erectile Dysfunction (Additional indication) | Each film coated tablet contains : Delamanid …..... 50mg | In exceptional cases and after a careful benefit/risk assessment Delamanid treatment can be initiated in children >6 years of age, for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. With the condition: For the use in Revised National Tuberculosis Control Program (RNTCP). | 27.07.2018 |
| Osimertinib Film coated tablet 40mg and 80mg (Additional indication) | Each film coated tablet contains: Osimertinib 40mg, 80mg | As first-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions mutations. With the condition: To be sold by retail on the prescription of Oncologist only. | 03.08.2018 |
| FDC of Ceftolozane (1.0 gm) and Tazobactum (0.5 gm) injection | FDC of Ceftolozane (1.0 gm) and Tazobactum (0.5 gm) injection | Indicated for the treatment of patients 18 years or older with the following infections caused by designated susceptible microorganisms: • Complicated intra-abdominal infections (cIAI) caused by the following Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus , Streptococcus constellatus, and Streptococcus salivarius in combination with metronidazole in ICU setting only. • Complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa in ICU setting only. | 06.08.2018 |
| Olaparib film coated tablets (100mg, 150 mg) | Olaparib film coated tablets (100mg, 150 mg) | Ovarian cancer: • For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. • For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Breast cancer: • In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. | 13.08.2018 |
| Nicotine Polacrilex Orally disintegrating strips 2mg & 4mg (New dosage form) | Each Orally disintegrating strips contains: Nicotine Polacrilex eq. to Nicotine 2mg, 4mg | To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and gutkha containing tobacco | 17.08.2018 |
| Each combikit contains: Part A: One film coated tablet of Atazanavir Sulphate and Ritonavir tablet. Each film coated tablet contains: Atazanavir Sulphate IP eq.to Atazanavir ..................................... 300mg Ritonavir IP… ............................... 100mg Part B: One film coated tablet of Abacavir Sulphate and Lamivudine tablet Each film coated tablet contains: Abacavir Sulphate IP eq to Abacavir ............................................ 600mg Lamivudine IP… ............................... 300mg | Each combikit contains: Part A: One film coated tablet of Atazanavir Sulphate and Ritonavir tablet. Each film coated tablet contains: Atazanavir Sulphate IP eq.to Atazanavir ..................................... 300mg Ritonavir IP… ............................... 100mg Part B: One film coated tablet of Abacavir Sulphate and Lamivudine tablet Each film coated tablet contains: Abacavir Sulphate IP eq to Abacavir ............................................ 600mg Lamivudine IP… ............................... 300mg | For management of Human Immunodeficiency Virus (HIV) infections | 17.08.2018 |
| Each sachet contains: ( Granules in sachet) Lopinavir IP………..40mg Ritonavir IP………..10mg (Additional Dosage Form) | Each sachet contains: ( Granules in sachet) Lopinavir IP………..40mg Ritonavir IP………..10mg (Additional Dosage Form) | Combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (14 days and older) | 21.08.2018 |
| Ethyl esters of Iodidzed fatty acids of Poppy Seed Oil solution for injection (Lipodol Ultra Fluid 10ml) (Additional Indication) | Each ampoule (10ml) contains: Ethyl esters of Iodidzed fatty acids of Poppy Seed Oil Iodine content 48% i.e. 480mg iodine per ml | Conventional Trans-Arterial Chemo-Embolization (cTACE) of Hepatocellular Carcinoma (HCC) in adults. | 06.09.2018 |
| Methylcobalamin nasal spray 250mcg/spray (New Dosage form) | Each 0.1ml contains: Methylcobalamin 500mcg Benzalkonium chloride (As preservative) 0.02% w/v | Treatment of Vitamin B12 deficiency in patients without having neurological involvement. | 28.09.2018 |
| Apomorphine Hydrochloride injection 10mg/ml (2ml and 5ml Ampoule) (subcutaneous use only) (Add. Dosage form and add. indication) | Each ml contains: Apomorphine hydrochloride 10mg | Treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson’s disease which persist despite individually titrated treatment with levodopa (with a peripheral decarboxylasee inhibitor) and/or other dopamine agonists. With the condition: to be sold by retail on the prescription of Neurologist only | 28.09.2018 |
| Carfilzomib for Injection 30mg/vial (Lyophilized injection) (Additional Strength) | Each vial contains: Carfilzomib 30mg | Carfilzomib for injection is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. Carfilzomib for injection is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. With the condition: to be sold by retail on the prescription of Oncologist only. | 28.09.2018 |
| Ceftazidime 2gm/Avibactam 0.5 gm powder for concentrate for solution for infusion | Ceftazidime 2gm/Avibactam 0.5 gm powder for concentrate for solution for infusion | Complicated Intra-abdominal infections (cIAI) Complicated Urinary tract infections (cUTI), including pyelonephritis Hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP) with susceptible gram negative microorganisms | 01.10.2018 |
| Each film coated tablet contains: Dapagliflozin…………5mg Metformin HCL ……. 1000mg (Immediate Release) | Each film coated tablet contains: Dapagliflozin…………5mg Metformin HCL ……. 1000mg (Immediate Release) | It is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Dapagliflozin and Metformin is appropriate. | 03.10.2018 |
| Each film coated tablet contains: 1. Carvedilol 6.25mg + Ivabradine hydrochloride 5.390mg eq. to Ivabradine 5mg 2. Carvedilol 6.25mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg 3. Carvedilol 12.5mg + Ivabradine hydrochloride 5.390mg eq. to Ivabradine 5mg 4. Carvedilol 12.5mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg 5. Carvedilol 25mg + Ivabradine hydrochloride Ivabradine 5.390mg eq. to 5mg 6. Carvedilol 25mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg. | Each film coated tablet contains: 1. Carvedilol 6.25mg + Ivabradine hydrochloride 5.390mg eq. to Ivabradine 5mg 2. Carvedilol 6.25mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg 3. Carvedilol 12.5mg + Ivabradine hydrochloride 5.390mg eq. to Ivabradine 5mg 4. Carvedilol 12.5mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg 5. Carvedilol 25mg + Ivabradine hydrochloride Ivabradine 5.390mg eq. to 5mg 6. Carvedilol 25mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg. | It is indicated for as substituted therapy in adult patients with normal sinus rhythm already controlled by Ivabradine and carvedilol taken concomitantly at the same doses level for: i. The symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients ii. The treatment of chronic heart failure (II-IV NYHA-Class) with systolic dysfunction. | 03.10.2018 |
| Sodium Alginate IP 250mg + Sodium Bicarbonate IP 133.5mg + Calcium Carbonate IP 80mg per 5ml oral liquid. | Sodium Alginate IP 250mg + Sodium Bicarbonate IP 133.5mg + Calcium Carbonate IP 80mg per 5ml oral liquid. | Indicated for the treatment of heartburn and indigestion. | 04.10.2018 |
| Each film coated tablet contains: Memantine Hydrochloride USP…. 10mg Donepezil Hydrochloride IP…….. 10mg (Additional Strength) | Each film coated tablet contains: Memantine Hydrochloride USP…. 10mg Donepezil Hydrochloride IP…….. 10mg (Additional Strength) | For the treatment of moderate to severe Alzheimer’s disease. | 16.10.2018 |
| Each film coated tablet contains: Piperaquine Tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP)….160mg Dihydroartemisinin (DHA) .... 20mg (Additional Strength) | Each film coated tablet contains: Piperaquine Tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP)...160mg Dihydroartemisinin (DHA) .... 20mg | For the treatment of uncomplicated Plasmodium Falciparum Malaria in paediatric and adolescent patients. | 16.10.2018 |
| Each uncoated tablet contains: Calcium Citrate US ...............1200mg eq. to elemental Calcium.........252mg Calcitriol IP.............................0.25mcg (Additional indication) | Each uncoated tablet contains: Calcium Citrate US ...............1200mg eq. to elemental Calcium.........252mg Calcitriol IP.............................0.25mcg (Additional indication) | It is indicated for:- 1. Treatment of Hypocalcaemia / Calcium & Phosphate abnormalities in patients with Uremic Osteodystrophy, Hypoparathyroidism & in hypophosphatemic rickets / osteomalacia. 2. Pre-dialysis Patients- management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (CCr 15 to 55 mL/min) not yet on dialysis. 3. Dialysis Patients- management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. 4. Prevention of corticosteroidinduced osteoporosis in patients with renal impairment commencing oral steroid therapy in a dose and regimen expected to result in a significant bone loss. 5. Established osteoporosis / Post Menopausal Osteoporosisdiagnosed by objective measuring techniques, such as densitometry, or by radiographic evidence of a traumatic fracture in patients with renal impairment. | 16.10.2018 |
| Nilotinib hard Capsules 150mg & 200mg (Additional indication) | Each Capsule contains: Nilotinib 150mg & 200mg | 1. Treatment of Paediatric patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukaemia (CML) in the chronic phase. 2. Treatment of Paediatric patients with chronic phase Philadelphia Chromosome Positive (CML) with resistance or intolerance to prior therapy including imatinib. With the condition: to be sold by retail on the prescription of Oncologist only. | 18.10.2018 |
| Dasatinib film coated tablet 20mg, 50mg, 70mg and 100mg (Additional indication) | Each film coated tablet contains: Dasatinib 20mg, 50mg, 70mg and 100mg | Treatment of Paediatric patients with Philadelphia Chromosome Positive Chronic myeloid leukemia (Ph+ CML) in chronic phase With the condition: to be sold by retail on the prescription of Oncologist only. | 18.10.2018 |
| Nifedipine Extended Release Tablet 60mg (Add. strength and indication) | Each Extended release film coated tablet contains: Nifedipine 60mg | Vasospastic Angina, Chronic stable Angina (Classical effort-Associated Angina), Hypertension. With the condition: to be sold by retail on the prescription of Cardiologist only. | 18.10.2018 |
| Evogliptin Tartrate Bulk and Tablets 5 mg | Evogliptin Tartrate Bulk and Tablets 5 mg | For treatment of type-2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control, when used as a monotherapy or in combination with Metformin | 22.10.2018 |
| Lorcaserin Hydrochloride Bulk and 10 mg tablets | Lorcaserin Hydrochloride Bulk and 10 mg tablets | An adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at one weight related comorbid condition (e.g. Hypertension, dyslipidaemia, type 2 diabetes) | 22.10.2018 |
| Levetiracetam injection 500mg/100ml, 1000 mg/100ml, and 1500mg/100ml. (Infussion bottle) (Additional dosage form) | Each 100 ml Infusion bottle contains: Levetiracetam in 0.82% sodium chloride (500mg/100ml) Levetiracetam in 0.75% sodium chloride (1000mg/100ml) Levetiracetam in 0.54% sodium chloride (1500mg/100ml) | As adjunctive therapy in adult (16 years and older) with the following types of seizures when oral administration is temporarily not feasible. Partial onset seizures, Myoclonic seizures in patients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy With the condition: to be sold by retail on the prescription of Neurologist only. | 27.10.2018 |
| Each film coated tablet contains: Ethinylestradiol IP.................30mcg Dienogest IP………………..2mg | Each film coated tablet contains: Ethinylestradiol IP.................30mcg Dienogest IP………………..2mg | Indicated for use as an oral contraceptive and in the treatment of mild to moderate acne in women who seek oral contraception | 30.10.2018 |
| Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP…4.00 % w/v Absolute AlcoholIP…… 10.00%v/v Topical Solution (Additional Indication) | Composition: Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP…4.00 % w/v Absolute AlcoholIP…… 10.00%v/v Topical Solution (Additional Indication) | For the treatment of acute lower back pain, osteoarthritis of shoulder, elbow, wrist, spine, hip, knee and ankle. | 06.11.2018 |
| Nepafenac Ophthalmic Suspension 0.3%w/v (Additional Indication) | Each ml contains: Nepafenac 3.0mg | For the treatment of post-operative pain and inflammation associated with cataract surgery. With the condition: to be sold by retail on the prescription of Ophthalmologist only. | 09.11.2018 |
| Ibuprofen soft gelatine capsules 400mg. (New Dosage form) | Each soft gelatin capsule contains Ibuprofen 400mg | For chronic arthritic disorder and painful musculoskeletal conditions. | 20.11.2018 |
| Fimasartan potassium trihydrate bulk drug and Fimasartan film coated tablets 30mg/60mg/120mg | Fimasartan potassium trihydrate bulk drug and Fimasartan film coated tablets 30mg/60mg/120mg | For the treatment of mild hypertension | 22.11.2018 |
| Clobazam Oral suspension 2.5mg/ml (New Dosage form) | Each ml contains Clobazam 2.5mg | 1. Acute and chronic anxiety states. 2. As an adjunctive therapy in patients with refractory epilepsy With the condition: To be sold by retail on the prescription of Neurologist/ Psychiatrist only. | 30.11.2018 |
| Everolimus tablets 2.5 mg (Additional Indication) | Each tablets contains: Everolimus 2.5 mg | Treatment of patients with Progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease, Treatment of patients with Advanced Renal Cell Carcinoma (RCC). With the condition: To be sold by retail on the prescription of Oncologist only. | 05.12.2018 |
| Clonazepam Mouth Dissolving tablets 0.25/0.5/1.0/2.0mg (New Dosage Form) | Each uncoated mouth dissolving tablet contains: Clonazepam 0.25/0.5/1.0/2.0 mg | Treatment of seizure disorders (Petit mal and its variant, akinetic and myoclonic seizures), Panic disorder & add-on therapy in acute mania. With the condition: To be sold by retail on the prescription of Neurologists or Psychiatrist only. | 10.12.2018 |
| Divalproex Sodium Oral Solution 250mg/5ml (Additional Strength) | Each 5 ml Contains: Divalproex 250mg | Monotherapy and adjunctive therapy in the treatment of patients with ‘complex partial seizures that occur either in isolation or in association with types of seizures for adult patients only. | 21.12.2018 |
| Ivermectin Cream 1.0% w/w (New Dosage form) | Each Gram Contains: Ivermectin 1.0% w/w | Treatment of inflammatory lesions of rosacea. With the condition: To be sold by retail on the prescription of Dermatologist only. | 21.12.2018 |
| Sacubitril/Valsartan (as sodium salt complex) and FDC of Sacubitril + Valartan 50 (24+26)/100 (49+51)/200 (97+103) mg film coated tablets | Sacubitril/Valsartan (as sodium salt complex) and FDC of Sacubitril + Valartan 50 (24+26)/100 (49+51)/200 (97+103) mg film coated tablets | To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction | 24.12.2018 |
| Donepezil Hydrochloride Orally Disintegrating Strips (Additional dosage form) | Each Orally Disintegrating Strips Contains: Donepezil Hydrochloride 5/10 mg | For the treatment of mild to moderate severe Alzheimer’s Dementia. With the condition:-To be sold by retail on the prescription of Neurologists only. | 11.01.2019 |
| Each Film coated tablets contains: Atorvastatin Calcium IP eq. to Atorvastatin + Vitamin D3 (Cholecalciferol) IP (10mg + 1000 IU) & (20mg + 1000 IU) | Each Film coated tablets contains: Atorvastatin Calcium IP eq. to Atorvastatin + Vitamin D3 (Cholecalciferol) IP (10mg + 1000 IU) & (20mg + 1000 IU) | For the treatment of patients with hyperlipidemia. | 22.01.2019 |
| Tapentadol Hydrochloride capsule 50mg (New dosage form) | Each capsule contains: Tapentadol Hydrochloride 50mg | For relief of moderate to severe acute pain in adults 18 years of age or older. | 30.01.2019 |
| Fenspiride hydrochloride film coated extended release tablet 80 mg and Fenspiride hydrochloride bulk | Fenspiride hydrochloride film coated extended release tablet 80 mg and Fenspiride hydrochloride bulk | 1. Acute Rhinosinusitis 2. Moderate persistent asthma as an add-on therapy | 04.02.2019 |
| Bilastine tablets 20 mg and Bilastine Bulk | Bilastine tablets 20 mg and Bilastine Bulk | For symptomatic treatment of allergic rhino-conjuctivitis (seasonal and perennial) and utricaria in adults | 06.02.2019 |
| Iguratimod film coated tablets 25mg and Iguratimod Bulk | Iguratimod film coated tablets 25mg and Iguratimod Bulk | For the treatment of active rheumatoid arthritis symptoms | 18.02.2019 |
| Midodrine Hydrochloride tablet 2.5mg, 5mg and 10mg (Additional strength) | Each tablet contains: Midodrine Hydrochloride 2.5mg, 5mg and 10mg | It is indicated in the treatment of symptomatic orthostatic hypotension. With the condition:-To be sold by retail on the prescription of Cardiologists only. | 20.02.2019 |
| Ribociclib film coated tablet 200mg (Additional indication) | Ribociclib succinate 254.40mg eq. To Ribociclib 200mg | Ribocicib in combination with an aromatase inhibitor for the treatment of pre/peri-menopausal or post-menopausal women, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2(HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. With the condition: To be sold by retail on the prescription of an Oncologist only. | 13.03.2019 |
| Each 1ml contains: Hydrocortisone Aceponate .......1.11mg Gentamicin Sulphate IP.............1505 IU Miconazole Nitrate IP................15.1mg Oily Suspension (For external use only) For Veterinary Use Only | Each 1ml contains: Hydrocortisone Aceponate .......1.11mg Gentamicin Sulphate IP.............1505 IU Miconazole Nitrate IP................15.1mg Oily Suspension (For external use only) For Veterinary Use Only | For the treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to Gentamicin and fungi susceptible to Miconazole in particular Malassezia pachydermatis | 19.03.2019 |
| Each capsule contains: Glycopyrrolate USP equivalent to Glycopyrronium..............................12.5mcg Formoterol Fumarate Dihydrate ….12mcg For Inhalation | Each capsule contains: Glycopyrrolate USP equivalent to Glycopyrronium..............................12.5mcg Formoterol Fumarate Dihydrate ….12mcg For Inhalation | It is indicated for:- As a maintenance bronchodilator treatment to relieve symptoms in adults patients with chronic obstructive pulmonary disease (COPD) | 19.03.2019 |
| Fingolimod Capsules 0.5mg and Fingolimod hydrochloridebulk | Fingolimod Capsules 0.5mg and Fingolimod hydrochloridebulk | For the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. | 25.03.2019 |
| Azacitidine for injection 150mg/vial (Additional strength) | Each vial contains: Azacitidine. 150mg Lyophilized powder for injection (for subcutaneous or Intravenous use) | For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome. With the condition: to be sold by retail on the prescription of Oncologist only. | 25.03.2019 |
| Lenvatinib capsule 4mg/10mg (Additional Indication) | Each capsule contains: Lenvatinib mesylate 4.90mg eq. To Lenvatinib 4mg., Lenvatinib mesylate 12.25 mg eq. To Lenvatinib 10mg. | For the first line treatment of patients with unresectable hepatocellular carcinoma. With the condition: to be sold by retail on the prescription of an Oncologist only. | 26.03.2019 |
| Primidone tablet 50mg (Additional Strength) | Each uncoated tablet contains: Primidone USP 50mg | It is indicated for the management of grand mal and psychomotor (temporal lobe) epilepsy. It is also of value in the management of focal or jacksonian seizures, myoclonic jerks and akinetic attacks. Management of essential tremor. With the condition: To be sold by retail on the prescription of an Neurologist only. | 15.04.2019 |
| Paroxetine Hydrochloride IP Eq. to Paroxetine (as extended release) + Clonazepam (25mg+0.5mg & 12.5mg+0.5mg) (Additional Dosage form) | Each film coated tablet contains: Paroxetine Hydrochloride IP Eq. to Paroxetine (as extended release) + Clonazepam (25mg+0.5mg & 12.5mg+0.5mg) (Additional Dosage form) | It is indicated for the treatment of patients with Co-morbid depression and anxiety. | 16.04.2019 |
| Each Dispersible tablet contains: Abacavir Sulphate IP eq .to Abacavir ……………60mg Lamivudine IP …………….30mg (Additional Dosage form) | Each Dispersible tablet contains: Abacavir Sulphate IP eq .to Abacavir ……………60mg Lamivudine IP …………….30mg (Additional Dosage form) | In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in children | 23.04.2019 |
| Each film coated tablet contains: Dolutegravir Sodium Eq. to Dolutegravir…………………50mg Emtricitabine IP……………. 200mg Tenofovir Alafenamide Fumarate eq. to Tenofovir Alafenamide……….25mg | Each film coated tablet contains: Dolutegravir Sodium Eq. to Dolutegravir…………………50mg Emtricitabine IP……………. 200mg Tenofovir Alafenamide Fumarate eq. to Tenofovir Alafenamide……….25mg | Indicated for the management of Human Immunodeficiency Virus (HIV) infections in adults weighing more than 40kg. | 23.04.2019 |
| Remogliflozin etabonate bulk and Remogliflozin etabonate film coated tablets 100 mg | Remogliflozin etabonate bulk and Remogliflozin etabonate film coated tablets 100 mg | Indicated in adults aged 18 years and older with type2 diabetes mellitus to improve glycemic control as:- Monotherapy when diet and exercise alone do not provide adequate glyceamic control. Add on therapy with metformin, together with diet and exercise, when these do not provide adequate glyceamic control. | 26.04.2019 |
| Amisulpride orodispersible tablet 50/100/200/300/400mg (New dosage form) | Each uncoated Oro dispersible tablet contains: Amisulpride 50/100/200/300/400mg | For acute and chronic schizophrenic disorders, in which positive and negative symptoms are prominent, including patients characterised by predominant negative symptoms. With the condition: To be sold by retail on the prescription of a Psychiatrist only. | 03.05.2019 |
| Progesterone solution for Injection 25mg/1.119ml vial (Add. Dosage form and add. route of administration) | Each vial (1.119 ml) contains: Progesterone 25mg (22.35mg/ml) (For subcutaneous or intramuscular use only) | It is indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations. With the condition: To be sold by retail on the prescription of Gynaecologists only. | 17.05.2019 |
| Concentrate of Proteolytic enzyme enriched in Bromelain topical gel | Concentrate of Proteolytic enzyme enriched in Bromelain topical gel | Indicated for removal of eschar in adults with deep partial-and full-thickness thermal burns | 17.05.2019 |
| Each uncoated tablet contains : Perindopril Erbumine BP ……4mg Indapamide IP .......1.25mg Amlodipine Besilate IP …...5mg | Each uncoated tablet contains : Perindopril Erbumine BP ……4mg Indapamide IP .......1.25mg Amlodipine Besilate IP …...5mg | For treatment of moderate to severe hypertension | 20.05.2019 |
| Eye Drops contains Alcaftadine ….. 0.25%w/v Ketorolac Tromethamine ….0.4%w/v | Eye Drops contains Alcaftadine ….. 0.25%w/v Ketorolac Tromethamine ….0.4%w/v | For the treatment of ocular itching and other symptomatic associated allergic conjunctivitis. | 21.05.2019 |
| Azilsartan medoxomil tablet 20/40/80mg (Additional lower Strength) | Each uncoated tablet contains: Azilsartan Kamedoxomil equivalent to Azilsartan medoxomil 20/40/80mg | Indicated for the treatment of hypertension in adult patients either alone or in combination with other antihypertensive agents. With the condition: To be sold by retail on the prescription of a Cardiologist only. | 27.05.2019 |
| Everolimus Tablet 0.25mg/0.5mg/0.75mg/1.0mg (Additional indication) | Each film coated tablet contains: Everolimus 0.25mg/0.5mg/0.75mg/1.0mg | Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In kidney and heart transplantation, Certican should be used in combination with ciclosporin for microemulsion and Corticosteroids. With the condition: To be sold by retail on the prescription of Cardiologist only. | 27.05.2019 |
| Each tablet contains Sulfamethaxazole IP ….800mg Trimethoprim IP ….160mg Isoniazid IP ….300mg Pyridoxine Hydrochloride IP…..25mg | Each tablet contains Sulfamethaxazole IP ….800mg Trimethoprim IP ….160mg Isoniazid IP ….300mg Pyridoxine Hydrochloride IP…..25mg | For the prevention of tuberculosis, bacterial pneumonia, malaria and isosporiasis and to reduce mortality and hospitalizations in HIV infected patients with advanced disease and without active TB. | 28.05.2019 |
| Diclofenac sodium 2% Topical Solution (New route of administration) | Each 1 gram of solution contains: Diclofenac sodium 20mg | For the treatment of pain of osteoarthritis of the knees. | 03.06.2019 |
| Each Film Coated Tablet Contains : 1. Metoprolol Succinate IP …..47.5mg Eq. to Metoprolol Tartarate ….50mg (As Extended Release) Cilnidipine …...10mg Telmisartan IP ……40mg 2. Metoprolol Succinate IP …..23.75mg Eq. to Metoprolol Tartarate ….25mg (As Extended Release) Cilnidipine …...10mg Telmisartan IP ……40mg | Each Film Coated Tablet Contains : 1. Metoprolol Succinate IP …..47.5mg Eq. to Metoprolol Tartarate ….50mg (As Extended Release) Cilnidipine …...10mg Telmisartan IP ……40mg 2. Metoprolol Succinate IP …..23.75mg Eq. to Metoprolol Tartarate ….25mg (As Extended Release) Cilnidipine …...10mg Telmisartan IP ……40mg | It is indicated for treatment of patients with uncontrolled essential hypertension and stable ischemic heart disease | 04.06.2019 |
| Menotrophin injection 600 IU/ml, 1 ml & 2 ml multi dose vial (Highly purified) | Menotrophin injection 600 IU/ml, 1 ml & 2 ml multi dose vial (Highly purified) | Menotropin is indicated for the treatment of female and male infertility in the following conditions: Anovulation , including Polycystic Ovarian Disease (PCOD), in women who have been unresponsive to the treatment with Clomiphene citrate. Women undegoing controlled ovarian hyperstimulation to induce the development of multiple follicles for Assisted Reproductive Technologies (ART). Hypogonadotropic hypogonadism in men | 17.06.2019 |
| Artesunate for injection 120mg with phosphate buffer 0.3M (Additional strength) | Each combi pack contains: a) Artesunate for injection 120mg Each vial contains: Artesunate IP 120mg b) Phosphate Buffer 0.3M (12ml) Each ampoule contains: Anhydrous Disodium Hydrogen Phosphate BP 4.0% w/v Potassium dihydrogen phosphate BP 0.2% w/v | Indicated for the treatment of severe falciparum malaria in areas where there is evidence of quinine resistance | 26.06.2019 |
| Injection For (Veterinary Use) Each ml Contains Buparvaquone …..50mg Furosemide IP .…55mg Sorbitan mono oleate BP …..100mg (As preservative) Oil base ……q.s. | Injection For (Veterinary Use) Each ml Contains Buparvaquone …..50mg Furosemide IP .…55mg Sorbitan mono oleate BP …..100mg (As preservative) Oil base ……q.s. | For the treatment of theileriosis (east coast fever) particularly for advanced cases with pulmonary oedema. | 27.06.2019 |
| Dry Powder For Inhalation Each Capsule Contains: Glycopyrronium (As Glycopyrrolate USP) …..25mcg Formoterol Fumarate Dihydrate .…12mcg | Dry Powder For Inhalation Each Capsule Contains: Glycopyrronium (As Glycopyrrolate USP) …..25mcg Formoterol Fumarate Dihydrate .…12mcg | Indicated as a maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease(COPD) | 28.06.2019 |
| Rifapentine 150mg film coated tablet | Rifapentine 150mg film coated tablet | “For the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph). Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. Rifapentine Tablets 150mg must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection” | 08.07.2019 |
| Each Film Coated Tablet contains: Azilsartan Kamedoxomil eq. To Azilsartan Medoxomil.........................40mg Chlorthalidone IP …............6.25mg (In additional strength) | Each Film Coated Tablet contains: Azilsartan Kamedoxomil eq. To Azilsartan Medoxomil.........................40mg Chlorthalidone IP …............6.25mg (In additional strength) | For the treatment of mild to moderate hypertension. | 09.07.2019 |
| Each Film Coated Tablet contains: Tadalafil IP + Dapoxetine Hydrochloride IP Eq. To Dapoxetine (20mg + 60mg, 20mg + 30mg & 10mg + 30mg) | Each Film Coated Tablet contains: Tadalafil IP + Dapoxetine Hydrochloride IP Eq. To Dapoxetine (20mg + 60mg, 20mg + 30mg & 10mg + 30mg) | For the treatment of co-existing Erectile Dysfunction and Premature Ejaculation in men 18 to 64 years of age. | 23.07.2019 |
| Tranexamic acid injection IP 100mg/ml (Additional Indication) | Each ml contains: Tranexamic acid IP 100 mg/ml | Indicated for short term use in prophylaxis and treatment in patients at high risk of per-and post-operative hemorrhage following: a) Prostatectomy. b) Conisation of the cervix. c) Surgical procedures and dental extractions in hemophiliacs | 26.07.2019 |
| Rivaroxaban tablets 2.5mg (Add. Indication) | Rivaroxaban tablets 2.5mg | Rivaroxaban 2.5mg tablet, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. With the condition:-To be sold by retail on the prescription of Cardiologists only. | 30.07.2019 |
| Olaparib 100 mg and 150 mg tablet (Additional Indication) | Olaparib 100 mg and 150 mg tablet | for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy With the condition:-To be sold by retail on the prescription of Oncologist only. | 30.07.2019 |
| Tapentadol Hydrochloride 25.000 milligram (mg) Capsules (Additional Lower Strength) | Tapentadol Hydrochloride 25.000 milligram (mg) Capsules | For relief of moderate to severe acute pain in adults 18 years of age or older | 30.07.2019 |
| Each orodispersible Tablets contains: Streptococcus faecalis T-110 JPC.....30 million Clostridium butyricum TO-A.............2 million Bacillus mesentericus TO-A JPC........1 million Lactic acid bacillus .......50 million (lactobacillus sporogenes) (In additional dosage form) | Each orodispersible Tablets contains: Streptococcus faecalis T-110 JPC.....30 million Clostridium butyricum TO-A.............2 million Bacillus mesentericus TO-A JPC........1 million Lactic acid bacillus .......50 million (lactobacillus sporogenes) (In additional dosage form) | For restoration of intestinal microflora | 30.07.2019 |
| Leuprolide 22.50mg depot Injection Powder for prolonged-release suspension for injection (Depot injection for I.M. use only) (Add. strength) | Each vial contains : Leuprolide acetate 22.5mg | Treatment of advanced Prostatic cancer. With the condition:-To be sold by retail on the prescription of Oncologist only. | 07.08.2019 |
| Clobazam Tablets IP 2.5mg & 7.5mg (Add. lower strength). | Each tablet contains: Clobazam 2.5mg & 7.5mg | As an adjunctive therapy in patients with refractory epilepsy. With the condition:-To be sold by retail on the prescription of Neurologist/ Psychiatrist only. | 07.08.2019 |
| Sildenafil for oral suspension 10mg/ml (Add. Indication) | Each ml of reconstituted suspension contains: Sildenafil citrate IP equivalent to Sildenafil 10mg | For the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delayed clinical worsening. With the condition:-To be sold by retail on the prescription of Cardiologist only. | 09.08-2019 |
| FDC of Bictegravir, Emtricitabine and Tenofovir alafenamide 50mg/200mg/25mg tablets | FDC of Bictegravir, Emtricitabine and Tenofovir alafenamide 50mg/200mg/25mg tablets | For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen for at least 3 month with no history of treatment failure and no known substitutions associated with resistance to Bictegravir, Emtricitabine and Tenofovir alafenamide | 09.08-2019 |
| Levomilnacipran ER capsules 20mg/40mg/80mg/120mg | Levomilnacipran ER capsules 20mg/40mg/80mg/120mg | For treatment of major depressive disorder | 13.08.2019 |
| Each Film Coated Tablet contains: Remogliflozin Etabonate + Metformin Hydrochloride IP (100mg + 500mg & 100mg + 1000mg) | Each Film Coated Tablet contains: Remogliflozin Etabonate + Metformin Hydrochloride IP (100mg + 500mg & 100mg + 1000mg) | Indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control: 1. In patients insufficiently controlled on their maximally tolerated dose of metformin alone 2. In patients already being treated with the combination of remogliflozin and metformin as separate tablets. | 14.08.2019 |
| Each Film Coated Tablet contains: Cephalexin IP (Extended Release) + Potassium Clavulanate Diluted IP eq. to Clavulanic acid (375mg + 125mg & 750mg + 125mg) | Each Film Coated Tablet contains: Cephalexin IP (Extended Release) + Potassium Clavulanate Diluted IP eq. to Clavulanic acid (375mg + 125mg & 750mg + 125mg) | For the treatment of upper respiratory tract infections (URTI) and uncomplicated skin and soft tissue infections. | 14.08.2019 |
| Pantoprazole dual-release gastro- resistant tablet 80mg (New Dosage form) | Each dual-release gastro- resistant tablet contains: Pantoprazole sodium equivalent to Pantoprazole 80mg | For the treatment of moderate to severe refractory Gastro-oesophageal reflux disease (GERD) for 4 weeks only. | 02.09.2019 |
| Pirfenidone tablet 400 mg (Add. Strength) | Each film coated tablet contains: Pirfenidone 400mg | For the treatment of idiopathic pulmonary fibrosis. With the condition:-To be sold by retail on the prescription of Pulmonologist only. | 02.09.2019 |
| Olopatadine HCI ophthalmic solution 0.7% w/v (Add. strength) | Each ml contains: Olopatadine HCI 0.7% w/v Benzalkonium chloride 0.015%w/v | For the treatment of ocular itching associated with allergic conjunctivitis. With the condition:-To be sold by retail on the prescription of Ophthalmologist only. | 06.09.2019 |
| Algard HWS-256 (didecyl dimethyl ammonium chloride 10.14% w/w + n-Alkyl dimethyl benzyl ammonium chloride 6.76% w/w | Algard HWS-256 (didecyl dimethyl ammonium chloride 10.14% w/w + n-Alkyl dimethyl benzyl ammonium chloride 6.76% w/w | Surface disinfectant for persistent disinfection of all inanimate surfaces | 09.09.2019 |
| Safinamide methane sulphonate bulk drug and Safinamide tablets 50, 100mg | Safinamide methane sulphonate bulk drug and Safinamide tablets 50, 100mg | For the treatment of adult patients with idiopathic Parkinson's disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other Parkinson's disease (PD) medicinal products in mid to late stage fluctuating patients. | 09.09.2019 |
| Bosutinib bulk and Bosutinib tablets 100mg, | Bosutinib bulk and Bosutinib tablets 100mg, | For the treatmnet of adult patients with: 1) Newly diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML) 2) Chronic phase, accelerated phase (AP), or blast phase (BP) Ph+CML with resistance or intolerance to prior therapy. | 09.09.2019 |
| Algard - R-82 (octyldecyl dimethyl ammonium chloride 6.510 w/w + Dioctyl dimethyl ammonium chloride 2.604% w/w + Didecyl dimethyl ammonium chloride 3.906% w/w + Alkyl dimethyl benzyl ammonium chloride 8.680% w/w | Algard - R-82 (octyldecyl dimethyl ammonium chloride 6.510 w/w + Dioctyl dimethyl ammonium chloride 2.604% w/w + Didecyl dimethyl ammonium chloride 3.906% w/w + Alkyl dimethyl benzyl ammonium chloride 8.680% w/w | Surface disinfectant for persistent disinfection of all inanimate surfaces (Against pathogens as annexed) | 09.09.2019 |
| Ibrutinib hard gelatin capsule 140mg (Add. indication) | Each capsule contains: Ibrutinib 140mg | For the treatment of patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). With the condition:-To be sold by retail on the prescription of Oncologist only. | 11.09.2019 |
| Ibrutinib hard gelatin capsule 140mg (Add. indication) | Each capsule contains: Ibrutinib 140mg | For the treatment of patients with Waldenstrom's macroglobulinemia | 11.09.2019 |
| Each Film Coated Tablets contains: Saxagliptin Hydrochloride 5.95mg Eq. To Saxagliptin........................5mg Dapagliflozin Propanediol monohydrate 12.3mg Eq. To Dapagliflozin.........10mg | Each Film Coated Tablets contains: Saxagliptin Hydrochloride 5.95mg Eq. To Saxagliptin........................5mg Dapagliflozin Propanediol monohydrate 12.3mg Eq. To Dapagliflozin.........10mg | Indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM). Not indicated for use in patients with type1 diabetes. Not to be used for the treatment of diabetic ketoacidosis. | 24.09.2019 |
| Droxidopa bulk drug and Droxidopa capsules 200mg/300mg | Droxidopa bulk drug and Droxidopa capsules 200mg/300mg | For the treatment of orthostatic dizziness, light headedness or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's Disease multiple system atrophy (MSA) and pure autonomic failure), dopamine beta-hydroxylase deficiency and non-diabetic autonomic neuropathy. | 24.09.2019 |
| Desonide Ointment 0.05% (Add. Dosage form) | Desonide topical ointment 0.05% | for sub-acute to chronic steroid responsive dermatoses. | 26.09.2019 |
| Atorvastatin calcium tablet 30/60 mg (Add. Strength) | Each film coated tablet contains : Atorvastatin calcium equivalent to Atorvastatin 30/60 mg | 1. As an Adjunct to Diet to Reduce Elevated Total Cholesterol and Triglyceride Levels in Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia (Type IIa and IIIb). 2. In adult patients with type II diabetes and without clinically evident coronary heart disease to reduce the risk of myocardial infarction and stroke. 3. To reduce the risk of stroke in adult patients without clinically evident coronary heart disease but multiple risk factors for coronary heart disease With the condition:-To be sold by retail on the prescription of Cardiologist only. | 27.09.2019 |
| Desloratadine tablets 10mg (Additional strength) | Each film coated tablet contains : Desloratadine 10mg | For the treatment of Chronic Idiopathic Urticaria in patients who have not responded to the standard 5mg dose of Desloratadine. | 27.09.2019 |
| Diclofenac sodium Rectal Solution 25 % w/v with applicator (Add. dosage form) | Each ml contains: Diclofenac sodium 25%w/v Each Squirt (0.2ml) delivers: Diclofenac Sodium 50 mg | Mild to moderate pain in adults. | 27.09.2019 |
| Perampanel tablets 2mg /4mg/6mg/8mg/10mg/12mg (Additional indication) | Each film coated tablet contains : Perampanel 2mg /4mg/6mg/8mg/10mg/12mg | For the adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older. With the condition:-To be sold by retail on the prescription of Neurologist only. | 27.09.2019 |
| Each spray Delivers: Mometasone Furoate BP............50mcg Azelastine Hydrochloride BP......140mcg Bezalkonium Chloride BP...........0.02%w/w (preservative) | Each spray Delivers: Mometasone Furoate BP............50mcg Azelastine Hydrochloride BP......140mcg Bezalkonium Chloride BP...........0.02%w/w (preservative) | For the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older. | 30.09.2019 |
| Ribociclib Film Coated Tablet 200mg (Additional Indication) | Ribociclib Succinate 254.40 mg equivalent to Ribociclib 200 mg | Indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulestrant as initial endocrine based therapy or in women who have received prior endocrine therapy. Warning: To be sold by retail on the prescription of oncologist only. | 04.10.2019 |
| Cinidipine Tablet 20 mg (Additional Strength) | Each Film Coated Tablets contain Clinidipine 20mg | For the treatment of mild to moderate hypertension | 11.10.2019 |
| Each Film coated tablet Contains: Ebastine..............10mg Montelukast........10mg | Each Film coated tablet Contains: Ebastine..............10mg Montelukast........10mg | For the treatment of allergic rhinitis in adults only | 14.10.2019 |
| Acalabrutinib 100mg capsules | Acalabrutinib 100mg capsules | For the treatment of patients with mantle cell lymphoma (MCL) who have received atleast one prior therapy | 18.10.2019 |
| Each uncoated bilayered tablets contains: Pregabalin IP (As prolonged Release).....75mg Etoricoxib IP....................60mg | Each uncoated bilayered tablets contains: Pregabalin IP (As prolonged Release).....75mg Etoricoxib IP....................60mg | In the treatment of chronic low back pain associated with neuropathic component. | 07.11.2019 |
| Each film coated bilayered tablet contains: Evogliptin Tartrate 6.869mg Eq. To Evogliptin.....................5mg Metformin Hydrochloride IP (as sustained release form)..................1000mg | Each film coated bilayered tablet contains: Evogliptin Tartrate 6.869mg Eq. To Evogliptin.....................5mg Metformin Hydrochloride IP (as sustained release form)..................1000mg | As an adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus who are appropriate for co administration of evogliptin and Metformin. Patients with inadequate glycemic control on Metformin monotherapy alternative for combination therapy of evogliptin and metformin. | 13.11.2019 |
| Glycopyrronium Solution Inhalation Solution 25mcg (For nebulisation) (Add. Dosage form) | Each 2ml contains Glycopyrrolate equivalent to Glycopyrronium 25mcg in isotonic solution | For the long term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema | 14.11.2019 |
| Abemaciclib 50mg, 100mg, 150mg and 200mg film coated tablets | Abemaciclib 50mg, 100mg, 150mg and 200mg film coated tablets | (i) Abemaciclib is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. • In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone- releasing hormone (LHRH) agonist. (ii) As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting . | 18.11.2019 |
| Formoterol Fumarate dihydrate IP.......5µg Glycopyrronium USP .........................7.2µg per acutation Inhalation Aerosol Preparation (In additional strength) | Formoterol Fumarate dihydrate IP.......5µg Glycopyrronium USP .........................7.2µg per acutation Inhalation Aerosol Preparation (In additional strength) | Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). | 20.11.2019 |
| Ripasudil hydrochloride hydrate bulk drug and Ripasudil Eye drops 0.4% w/v | Ripasudil hydrochloride hydrate bulk drug and Ripasudil Eye drops 0.4% w/v | To treat glaucoma and ocular hypertension when other medicines for glaucoma have insufficient effect or cannot be used. | 20.11.2019 |
| Diperoxochloric acid concentrate and Diperoxochloric acid topical solution | Diperoxochloric acid concentrate and Diperoxochloric acid topical solution | Indicated for wound healing in diabetic neuropathic ulcers of skin and subcutaneous tissues reduction | 20.11.2019 |
| Cefpodoxim Proxetil Sustained Release Tablet 200/400mg (Add. Dosage form) | Each film coated sustained release Tablet contains: Cefpodoxime Proxetil, Equivalent to Cefpodoxime 200mg & 400mg | Acute bronchitis, exacerbations of chronic bronchitis, pneumonia, sinusitis, recurrent chronic tonsillitis, pharyngitis and acute otitis. | 03.12.2019 |
| Ivermectin Topical lotion 0.5% w/w | Each ml contains: Ivermectin 0.5% w/w | For the topical treatment of head lice infestation in patients 6months of age and older. | 03.12.2019 |
| Lenvatinib Capsules 4mg and 10mg (Additional Indication) | Each capsule contains Lenvatinib mesylate 4.90 mg equivalent to Lenvatinib 4mg and Lenvatinib mesylate 12.25mg equivalent to Lenvatinib 10 mg. | In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. Warning: To be sold by prescription of a “Oncologist” only. | 04.12.2019 |
| Bilastine Oral Solution 2.500 mg/ml (Add. Dosage form) | Each ml contains: Bilastine 2.5000 mg | Symptomatic treatment of allergic rhino- conjunctivitis (seasonal and perennial) and urticaria. Bilastine is indicated in children aged 6 to 11 years with a body weight of at least 20 kg. | 10.12.2019 |
| Endoxifen citrate bulk and Endoxifen tablets 8 mg | Endoxifen citrate bulk and Endoxifen tablets 8 mg | For the acute treatment of manic episodes with or without mixed features of Bipolar I disorder | 10.12.2019 |
| Azelnidipine bulk and Azelnidipine tablets 16 mg | Azelnidipine bulk and Azelnidipine tablets 16 mg | For the treatment of Stage II Hypertension | 10.12.2019 |
| Genopep bulk and Genopep 0.05% w/w cream | Genopep bulk and Genopep 0.05% w/w cream | Indicated for treatment of burn wound, antimicrobial therapy, scar prevention/reduction | 11.12.2019 |
| Pregabalin Extended Release Tablets 82.50 mg and 165mg | Each film coated Extended Release Tablet contains: Pregabalin 82.50 mg/165 mg | For treatment of peripheral neuropathic pain in adults. | 12.12.2019 |
| Each uncoated tablet contains: Repaglinide IP + Voglibose IP (0.5mg + 0.2mg, 0.5mg + 0.3mg, 1mg + 0.2mg & 1mg + 0.3mg) | Each uncoated tablet contains: Repaglinide IP + Voglibose IP (0.5mg + 0.2mg, 0.5mg + 0.3mg, 1mg + 0.2mg & 1mg + 0.3mg) | For the treatment of Type 2 Diabetes Mellitus as an adjunct to diet and exercise to improve glycemic control. | 13.12.2019 |
| Alalevonadifloxacin mesylate bulk and Levonadifloxcin tablets 500mg | Alalevonadifloxacin mesylate bulk and Levonadifloxcin tablets 500mg | Indicated in adults (≥ 18 years of age) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) including diabetic foot infections and concurrent bacteraemia caused by susceptible isolates of the following: Gram-positive organisms:- Staphylococcus aureus (methicillin-resistant, methicillin-susceptible, quinolone-resistant, quinolone-susceptible isolates), Streptococcus pyogenes, Enterococcus faecalis, Streptococcus dysgalactiae ssp. dysgalactiae, Streptococcus agalactiae. | 13.12.2019 |
| Clobetasol Propionate Topical Foam 0.5% w/w (Add.dosage form) | Each gram of cream Contains: Clobetasol Propionate 0.05% w/w Phenoxyethanol 1.0% w/w | Treatment of Inflammatory and pruritic manifestation of corticosteroid responsive dermatoses in patients 12 years of age or older. | 16.12.2019 |
| Clobetasol Propionate Cream, 0.025% w/w (Add.Strength) | Each gram of cream contains: Clobetasol Propionate 0.25mg | Indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. | 16.12.2019 |
| Midodrine hydrochloride bulk drug | Midodrine hydrochloride bulk drug | 26.12.2019 | |
| Lorlatinib film coated tablets 25mg and 100 mg | Lorlatinib film coated tablets 25mg and 100 mg | For the treatment of ALK fusion gene-positive unresectable advanced and/or recurrent non-small cell lung cancer with resistane or intolerance to ALK tyrosine kinase inhibitor(s) | 26.12.2019 |
| Levonadifloxacin L-arginine tetrahydrate bulk and Levonadifloxacin injection 800mg/100ml | Levonadifloxacin L-arginine tetrahydrate bulk and Levonadifloxacin injection 800mg/100ml | Indicated in adults (≥ 18 years of age) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) including diabetic foot infections and concurrent bacteraemia caused by susceptible isolates of the following: Gram-positive organisms:- Staphylococcus aureus (methicillin-resistant, methicillin-susceptible, quinolone-resistant, quinolone-susceptible isolates), Streptococcus pyogenes, Enterococcus faecalis, Streptococcus dysgalactiae ssp. dysgalactiae, Streptococcus agalactiae. | 30.12.2019 |
| Betahistine Dihydrochloride Orally Disintegrating Strips 16mg /24 mg (New Dosage form) | Each Orally Disintegrating Strips contains: Betahistine Dihydrochloride …….16mg/24 mg | Indicated in the treatment of Menier’s syndrome, Characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss | 02.01.2020 |
| Posaconazole Gatro-Resistant Tablet 100 mg (Modified Release dosage form) | Each-Gastro-Resistant Tablet Contains: Posaconazole………..............100mg | For Prophylaxis of invasive Aspregilus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia form chemotherapy. Posaconazole Gastro Resistant tablets are indicated in patients 13 years of age and older Warning: To be sold by retail on the prescription of Specialist only. | 03.01.2020 |
| Cidofovir dihydrate bulk drug and Cidofovir injection 75 mg/ ml (5 ml single use vial) | Cidofovir dihydrate bulk drug and Cidofovir injection 75 mg/ ml (5 ml single use vial) | Cidofovir is indicated for the treatment of CMV retinitis in adults with acquired immune deficiency syndrome (AIDS) and without renal dysfunction. It should be used only when other medicinal products are considered as unsuitable. | 03.01.2020 |
| Dacomitinib tablet 15mg, 30mg and 45mg | Dacomitinib tablet 15mg, 30mg and 45mg | For the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. | 03.01.2020 |
| Alpelisib film coated tablets (50mg, 150mg, 200 mg) | Alpelisib film coated tablets (50mg, 150mg, 200 mg) | Alpelisib is a kinase inhibitor indicated in combination with Fulvestrant for the treatment of postmenopausal women, and men, with Hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. | 03.01.2020 |
| Pirfenidone tablet 600 mg (Additional strength) | Each Film coated Tablet contains: Pirfenidone….600mg | For the Treatment of idiopathic pulmonary fibrosis Warning: To be sold by retail on the prescription of Pulmonologist only. | 01.08.2020 |
| Saroglitazar Tablet 2mg/4 mg (Additional indication) | Each uncoated tablet contains: Saroglitazar……… 2/4 mg | Type 2 Diabetes mellitus-as an add-on therapy to metformin | 13.01.2020 |
| Each uncoated bilayered tablet contains : Glimepiride IP + Voglibose IP + Metformin HCl IP (as ER) (1mg + 0.2mg + 500mg & 2mg + 0.2mg +500mg ) | Each uncoated bilayered tablet contains : Glimepiride IP + Voglibose IP + Metformin HCl IP (as ER) (1mg + 0.2mg + 500mg & 2mg + 0.2mg + 500mg ) | As 3rd line treatment of type 2 diabetes mellitus when diet, exercise and the single agents and second line therapy with two drugs do not result in adequate glycemic control. | 14.01.2020 |
| Enzalutamide Soft Capsule 40 mg (Additional indication) | Each soft capsules contains: Enzalutamide…40 mg | In the treatment of adult men with metastic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated Warning: To be sold by retail on the prescription of Oncologist only. | 23.01.2020 |
| Each Film coated tablet contains : Sildenafil + Dapoxetine (100mg + 60mg, 50mg + 60mg & 50mg + 30mg) | Each Film coated tablet contains : Sildenafil + Dapoxetine (100mg + 60mg, 50mg + 60mg & 50mg + 30mg) | For the treatment of co-existing erectile dysfunction and premature ejaculation in men 18 to 64 years of age. | 10.02.2020 |
| Each Uncoated Bilayered Tablet Contains: S(-) Amlodipine Besylate IP eq.to S(-) Amlodipine + Telmisartan IP (5mg + 40mg & 2.5mg + 40mg) | Each Uncoated Bilayered Tablet Contains: S(-) Amlodipine Besylate IP eq.to S(-) Amlodipine + Telmisartan IP (5mg + 40mg & 2.5mg + 40mg) | It is indicated for the treatment of essential hypertension. | 14.02.2020 |
| Isavuconazole sulfate 100mg capsules | Isavuconazole sulfate 100mg capsules | Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis | 14.02.2020 |
| Canagliflozin 100 mg and 300 mg Tablet (Additional Indication) | Each film coated tablet contains: Canagliflozin 100mg/300mg | To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. | 17.02.2020 |
| Norethisterone Acetate Controlled Release Tablet 10 mg (Additional Dosage form & Indication) | Each film coated controlled release tablet contains: Norethisterone Acetate 10mg | To arrest bleeding in women with dysfunctional uterine bleeding due to hormonal imbalance. | 24.02.2020 |
| Each film coated tablet contains: Efonidipine Hydrochloride Ethanolate.......…...............20mg Telmisartan IP…………....40mg | Each film coated tablet contains: Efonidipine Hydrochloride Ethanolate.......…...............20mg Telmisartan IP…………....40mg | It is indicated for the management of stage II hypertension. | 24.02.2020 |
| Lidocaine Hydrochloride 2% Solution (Additional Dosage Form) | Each ml contains: Lidocaine Hydrochloride 20mg | Indicated in adults: • For the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. • For reducing gagging during the taking of X-ray pictures and dental impressions. | 25.02.2020 |
| Itraconazole Capsule 200 mg (Additonal Strength) | Each capsule contains: Itraconazole 200 mg | For the treatment of onychymycosis of the toenail due to Trichophyton rubrum or T. mentagrophytes in non-immunocompromised patients Warning: To be sold by retail on the prescription of a Specialist only. | 03.03.2020 |
| Nepafenac Ophthalmic suspension 0.3% w/v (Additional Indication) | Each ml contains: Nepafenac 3mg | Reeducation in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients Warning: To be sold by retail on the prescription of a Opthamologists only. | 03.03.2020 |
| Each uncoated bilayered tablet contains: Gliclazide IP (as extended release form)....................60mg Metformin Hydrochloride IP (as extended release form)….............1000mg | Each uncoated bilayered tablet contains: Gliclazide IP (as extended release form)....................60mg Metformin Hydrochloride IP (as extended release form)….............1000mg | For the treatment of noninsulin dependent diabetes (Type-II) in adult patients where single drug therapy, diet and exercise do not result in adequate glycaemic control. | 03.03.2020 |
| Azelnidipine tablets IP 8 mg | Azelnidipine tablets IP 8 mg | For the treatment of Stage I Hypertension | 04.03.2020 |
| Bisoprolol Fumarate tablet 1.25 mg (Additional strength) | Each film coated tablet contains: Biosoprolol Fumarate 1.25 mg | For the treatment of congestive heart failure (CHF) | 04.03.2020 |
| Pirfenidone Tablets 267 & 801 mg (Additional Strength) | Each film coated tablet contains: Pirfenidone 267mg/801 mg | For the treatment of idiopathic pulmonary fibrosis Warning: To be sold by retail on the prescription of a Pulmonologist only. | 04.03.2020 |
| Pegaspargase Injection 3750 IU/5ml (Additional Indication) | Each 5ml vial contains: Pegaspargase Injection 3750 IU | Injection as first-Line chemotherapeutic agent for treatment of patients with acute Lymphoblastic Leukemia (ALL) Warning: To be sold by retail on the prescription of a Oncologist only. | 04.03.2020 |
| Norethisterone Acetate Controlled Release Tablet 15 mg (Additional Strength) | Each film coated controlled release tablets contains: Norethisterone Acetate 15 mg | To arrest bleeding in women with Heavy Menstrual Bleeding (HMB)/abnormal Uterine Bleeding (AUB) due to hormonal imbalance Warning: To be sold by retail on the prescription of a Gynaecologist/Obstertrician only. | 09.03.2020 |
| Estriol Tablets 1mg/2mg (Additional strength) | Each uncoated Tablet contains: Estriol 1mg/2mg | Estrogen deficiency symptoms due to menopause Warning: To be sold by retail on the prescription of a Gynaecologist only. | 09.03.2020 |
| Busulfan Injection 60 mg/10ml (Additional Strength) | Each 10 ml vial contains: Buslfan 60mg | In combination with cyclophosphamide as a conditioning regimen prior to allogenic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia Warning: To be sold by retail on the prescription of a Oncologist only. | 09.03.2020 |
| Each film coated bilayered tablet Contains: Montelukast sodium eq. to Montelukast IP…………..10mg Bilastine …………… …..20mg | Each film coated bilayered tablet Contains: Montelukast sodium eq. to Montelukast IP…………..10mg Bilastine …………… …..20mg | For the treatment of allergic rhinitis in adults. | 09.03.2020 |
| Riboflavin Ophthalmic Solution 0.1% | Riboflavin Ophthalmic Solution 0.1% | It is intended to treat keratoconus and corneal ecstasia following refractive surgery | 11.03.2020 |
| Pixantrone 29mg powder for concentrate for solution for infusion | Pixantrone 29mg powder for concentrate for solution for infusion | Indicated as 3rd line and 4th line therapy for the treatment of adult patients with multiply relapsed or refractory aggresive Non-Hodgkins B-Cell Lymphomas (NHL) | 11.03.2020 |
| FDC of Bilastine 20mg and Montelukast 10mg tablets | FDC of Bilastine 20mg and Montelukast 10mg tablets | Indicated for the treatment of allergic rhinitis in adults. | 11.03.2020 |
| Obeticholic acid bulk drug and Obeticholi acid 5mg/10mg tablets | Obeticholic acid bulk drug and Obeticholi acid 5mg/10mg tablets | For the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adult with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. | 11.03.2020 |
| Isavuconazole (as Isavuconazonium sulfate) 200mg powder for concentrate for solution for infusion | Isavuconazole (as Isavuconazonium sulfate) 200mg powder for concentrate for solution for infusion | Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis. | 11.03.2020 |
| Ulipristal Acetate Tablet 30 mg (Additional strength& indication) | Each film coated tablet contains: Ulipristal acetate 30 mg | Emergency contraception within 120 hrs (5 days) of unprotected sexual intercourse or contraceptive failure Warning: To be sold by retail on the prescription of a Gynaecologist only. | 11.03.2020 |
| Canagliflozin Tablet 100/300 mg (Additional Indication) | Each film coated tablet contains: Canagliflozin 100/300 mg | To reduce the risk of end-stage kidney disease (ESKD), doubling of serum creathinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria 300mg/day. | 11.03.2020 |
| Each film coated bilayered tablet contains: Metoprolol Succinate IP eq. to Metoprolol Tartarate IP (as Extended Release ) + Telmisartan IP + Chlorthalidone IP (25mg + 40mg + 12.5mg & 50mg + 40mg + 12.5mg) | Each film coated bilayered tablet contains: Metoprolol Succinate IP eq. to Metoprolol Tartarate IP (as Extended Release ) + Telmisartan IP + Chlorthalidone IP (25mg + 40mg + 12.5mg & 50mg + 40mg + 12.5mg) | For the treatment of essential hypertension with stable coronary artery disease. | 17.03.2020 |
| Nintedanib Soft Gelatin Capsules 100/150 mg (Additional Indication) | Each soft gelatin capsule contains: Nintedanib Ethanesulfonate equivalent to Nintedanib 100/150 mg | For the treatment of systemic sclerosis associated interstitial Lung Disease (SSc-ILD) Warning: To be sold by retail on the prescription of a Pulmonologist only. | 20.03.2020 |
| Polymyxin B for injection 500000 IU | Polymyxin B for injection 500000 IU | Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Ps. Aeruginosa. It may also be used as subconjuctival infection in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. It may be indicated in serious infections caused by susceptibel strains of the following organisms, 1. H. influenzae, specifically meningeal infections 2. Escherichia coli, specifically urinary tract infections 3. Aerobacter aerogenes, specifically bacteremia 4. Klebsiella pneumoniae, specifically bacteremia | 30.03.2020 |
| Each capsule contains: Glycopyrrolate USP eq. to Glycopyrronium.......... 12.5mcg Formoterol Fumarate Dihydrate IP……....... 12mcg Fluticasone Propionate IP……250mcg Dry powder for inhalation | Each capsule contains: Glycopyrrolate USP eq. to Glycopyrronium.......... 12.5mcg Formoterol Fumarate Dihydrate IP……....... 12mcg Fluticasone Propionate IP……250mcg Dry powder for inhalation | It is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). | 16.04.2020 |
| Sucroferric oxyhydroxide bulk and Sucroferric oxyhydroxide chewabale tablet 500mg | Sucroferric oxyhydroxide bulk and Sucroferric oxyhydroxide chewabale tablet 500mg | Phosphate binder indicated for the control of serum phosphorous levels in patients with chronic kidney disease on dialysis | 18.04.2020 |
| Sodium Hyaluronate…….0.15% w/v Polyethylne Glycol 400……0.4%w/v Propylene Glycol ………….0.3%w/v Lubricant eye drops | Sodium Hyaluronate…….0.15% w/v Polyethylne Glycol 400……0.4%w/v Propylene Glycol ………….0.3%w/v Lubricant eye drops | For the temporary relief of burning and irritation due to dryness of the eye and for use in lubricating and rewetting of all silicone hydrogel and soft hydrophilic contact lenses. | 22.04.2020 |
| Each film coated bilayered tablet contains: Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Cilnidipine (40mg + 5mg & 40mg+ 10mg) | Each film coated bilayered tablet contains: Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Cilnidipine (40mg + 5mg & 40mg+ 10mg) | For the treatment of stage II hypertension. | 24.04.2020 |
| Each film coated tablet contains: Capecitabine IP + Cyclophosphamide IP eq. to anhydrous Cyclophosphamide (400mg + 21.4mg eq. to 20mg & 700mg + 32.1mg eq. to 30mg) | Each film coated tablet contains: Capecitabine IP + Cyclophosphamide IP eq. to anhydrous Cyclophosphamide (400mg + 21.4mg eq. to 20mg & 700mg + 32.1mg eq. to 30mg) | For the treatment of patients with metastatic breast cancer after failure of prior anthracycline and /or taxane chemotherapy. | 28.04.2020 |
| Hydrogen peroxide 0.5% w/w wipes | Hydrogen peroxide 0.5% w/w wipes | Cleans, disinfects and deodorizes hard non-porous inanimate environmental surfaces | 29.04.2020 |
| Oxaliplatin Injection 50 mg/vial & 100 mg/vial (Additional Dosage Form) | Each Vial contains: Sterile Solution of Oxaliplatin 50mg and 100mg | For the treatment of advanced colorectal cancer. Warning: To be sold by retail on the prescription of an oncologist only. | 29.04.2020 |
| Tropicamide IP 0.2mg + Phenylephrine Hydrochloride IP 3.1mg + Lidocaine Hydrochloride IP 10mg per ml injection. Intracameral Injection | Tropicamide IP 0.2mg + Phenylephrine Hydrochloride IP 3.1mg + Lidocaine Hydrochloride IP 10mg per ml injection. Intracameral Injection | It is indicated for cataract surgery to obtain mydriasis and intraocular anesthesia during surgical procedure. | 04.05.2020 |
| Metformin Hydrochloride Prolonged Release Tablets 500mg (Additional Indication) | Each Prolonged Release Tablets contains: Metformin Hydrochloride 500mg | For the treatment of Polycystic Ovary Syndrome (PCOS) with established insulin resistance WARNING: To be sold by retail on the prescription of a RMP only In the package insert - Special warnings and precautions: Pregnancy: “There are no adequate and well-controlled studies in pregnant women with Metformin and Metformin should not be used during pregnancy unless clearly needed” | 05.05.2020 |
| Olaparib 100 mg and 150 mg Tablets (Additional Indication) | Each Film coated tablet contains: Oloaparib…100mg/150mg. | Olaparib is indicated as monotherapy for the Maintenance treatment of adult patients with germline BRCA-mutated metastatic adenocarcinoma of the pancreas whose disease has not progressed on first-line platinum-based chemotherapy “WARNING: To be sold by retail on the prescription of Oncologist only” | 06.05.2020 |
| Brotezomib For injection 2.5mg/ml (Additional Pack Size) | Each Vial Contains: Bortezomib 2.5 mg | For the treatment of patients with multiple myeloma For the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. WARNING: To be sold by retail on the prescription of Oncologist only” which shall be in red box; | 12.05.2020 |
| Centhaquine citrate bulk and Centhaquine citrate injection 1.0mg/vial | Centhaquine citrate bulk and Centhaquine citrate injection 1.0mg/vial | Add on resuscitative agent for hypovolemic shock | 15.05.2020 |
| Per 1000ml contains (after mixing) Glucose Monohydrate EP.................1.100gm Magnesium Chloride Hexahydrate EP…............................0.1017gm Calcium Chloride Dihyadrate EP…..............................0.2205gm Sodium Hydrogen Carbonate EP..............................….2.940gm Sodium Chloride EP…….................6.136gm Solution for haemodialysis / haemofiltration (multiBic potassium free) | Per 1000ml contains (after mixing) Glucose Monohydrate EP.................1.100gm Magnesium Chloride Hexahydrate EP…............................0.1017gm Calcium Chloride Dihyadrate EP…..............................0.2205gm Sodium Hydrogen Carbonate EP..............................….2.940gm Sodium Chloride EP…….................6.136gm Solution for haemodialysis / haemofiltration (multiBic potassium free) | MultiBic Potassium-free is indicated for intravenous use as substitution solution in haemofilteration and haemodiafilteration, and as dialysis solution in haemodailysis and haemodiafiltration. | 15.05.2020 |
| MultiBic 2 mmol/l potassium Per 1000ml contains (After mixing) Potassium Chloride……..................0.1491gm Sodium Chloride ……….................6.136gm Sodium Hydrogen Carbonate……...2.940gm Calcium Chloride Diydrate………...0.2205gm Magnesium Chloride Hexahydrate…..................................0.1017gm Glucose Monohydrate …..................1.100gm MultiBic 4 mmol/l potassium Per 1000ml contains (After mixing) Potassium Chloride ………………..0.2982gm Sodium Chloride …………………..6.136gm Sodium Hydrogen Carbonate……....2.940gm Calcium Chloride Diydrate……….. 0.2205gm Magnesium Chloride Hexahydrate…................ 0.1017gm Glucose Monohydrate……………...1.100gm Solution for Haemodialysis/Heamofiltration | MultiBic 2 mmol/l potassium Per 1000ml contains (After mixing) Potassium Chloride……..................0.1491gm Sodium Chloride ……….................6.136gm Sodium Hydrogen Carbonate……...2.940gm Calcium Chloride Diydrate………...0.2205gm Magnesium Chloride Hexahydrate…..................................0.1017gm Glucose Monohydrate …..................1.100gm MultiBic 4 mmol/l potassium Per 1000ml contains (After mixing) Potassium Chloride ………………..0.2982gm Sodium Chloride …………………..6.136gm Sodium Hydrogen Carbonate……....2.940gm Calcium Chloride Diydrate……….. 0.2205gm Magnesium Chloride Hexahydrate…................................ 0.1017gm Glucose Monohydrate……………...1.100gm Solution for Haemodialysis/Heamofiltration | MultiBic 2 mmol/l and 4 mmol/l Potassium is indicated for intravenous use as substitution solution in haemofiltartion and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration. | 15.05.2020 |
| Each film coated tablet contains: Alogliptin Benzoate 17mg eq. to Alogliptin + Metformin Hydrochloride (12.5mg + 500mg & 12.5mg + 1000mg) | Each film coated tablet contains: Alogliptin Benzoate 17mg eq. to Alogliptin + Metformin Hydrochloride (12.5mg + 500mg & 12.5mg + 1000mg) | As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | 18.05.2020 |
| Per 12.5mg blister contains : Fluticasone Furoate ……..100mcg Umeclidinium bromide 74.2mcg eq. to Umeclidinium…………......62.5mcg Vilanterol trifenatate 40mcg eq. to Vilanterol………………….25mcg | Per 12.5mg blister contains : Fluticasone Furoate ……..100mcg Umeclidinium bromide 74.2mcg eq. to Umeclidinium…………......62.5mcg Vilanterol trifenatate 40mcg eq. to Vilanterol………………….25mcg | Indicated for maintenance treatment to prevent and relieve symptoms associate with chronic obstructive pulmonary disease (COPD). | 18.05.2020 |
| Disoidum Phosphate Dihydarte EP...................................1870g/L Potassium Chloride EP…................0.3140g/L Sodium Hydrogen Carbonate EP….2.1200g/L Sodium Chloride EP…....................7.0100g/L Magnesium Chloride Hexahydrate EP...............................3.0500g/L Solution for Haemodialysis or Haemoflitration | Disoidum Phosphate Dihydarte EP...................................1870g/L Potassium Chloride EP…................0.3140g/L Sodium Hydrogen Carbonate EP….2.1200g/L Sodium Chloride EP…....................7.0100g/L Magnesium Chloride Hexahydrate EP...............................3.0500g/L Solution for Haemodialysis or Haemoflitration | Biphozyl is used as replacement solution and as a dialysate for treatment of acute kidney injury during continuous renal replacement therapy. Biphozyl is used in a post –acute phase after initiation of renal replacement therapy when therapy when pH, potassium and phosphate concentration have returned to normal. Biphozyl is also used when other buffer sources are available as well as during regional citrate anticoagulation. Moreover, Biphozyl is used in patients with hypercalcaemia. Biphozyl may also be used in cases of drug poisoning or intoxications when the substances are dialysable or filterable. | 21.05.2020 |
| Sodium Citrate ……….5.2900g/L Sodium Chloride……...5.0300g/L Solution for Haemofiltration | Sodium Citrate ……….5.2900g/L Sodium Chloride……...5.0300g/L Solution for Haemofiltration | Regiocit is used as replacement fluid for continuous renal replacement therapy (CRRT) using regional citrate anticoagulation. Citrate is particularly relevant when systemic anticoagulation with heparin is contraindicated for example in patients with increased bleeding risk. | 21.05.2020 |
| Hydrogen peroxide 0.5% w/w spray | Hydrogen peroxide 0.5% w/w spray | Cleans, disinfects and deodorizes hard non-porous inanimate environmental surfaces | 28.05.2020 |
| Each kit contains: A) 14 Ticagrelor tablets…….90mg Each film coated tablet contains: Ticagrelor IP……….90mg B) 7 Aspirin Gastro-resistant tablets IP…..75mg Each enteric coated tablet contains: Aspirin IP…………..75mg | Each kit contains: A) 14 Ticagrelor tablets…….90mg Each film coated tablet contains: Ticagrelor IP……….90mg B) 7 Aspirin Gastro-resistant tablets IP…..75mg Each enteric coated tablet contains: Aspirin IP…………..75mg | For the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with acute coronary syndromes (ACS) including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG) where both Ticagrelor and Aspirin are required. | 29.05.2020 |
| Remdesivir Injection 5 mg/mL and Remdesivir lyophilised powder for Injection 100 mg | Remdesivir Injection 5 mg/mL and Remdesivir lyophilised powder for Injection 100 mg | For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and children hospitalised with severe disease.in light of Covid 19 outbreak, for restricted emergency use in the country. | 01.06.2020 |
| Lymphoseek 50mcg kit (each kit contains : Tilmanocept 50mcg, Glycine 0.1mg, Sodium ascorbate 0.1mg, Trehalose dihydrate 16mg, stannous chloride dihydrate 0.015mg, sodium hydoxide q.s, hydrochloric acid q.s, Nitrogen q.s, water for injection q.s) | Lymphoseek 50mcg kit (each kit contains : Tilmanocept 50mcg, Glycine 0.1mg, Sodium ascorbate 0.1mg, Trehalose dihydrate 16mg, stannous chloride dihydrate 0.015mg, sodium hydoxide q.s, hydrochloric acid q.s, Nitrogen q.s, water for injection q.s) | Indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. This medicinal product is for diagnostic only. | 04.06.2020 |
| Sodium Fluoride varnish (50mg/ml) (Dental Suspension) (New Dosage Form) | Each ml of Dental Suspension contains: Sodium Fluoride……50 mg | For the prevention of caries in children and adults as part of a comprehensive control programme, for the: - prevention of recurring (or marginal) caries - prevention of progression of caries - prevention of decalcification around orthodontic appliances - prevention of pit and fissure (occlusal) caries. For the desensitisation of hypersensitive teeth as part of a treatment regimen which includes the daily use of a suitable toothpaste. Warning:“To be sold by retail on the prescription of a Dentist only” | 05.06.2020 |
| Amoxicillin Trihydrate……759.04 mg eq. to Amoxicillin free acid……...652.78 mg Potassium Clavulanate……61.48 mg eq. to Clavulanic acid…………...50.41mg per 5ml powder for reconstitution into suspension | Amoxicillin Trihydrate……759.04 mg eq. to Amoxicillin free acid……...652.78 mg Potassium Clavulanate……61.48 mg eq. to Clavulanic acid…………...50.41mg per 5ml powder for reconstitution into suspension | It is indicated for short term treatment of paediatric patients with bacterial infections at the following sites when caused by amoxicillin-clavulanate-susceptible organisms: 1. Upper Respiratory Tract Infections (including ENT) e.g. Acute otitis media (AOM), persistent AOM, or recurrent AOM, typically caused by Streptococcus pneumonia Haemophilus influenzae and Moraxella catarrhalis. Tonsillo-pharyngitis and sinusitis, typically caused by Streptococcuspneumonia. Haemophilus Influenza Moraxella catarrhalis and Streptococcus pyogenes. 2. Lower Respiratory Tract Infections e.g. lobar and bronchopneumonia typically caused by Streptococcus pneumonia Haemophilus influenza and Moraxella catarrhalis 3. Skin and Soft Tissue Infections typically caused by Staphylococcus aureus and Streptococcus pyogenes. 4. Urinary tract infections e.g. cystitis, pyelonephritis Penicillin minimum inhibitory concentration (MIC) less than or equalto 4 micrograms/ml Some members of these species of bacteria producebeta-lactamase, rendering them insensitive to amoxicillin alone. | 8/6/2020 |
| Paclitaxel Lipid Suspension for injection 100 mg/vial\ (Additional Strength) | Each vial contains: Paclitaxel ………100 mg | 1. For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. 2. For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. 3. As first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, it is indicated in combination with cisplatin. 4. In combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. 5. For the second-line treatment of AIDS- related Kaposi’s sarcoma Warning:“To be sold by retail on the prescription of a Oncologist only” | 16.06.2020 |
| Favipiravir bulk and Favipiravir film coated tablet 200mg | Favipiravir bulk and Favipiravir film coated tablet 200mg | For the treatment of patients with mild to moderate Covid-19 disease. | 19.06.2020 |
| Itraconazole Oral Solution 10 mg/ml (New Dosage Form) | Each ml Contains: Itraconazole………10 mg | For the Treatment of Orophyaryngeal and Esophageal candidiasis Warning:“To be sold by retail on the prescription of a Specialist only” | 25.06.2020 |
| Bilastine Orodispersible Tablet 10 mg (New Dosage Form) | Each uncoated orodispersible tablet contains: Bilastine…… 10 mg | For symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticarial. Bilastine is indicated in children aged 6 to 11 years with a body weight of at least 20 kg | 25.06.2020 |
| Film coated bilayered tablets contains: Metformin Hydrochloride IP………………………500mg Evogliptin Tartrate………5mg (In additional Strength) | Film coated bilayered tablets contains: Metformin Hydrochloride IP………………………500mg Evogliptin Tartrate………5mg (In additional Strength) | As an adjunct to diet and exercise to improve glycaemic control in adults patients with type 2 diabetes mellitus who are appropriate for co-administration of Evogliptin and Metformin. Patients with inadequate glycaemic control on Metformin monotherapy alternative for combination therapy of Evogliptin and Metformin. | 26.06.2020 |
| Itraconazole 50 mg Capsule (Modified Dosage Form) | Each capsule contains: Itraconazole……50 mg | for the treatment of Systematic aspergillosis, candidiasis, cryptococcosis, sportrichosis, paracoccidioidomycossis, blastomycosis and other rarely occuring systemic or tropical mycosis "WARNING: To be sold by retail on the prescription of a Specialist only”. Caution: “This Itraconazole Capsules 50mg has equivalent bioavailability with that of itraconazole capsules 100mg. One capsule of this Itraconazole Capsule 50mg is therapeutically equivalent to one 100mg capsule of conventional Itraconazole capsules100mg. The recommended dose of this Itraconazole Capsules 50mg is therefore half the recommended dose for conventional itraconazole capsules 100 mg. This Itraconazole Capsules 50mg and conventional Itraconazole Capsules 100mg are not interchangeable”. | 30.06.2020 |
| Meropenem dry powder for injection 2000 mg | Each Vial Contains: Meropenem Trihydrate Equivalent to Meropenem …. 2000mg Sodium Carbonate Equivalent to sodium ….. 180.4 mg | • Nosocomial Pneumonia like Hospital Acquired Pneumonia (HAP)/Ventilator Associated Pneumonia • Urinary Tract Infections like Complicated Urinary Tract Infections • Intra-Abdominal infection like Complicated Intra-Abdominal Infection • Meningitis like Acute Meningitis • Septicemia • Empiric Treatment of Presumed infection in Adult Patients with Febrile Neutropenia | 02.07.2020 |
| Dapagliflozin 10 mg Tablet | Each Film coated tablet contains: Dapagliflozin Propanediol Monohydrate equivalent to Dapagliflozin………10 mg | Dapagliflozin is indicated in adults for the treatment of heart failure with reduced ejection fraction. | 03.07.2020 |
| Ceftaroline fosamil powder for concentrate for solutin for infusion | Each Vial Contains: Ceftaroline Fosamil…………..600mg L-Arginine…………………..395mg | For the tratment of the adults with complicated skin and soft tissue infections (Cssti) | 06.07.2020 |
| Nintedanib 100mg/150mg | Each soft Gelatin capsule contains: Nintedanib Ethanesulfonate equivalent to Nintedanib……..100mg/150mg | For the treatment of other chronic fibrosing interstitial Lung Diseases (ILDs) with a Progressive phenotype | 09.07.2020 |
| Ivabradine PR Tablets 10/15mg | Each film coated prolonged release tablet contains: Ivabradine hydrochloride equivalent to Ivabradine……………….10 mg / 15 mg. | For the treatment of chronic stable angina pectoris in patients with coronary artery disease and treatment of chronic heart failure. | 14.07.2020 |
| Paracetamol Orally Disintegrating 60/120 mg | Each Orally Disintegrating Strip Contains: Paracetamol…………………….60mg / 120 mg | For use in pediatric age group, for symptomatic treatment of pain and fever | 14.07.2020 |
| Film coated bilayered tablet contains: Pregabalin IP (As prolonged Release)................75mg Etoricoxib IP........60mg (In additional Strength) | Film coated bilayered tablet contains: Pregabalin IP (As prolonged Release)................75mg Etoricoxib IP........60mg (In additional Strength) | For the treatment of chronic low back pain associated with neuropathic component. | 15.07.2020 |
| Sodium Citrate Granules 4.0 gm | Each sachet (5.6g) Contains: Sodium Citrate 4.0 g | As an alkalising agent in cystitis in women | 16.07.2020 |
| Glycopyrronium IP……….25mcg Formoterol Fumarate IP…..12mcg Budesonide IP…………….400mcg Inhalation Powder | Glycopyrronium IP……….25mcg Formoterol Fumarate IP…..12mcg Budesonide IP…………….400mcg Inhalation Powder | Indicated as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). | 17.07.2020 |
| Trimetazidine Hydrochloride Extended Release Capsules 80mg | Each hard gelatin capsule contains: Trimetazidine hydrochloride (as extended release pellets)… 80 mg | Indicated as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). | 21.07.2020 |
| Zinc chloride Ph. Eur. ……………1050 μg Sodium fluoride Ph. Eur.….210.0 μg Potassium iodide Ph. Eur……..16.60 μg Sodium Molybdate dihydrate Ph. Eur. …………4.850 μg Sodium selenite anhydrous ……17.29 μg Copper chloride dihydrate USP ………………… 102.3 μg Manganese chloride tetrahydrate USP………….19.79 μg Ferric chloride hexahydrate Ph. Eur ……………...540.0 μg Chromic chloride hexahydrate USP ……………..5.330 μg Concentrate for Solution for Infusion | Zinc chloride Ph. Eur. ……………1050 μg Sodium fluoride Ph. Eur.….210.0 μg Potassium iodide Ph. Eur……..16.60 μg Sodium Molybdate dihydrate Ph. Eur. …………4.850 μg Sodium selenite anhydrous ……17.29 μg Copper chloride dihydrate USP ………………… 102.3 μg Manganese chloride tetrahydrate USP……….19.79 μg Ferric chloride hexahydrate Ph. Eur …………...540.0 μg Chromic chloride hexahydrate USP ………….5.330 μg Concentrate for Solution for Infusion | To meet basal to moderately increased requirements of trace elements in intravenous nutrition. | 30.07.2020 |
| n-alkyl dimethyl benzyl ammonium chloride 0.105% w/w spray | n-alkyl dimethyl benzyl ammonium chloride 0.105% w/w spray | Cleans, disinfects, deodorizes hard, nonporous inanimate environmental surfaces | 31.07.2020 |
| Defetilide bulk and Dofetilide capsules 125mcg, 250mcg, 500mcg | Defetilide bulk and Dofetilide capsules 125mcg, 250mcg, 500mcg | Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/ atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because Dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients. Conversion of Atrial Fibrillation/Flutter Dofetilide is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation. | 31.07.2020 |
| Regorafenib Tablet 40 mg (Additional Indication) | Each film coated tablet contains: Regorafenib…..40 mg | For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib Warning “To be sold by retail on the Prescription of an Oncologist only | 03.08.2020 |
| Baclofen Extended Release tablet 30mg (Additional dosage & Strength) | Each uncoated extended release tablet contains: Baclofen….30 mg | For the symptomatic treatment of neuronal spasticity due to multiple sclerosis, spinal chord, pathology & injury | 04.08.2020 |
| Tofacitinib Tablet 5 mg (Additional Indication) | Each film coated tablet contains: Tofacitinib citrate equivalent to tofacitinib…..5 mg | For the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) Warning “To be the prescription of a Rheumatologist or Specialist in Internal Medicine only” | 04.08.2020 |
| Enzalutamide 80 mg capsules (Additional strength) | Each hard gelatin capsule contains: Enzalutamide….80mg | For the treatment adults with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after Docetaxel therapy. Warning “To be sold by retail on the Prescription of an Oncologist only” | 06.08.2020 |
| Oxaceprol Sustained Release Tablet 600 mg (Additional strength) | Each film coated SR tablet contains: Oxaceprol……600 mg | Treatment of pain associated with osteoarthritis of knee in adult patients | 07.08.2020 |
| Octyl decyl dimethyl ammonium chloride 6.670% spray | Octyl decyl dimethyl ammonium chloride 6.670% spray | Cleans, disinfects, deodorizes hard, nonporous inanimate environmental surfaces. | 07.08.2020 |
| Each Uncoated tablets contains: Aceclofenac IP……..200mg (as extended release) Rabeprazole…………..20mg (as delayed release) (In additional dosage form) | Each Uncoated tablets contains: Aceclofenac IP……..200mg (as extended release) Rabeprazole…………..20mg (as delayed release) (In additional dosage form) | It is indicated for the treatment of Painful inflammatory conditions associated with gastroduodenal ulcers. | 10.08.2020 |
| Each Uncoated tablets contains: Azelnidipine IP…………8mg/8mg Olmesartan Medoxomil IP ……….20mg/40mg | Each Uncoated tablets contains: Azelnidipine IP…………8mg/8mg Olmesartan Medoxomil IP………….20mg/40mg | For the treatment of patients with stage II hypertension. | 14.08.2020 |
| Glycopyrrolate IP……9mcg Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate……4.8mcg Per actuation deliver Inhalation Aerosol (In additional Strength) | Glycopyrrolate IP……9mcg Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate……4.8mcg Per actuation deliver Inhalation Aerosol (In additional Strength) | Indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. | 14.08.2020 |
| Didecyl dimethyl Ammonium Chloride………………..10.14% w/w N-Alkyl Dimethyl Benzyl Ammonium Chloride…………………6.76% w/w Surface Disinfectatnt | Didecyl dimethyl Ammonium Chloride………………..10.14% w/w N-Alkyl Dimethyl Benzyl Ammonium Chloride…………………6.76% w/w Surface Disinfectatnt | Antimicrobial product for use against Novel coronavirus SARS-Cov-2, the cause of COVID-19. | 14.08.2020 |
| Octyl Decyl Dimethyl Ammonium Chloride ……………………….6.510% w/w Dioctyl Dimethyl Ammonium Chloride……………...2.604% w/w Didecyl Dimethyl Ammonium Chloride……………..3.906% w/w Alkyl dimethyl Benzyl Ammonium Chloride……………..8.680% w/w Surface Disinfectant | Octyl Decyl Dimethyl Ammonium Chloride …………….6.510% w/w Dioctyl Dimethyl Ammonium Chloride……………...2.604% w/w Didecyl Dimethyl Ammonium Chloride……………..3.906% w/w Alkyl dimethyl Benzyl Ammonium Chloride……………..8.680% w/w Surface Disinfectant | Antimicrobial product for use against Novel Coronavirus SARS-Cov-2, the cause of COVID-19. | 14.08.2020 |
| Levofloxacin Dispersible Tablets 100 mg (New Dosage Foam) | Each dispersible tablet contains: Levofloxacin hemihydrate Equivalent to Levofloxacin ……. 100 mg | Indicated in combination with other anti-tuberculosis agents, for the treatment of tuberculosis caused by Mycobacterium tuberculosis in children. Warning “To be sold by the prescription of a Medical Specialist only” | 18.08.2020 |
| Trihexyphenidyl Hydrochloride 1 mg (Additional strength) | Each uncoated tablet contains: Trihexyphenidyl hydrochloride ……………… …….1 mg | It is indicated in all forms of Parkinsonism (postencephalitic, arteriosclerotic and idiopathic). It is often useful as adjuvant therapy when treating these forms of Parkinsonism with levodopa. Trihexyphenidyl is also indicated to control extrapyramidal disorders due to central nervous system drugs such as reserpine and the phenothiazines. Warning “To be sold by the prescription of Neurologist only” | 18.08.2020 |
| Each tablet contains: Vildagliptin………….50mg/50mg Metformin Hydrochloride (Sustained Release) IP…………………...500mg/1000mg | Each tablet contains: Vildagliptin………….50mg/50mg Metformin Hydrochloride (Sustained Release) IP…………………...500mg/1000mg | For the treatment of type_II diabetes mellitus when single drug therapy along with diet, exercise do not result in adequate glycemic control. | 18.08.2020 |
| Film coated bilayered tablet contains: Azelnidipine ………..8mg/8mg Telmisartan…………40mg/80mg | Film coated bilayered tablet contains: Azelnidipine ………..8mg/8mg Telmisartan…………40mg/80mg | For treatment of Stage-II Hypertension. | 19.08.2020 |
| Each vial contains: Amoxycillin Sodium IP (sterile) eq. to Amoxycillin…………125mg Potassium Clavulanate IP (sterile) eq. to Clavulanate…………..25mg Injection | Each vial contains: Amoxycillin Sodium IP (sterile) eq. to Amoxycillin…………125mg Potassium Clavulanate IP (sterile) eq. to Clavulanate…………..25mg Injection | For the treatment of bacterial infections. | 19.08.2020 |
| Each film coated tablets contains: Efonidipine Hydrochloride Ethanolate ……..20mg/20mg Metoprolol Succinate (Extended Release)…25mg/50mg | Each film coated tablets contains: Efonidipine Hydrochloride Ethanolate …………..20mg/20mg Metoprolol Succinate (Extended Release)…25mg/50mg | It is indicated for the management of Stage - II Hypertension. | 25.08.2020 |
| Ferric Carboxymaltose Solution for Injection/Infusion 20mg/vial (Additional Pack Size) | Each ml contains: Ferric Carboxymaltose equivalent to Elemental Iron….50 mg. | For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used. | 27.08.2020 |
| Lipid Based Tacrolimus Ointment 0.1% w/w (Additional indication) | Each gram contains: Tacrolimus Monohydrate Equivalent to Tacrolimus…....0.1% w/w | For the short-term and non-continuous chronic treatment of symptomatic lichen planus (oral and mucosal forms) in nonimmunocompromised patients Warning “To be the prescription of a Dermatologists only” | 28.08.2020 |
| Moxifloxacin Dispersible Tablets 100 mg (New Form dosage) | Each dispersible tablet contains: Moxifloxacin Hydrochloride Equivalent to Moxifloxacin 100 mg | Indicated in combination with other antituberculosis agents for the treatment of tuberculosis caused by Mycobacterium tuberculosis. as a second-line antimycobacterial drug when use of first line drugs is not appropriate due to resistance or intolerance | 02.09.2020 |
| Tapentadol Hydrochloride Nasal Spray 225 mg/ml (New Form dosage) | Each Spray (0.1 ml) contains: Tapentadol Hydrochloride22.5 mg Benzalkonium chloride (50%) 0.02%w/v (As Preservative) | For treatment of moderated to severe post-operative pain in hospital admitted patients | 02.09.2020 |
| Carbetocin bulk and Carbetocin injection 100 mcg/ml | Carbetocin bulk and Carbetocin injection 100 mcg/ml | Prevention of postpartum haemorrhage due to uterine atony | 21.09.2020 |
| Each uncoated bilayered tablets contains: Atorvastatin Calcium IP eq. to Atorvastatin……10mg/20mg Clopidogrel Bisulphate IP eq. to Clopidogrel ………………...75mg/75mg (In additional dosage form) | Each uncoated bilayered tablets contains: Atorvastatin Calcium IP eq. to Atorvastatin……10mg/20mg Clopidogrel Bisulphate IP eq. to Clopidogrel ………………...75mg/75mg | Post coronary intervention and acute syndrome. | 23.09.2020 |
| Favipiravir 800mg Tablet (Additional strength) | Each film coated tablet contains: Favipiravir 800 mg | For the treatment of patients with mild to moderate Covid-19 disease, in light of Covid 19 outbreak, for restricted emergency use in the country. “WARNING: To be sold on the prescription of medical specialist” | 24.09.2020 |
| Isotretinoin Capsules 8/16/24 mg (Additional Strength & Indication) | Each soft gelatin capsule contains: Isotretinoin…8mg /16mg/24mg | For the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, it is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. “Warning: To be sold by retail on the prescription of Dermatologist only” | 29.09.2020 |
| Brivaracetam Tablets (Additional Strength) | Each film coated tablet contains: Brivaracetam 25mg | As adjunctive therapy in the treatment of partialonset seizures in patients 16 years of age and older with epilepsy | 01.10.2020 |
| Perampanel Tablets 2 mg/4mg /6 mg/8 mg/12 mg (Additional Indication) | Each film coated tablet Contains: Perampanel 2mg/4mg/6mg/8mg/10 mg/12mg | As an adjunctive treatment of partialonset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older “Warning: To be sold by retail on the prescription of Neurologist only” | 01.10.2020 |
| Acotiamide 300 mg Tablet (Additional dosage foam) | Each film coated Extended release tablet contains: Acotiamide Hydrochloride Hydrate 300mg | For the treatment of bloating after meals, epigastric bloating and early satiety in functional dyspepsia | 05.10.2020 |
| Each Dispersible tablets contains: Lamivudine USP………..60mg Abacavir Sulphate USP…120mg | Each Dispersible tablets contains: Lamivudine USP………..60mg Abacavir Sulphate USP…120mg | Indicated in the treatment of HIV-1 infection in children. | 06.10.2020 |
| Each tablet contains: Tenofovir Alafenamide Fumarate …… 25mg Emtricitabine……200mg (In additional Indication) | Each tablet contains: Tenofovir Alafenamide Fumarate …… 25mg Emtricitabine……200mg (In additional Indication) | Indicated for use in high risk adults and adolescents weighing at least 35kg for PrEP to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. | 12.10.2020 |
| Each 1.8ml solution for injection contains: Lignocaine Hydrochloride Ph. Eur…36mg Adrenaline Tartrate Ph. Eur…….0.0225mg | Each 1.8ml solution for injection contains: Lignocaine Hydrochloride Ph. Eur…36mg Adrenaline Tartrate Ph. Eur…….0.0225mg | It is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults and in children and adolescents aged 4 to 18 years of age. It is appropriate for procedures of long durations and when there is a risk of significant bleeding into the operative field. | 12.10.2020 |
| Each 1.7ml solution for injection: Articaine Hydrochloride EP.....68mg Adrenaline Tartrate EP……….0.0300mg | Each 1.7ml solution for injection: Articaine Hydrochloride EP.....68mg Adrenaline Tartrate EP……….0.0300mg | It is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental procedures in adults. It is intended for adults, adolescents and in children over 4 years old. | 14.10.2020 |
| Netarsudil mesylate bulk and Netarsudil ophthalmic solution 0.02%w/v | Netarsudil mesylate bulk and Netarsudil ophthalmic solution 0.02%w/v | For the reduction of elevated intraocular pressure in patients with open angle galucoma or ocular hypertension | 14.10.2020 |
| Azathioprine 75 mg Tablet (Additional Strength) | Each film coated tablet contains: Azathioprine 75 mg | Indicated for facilitating the survival and function of organ transplants “Warning: To be sold by retail on the prescription of Medical Specialist only” | 14.10.2020 |
| Travoprost Eye Drops 0.004% w/v (Preserved with an ionic buffer system) | Each ml contains Travoprost .0.004% w/v | For the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension “Warning: To be sold by retail on the prescription of Ophthalmologist only” | 16.10.2020 |
| Risdiplam powder for oral solution 60mg | Risdiplam powder for oral solution 60mg | For treatment of Spinal Muscular Atrophy (SMA) in patients 2 months of age and older | 16.10.2020 |
| FDC of Azelnidipine 8mg and Telmisartan 40mg tablet | FDC of Azelnidipine 8mg and Telmisartan 40mg tablet | For the treatment of Stage-II hypertension | 16.10.2020 |
| Remdesivir for Injection 100 mg/vial (lyophilized) (Expansion of Indication) | Each vial Contains: Remdesivir 100 mg (lyophilized) | For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID19) in adults and children hospitalised with moderate to severe disease.In light of Covid 19 outbreak, for restricted emergency use in the country. “Warning: To be sold by retail on the prescription of specialist for use in Hospital/Institutional Setup only” | 19.10.2020 |
| Each Actuation delivers (Ex-actuator) contains: Glycopyrrolate IP ...................9.0mcg Formoterol Fumarate dihydrate IP eq. to Formoterol Fumarate………..4.8mcg Inhalation Aerosol (In additional strength) | Each Actuation delivers (Ex-actuator) contains: Glycopyrrolate IP ...................9.0mcg Formoterol Fumarate dihydrate IP eq. to Formoterol Fumarate………..4.8mcg Inhalation Aerosol (In additional strength) | Indicated for the long term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. | 26.10.2020 |
| Lidocaine Spray 10% w/v (Additional Strength) | Each ml Contains: Lidocaine ……100 mg Ethanol…….. 30.4% v/v Flavored Base …………… q .s. | Lidocaine Spray 10% w/v is indicated for the prevention of pain associated with the following procedures: Otorhinolaryngology: Anesthesia prior to minor non-invasive procedures in the nasal cavity, pharynx and epipharynx including rhinos copy and laryngoscopy. Obstetrics: During the final stages of delivery and before episiotomy and perineal suturing as supplementary pain control. Insertion of instruments and catheters into the respiratory and digestive tract: Provides surface anesthesia for the oropharyngeal and tracheal areas to reduce reflex activity, attenuate hemodynamic response and to facilitate insertion of the catheter or the passage of instruments during endotracheal intubation, laryngoscopy, bronchoscopy, esophagostomy and gastroscopy. Dental practice: Before minor dental procedures where local anesthesia is desired. | 02.11.2020 |
| Combipack OF Favipiravir Tablets (Combipack) | Each Combipack contains: Favipiravir Tablets 200 mg (2 tablets) Each film coated tablets contains: Favipiravir ……………..200mg Favipiravir Tablets 800 mg (16 tablets) Each film coated tablets contains: Favipiravir……………..800mg | For restricted emergency use for the treatment of patients with mild to moderate Covid-19 disease “WARNING: To be sold on the prescription of medical specialist” which shall be in box with red background. | 27.11.2020 |
| Each Film Coated Tablets contains: Rosuvastatin Calcium IP eq. to Rosuvastatin ……20mg Clopidogrel Bisulphate IP eq. to Clopidogrel …75mg | Each Film Coated Tablets contains: Rosuvastatin Calcium IP eq. to Rosuvastatin ……20mg Clopidogrel Bisulphate IP eq. to Clopidogrel …75mg | Post coronary intervention and acute coronary syndrome. | 27.11.2020 |
| Each Film Coated Tablets contains: Remogliflozin Etabonate……100mg Vildagliptin…………………..50mg | Each Film Coated Tablets contains: Remogliflozin Etabonate……100mg Vildagliptin…………………..50mg | It is indicated in adults aged 18 years and older with type 2 diabetes mellitus: To improve glycaemic control when Metformin and one of mono-components of Fixed dose combination of Remogliflozin Etabonate & Vildagliptin do not provide adequate glycaemic control. When already being treated with the free combination of Remogliflozin Etabonate & Vildagliptin. | 27.11.2020 |
| Each Film Coated Tablets contains: Ivabradine Hydrochloride eq. to Ivabradine + Metoprolol Tartrate IP (7.5mg+25mg, 5mg +50mg, 5mg+25mg & 7.5mg+50mg) | Each Film Coated Tablets contains: Ivabradine Hydrochloride eq. to Ivabradine + Metoprolol Tartrate IP (7.5mg+25mg, 5mg +50mg, 5mg+25mg & 7.5mg+50mg) | For the symptomatic treatment of chronic stable angina pectoris substitution therapy in adult patients with normal sinus rhythm already controlled by Metoprolol and Ivabradine taken concomitantly at the same dose level | 27.11.2020 |
| Vildagliptin Sustained Release Tablets 100 mg (OROS) (Additional Strength) | Each film coated sustained release bi-layered tablet contains: Vildagliptin…………..100mg | As an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes mellitus (T2DM) | 15.12.2020 |
| Thyroxine Sodium Tablets 112 mcg (Additional Strength) | Each uncoated tablet contains: Thyroxine Sodium…….11 2 mcg | For the treatment of hypothyroidism | 17.12.2020 |
| Each Film Coated Tablets contains: Metoprolol Succinate IP eq. to Metoprolol Tartrate (as extended release)+ Chlorthalidone IP + Telmisartan IP (47.5mg eq. to 50mg + 6.25mg + 40mg & 23.75mg eq. to 25mg + 6.25mg+ 40mg) | Each Film Coated Tablets contains: Metoprolol Succinate IP eq. to Metoprolol Tartrate (as extended release)+ Chlorthalidone IP + Telmisartan IP (47.5mg eq. to 50mg + 6.25mg + 40mg & 23.75mg eq. to 25mg + 6.25mg+ 40mg) | It is indicated for the treatment of patients with uncontrolled essential hypertension and stable coronary artery disease (CAD) | 21.12.2020 |
| Triamcinolone Acetonide Cream 0.1%w/w (New Dosage Foam) | Each gm contains: Triamcinolone Acetonide…..1mg Benzyl alcohol (aspreservative)………….2% w/w In a cream base………………….…q.s. | Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. "WARNING: To be sold by retail on the prescription of Dermatologist only” | 22.12.2020 |
| Palbociclib Tablets 75/100/125 mg | Each film coated tablet contains: Palbociclib………...….75mg/100mg/1 25 mg | 1. Palbociclib is a kinase inhibitor indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) - negative advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. 2. Palbociclib is a kinase inhibitor indicated in combination with Letrozole for the treatment of postmenopausal women with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine based therapy for their metastatic disease. "WARNING: To be sold by retail on the prescription of an Oncologist only” | 22.12.2020 |
| Lurasidone Hydrochloride Tablets 20mg (Additional Strength) | Each film coated tablets contains: Lurasidone Hydrochloride………………….20 mg | For treatment of patients with Schizophrenia "WARNING: To be sold by retail on the prescription Neurologist only” | 24.12.2020 |
| Hydrocortisone Sodium Succinate Injection (Additional Strength) | Each vial contains: Hydrocortisone Sodium Succinate (Buffered) Eq. to Hydrocortisone……200 mg | Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (StevensJohnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hyper calcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus. | 28.12.2020 |
| Each Film Coated Tablets contains: Carvedilol IP…………3.125mg Ivabradine Hydrochloride eq. to Ivabradine…………....5mg | Each Film Coated Tablets contains: Carvedilol IP…………3.125mg Ivabradine Hydrochloride eq. to Ivabradine…………....5mg | It is indicated for as substituted therapy in adult patients with normal sinus rhythm already controlled by Ivabradine and carvedilol taken concomitantly at the same doses level for: I. The symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients II. The treatment of chronic heart failure (II-IV NYHA-class) with systolic dysfunction. | 30.12.2020 |
| Each gram contains: Adapalene EP……………0.3% w/w Benzoyl Peroxide EP…….2.5% w/w Topical Gel (Additional Strength) | Each gram contains: Adapalene EP……………0.3% w/w Benzoyl Peroxide EP…….2.5% w/w Topical Gel | For the cutaneous treatment of Acne vulgaris, when comedones, numerous papules and pustules are present. | 08.01.2021 |
| Atropine Sulfate Ophthalmic Solution USP 0.01% w/v (Additional Strength) | Each ml Contains: Atropine Sulfate…………….0.1 mg Polyhexamethylene biguanide Hydrochloride… ……0.05mg (As Preservative) | It is indicated to control the progression of myopia in children of 5 years and above "WARNING: To be sold by retail on the prescription of Ophthalmologist only” With the Condition to conduct phase IV Clinical trial to assess long term safety of the product. | 12.01.20021 |
| Colistimethate Sodium For Injection IP 3 MIU/ 4.5 MIU (Additional Strength) | (i) Colistimethate Sodium for Injection IP 3 MIU Each Vial contains Colistimethate Sodium….300 0000 IU (ii) Colistimethate sodium for Injection IP 4.5 MIU Each Vial Contains: Colistimethate Sodium……..4500 000 IU | For the treatment of some serious infections caused by Gram-negative bacteria, including those of the lower respiratory tract and urinary tract, when more commonly used systemic antibacterial agents may be contraindicated or may be ineffective because of bacterial resistance. "WARNING: To be sold by retail on the prescription of a Medical Specialist only” | 15.01.2021 |
| Each modified release bilayered tablet contains: S (-) Metoprolol Succinate eq. to S (-) Metoprolol Tartrate (as extended release) + Telmisartan IP (Immediate Release) (25 mg + 20 mg & 25mg + 40 mg) | Each modified release bilayered tablet contains: S (-) Metoprolol Succinate eq. to S (-) Metoprolol Tartrate (as extended release) + Telmisartan IP (Immediate Release) (25 mg + 20 mg & 25mg + 40 mg) | For the treatment of essential hypertension | 18.01.2021 |
| Zinc Citrate Trihydrate eq. to Zinc ……………………10mg Ascorbic Acid IP …………1000mg Effervescent tablets | Zinc Citrate Trihydrate eq. to Zinc ……………………10mg Ascorbic Acid IP …………1000mg Effervescent tablets | For the treatment of Vitamin C and Zinc deficiency. | 01.02.2021 |
| Dapagliflozin Tablets 10 mg (Additional Indication) | Each film-coated tablets contains: Dapagliflozin propanediol monohydrate equivalent to Dapagliflozin…….. 10 mg | For the treatment of patients of Chronic Kidney Disease (CKD) up to Stage III (eGFR of greater than or equal to 30ml/min/1.73 sq.m) “WARNING: To be sold by retail on the prescription of Nephrologist only” | 03.02.2021 |
| Brivaracetam Oral Solution Solution 10mg/ml Additional Dosage Foam | Each ml contains: Brivaracetam ……10mg/ml | As adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy | 03.02.2021 |
| Each Capsules contains: Atorvastatin Calcium IP eq. to Atorvastatin……40mg Aspirin IP…...75mg (As one gastro-resistant tablet) (Additional Strength) | Each Capsules contains: Atorvastatin Calcium IP eq. to Atorvastatin……40mg Aspirin IP…...75mg (As one gastro-resistant tablet) (Additional Strength) | Treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke, or peripheral vascular disease. | 05.02.2021 |
| Each 20ml vial contains: Ceftazidime pentahydrate eq. to Ceftazidime ……….2gm Avibactam Sodium eq. to Avibactam………….0.5gm Powder for concentrate for solution for infusion | Each 20ml vial contains: Ceftazidime pentahydrate eq. to Ceftazidime ……….2gm Avibactam Sodium eq. to Avibactam………….0.5gm Powder for concentrate for solution for infusion | Complicated Intra-abdominal infections (cIAI) Complicated Urinary tract infections (cUTI), including pyelonephritis Hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP) with susceptible gram negative microorganisms. Treatment of patients with bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above. | 12.02.2021 |
| Drospirenone Tablets 4 mg (Additional Strength) | Each for uncoated Tablets Drospirenone……4 mg | Drospirenone is a Progestin intended for its use by females of reproductive potentials to prevent pregnancy | 15.02.2021 |
| Apomorphine Hydrochloride 5 mg/ml solution for infusion in 20ml vial Apomorphine Hydrochloride 10 mg/ml solution for injection in 3ml cartridge Additional pack size & strength | Apomorphine Hydrochloride solution for infusion in 20ml vial Each ml contains: Apomorphine Hydrochloride……… 5mg Apomorphine Hydrochloride solution for injection in 3ml cartridge Each ml contains: Apomorphine Hydrochloride…… 10 mg | For the treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson’s disease which persist individually titrated treatment with Levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine agonists. “WARNING: To be sold by retail on the prescription of Neurologists only” | 16.02.2021 |
| Each uncoated tablet contains: Azelnidipine IP + Chlorthalidone IP (8mg + 6.25mg & 8mg+12.5mg) | Each uncoated tablet contains: Azelnidipine IP + Chlorthalidone IP (8mg + 6.25mg & 8mg+12.5mg) | For the treatment of essential hypertension | 19.02.2021 |
| Composition of Amino acid Solution 8% solution for intravenous infusion (Pack size 500ml in Glass bottle) Per 1000ml solution for infusion contains: L-isoleucine Ph. Eur 10.40 g, L-leucine Ph. Eur 13.09 g L-lysine monoacetate corresponding to L- lysine USP 9.71g corresponding to 6.88 g, L-methionine Ph. Eur. 1.10 g N-acetyl-L-cysteine Corresponding to L-Cysteine Ph. Eur 0.70 g corresponding to 0.52 g, L-phenylalanine Ph. Eur. 0.88 g L-threonine Ph. Eur. 4.0 g, L-tryptophan Ph. Eur. 0.70 g L-valine Ph. Eur. 10.08 g,L-arginine Ph. Eur 10.72 g L-histidine Ph. Eur. 2.80 g, Glycine (Amino acetic acid) Ph. Eur. 5.82 g,L-alanine Ph. Eur. 4.64 g, L-proline Ph. Eur. 5.73 g Glacial acetic acid Ph. Eur 4.42 g,Other Excipients: Water for injections Ph. Eur….q.s. | Composition of Amino acid Solution 8% solution for intravenous infusion (Pack size 500ml in Glass bottle) Per 1000ml solution for infusion contains: L-isoleucine Ph. Eur 10.40 g, L-leucine Ph. Eur 13.09 g L-lysine monoacetate corresponding to L- lysine USP 9.71g corresponding to 6.88 g, L-methionine Ph. Eur. 1.10 g N-acetyl-L-cysteine Corresponding to L-Cysteine Ph. Eur 0.70 g corresponding to 0.52 g, L-phenylalanine Ph. Eur. 0.88 g,L-threonine Ph. Eur. 4.0 g, L-tryptophan Ph. Eur. 0.70 g,L-valine Ph. Eur. 10.08 g,L-arginine Ph. Eur 10.72 g L-histidine Ph. Eur. 2.80 g, Glycine (Amino acetic acid) Ph. Eur. 5.82 g,L-alanine Ph. Eur. 4.64 g, L-proline Ph. Eur. 5.73 g ,Glacial acetic acid Ph. Eur 4.42 g,Other Excipients: Water for injections Ph. Eur….q.s. | For supply of amino acids as part of a parenteral nutrition regimen in serve forms of hepatic insufficiency with and without hepatic encephalopathy when oral or enteral nutrition is impossible or insufficient or contraindicated. | 19.02.2021 |
| Thyroxine Sodium Tablets 88 mcg / 200mcg Additional Strength | Each uncoated tablet contains: Thyroxine Sodium………...88 mcg / 200 mcg | For the treatment of hypothyroidism | 22.02.2021 |
| Brivaracetam injection 50mg/5ml (10mg/ml) Additional dosage form & New route of administration | Each ml Contains: Brivaracetam… …….10mg | As adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy | 24.02.2021 |
| Each Film Coated tablet contains: Benidipine Hydrochloride JP + Telmisartan IP (4mg + 40mg & 4mg + 80mg) | Each Film Coated tablet contains: Benidipine Hydrochloride JP + Telmisartan IP (4mg + 40mg & 4mg + 80mg) | For the treatment of hypertension | 26.02.2021 |
| Avanafil bulk and Avanafil tablets 50mg/100mg/200mg | Avanafil bulk and Avanafil tablets 50mg/100mg/200mg | For the treatment of erectile dysfunction | 26.02.2021 |
| Riboflavin Sodium Phosphate IP eq. to Riboflavin 0.1 % w/v Ophthalmic Solution for PFS (pack size is 3.0 ml) | Riboflavin Sodium Phosphate IP eq. to Riboflavin 0.1 % w/v Ophthalmic Solution for PFS (pack size is 3.0 ml) | To treat keratoconus and corneal ectasia following refractive surgery | 27.02.2021 |
| Aripiprazole powder and solvent for prolong-release suspension for injection 300mg/vial and 400 mg/vial (Modified Dosage Form) | Each vial contains: Aripiprazole………300mg / 400mg (Supplied along with solvent/diluent) | Maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. “WARNING: To be sold by retail on the prescription of an Psychiatrist only” | 01.03.2021 |
| Rebamipide Ophthalmic Suspension 2% w/v with Stabilized Oxychloro complex (as preservative) | Each ml contains: Rebamipide…..2.0 %w/v Stabilized Oxychloro Complex…..0.01% w/v (As Preservative) | Indicated for the treatment of dry eye signs and symptoms. | 01.03.2021 |
| Pancreatin Tablets USP 200 mg (Additional Strength/New dosage form/New Indication) | Each uncoated tablet Contains: Pancreatin ...200mg Equivalent to Lipase ……..10,440 USP units Amylase…………….39,150 USP units Protease…………...3 9150 USP units | Indicated in combination with a proton pump inhibitor in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. | 01.03.2021 |
| Pemetrexed for injection 100mg/500mg (Additional Indication) | Each vial contains: Pemetrexed Disodium equivalent to Pemetrexed …100mg/500mg | In combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. "WARNING: To be sold by retail on the prescription of oncologist only” | 08.03.2021 |
| Ibuprofen solution for infusion 400mg/100ml (New Dosage Form) | Each ml contains: Ibuprofen ……………4mg | Indicated in adults for the shortterm symptomatic treatment of acute moderate pain, and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified when other routes of administration are not possible. | 08.03.2021 |
| Cholecalciferol oral drops 800IU/ml (Additional Strength/New dosage Form) | Each ml contains: Cholecalciferol ……800IU | For the treatment of vitamin D3 deficiency | 08.03.2021 |
| Osimertinib Tablets 40mg and 80mg (Additional Indication) | Each film coated tablets contains: Osimertinib (as mesylate)…...4 0mg/80mg | Osimertinib as monotherapy is indicated for: The adjuvant treatment after complete tumour resection in patients with nonsmall cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations “WARNING: To be sold by retail on the prescription of oncologist only” | 09.03.2021 |
| Omidenepag isopropyl ophthalmic solution 0.002% w/v | Omidenepag isopropyl ophthalmic solution 0.002% w/v | For the treatment of glaucoma and ocular hypertension | 12.03.2021 |
| Composition of Amino acid Solution for intravenous infusion (Pack size 100ml, 250ml, 500ml in Glass bottle) Per 1000ml solution for infusion contains: Active Ingredients Quality L-isoleucine Ph. Eur 5.10 g L-leucine Ph. Eur. 10.30 g L-lysine 10.01 g monoacetate corresponding to Llysine USP 7.1 g L-methionine Ph. Eur. 2.80 g N-acetyl-L-cysteine 0.50 g Corresponding to L-Cysteine Ph. Eur. 0.37 g L-phenylalanine Ph. Eur. 3.80 g L-threonine Ph. Eur. 4.80 g L-tryptophan Ph. Eur. 1.90 g L-valine Ph. Eur. 6.20 g L-arginine Ph. Eur. 4.90 g L-histidine Ph. Eur. 4.30 g Glycine (Amino acetic acid) Ph. Eur. 3.20 g L-alanine Ph. Eur. 6.30 g L-proline Ph. Eur. 4.30 g L-serine Ph. Eur. 4.50 g L-malic acid 1.50 g Glacial acetic acid Ph. Eur. 1.38 g Other Excipients: Water for injections Ph. Eur. | Composition of Amino acid Solution for intravenous infusion (Pack size 100ml, 250ml, 500ml in Glass bottle) Per 1000ml solution for infusion contains: Active Ingredients Quality L-isoleucine Ph. Eur 5.10 g L-leucine Ph. Eur. 10.30 g L-lysine 10.01 g monoacetate corresponding to Llysine USP 7.1 g L-methionine Ph. Eur. 2.80 g N-acetyl-L-cysteine 0.50 g Corresponding to L-Cysteine Ph. Eur. 0.37 g L-phenylalanine Ph. Eur. 3.80 g L-threonine Ph. Eur. 4.80 g L-tryptophan Ph. Eur. 1.90 g L-valine Ph. Eur. 6.20 g L-arginine Ph. Eur. 4.90 g L-histidine Ph. Eur. 4.30 g Glycine (Amino acetic acid) Ph. Eur. 3.20 g L-alanine Ph. Eur. 6.30 g L-proline Ph. Eur. 4.30 g L-serine Ph. Eur. 4.50 g L-malic acid 1.50 g Glacial acetic acid Ph. Eur. 1.38 g Other Excipients: Water for injections Ph. Eur. | Balanced supply of protein elements in acute and chronic renal insufficiently as well as during peritoneal and hemodialysis treatment. | 15.03.2021 |
| Composition of Amino acid Solution 5% for intravenous infusion (Pack size 500ml in Glass bottle) Per 1000ml solution for infusion contains: Active Ingredients Quality Isoleucine Ph. Eur 2.50 g Leucine Ph. Eur. 3.70 g Lysine monoacetate 4.655 g corresponding to Lysine USP 3.30 g Methionine Ph. Eur. 2.15 g Phenylalanine Ph. Eur. 2.55 g Threonine Ph. Eur. 2.20 g Tryptophan Ph. Eur. 1.00 g Valine Ph. Eur. 3.10 g Arginine Ph. Eur. 6.00 g Histidine Ph. Eur. 1.50 g Glycine Ph. Eur. 5.50 g Alanine Ph. Eur. 7.00 g Proline Ph. Eur. 5.60 g Serine Ph. Eur. 3.25 g Taurine 0.50 g Tyrosine Ph. Eur. 0.20 g Other Excipients: Glacial acetic acid Ph. Eur. Water for injections Ph. Eur. | Composition of Amino acid Solution 5% for intravenous infusion (Pack size 500ml in Glass bottle) Per 1000ml solution for infusion contains: Active Ingredients Quality Isoleucine Ph. Eur 2.50 g Leucine Ph. Eur. 3.70 g Lysine monoacetate 4.655 g corresponding to Lysine USP 3.30 g Methionine Ph. Eur. 2.15 g Phenylalanine Ph. Eur. 2.55 g Threonine Ph. Eur. 2.20 g Tryptophan Ph. Eur. 1.00 g Valine Ph. Eur. 3.10 g Arginine Ph. Eur. 6.00 g Histidine Ph. Eur. 1.50 g Glycine Ph. Eur. 5.50 g Alanine Ph. Eur. 7.00 g Proline Ph. Eur. 5.60 g Serine Ph. Eur. 3.25 g Taurine 0.50 g Tyrosine Ph. Eur. 0.20 g Other Excipients: Glacial acetic acid Ph. Eur. Water for injections Ph. Eur. | For supply of amino acids as part of a parenteral nutrition regimen | 15.03.2021 |
| Composition of Amino acid Solution 10% for intravenous infusion (Pack size 500ml in Glass bottle) Per 1000ml solution for infusion contains: Active Ingredients & Quality - L-Isoleucine Ph. Eur 5.00 g , L-Leucine Ph. Eur.7.40 g, L-Lysine monoacetate 9.31 g, corresponding to Llysine USP 6.60 g,L-Methionine Ph. Eur. 4.30 g,L-Phenylalanine Ph. Eur.5.10 g,L-Threonine Ph. Eur. 4.40 g,L-Tryptophan Ph. Eur. 2.00 g, L-Valine Ph. Eur. 6.20 g,L-Arginine Ph. Eur.12.00 g,L-Histidine Ph. Eur. 3.00 g,Glycine (Amino acetic acid)Ph. Eur. 11.00 g,L-Alanine Ph. Eur.14.00 g,L-Proline Ph. Eur.11.20 g,L-Serine Ph. Eur. 6.50 g,Taurine 1.00 g, L-Tyrosine Ph. Eur. 0.40 g,Other Excipients: Glacial acetic acid Ph. Eur.,Water for injections Ph. Eur | Composition of Amino acid Solution 10% for intravenous infusion (Pack size 500ml in Glass bottle) Per 1000ml solution for infusion contains: Active Ingredients & Quality - L-Isoleucine Ph. Eur 5.00 g , L-Leucine Ph. Eur.7.40 g, L-Lysine monoacetate 9.31 g, corresponding to Llysine USP 6.60 g,L-Methionine Ph. Eur. 4.30 g,L-Phenylalanine Ph. Eur.5.10 g,L-Threonine Ph. Eur. 4.40 g,L-Tryptophan Ph. Eur. 2.00 g, L-Valine Ph. Eur. 6.20 g,L-Arginine Ph. Eur.12.00 g,L-Histidine Ph. Eur. 3.00 g,Glycine (Amino acetic acid)Ph. Eur. 11.00 g,L-Alanine Ph. Eur.14.00 g,L-Proline Ph. Eur.11.20 g,L-Serine Ph. Eur. 6.50 g,Taurine 1.00 g, L-Tyrosine Ph. Eur. 0.40 g,Other Excipients: Glacial acetic acid Ph. Eur.,Water for injections Ph. Eur | For supply of amino acids as part of a parenteral nutrition regimen | 15.03.2021 |
| Each extended release tablet contains: Pseudoephedrine Hydrochloride IP…120mg Fexofenadine Hydrochloride IP……..60mg (Additional Dosage form) | Each extended release tablet contains: Pseudoephedrine Hydrochloride IP…120mg Fexofenadine Hydrochloride IP……..60mg (Additional Dosage form) | It is indicated for the relief of symptoms associated with allergic rhinitis in adults and children 12 years of age and older. | 19.03.2021 |
| Dolutegravir Dispersible Tablets 10mg (Additional Dosage Form) | Each Tablet contains: Dolutegravir sodium equivalent to Dolutegravir 10mg | In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus type1 (HIV-l) infection in adults (treatment-naive or-experienced) and in pediatric patients (treatment-naive or -experienced but integrase strand transfer inhibitor [INSTI]-naive) aged at least 4 weeks and weighing at least 3 kg "WARNING: To be sold by retail on the prescription of a Specialist only” | 23.03.2021 |
| Sildenafil Citrate Oral Spray 12.5% w/v (Additional Dosage Form) | Each Spray (0.2ml) delivers Sildenafil citrate equivalent to Sildenafil…….25 mg | For the treatment of Erectile Dysfunction in men “WARNING: To be sold by retail on the prescription of an Urologist, Psychiatrist and Endocrinologist only” | 3/26/2021 |
| Dexamethasone Tablets 6 mg (Additional Strength) | Each film coated tablet contains : Dexamethasone ……6 mg | Dexamethasone is indicated for treatment of variety of disorders in which systemic glucocorticoids are indicated including: • Neurology: Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a primary or metastatic brain tumour, craniotomy or head injury. • Dermatology: Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids, e.g. erythroderma, pemphigus vulgaris. • Autoimmune disorders/rheumatology: Initial treatment of autoimmune disorders like systemic lupus erythematodes, in acute gouty arthritis ,acute arthritis carditis, ankylosing spondylitis ,psoriatic arthritis , Severe progressive course of active rheumatoid arthritis Severe systemic course of juvenile idiopathic arthritis (Still's disease). • Haematological disorder: Idiopathic thrombocytopenic purpura in adults. • Oncologists only- for steroid responsive neoplastic disease like leukemias and lymphomas in adults only. | 06.04.2021 |
| Betahistine Hydrochloride Orally Disintegrating tablet 8mg/16mg/24 mg (New Dosage Form) | Each Uncoated Orally Disintegrating Tablet Contains: Betahistine Hydrochloride mg/16mg/24mg Excipients q.s. | Indicated for the symptomatic treatment of vertigo caused due to conditions including Menier’s syndrome | 06.04.2021 |
| Each Film coated bilayered tablets contains: Mirabegron (in extended release) + Solifenacin Succinate (50mg + 5mg & 25mg + 5mg) | Each Film coated bilayered tablets contains: Mirabegron (in extended release) + Solifenacin Succinate (50mg + 5mg & 25mg + 5mg) | It is indicated for the treatment of overactive bladder (OAB) | 08.04.2021 |
| Each 10ml liquid sachet contains: Sodium Hyaluronate BP………….1.24% Chondroitin Sulfate Sodium BP….3.12% Poloxamer IP (407)……………….2.7% Oral Liquid | Each 10ml liquid sachet contains: Sodium Hyaluronate BP………….1.24% Chondroitin Sulfate Sodium BP….3.12% Poloxamer IP (407)……………….2.7% Oral Liquid | For the treatment of symptoms of Gastro Esophageal Reflux Disease (GERD) | 09.04.2021 |
| Pegaspargase powder for solution for injection/ infusion (New Dosage Form & Indication) | Each vial contains: Pegaspargase ……3750 U (After reconstitution each ml contains 750U of Pegaspargase) | Indicated as a component of anti-neoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients | 09.04.2021 |
| Each pack (200 ml) contains: Zinc Sulphate Monohydrate IP ….0.0110g Sodium Citrate IP………..0.5800g Potassium chloride IP……0.3000g Sodium Chloride IP………0.5200g Dextrose Anhydrous IP……2.7000g | Each pack (200 ml) contains: Zinc Sulphate Monohydrate IP ….0.0110g Sodium Citrate IP………………..0.5800g Potassium chloride IP……………0.3000g Sodium Chloride IP………………0.5200g Dextrose Anhydrous IP…………..2.7000g | For oral rehydration in various etiology | 15.4.2021 |
| Ozenoxacin bulk and Ozenoxacin cream 1% w/w | Ozenoxacin bulk and Ozenoxacin cream 1% w/w | Indicated for the topical treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes in adult and pediatric patients 2 months of age and older | 15.04.2021 |
| Drospirenone Tablets 4mg (New Dosage Form) | Each Film Coated Tablet Contains: Drospirenone ………4mg | Drospirenone is a Progestin intended for its use by females of reproductive potentials to prevent pregnancy | 22.04.2021 |
| Baricitinib Tablets 1mg, 2mg, & 4 mg (Additional Strength & Additional Indication) | Each Film Coated Tablet Contains: Baricitinib…1 mg/2mg/4 mg | Baricitinib, in combination with Remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) “WARNING: To be sold by retail on the prescription of specialist for use in Hospital/ Institutional set up only” | 01.05.2021 |
| 2-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose 2.34g & 5.85g sachet | 2-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose 2.34g & 5.85g sachet | As an adjunct therapy only in moderate to severe Covid-19 patients | 01.05.2021 |
| Remdesivir Injection 100mg/20 ml (without Cyclodextrin) | Each ml Contains Remdesivir...5 mg | For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID19) in adults and children hospitalized with moderate to severe disease “WARNING: To be sold by retail on the prescription of specialist for use in Hospital/ Institutional set up only” | 06.05.2021 |
| Capmatinib 150mg and 200mg film coated tablets | Capmatinib 150mg and 200mg film coated tablets | Capmatinib is a kinase inhibitor indicated for the treatment of adult patient with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal epithelial transition (MET) exon 14 skipping. | 12.05.2021 |
| Rucaparib camsylate bulk and Rucaparib tablets 200mg/300mg | Rucaparib camsylate bulk and Rucaparib tablets 200mg/300mg | Ovarian cancer • For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. • For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDAapproved companion diagnostic for RUBRACA. Prostate cancer • For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic) associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. | 12.05.2021 |
| Each Film Coated tablets contains: L-Tyrosine USP……………60mg Histidine Hydrochloride Monohydrate BP eq. to Histidine…………………76mg L-Tryptophan USP…………46mg L-Threonine USP………….106mg L-Lysine Acetate USP…......210mg Calcium-DL-2-hydroxy-4(methylthio) Butyrate (α-Ketoanalogue to MethionineCalcium salt) IH…...........118mg Calcium-3-Methyl-2 Oxo-Butyrate (α-Ketoanalogue to Valine Calcium salt) IH…………………………..172mg Calcium-2-Oxo-3-Phenylpropionate (α-Ketoanalogue to Phenylalanine Calcium salt) IH………………136mg Calcium-4-Methyl-2-Oxo-Valerate (α-Ketoanalogue to Leucine Calcium salt) IH…………………………….202mg Calcium-3-methyl-2-Oxo-Valerate (α-Ketoanalogue to Isoleucine Calcium salt) IH…............……..………….134mg | Each Film Coated tablets contains: L-Tyrosine USP……………60mg Histidine Hydrochloride Monohydrate BP eq. to Histidin……76mg L-Tryptophan USP…………46mg L-Threonine USP………….106mg L-Lysine Acetate USP…......210mg Calcium-DL-2-hydroxy-4(methylthio) Butyrate (α-Ketoanalogue to MethionineCalcium salt) IH…...........118mg Calcium-3-Methyl-2 Oxo-Butyrate (α-Ketoanalogue to Valine Calcium salt IH……………..172mg Calcium-2-Oxo-3-Phenylpropionate (α-Ketoanalogue to Phenylalanine Calcium salt) IH………………136mg Calcium-4-Methyl-2-Oxo-Valerate (α-Ketoanalogue to Leucine Calcium salt) I……….202mg Calcium-3-methyl-2-Oxo-Valerate (α-Ketoaalogue to Isoleucine Calcium salt) IH….......134mg | Prevention and treatment of damages due to faulty of or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40g/day or less (adult). Usually this applies to patients whose glomerular filtration rate (GFR) is less than 25ml/min | 18.05.2021 |
| Favipiravir Oral suspension 100mg/ml (New Dosage Form) | Each ml contains: Favipiravir…….. ....100mg | For the treatment of patients with mild to moderate Covid19 disease “Warning To be sold on prescription of medical specialist” | 19.05.2021 |
| Posaconazole DelayedRelease Tablets (Additional Indication) | Each Delayed Release Tablets contains: Posaconazole ……. 100mg | For the treatment oforopharyngeal candidiasis, including oropharyngeal candidiasis refractory to Itraconazole and/or fluconazole for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Zygomycosis (Mucormycosis) in patients with diseases refractory to other therapy ,or or patients who are intolerant to other therapy “Warning To be sold on prescription of medical specialist” | 28.05.2021 |
| Trientine Tetrahydrochloride bulk and Trientine Tetrahydrochloride capsules 333 mg (Each capsule contains Trientine tetrahydrochloride 333mg equivalent to Trientine 167mg base) | Trientine Tetrahydrochloride bulk and Trientine Tetrahydrochloride capsules 333 mg (Each capsule contains Trientine tetrahydrochloride 333mg equivalent to Trientine 167mg base) | For the treatment of Wilson's disease (hepatolenticular degeneration) in patients intolerant to Penicillamine. It should be used when continued treatment with Penicillamine is no longer possible because of intolerable or life endangering side effects | 08.06.2021 |
| Methylcobalamin Nasal Spray 250mcg/0.1ml | Methylcobalamin Nasal Spray 250mcg/0.1ml | For treatment and maintenance therapy of Vitamin B12 deficiency in patients | 09.06.2021 |
| Rucaparib tablets 250 mg | Rucaparib tablets 250 mg | Ovarian cancer • For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. • For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDAapproved companion diagnostic for RUBRACA. Prostate cancer • For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic) associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. | 18.06.2021 |
| Vigabatrin bulk and Vigabatrin powder for oral solution 500mg | Vigabatrin bulk and Vigabatrin powder for oral solution 500mg | For the treatment of 1) Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin for Oral Solution, USP, 500 mg is not indicated as a first line agent. 2) Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss | 18.06.2021 |
| Cangrelor tetra sodium bulk and Cangrelor for injection 50mg/vial | Cangrelor tetra sodium bulk and Cangrelor for injection 50mg/vial | Indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revarscularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor | 21.06.2021 |
| Each 5ml sustained release oral suspension contains: Dextromethorphan Polistirex eq. to Dextromethorphan Hydrobromide IP 30mg Chlorpheniramine Polistirex eq. to Chlorpheniramine Maleate IP ……….4mg Methyl Paraben IP …………………10mg Propyl paraben IP ………………….1mg | Each 5ml sustained release oral suspension contains: Dextromethorphan Polistirex eq. to Dextromethorphan Hydrobromide IP 30mg Chlorpheniramine Polistirex eq. to Chlorpheniramine Maleate IP ……….4mg Methyl Paraben IP …………………10mg Propyl paraben IP ………………….1mg | For the temporary relief of cough, due to throat irritation, sneezing and running nose | 23.06.2021 |
| Ulinastatin for Injection 200, 000 IU (Liquid) | Ulinastatin for Injection 200, 000 IU (Liquid) | • For the treatment of severe sepsis. • For the treatment of mild and severe acute pancreatitis | 24.06.2021 |
| Rifapentine bulk and FDC of Isoniazid and Rifapntine (300mg/300mg) | Rifapentine bulk and FDC of Isoniazid and Rifapntine (300mg/300mg) | Indicated for treatment of latent tuberculosis, caused by Mycobacterium tuberculosis (For use in NTEP only) | 28.06.2021 |
| Remogliflozin Etabonate……100mg Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin ………10mg | Each tablet contains: RemogliflozinEtabonate……100mg Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin ……10mg | It is indicated in adults aged 18 years and older with type 2 diabetes mellitus: To improve glycaemic control when Metformin and one of monocomponents of fixed dose combination of RemogliflozinEtabonate& Teneligliptin do not provide adequate glycaemic control, When already being treated with the free combination of RemogliflozinEtabonate& Teneligliptin. | 28.06.2021 |
| Clozapine Tablet 12.5 mg (Additional Strength) | Each uncoated tablet contains: Clozapine12.5 mg | Indicated in the management ofschizophrenic patients "WARNING: To be sold by retail on the prescription of Neurologist only” | 29.06.2021 |
| Sorafenib 400 mg Tablet (Additional Strength) | Each film coated tablets contains : Sorafenib Tosylate eq. to Sorafenib…400 mg | For the treatment of hepatocellular carcinoma, advanced renal cell carcinoma and locally advance or metastatic differentiated thyroid carcinoma refractory to radioactive iodine "WARNING: To be sold by retail on the prescription of Oncologist only” | 30.06.2021 |
| Lemborexant tablets 5 mg and 10 mg | Lemborexant tablets 5 mg and 10 mg | Treatment for insomnia | 01.07.2021 |
| Each capsule contains: Tamsulosin Hydrochloride IP (as prolonged release pellet)……..0.4mg Tadalafil IP (as film coated tablet)……5mg | Each capsule contains: Tamsulosin Hydrochloride IP (as prolonged release pellet)……..0.4mg Tadalafil IP (as film coated tablet)……5mg | Substitution therapy in treatment of benign prostatic hyperplasia and erectile dysfunction in patients who are already taking Tamsulosin and Tadalafil concomitantly | 02.07.2021 |
| Rosuvastatin Calcium IP eq. to Rosuvastatin………………..20mg (as film coated immediate release tablet) Choline Fenofibrate IP eq. to Fenofibric acid (as delayed release tablet)…..135mg | Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin………………..20mg (as film coated immediate release tablet) Choline Fenofibrate IP eq. to Fenofibric acid (as delayed release tablet)…..135mg | For the treatment of mixed dyslipidemia | 06.07.2021 |
| Favipiravir Powder for Oral suspension 800mg (AdditionalDosage Form) | Each sachet contains: 1.5g of Favipiravir powder contains: Favipiravir...........800 mg Excipients.....q.s | For the treatment of patients with mild to moderate Covid-19 disease “WARNING: To be sold on the prescription of medical specialist” | 06.07.2021 |
| Each 1 g contains: Lincomycin Hydrochloride…….0.222g Spectinomycinsulphate………..0.445g | Each 1 g contains: Lincomycin Hydrochloride…….0.222g Spectinomycinsulphate………..0.445g | Poultry: For prevention and treatment of Chronic Respiratory Disease(CRD)/airsacculitis caused by Mycoplasma spp. And CCRD (Complicated Chronic Respiratory Disease) associated with Mycoplasma and coliform infections ofpoultry susceptible to the combination of lincomycin and spectinomycin. Swine(pigs): For the treatment of swine dysentery, bacterial enteritis caused by Ecoli or Salmonella spp., porcine proliferative enteropathy (Ileitis) caused by Lawsoniaintracellularis and infectious arthritis caused by organismssusceptible to the combination of lincomycin and spectinomycin. [This drug combination will be used for therapeutic purpose (not for the growth promotion purpose) considering the growing concernof Antimicrobial resistance] | 09.07.2021 |
| Heparin Sodium Topical Solution 1000 IU/ml (Additional Indication) | Each ml contains : Heparin Sodium…..........1000 IU/ml Absolute Alcohol……….10.00% v/v Topical Solution base…….q.s. | For Prevention of infusion associated phlebitis "WARNING: To be sold by retail on the prescription of Specialists only” | 09.07.2021 |
| Cetilistat bulk and Cetilistat 120 mg tablets | Cetilistat bulk and Cetilistat 120 mg tablets | For the treatment of Obseity (limited to patients with both type 2 diabetes mellitus and dyslipidaemia, and with a BMI ≥ 25 kg/m2 inspite of dietary treatment and /or excersise therapy) | 09.07.2021 |
| Benzonatate bulk and Benzonatate capsules 100mg | Benzonatate bulk and Benzonatate capsules 100mg | For the treatment of refractory cough | 15.07.2021 |
| Dextromethorphan Hydrobromide IP……………..10mg Phenylephrine Hydrochloride IP…..5mg Chlorpheniramine Maleate IP…..2mg | Dextromethorphan Hydrobromide IP……………..10mg Phenylephrine Hydrochloride IP…..5mg Chlorpheniramine Maleate IP…..2mg | Indicated for relief from the symptoms of common cold and nasal congestion and associated fever due to allergic reactions. | 16.07.2021 |
| Fluticasone Furoate………………..27.5mcg Oxymetazoline Hydrochloride IP…50mcg Composition: Fluticasone Furoate……..0.028%w/w Oxymetazoline Hydrochloride IP………………………..0.050%w/w Benzalkonium Chloride solution IP………..0.030%w/w | Each spray delivers contains: Fluticasone Furoate………………..27.5mcg Oxymetazoline Hydrochloride IP…50mcg Composition: Fluticasone Furoate……..0.028%w/w Oxymetazoline Hydrochloride IP………………………..0.050%w/w Benzalkonium Chloride solution IP………………………..0.030%w/w | Indicated for the treatment of symptoms of allergic rhinitis with nasal congestion | 16.07.2021 |
| Dydrogesterone IP……2.5mg Estradiol EP…………0.5mg | Each tablets contains: Dydrogesterone IP……2.5mg Estradiol EP…………0.5mg | For the treatment of Hormone replacement therapy (HRT) in estrogen deficiency in postmenopausal women with a uterus | 16.07.2021 |
| Cariprazine hydrochloride bulk and Cariprazine capsules 1.5mg/3mg/4.5mg and 6mg | Cariprazine hydrochloride bulk and Cariprazine capsules 1.5mg/3mg/4.5mg and 6mg | For the treatment of Schizophrenia in adults. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults | 16.07.2021 |
| Acetylsalicylic acid effervescent Tablets 500 mg | Acetylsalicylic acid effervescent Tablets 500 mg | Analgesic & Anti pyretic | 16.07.2021 |
| Pemetrexed for injection 1000mg (Lyophilized) (Additional Strength) | Each vial contains: Pemetrexed Disodium heptahydrate IP equivalent to Pemetrexed……1000mg | 1. Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. First line treatment Should be a platinum doublet with gemcitabine, paclitaxel or docetaxel. 2. In combination with cisplatin is indicated for the first line treatment of patients with locally advancedor metastatic non-small cell lung cancer other than predominantly squamous cell histology. 3. As monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. 4. As monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has to progressed immediately following platinum based chemotherapy. | 16.07.2021 |
| Amikacin Injection 750 mg/3ml & 100mg/4ml | Amikacin Injection 750 mg/3ml & 100mg/4ml | Amikacin Injection is indicated in the treatment of serious infections due to Amikacin sensitive organisms | 23.07.2021 |
| Riboflavin Sodium Phosphate IP eq. to Riboflavin 0.1 % w/v with Hypromellose Ophthalmic Solution in PFS (Pack Size is 3.0ml) (Additional Pack Size) | Each ml contains: Riboflavin Sodium Phosphate IP Eq. to Riboflavin …0.1% w/v Hypromellose I.P…….1.1%w/v | To treat keratoconus and corneal ectasia following refractive surgery | 27.07.2021 |
| Composition of Hydroxyl Ethyl Starch 6% Solution for infusion (Pack Size-250ml, 500ml) Per 1000ml solution for infusion contains: Poly (O-2-hydroxyethyl) starch….60.00g Sodium Chloride Ph. Eur. ……….9.00g Other Excipients: Sodium hydroxide Ph. Eur. Hydrochloride acid Ph. Eur., Water for injections Ph. Eur. Electrolytes: Na+, C1-154 mmo1, 154 mmo1 | Composition of Hydroxyl Ethyl Starch 6% Solution for infusion (Pack Size-250ml, 500ml) Per 1000ml solution for infusion contains: Poly (O-2-hydroxyethyl) starch….60.00g Sodium Chloride Ph. Eur. ……….9.00g Other Excipients: Sodium hydroxide Ph. Eur. Hydrochloride acid Ph. Eur., Water for injections Ph. Eur. Electrolytes: Na+, C1-154 mmo1, 154 mmo1 | For the treatment and prophylaxis of hypovolaemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma | 29.07.2021 |
| Each Combipack contains: One Tablet of Netupitant300mg (each film coated) and One tablet of Palonosetron Hydrochloride USP eq. to Palonosetron0.5mg (each uncoated tablet) | Each Combipack contains: One Tablet of Netupitant300mg (each film coated) and One tablet of Palonosetron Hydrochloride USP eq. to Palonosetron0.5mg (each uncoated tablet) | For the prevention of acute and delayed nausea and vomiting associated with highly emetogenic Cisplatin-based cancer chemotherapy. For the prevention of acute and delayed nausea and vomiting associated with moderate emetogenic cancer chemotherapy | 29.07.2021 |
| Gadoteridol 279.3 mg/ml for injection | Gadoteridol 279.3 mg/ml for injection | For intravenous use in magnetic reasonance imaging (MRI) in adults and pediatric patients over 2 years of age for whole body MRI including the head, neck, liver, breast, musculoskeletal system and soft tissue pathologies | 29.07.2021 |
| Amorolfine Lotion 0.25% w/v (Additional Dosage Form) | Each ml contains: Amorolfine Hydrochloride Equivalent to Amorolfine…….0.2 5% w/v | For the treatment of dermatomycosis caused by dermatophytes, cutaneous candidiasis and pityriasis versicolor "WARNING: To be sold by retail on the prescription of an Dermatologist only” | 29.07.2021 |
| Magnesium chloride Hexahydrate 0.3gm + Potassium chloride 0.3gm + Sodium chloride 6.02gm + Sodium acetate Trihydrate 4.63gm + Poly (O-2-hydroxyethyl) starch 60gm per 1000ml solution for infusion (Pack size 250ml & 500ml) | Magnesium chloride Hexahydrate 0.3gm + Potassium chloride 0.3gm + Sodium chloride 6.02gm + Sodium acetate Trihydrate 4.63gm + Poly (O-2-hydroxyethyl) starch 60gm per 1000ml solution for infusion (Pack size 250ml & 500ml) | For the treatment and prophylaxis of hypovolaemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma | 30.07.2021 |
| Silodosin Tablet 8 mg (Additional Dosage Form) | Each film coated tablets contains : Silodosin…8 mg | For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only "WARNING: To be sold by retail on the prescription of a Urologist only” | 30.07.2021 |
| 1. Sodium Alginate IP 250mg + Sodium Bicarbonate IP 106.5mg + Calcium Carbonate IP 187.5mg chewable tablet 2. Sodium Alginate IP 250mg + Sodium Bicarbonate IP 106.5mg + Calcium Carbonate IP 162.5mg per 5ml suspension | 1. Sodium Alginate IP 250mg + Sodium Bicarbonate IP 106.5mg + Calcium Carbonate IP 187.5mg chewable tablet 2. Sodium Alginate IP 250mg + Sodium Bicarbonate IP 106.5mg + Calcium Carbonate IP 162.5mg per 5ml suspension | Heartburn and Indigestion | 05.08.2021 |
| Remdesivir Injection 100mg/20ml (5mg/ml) (with Hydroxypropyl Betadex as Excipent) | Each ml contains: Remdesivir…5mg Hydrocypropyl Betadex (As excipient)…300mg | For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and children hospitalized with moderate to severe disease, in light of Covid 19 outbreak, for restricted emergency use in the country. “Warning : To be Sold by retail on the prescription of specialist for use in Hospital/Institutional set up only” | 05.08.2021 |
| Bilastine Tablets 40mg (Additional Strength) | Each film-coated tablet contains : Bilastine ……40mg. | For the treatment of Chronic Spontaneous Urticaria The firm should conduct an active PMS study. Accordingly, the firm should submit active PMS protocol for review by the committee "WARNING: To be sold by retail on the prescription of Dermatologist only” | 06.08.2021 |
| Enzalutamide Hard Gelatin Capsules 80mg (Additional Indication) | Each Hard Gelatin Capsule contains : Enzalutamide……..80mg | In the treatment of adult men with metastatic castrationresistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. "WARNING: To be sold by retail on the prescription of Oncologist only” | 06.08.2021 |
| Triptorelin powder for Injection 3.75 mg/vial (Additional Indication) | Each pack contains: One vial of Triptorelin pamoate for injection Each single dose vial contains: (Sterile Lyophilized) Triptorelin pamoate equivalent to Triptorelin ….. 3.75 mg Excipients…….q.s. | Indicated for the adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of hormone receptor-positive early stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after completion of chemotherapy”. “WARNING: To be sold by retail on the prescription of Oncologist only” | 06.08.2021 |
| Lorlatinib tablets 25/100 mg (Additional Indication) | Each film-coated tablets contains: Lorlatinib……25mg/100mg | Lorlatinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) positive “WARNING: To be sold by retail on the prescription of oncologist only” | 06.08.2021 |
| Palbociclib Capsules and Palbociclib Tablets 75/100/125 mg (Additional Indication) | Each Hard Gelatin Capsule contains: Palbociclib……… ….75mg/100mg/125 mg Each FilmCoated Tablets contains: Palbociclib……… ….75mg/100mg/125mg | “Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)- negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy and with Fulvestrant in patients who have received prior therapy for Male patients" “WARNING: To be sold by retail on the prescription of oncologist only | 06.08.2021 |
| Itraconazole Capsule 130 mg(Suprabioavailable formulation) (Additional Strength, Modified Dosage form) | Each Capsule Contains: Itraconazole……… ..130 mg | Itraconazole 130 mg Capsule is indicated for the treatment of the following fungal infections in immunocompromised and non- immunocompromised adult patients: Blastomycosis, Pulmonary and Extra pulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis. Aspergillosis, pulmonary and extra-pulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy "WARNING: To be sold by retail on the prescription of a Specialist only” | 09.08.2021 |
| Atorvastatin Calcium IP Eq. to Atorvastatin…………..40mg ClopidogrelBisulphate IP Eq. to Clopidogrel……………75mg (Additional Strength) | Each hard gelatin capsule contains: Atorvastatin Calcium IP Eq. to Atorvastatin…………..40mg ClopidogrelBisulphate IP Eq. to Clopidogrel……………75mg (Additional Strength) | For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease | 13.08.2021 |
| Lamivudine IP…….300mg Dolutegravir Sodium eq. to Dolutegravir……….50mg | Each Film Coated Tablet contains: Lamivudine IP…….300mg Dolutegravir Sodium eq. to Dolutegravir……….50mg | Indicated as a complete regimen for the treatment of human immunodeficiency virus type1 (HIV-1) infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components. | 13.08.2021 |
| Ropivacaine Hydrochloride IP Eq. to anhydrous Ropivacaine Hydrochloride……………7.5mg Dextrose (Monohydrate) IP……………….80mg Water for Injections IP……..q.s | Each ml contains: Ropivacaine Hydrochloride IP Eq. to anhydrous Ropivacaine Hydrochloride……………7.5mg Dextrose (Monohydrate) IP……………….80mg Water for Injections IP……..q.s | For the patients undergoing lower limb orthopedic surgeries under Spinal Anesthesia. | 13.08.2021 |
| Darolutamide 300mg film coated tablets | Each film coated tablets contains : Darolutamide …...300mg | For the treatment of patients with nonmetastatic castration resistant prostate cancer (nmCRPC) | 13.08.2021 |
| Tetracosactide BP bulk and Tetracosactide injection BP 250 mcg/ml | Tetracosactide BP bulk and Tetracosactide injection BP 250 mcg/ml | Diagnostic test for the investigation of adrenocortical insufficiency | 14.08.2021 |
| Progesterone Solution for Injection (50mg/2.237ml) (Additional Strength) | Each Vial (2.237ml) Contains: Progesterone …………………. 50mg (22.35 mg/ml) Water for Injections IP…………q.s | Indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations. "WARNING: To be sold by retail on the prescription of a Gynecologists only” | 17.08.2021 |
| Estradiol 1.53 mg/ actuation, Transdermal spray, solution (Additional dosage form and Additional Indication) | Each actuation delivers Estradiol Ph. Eur……………… …1.53 mg (Equivalent to 1.58mg Estradiol hemihydrate) Ethanol 96% USP …………………0.09 ml (Octisalate USP and Ethanol 96% used as excipients) | Hormone Replacement Therapy (HRT) for Estrogen deficiency symptoms in Peri / postmenopausal women (in women at least 6 months since last menses or surgical menopause, with or without a uterus). The experience in treating women older than 65 years is limited Firm should conduct active Post Marketing Surveillance study to assess the safety and efficacy. Firm should submit the results of the PMS study within one year from date of approval. “WARNING: To be sold by retail on the prescription of Gynecologists only” | 17.08.2021 |
| Posaconazole Gastro Resistant Tablets 300 mg (Additional Indication) | Each Gastro Resistant Tablets Contains: Posaconazol … .300 mg | For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as Hematopoietic Stem Cell Transplant (HSCT) recipients with Graft-Versus Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Zygomycosis (Mucormycosis). in patients with disease refractory to other therapy, or patients who are intolerant of other therapy "WARNING: To be sold by retail on the prescription of a Medical Specialist only” | 17.08.2021 |
| Mesalazine Prolonged Release Granules 1gm & 2gm (Additional dosage form & strength) | (i) Mesalazine Prolonged Release Granules 1gm Each Sachet Contains: Mesalazine ………… 1gm Excipients …………...q.s (as film coated granules) (ii) Mesalazine Prolonged Release Granules 2gm Each Sachet Contains: Mesalazine ………… 2gm Excipients …………... q.s (as film coated granules) | Chronic inflammatory bowel disease (Ulcerative Colitis and Crohn’s disease) | 17.08.2021 |
| Cyclosporine Ophthalmic Solution 0.09% w/v (Additional dosage & Additional Indication) | Each ml contains: Cyclosporine IP………………0.09 mg Aqueous Buffered Vehicle…………q. s | Indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). Firm required to conduct Phase IV clinical trial. Accordingly firm should submit phase IV protocol “WARNING: To be sold by retail on the prescription of Ophthalmologist only” | 23.08.2021 |
| Azacitidine Tablets 300 mg (New Dosage form & Additional Indication) | Each film coated tablet contains: Azacitidine IP …………300 mg | For continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRI) following intensive induction chemotherapy and are not able to complete intensive curative therapy "WARNING: To be sold by retail on the prescription of Oncologist only” | 23.08.2021 |
| Minoxidil Topical Solution 2% and 5% (Additional Indication) | Minoxidil Topical Solution 2% Each ml contains: Minoxifil IP 20mg Alcohol (95%) IP equivalent to absolute alcohol 63% v/v Minoxidil Topical Solution 5% Each ml contains: Minoxifil IP 50mg Alcohol (95%) IP equivalent to absolute alcohol 40% v/v | For the treatment of androgenic alopecia in females (female pattern hair loss) "WARNING: To be sold by retail on the prescription of a Dermatologist only” | 02.09.2021 |
| Moxifloxacin Ophthalmic Solution 0.5% w/v (Additional Indication) | Each ml of Ophthalmic Solution contains: Moxifloxacin Hydrochloride equivalent to Moxifloxacin base…5 mg | Indicated for sterilization during the perioperative period of ophthalmic surgery “WARNING: To be sold by retail on the prescription of Ophthalmologists only” The firm should submit protocol for active PMS Study | 02.09.2021 |
| Pemetrexed Solution for Infusion 5mg/ml, 6mg/ml, 6.5mg/ml, 7mg/ml, 7.5mg/ml, 8mg/ml, 8.5mg/ml, 9mg/ml, 10mg/ml & 11mg/ml (100ml ready to use infusion bag (Additional Dosage Form) | Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed…5mg Sodium Chloride ………………9mg Water for Injections ………………. q. s. Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 6mg Sodium Chloride ……………… 9mg Water for Injections...….…………q. s. Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 6.5mg Sodium Chloride …9mg Water for Injections ………………. q.s. Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed….7mg Sodium Chloride ……………….9mg Water for Injections ………………. q. s. Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 7.5mg Sodium Chloride………………………9mg Water for Injections.………………. q. s Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed…...8mg Sodium Chloride ………………………9mg Water for Injections ………………q. s. Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 8.5mg Sodium Chloride .......……………….9mg Water for Injections ………………q. s. Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed….9mg Sodium Chloride …………………….9mg Water for Injections ………………. q. s. Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 10mg Sodium Chloride ….…………….9mg Water for Injections ….…………….q. s. Each ml Contains: Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 11mg Sodium Chloride ……………….9mg Water for Injection ..........q.s. | 1. Malignant pleural mesothelioma: In combination with Cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. 2. Non-Small Cell Lung Cancer (NSCLC): In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology. As a monotherapy for the second-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology. As a monotherapy for the maintenance treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. In combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. "WARNING: To be sold by retail on the prescription of anoncologist only” | 03.09.2021 |
| Isoniazid IP…………300mg Rifampentine…………..300mg (Additional Indication) | Each Film Coated tablet contains:- Isoniazid IP…………300mg Rifampentine…………..300mg (Additional Indication) | For the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in patients who are at risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph) | 09.06.2021 |
| Sodium Alginate IP……….500mg Sodium Bicarbonate IP……213mg Calcium Carbonate IP……..325mg Oral Suspension | Each 10 ml contains:- Sodium Alginate IP……….500 mg Sodium Bicarbonate IP……213 mg Calcium Carbonate IP……..325mg Oral Suspension | Heartburn and indigestion | 07.09.2021 |
| Cabozantinib (S) - Maleate bulk and Cabozantinib tablets 20mg, 40mg and 60mg | Each tablets contains : Cabozantinib ……20mg, 40 mg, 60 mg | (1) For the treatment of patients with advanced renal cell carcinoma (RCC). (2) For the treatment of patients with Hepatocellular Carcinoma (HCC) who have been previously treated with sorafenib. | 10.09.2021 |
| 1. Solution for Infusion 1000ml (NutriflexPeri)Upper Chamber contains (400mI): Isoleucine 2.34gm + Leucine 3.13gm + Lysine Hcl 2.84gm as Lysine 2.27gm + Methionine 1.96gm + Phenylanine 3.51gm + Threonine 1.82gm + Tryptophan 0.57gm + Valine 2.60gm + Arginine Monoglutamate 4.98gm as Arginine 2.70gm + Glutamic Acid 2.28gm + Histidine HCI Monohydrate 1.69gm as Histidine 1.25gm + Alanine 4.85gm + Aspartic Acid 1.50gm + Glutamic Acid 1.22gm + Glycine 1.65gm + Proline 3.40gm + Serine 3.00gm + Magnesium Acetate Tetrahydrate 0.86gm + Sodium Acetate Trihydrate 1.56gm + Potassium Dihydrogen Phosphate 0.78gm + Potassium Hydroxide 0.52gm + Sodium Hydroxide 0.50gm Lower Chamber Contains (600mI): Glucose Monohydrate 88.0gm as Anhydrous Glucose 80gm + Sodium Chloride 0.17gm + Calcium Chloride Dihydrate 0.37gm | 1. Solution for Infusion 1000ml (NutriflexPeri)Upper Chamber contains (400mI): Isoleucine 2.34gm + Leucine 3.13gm + Lysine Hcl 2.84gm as Lysine 2.27gm + Methionine 1.96gm + Phenylanine 3.51gm + Threonine 1.82gm + Tryptophan 0.57gm + Valine 2.60gm + Arginine Monoglutamate 4.98gm as Arginine 2.70gm + Glutamic Acid 2.28gm + Histidine HCI Monohydrate 1.69gm as Histidine 1.25gm + Alanine 4.85gm + Aspartic Acid 1.50gm + Glutamic Acid 1.22gm + Glycine 1.65gm + Proline 3.40gm + Serine 3.00gm + Magnesium Acetate Tetrahydrate 0.86gm + Sodium Acetate Trihydrate 1.56gm + Potassium Dihydrogen Phosphate 0.78gm + Potassium Hydroxide 0.52gm + Sodium Hydroxide 0.50gm Lower Chamber Contains (600mI): Glucose Monohydrate 88.0gm as Anhydrous Glucose 80gm + Sodium Chloride 0.17gm + Calcium Chloride Dihydrate 0.37gm | Supply of the daily requirement of energy, amino acids, electrolytes, and fluids during Parenteral nutrition for patients with mild to moderately severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated. | 13.09.2021 |
| 1. Solution for Infusion 1000ml (NutriflexPeri)Upper Chamber contains (400mI): Isoleucine 2.34gm + Leucine 3.13gm + Lysine Hcl 2.84gm as Lysine 2.27gm + Methionine 1.96gm + Phenylanine 3.51gm + Threonine 1.82gm + Tryptophan 0.57gm + Valine 2.60gm + Arginine Monoglutamate 4.98gm as Arginine 2.70gm + Glutamic Acid 2.28gm + Histidine HCI Monohydrate 1.69gm as Histidine 1.25gm + Alanine 4.85gm + Aspartic Acid 1.50gm + Glutamic Acid 1.22gm + Glycine 1.65gm + Proline 3.40gm + Serine 3.00gm + Magnesium Acetate Tetrahydrate 0.86gm + Sodium Acetate Trihydrate 1.56gm + Potassium Dihydrogen Phosphate 0.78gm + Potassium Hydroxide 0.52gm + Sodium Hydroxide 0.50gm Lower Chamber Contains (600mI): Glucose Monohydrate 88.0gm as Anhydrous Glucose 80gm + Sodium Chloride 0.17gm + Calcium Chloride Dihydrate 0.37gm | 1. Solution for Infusion 1000ml (NutriflexPeri)Upper Chamber contains (400mI): Isoleucine 2.34gm + Leucine 3.13gm + Lysine Hcl 2.84gm as Lysine 2.27gm + Methionine 1.96gm + Phenylanine 3.51gm + Threonine 1.82gm + Tryptophan 0.57gm + Valine 2.60gm + Arginine Monoglutamate 4.98gm as Arginine 2.70gm + Glutamic Acid 2.28gm + Histidine HCI Monohydrate 1.69gm as Histidine 1.25gm + Alanine 4.85gm + Aspartic Acid 1.50gm + Glutamic Acid 1.22gm + Glycine 1.65gm + Proline 3.40gm + Serine 3.00gm + Magnesium Acetate Tetrahydrate 0.86gm + Sodium Acetate Trihydrate 1.56gm + Potassium Dihydrogen Phosphate 0.78gm + Potassium Hydroxide 0.52gm + Sodium Hydroxide 0.50gm Lower Chamber Contains (600mI): Glucose Monohydrate 88.0gm as Anhydrous Glucose 80gm + Sodium Chloride 0.17gm + Calcium Chloride Dihydrate 0.37gm | Supply of the daily requirement of energy, amino acids, electrolytes, and fluids during Parenteral nutrition for patients with mild to moderately severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated. | 13.09.2021 |
| Tofacitinib Tablets 5mg (Additional Indication) | Each Film coated tablets contains: Tofacitinib citrate equivalent to Tofacitinib…… 5mg | In treatment of adult patient with moderately to severely active Ulcerative Colitis (UC), who have an inadequate response and who are intolerant to TNF blockers “WARNING: To be sold by retail on the prescription of Rheumatologist, Gastroenterologist, Hepatologist or “Specialist in internal Medicine only” | 13.09.2021 |
| Tipiracil hydrochloride bulk and FDC of 1) Trifluridine 15mg + Tipiracil 6.14mg and 2) Trifluridine 20mg + Tipiracil 8.19mg | Tipiracil hydrochloride bulk and FDC of 1) Trifluridine 15mg + Tipiracil 6.14mg and 2) Trifluridine 20mg + Tipiracil 8.19mg | Indicated for the treatment of i) adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an antiVEGF biological therapy, and if RAS wildtype, an anti-EGFR therapy ii) Adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/ neu-targeted therapy. | 16.09.2021 |
| Selumetinib 10mg & 25mg capsule | Each capsule contains : Selumetinib 10mg & 25mg | Indicated for the treatment of Pediatric patients 3 years of age and older with neurofibromatosis type 1 (NF1) and who have symptomatic, inoperable plexiform neurofibromas (PN). | 17.09.2021 |
| Biapenem sterile bulk and Biapenem for injection 300mg | Biapenem sterile bulk and Biapenem for injection 300mg | Complicated urinary tract infections | 17.09.2021 |
| RemogliflozinEtabonate + Vildagliptin + Metformin Hydrochloride IP (100mg + 50mg + 500mg & 100mg + 50mg + 1000mg) | Each Film Coated Tablets contains: RemogliflozinEtabonate + Vildagliptin + Metformin Hydrochloride IP (100mg + 50mg + 500mg & 100mg + 50mg + 1000mg) | It is indicated as an adjunct to diet and exercise in adults aged 18 years and older with type 2 diabetes mellitus: To improve glycaemic control when Metformin and one of other twomonocomponents of RemogliflozinEtabonate&Vildagliptindo not provide adequate glycaemic control. When already being treated with the free combination of Metformin, Remogliflozin&Vildagliptin. | 21.09.2021 |
| Prucalopride Orally Disintegrating Strips 1/2 mg (Additional Dosage Form) | Each Orally Disintegrating Strips Contains: Prucalopride succinate is equivalent to Procalopride ……… 1 mg/2 mg | For the treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief | 27.09.2021 |
| Each Kit contains: A) 14 nos. Rivaroxaban tablets 2.5mg Each film coated tablet contains: Rivaroxaban…………..2.5mg B) 07 nos. Aspirin tablets 75mg Each gastro resistant tablet contains: Aspirin IP………………75mg | Each Kit contains: A) 14 nos. Rivaroxaban tablets 2.5mg Each film coated tablet contains: Rivaroxaban…………..2.5mg B) 07 nos. Aspirin tablets 75mg Each gastro resistant tablet contains: Aspirin IP………………75mg | Rivaroxaban in combination with Aspirin is indicated to reduce the risk of major cardiovascular events (Cardiovascular (CV) death, myocardia infarction (MI) and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD) | 01.10.2021 |
| Itraconazole Capsule BP 65 mg (Suprabioavailable formulation) (Additional Strength) | Each Capsule Contains: Itraconazole……… …65 mg | Itraconazole 65 mg Capsule (Supra-bioavailable formulation) is indicated for the treatment of the following fungal infections in immunocompromised and nonimmunocompromised adult patients: Blastomycosis, Pulmonary and Extra pulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis. Aspergillosis, pulmonary and extra-pulmonary, in patients who are intolerant of or who arerefractory to amphotericin B therapy The package insert should contain the following caution “This Itraconazole Capsules BP 65mg (Supra-bioavailable formulation) is not interchangeable or substitutable with other Itraconazole products due to the differences in dosing between Itraconazole capsule BP 65 (Supra bioavailable formulation) and other Itraconazole products "WARNING: To be sold by retail on the prescription of a Specialist only” | 08.10.2021 |
| Remdesivir Injection 100mg/ml (1ml/vial) (Single dose vial) (Additional Strength) | Each ml contains: Remdesivir …………………100 mg Alcohol ……………….20% w/v Benzyl alcohol………5%w/v | For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and children hospitalised with moderate to severe disease “WARNING: To be sold by retail on the prescription of specialist for use in Hospital/ Institutional set up only” | 08.10.2021 |
| Azacitidine Tablets 200mg (Additional Strength) | Each film coated tablet contains: Azacitidine IP …………………200 mg | For continued treatment of patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy "WARNING: To be sold by retail on the prescription of Oncologist only” | 14.10.2021 |
| Empagliflozin Tablets 10/25mg (additional Indication) | Each Film coated tablets contains: Empagliflozin ………… ……. 10/25mg | To reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction | 25.10.2021 |
| Each hard gelatin capsule contains: Pregabalin IP + Duloxetine Hydrochloride IP eq. to Duloxetine (as delayed release pellets) (75mg + 20mg, 50mg + 20mg & 75mg + 30mg) ± | Each hard gelatin capsule contains: Pregabalin IP + Duloxetine Hydrochloride IP eq. to Duloxetine (as delayed release pellets) (75mg + 20mg, 50mg + 20mg & 75mg + 30mg) ± | For the treatment of Neuropathic pain | 25.10.2021 |
| Each uncoated bilayered tablet contains: - Efonidipine Hydrochloride Ethanolate (as immediate release) ……………40mg S (-) Metoprolol Succinate eq. to S (-) Metoprolol Tartrate (as prolonged release)………25mg | Each uncoated bilayered tablet contains: - Efonidipine Hydrochloride Ethanolate (as immediate release) ………40mg S (-) Metoprolol Succinate eq. to S (-) Metoprolol Tartrate (as prolonged release)…...25mg | It is indicated for the management of hypertension. | 26.10.2021 |
| Each 10 ml contains: Sodium Alginate IP ………………1000mg Potassium Hydrogen Carbonate Ph. Eur……..……200mg Oral Suspension | Each 10 ml contains: Sodium Alginate IP ………………1000mg Potassium Hydrogen Carbonate Ph. Eur……..……200mg Oral Suspension | To treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or withdrawal of acid suppressing therapy | 01.11.2021 |
| Clobazam Mouth Dissolving Tablets 2.5 mg (Additional Dosage Form) | Each uncoated mouth dissolving tablet contains: Clobazam 2.5 mg | As an adjunctive therapy in patients with refractory epilepsy "WARNING: To be sold by retail on the prescription of Neurologist/Psychiatrist only” | 01.11.2021 |
| Pegylated Liposomal Irinotecan 4.3mg/ml (Additional Dosage Form) | Each vial contains: Pegylated Liposomal Irinotecan……4.3 mg/ml | Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5- FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy “WARNING: To be sold by retail on the prescription of Oncologist only” | 01.11.2021 |
| Amantadine Extended Release Tablets 129 mg and 193 mg (Additional Dosage Form) | Each extended release film coated tablets contains: Amantadine Hydrochloride equivalent to Amantadine……129 mg and 193 mg | For the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients Firm should conduct a PhaseIV Clinical Trial protocol before the Committee prior to launch of the product in the market "WARNING: To be sold by retail on the prescription of a Neurologist only” | 01.11.2021 |
| Gemcitabine Hydrochloride Injection 10mg/ml (220 ml ready to use infusion bag) (Additional Pack Size) | Each ml contains: Gemcitabine Hydrochloride equivalent to Gemcitabine ……10mg/ml | Ovarian cancer – Gemcitabine injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy. Breast cancer – Gemcitabine injection in combination with paclitaxel is indicated for the first line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated Non-small cell lung cancer – Gemcitabine injection is indicated in combination with cisplatin for the first line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer Pancreatic cancer – Gemcitabine injection is indicated as first line treatment for patient with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine injection is indicated for patients previously treated with 5-FU "WARNING: To be sold by retail on the prescription of an Oncologist only” | 02.11.2021 |
| Each 5 gram contains: Sildenafil Citrate IP eq. to Sildenafil ...100mg Dapoxetine Hydrochloride eq. to Dapoxetine….......60mg Oral Jelly (In Additional Dosage form) | Each 5 gram contains: Sildenafil Citrate IP eq. to Sildenafil ...100mg Dapoxetine Hydrochloride eq. to Dapoxetine….......60mg Oral Jelly (In Additional Dosage form) | For the treatment of co-existing erectile dysfunction and premature ejaculation in men 18-64 years of age. | 09.11.2021 |
| Clindamycin Phosphate USP …1.2% Benzoyl Peroxide USP …………….5% Topical gel | Clindamycin Phosphate USP …1.2% Benzoyl Peroxide USP …………….5% Topical gel | For the treatment of Acne Vulgaris | 09.11.2021 |
| Each film coated tablet contains:- Sitagliptin Phosphate eq. to Sitagliptin IP + Metformin Hydrochloride IP (as an extendedrelease form) (100mg +1000mg & 100mg + 500mg) | Each film coated tablet contains:- Sitagliptin Phosphate eq. to Sitagliptin IP + Metformin Hydrochloride IP (as an extendedrelease form) (100mg +1000mg & 100mg + 500mg) | It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Sitagliptin and Metformin is appropriate. | 11.11.2021 |
| Baricitinib Tablets 2 mg & 4 mg (Additional Indication) | Each Film Coated Tablet Contains: Baricitinib………..2 mg/4 mg | Baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) “WARNING: To be sold by retail on the prescription of specialist for use in Hospital/ Institutional set up only” | 15.11.2021 |
| Each Capsule contains: Aspirin (eneteric coated pellets form)…75mg Atorvastatin (As pellets form)…………20mg | Each Capsule contains: Aspirin (eneteric coated pellets form)…75mg Atorvastatin (As pellets form)…………20mg | For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease. | 23.11.2021 |
| Faropenem Sodium for Oral Suspension 100mg/5ml (Additional Dosage Form) | Each 5ml of reconstituted suspension Contains: Faropenem Sodium equivalent to Faropenem………… …100mg | For the treatment of superficial and deep skin infections like chronic pyoderma, Pharyngitis/laryngitis and ENT infections like Otitis media, Tonsillitis, Sinusitis, Acute tracheo-bronchitis, Bacterial pneumonia, UTls like cystitis, Pyelonephritis, Lymphangitis/Lymphadenitis, Teeth Periodontitis, Scarlet fever and Whooping cough | 24.11.2021 |
| Teriparatide Injection solution for injection in a pre-filled pen 600 mcg/2.4 ml (Synthetic Origin) | Each ml contains: Teriparatide (Synthetic Origin)…….250 mcg Mannitol ….45.4 mg Glacial Acetic Acid …………...0.41mg Sodium Acetate Anhydrous ….0.1mg Metacresol….3.0 mg (as Preservative) Sodium Hydroxide IP q.s. for pH adjustment Hydrochloric Acid IP q.s. for pH adjustment Water for Injections IP q.s. to 1.0ml | 1.For the treatment of men and postmenopausal women with osteoporosis who are at a high risk of fracture. It increases bone mineral density (BMD) and reduces the risk of vertebral and non-vertebral fractures 2. It is also indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture Firm shall submit Phase IV clinical trial study protocol within three months of approval | 25.11.2021 |
| Each film coated tablets contains:- Amlodipine Besylate USP Eq. to Amlodipine………….10mg Olmesartan Medoxomil USP ……40mg (In Additional Strength) | Each film coated tablets contains:- Amlodipine Besylate USP Eq. to Amlodipine………….10mg Olmesartan Medoxomil USP ……40mg (In Additional Strength) | 1. For the treatment of hypertension alone or with other antihypertensive agents. 2. To use as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals. | 25.11.2021 |
| Each ml contains:- Levobupivacaine Hydrochloride eq. to Levobupivacaine………………5mg Dextrose (Monohydrate) IP…… 80mg Water for injections IP………..Q.S | Each ml contains:- Levobupivacaine Hydrochloride eq. to Levobupivacaine…………5mg Dextrose (Monohydrate) IP……80mg Water for injections IP………..Q.S | For spinal anesthesia in adults patients | 26.11.2021 |
| Calcium Polystyrene Sulphonate Suspension 15g/60ml (Additional Dosage Form) | Each 60ml contains: Calcium Polystyrene Sulphonate…….. 15g Excipients……q.s | For the treatment of hyperkalemia associated with oliguria, anuria or dialysis | 30.11.2021 |
| Tafamidis soft gelatin capsules 61 mg | Each Capsules contains: Tafamidis …..........61 mg | Indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRCM) | 30.11.2021 |
| Ethambutol Dispersible Tablets 100 mg (Additional Dosage Form) | Each uncoated dispersible tablet contains: Ethambutol Hydrochloride… 100 mg | For the management of Mycobacterium Tuberculosis | 07.12.2021 |
| Each ml contains: Brinzolamide IP………………………10mg Timolol Maleate IP eq. to Timolol……5mg Potassium Sorbate IP……………0.47%w/v (as preservative) Ophthalmic Suspension | Each ml contains: Brinzolamide IP………………………10mg Timolol Maleate IP eq. to Timolol……5mg Potassium Sorbate IP……………0.47%w/v (as preservative) Ophthalmic Suspension | Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction | 9.12.2021 |
| Bedaquiline Tablets 20 mg (Additional Strength) | Each tablets contains 20mg of Bedaquiline (equivalent to 24.18mg of Bedaquiline fumarate) | Indicated in adult (≥ 18 years) and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) as part of combination therapy of pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis The drug is approvedforconditional access i.e itshallbeused under NationalTuberculosisEliminationProgrme(NTEP) framework for conditional access through the PMDT program for treatment of MDR-TB patients only “WARNING: For use in National Tuberculosis Elimination programme (NTEP)” | 16.12.2021 |
| Gliclazide Extended Release Tablets 90 and 120 mg (Additional Strength &Additional Indication) | Each Extended Release Tablets Contains: Gliclazide ………90 and 120 mg | Treatment of Non-insulin dependent Diabetes mellitus (Type II) in association with dietary measures in adults only The firm should submit protocol for active post marketing surveillance (PMS) for Gliclazide Extended release Tablet 90/120mg within 3 months of granting approval to manufacture and market Gliclazide Extended Release Tablet 90/120mg. | 22.12.2021 |
| Etoricoxib Tablets 30mg (Additional Strength) | Each film-coated Tablets contains: Etoricoxib …………………30 mg | For the treatment of Symptomatic relief of Osteoarthritis and rheumatoid arthritis, acute gouty arthritis, acute pain associated with dental surgery, primary dysmenorrhea | 22.12.2021 |
| Faropenem Sodium for Syrup 50mg/5ml (Additional Dosage form) | Each 5ml of reconstituted syrup contains: Faropenem Sodium hydrate equivalent to Faropenem…… …50mg | For the treatment of upper and lower respiratory tract infection, urinary tract infection and skin structure infection | 22.12.2021 |
| 17-β estradiol gel 0.06%w/w metered pump (Metered-pump presentation and Additional Indication) | Each dose of 1.25g (1 pump) contains: 17-β estradiol …………….0.06%w/ w | 1. Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women. 2. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The experience treating women older than 65 years is limited.\ “WARNING: To be sold by retail on the prescription of Gynecologists only” | 23.12.2021 |
| Phenylephrine Injection 50mcg/ml (Additional Strength) | Each ml contains: Phenylephrine Hydrochloride …………………50 mcg Water for Injections ……………………… Q.S | Treatment of Hypotension during spinal, epidural or general anaesthesia "WARNING: To be sold by retail on the prescription of a Specialist only” | 23.12.2021 |
| Pregabalin Oral Solution 20 mg/ml (Additional Dosage Form) | Each ml contains: Pregabalin ………………… 20 mg | For the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and Fibromyalgia | 27.12.2021 |
| Medroxyprogesterone Acetate Sustained Release (SR) Tablets 30mg (Additional Dosage Form) | Each Uncoated Sustained Release Tablet Contains: Medroxyprogesteron e Acetate IP……………..30mg | Mild to Moderate Endometriosis | 27.12.2021 |
| Molnupiravir bulk and Molnupiravir capsules 200mg | Each Capsules contains: Molnupiravir …..........200 mg | For treatment of adult patients with COVID-19, with SpO2 >93% and who have high risk of progression of the disease including hospitalization or death, in light of Covid 19 outbreak for restricted emergency use in the country | 28.12.2021 |
| Selexipag bulk and Selexipag tablets…200mcg/ 400mcg/ 600mcg/ 800mcg/ 1000mcg/ 1200mcg/ 1400mcg/ 1600mcg | Each Tablet contains: Selexipag …..........200 mcg/400mcg/600mcg/800mcg/ 1000mcg/1200mcg/1400mcg/1600mcg/ | For the treatment of Pulmonary Arterial Hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. | 31.12.2021 |
| Carfilzomib for Injection 10mg/Vial (Additional Strength) | Each Vial contains: Carfilzomib ……………………… …….. 10mg | 1. In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. 2. As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy "WARNING: To be sold by retail on the prescription of Oncologist only | 31.12.2021 |
| Ivermectin Tablets 12 mg (Additional Strength) | Each uncoated tablet contains: Ivermectin IP…………………12 mg Excipients………….QS | Treatment of intestinal helminths and suppression of microfilaraemia especially with bancrofti infections | 03.01.2022 |
| Benidipine Hydrochloride….. 4mg Telmisartan IP ………………40mg (Additional Dosage Form) | Each film coated bilayered tablet contains: Benidipine Hydrochloride….. 4mg Telmisartan IP ………………40mg (Additional Dosage Form) | For the treatment of hypertension | 03.01.2022 |
| Enzalutamide Tablets 160mg (Additional Dosage form & Strength) | Each film coated tablets contains : Enzalutamide ………………….160mg | The treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. The treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy "WARNING: To be sold by retail on the prescription of Oncologist only” | 04.01.2022 |
| Glimepiride IP + Voglibose IP + Metformin HCl (SR) IP (1mg + 0.2mg + 1000mg & 2mg + 0.2mg + 1000mg) (Additional Strength) | Each uncoated bilayered tablets contains: Glimepiride IP + Voglibose IP + Metformin HCl (SR) IP (1mg + 0.2mg + 1000mg & 2mg + 0.2mg + 1000mg) | As 3rd line treatment of type 2 diabetes mellitus when diet, exercise and the single agents and second line therapy with two drugs do not result in adequate glycemic control. | 06.01.2022 |
| Methotrexate Injection 1000mg/10ml (Additional Strength) | Each ml contains: Methotrexate …………………100mg | 1. Acute lymphocytic leukaemias (ALL): in combination with other cytotoxic medicinal products. 2. Non-Hodgkin's lymphomas: in combination with other cytotoxic medicinal products in adult patients with Non-Hodgkin's lymphomas of intermediate and high degree of malignancy & in combination with other cytotoxic medicinal products in paediatric patients. 3. Head and neck cancer: as palliative monotherapy in patients with metastatic or recurrent disease. 4. Breast cancer: in combination with other cytotoxic medicinal products in patients for adjuvant treatment after tumour resection or mastectomy and for palliative treatment in advanced disease. 5.Choriocarcinoma and similar trophoblastic diseases: as monotherapy in patients with good prognosis (low risk) & in combination with other cytotoxic medicinal products in patients with poor prognosis (high risk). 6.Osteosarcoma: in combination with other cytotoxic medicinal products for adjuvant and neoadjuvant therapy. 7.Cancer of the bladder: in combination with other cytotoxic medicinal products. "WARNING: To be sold by retail on the prescription of Oncologist only” | 11.01.2022 |
| Tofacitinib Tablets 10 mg (Additional Strength) | Each tablet contains: Tofacitinib Citrate 16.16mg equivalent to Tofacitinib ………….. 10mg | 1. For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to Methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic diseasemodifying antirheumatic drugs (DMARDs). 2. For the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to Methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs). The firm should conduct Phase IV study in rheumatoid arthritis and psoriatic arthritis with statistically significant number of patients. Accordingly, firm should submit Phase IV CT protocol within 3 months after approval and study should be completed within 2 years from the approval of the study "WARNING: To be sold by retail on the prescription of a Rheumatologist or Specialist in Internal Medicine only” | 11.01.2022 |
| Triamcinolone Hexacetonide injectable suspension 20mg/ml | Each ml of vial contains: Triamcinolone Hexacetonide…....20mg | For intraarticular, intra-synovial or periarticular use in adults and adolescents for the symptomatic treatment of subacute and chronic inflammatory joint diseases including rheumatoid arthritis and Juvenile Idiopathic Arthritis (JIA), Osteoarthritis and post-tramautic arthritis, Synovitis, tendinitis, bursitis and epicondylitis. | 20-01-2022 |
| Lincomycin Hydrochloride Sustained Release Tablet 1000 mg (Additional Dosage Form) | Each film coated Sustained Release tablets contains: Lincomycin Hydrochloride eq to Lincomycin…….…..…1000mg | Indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patient or for whom penicillin is inappropriate The firm should submit safety data of the product to CDSCO every two months for the next one year "WARNING: To be sold by retail on the prescription of Medical specialist only” | 21.01.2022 |
| Pyridoxine Hydrochloride IP 3mg + Folic acid IP 5mg + Vitamin D3 IP 1000IU + Methylcobalamin IP 1500mcg | Each uncoated mouth dissolving tablets contains: Pyridoxine Hydrochloride IP 3mg + Folic acid IP 5mg + Vitamin D3 IP 1000IU + Methylcobalamin IP 1500mcg | For the management of diabetic neuropathy in patients with hyperhomocysteinemia | 01.02.2022 |
| Gimeracil bulk & Oteracil potassium bulk and Tegafur 15mg/20mg, Gimeracil 4.35mg/5.8mg and Oteracil 11.8mg/15.8mg capsules | Gimeracil bulk & Oteracil potassium bulk and Tegafur 15mg/20mg, Gimeracil 4.35mg/5.8mg and Oteracil 11.8mg/15.8mg capsules | indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin. | 01.02.2022 |
| Clobazam oral suspension 5mg/5mL & 10mg/5mL (Additional Strength) | Each 5ml contains: Clobazam I.P.………5mg/10mg Approved colours used | 1. Acute and chronic anxiety states. 2. As an adjunctive therapy in patients with refractory epilepsy. "WARNING: To be sold by retail on the prescription ofNeurologist/Psychiatrist only” | 02.02.2022 |
| Dutasteride IP…..0.5mg Silodosin………..4 mg (Additional Strength) | Each hard gelatin capsule contains: Dutasteride IP…..0.5mg Silodosin………..4 mg | For the treatment of the signs and symptoms of BPH in men with an enlarged prostate | 03.02.2022 |
| Topiroxostat tablets 20mg, 40mg and 60mg and bulk | Topiroxostat tablets 20mg, 40mg and 60mg and bulk | Gout, hyperuricemia | 04.02.2022 |
| Efonidipine Hydrochloride Ethanolate…….40mg Telmisartan IP…..40mg | Each film coated bilayered tablet contains: Efonidipine Hydrochloride Ethanolate…………….40mg Telmisartan IP………..40mg | For the management of stage II hypertension | 07.02.2022 |
| Glycopyrrolate IP………...9mcg Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate……4.8mcg Budesonide IP………….160mcg Metered dose inhaler | Glycopyrrolate IP………...9mcg Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate……4.8mcg Budesonide IP………….160mcg Metered dose inhaler | For the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) | 07.02.2022 |
| Nitric oxide nasal spray | Nitric oxide nasal spray | For treatment of adult high risk patients with mild Covid-19 having risk of progression of the disease. | 08.02.2022 |
| Rosuvastatin Calcium IP eq. to Rosuvastatin + Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin (5mg + 20mg, 10mg + 20mg & 20mg + 20mg) | Each film coated tablets contains: Rosuvastatin Calcium IP eq. to Rosuvastatin + Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin (5mg + 20mg, 10mg + 20mg & 20mg + 20mg) | Dyslipidemia associated with Type II Diabetes Mellitus | 25.2.2022 |
| Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin + Pioglitazone Hydrochloride eq. to Pioglitazone (20mg + 15mg & 20mg + 30mg) | Each film coated tablets contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin + Pioglitazone Hydrochloride eq. to Pioglitazone (20mg + 15mg & 20mg + 30mg | For the treatment of type 2 diabetes mellitus | 25.2.2022 |
| Vericiguat tablets 2.5mg/ 5mg/ 10mg | Vericiguat tablets 2.5mg/ 5mg/ 10mg | Indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% | 25.2.2022 |
| Rosuvastatin Sprinkle Capsules 10mg, 20 mg and 40mg (Additional Strength) | Each capsule contains: Rosuvastatin calcium equivalent to Rosuvastatin…………. 10 mg / 20 mg / 40 mg Excipients q.s. | • As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. • As an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hypolipoproteinemia). • As adjunctive therapy to other lipid lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDLC, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. | 28.02.2022 |
| Minocycline Hydrochloride Topical Gel 4% (Additional Dosage Form & Additional Indication) | Each gram of gel contains: 40 mg of Minocycline equivalent to 43 mg of Minocycline Hydrochloride Ph. Eur. | Indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older The firm should conduct Phase IV Clinical trial | 28.02.2022 |
| Inosine pranobex bulk and Inosine pranobex 500mg tablet | Inosine pranobex bulk and Inosine pranobex 500mg tablet | As add on therapy for treatment of mild Covid-19 patients with co-morbidities and moderate Covid-19 patients, in light of Covid 19 outbreak for restricted emergency use in the country | 02.03.2022 |
| Lenalidomide Capsules 5mg/10mg/15mg (Additional Indication) | Each hard gelatin capsule contains: Lenalidomide…..5mg/10mg/15mg | Follicular Lymphoma: Lenalidomide in combination with a Rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL). Marginal Zone Lymphoma: Lenalidomide in combination with a Rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL) "WARNING: To be sold by retail on the prescription of oncologist only” | 02.03.2022 |
| Thymosin Alpha-1 for injection 1.6 mg (Additional Indication) | Each Vial Contains: Thymosin Alpha 1 for Injection… 1.6 mg Excipients…q. s. | As add-on therapy for the treatment of moderate to severe Covid patients requiring ventilator support (NIV as well as Mechanical ventilation) The firm should conduct active PMS study for which protocol should be submitted for further review by the committee “WARNING: To be sold by retail on the prescription of Medical specialists only” | 02.03.2022 |
| Desidustat bulk and Desidustat tablets 25mg and 50mg | Desidustat bulk and Desidustat tablets 25mg and 50mg | For treatment of Anemia in adult patients with chronic kidney disease (CKD) not on Dialysis and on Dialysis | 03.03.2022 |
| Lumacaftor bulk, Ivacaftor bulk Lumacaftor and Ivacaftor tablets 100mg/125mg and 200mg/125mg | Lumacaftor bulk, Ivacaftor bulk Lumacaftor and Ivacaftor tablets 100mg/125mg and 200mg/125mg | Lumacaftor bulk, Ivacaftor bulk & Lumacaftor and Ivacaftor tablets 100mg/125mg and 200mg/125mg | 11.03.2022 |
| Glutathione for Injection 600 mg / vial (Additional Indication) | Each Vial Contains: Glutathione BP……. 600 mg Excipients… q. s. | As an add-on to the standard of care in moderate COVID-19 patients “WARNING: To be sold by retail on the prescription of Medical specialists only” | 11.03.2022 |
| Per 5ml suspension contains: Bilastine……..10mg Montelukast Sodium IP Eq. to Montelukast….4mg | Per 5ml suspension contains: Bilastine……..10mg Montelukast Sodium IP Eq. to Montelukast….4mg | For the treatment of Allergic rhinitis in children aged 6 to 11 years (both inclusive) with a body weight of atleast 20kg. | 11.03.2022 |
| Each Orodispersible tablets contains: Montelukast sodium eq. to Montelukast IP…………..10mg Bilastine …………… …..20mg (Additional Dosage form) | Each Orodispersible tablets contains: Montelukast sodium eq. to Montelukast IP…………..10mg Bilastine …………… …..20mg | For the treatment of allergic rhinitis in adults. | 11.03.2022 |
| Levosalbutamol tartrate Inhalation Aerosol (Levosalbutamol 45mcg/actuation) | Each actuation delivers (ex-actuator): Levosalbutamol Tartrate 59 mcg equivalent to Levosalbutamol….45mcg Ethanol anhydrous Ph Eur ….4.7% w/w Excipients – Oleic Acid USP NF Norflorane Ph.Eur.(Propellant HFA 134a)…..q.s | Indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease | 14.03.2022 |
| Trametinib 0.5 mg and 2 mg tablets (Additional Indication) | Each film coated tablet contains: Trametinib dimethyl sulfoxide equivalent to Trametinib…........0.5mg/2mg | Trametinib is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations as detected by an appropriate test and involvement of lymph node(s), following complete resection “WARNING: To be sold by retail on the prescription of Oncologist only” | 17.03.2022 |
| Trametinib 0.5 mg and 2 mg tablets (Additional Indication) | Each film coated tablet contains: Trametinib dimethyl sulfoxide equivalent to Trametinib……………0.5mg/2mg | Trametinib is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAFV600E mutation and with no satisfactory locoregional treatment Options “WARNING: To be sold by retail on the prescription of Oncologist only” | 17.03.2022 |
| Each film coated bilayered tablets contains: Mecobalamin IP…….1500mcg Nortriptyline Hydrochloride IP Eq. to Nortriptyline ……..10mg Pregabalin PR (IP)…..75mg | Each film coated bilayered tablets contains: Mecobalamin IP…….1500mcg Nortriptyline Hydrochloride IP Eq. to Nortriptyline ……..10mg Pregabalin PR (IP)…..75mg | For the treatment of patients with diabetic peripheral neuropathic pain coexistent Vitamin B12 deficiency. | 17.03.2022 |
| Lidocaine Hydrochloride IP 2% w/w + Diltiazem Hydrochloride IP 2% w/w gel | Lidocaine Hydrochloride IP 2% w/w + Diltiazem Hydrochloride IP 2% w/w gel | For the treatment of anal fissure. | 24.03.2022 |
| Each film coated tablets contains: Sitagliptin Phosphate IP eq. to Sitagliptin + Metformin Hydrochloride IP (as sustained release form) (50mg +500mg, 50mg + 1000mg & 100mg + 1000mg) (Additional Strength) | Each film coated tablets contains: Sitagliptin Phosphate IP eq. to Sitagliptin + Metformin Hydrochloride IP (as sustained release form) (50mg +500mg, 50mg + 1000mg & 100mg + 1000mg) | It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Sitagliptin and Metformin is appropriate. | 24.03.2022 |
| Each film coated tablets contains: Nortriptyline Hydrochloride IP eq. to Nortriptyline ………10mg Pregabalin IP…………50mg (Additional Strength) | Each film coated tablets contains: Nortriptyline Hydrochloride IP eq. to Nortriptyline ………10mg Pregabalin IP…………50mg | For the treatment of neuropathic pain. | 25.03.2022 |
| Each film coated tablets contains: Empagliflozin + Metformin Hydrochloride (as extended release) (5mg + 1000mg, 10mg + 1000mg, 12.5mg + 1000mg & 25mg + 1000mg | Each film coated tablets contains: Empagliflozin + Metformin Hydrochloride (as extended release) (5mg + 1000mg, 10mg + 1000mg, 12.5mg + 1000mg & 25mg + 1000mg | It is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients with type 2 diabetes mellitus who are not adequately controlled on a regimen containing Empagliflozin or Metformin, or in patients already being treated with both Empagliflozin and Metformin. | 29.03.2022 |
| Each film coated tablet contains: Metformin Hydrochloride IP (as immediate release form)….500mg Dapagliflozin………………..5mg | Each film coated tablet contains: Metformin Hydrochloride IP (as immediate release form)…….500mg Dapagliflozin………………..5mg | It is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Dapagliflozin and Metformin is appropriate. | 04.04.2022 |
| Liothyronine sodium bulk and Liothyronine sodium tablets 5mcg & 20 mcg | Liothyronine sodium bulk and Liothyronine sodium tablets 5mcg & 20 mcg | To treat some of the more severe conditions in which the thyroid does not produce enough thyroxine and balance the effect of medicines used to treat an overactive thyroid. | 04.04.2022 |
| Tacrolimus Hard Gelatin Capsules 0.75mg (Additional Strength) | Tacrolimus Hard Gelatin Capsules 0.75mg | For the prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplants "WARNING: To be sold by retail on the prescription of a Nephrologist only” | 05.04.2022 |
| Polyhexamethylene guanidine hydrochloride 1.000 lit | Polyhexamethylene guanidine hydrochloride 1.000 lit | For surface disinfection | 06.04.2022 |
| Each film coated tablets contains: Linagliptin + Metformin Hydrochloride IP (as extended release) (2.5mg + 1000mg & 5mg + 1000mg) (Additional Strength) | Each film coated tablets contains: Linagliptin + Metformin Hydrochloride IP (as extended release) (2.5mg + 1000mg & 5mg + 1000mg) | Indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients with type-II diabetes mellitus when treatment with Linagliptin and Metformin is appropriate. | 08.04.2022 |
| Each uncoated bilayered tablet contains: Vildagliptin (as sustained release) + Dapagliflozin (100mg + 5mg & 100mg + 10mg) | Each uncoated bilayered tablet contains: Vildagliptin (as sustained release) + Dapagliflozin (100mg + 5mg & 100mg + 10mg) | For the treatment of patients with type 2 Diabetes mellitus inadequately controlled on Metformin monotherapy. | 08.04.2022 |
| Estriol Cream BP 1mg/gm (Additional Dosage Form) | Each gram contains: Estriol BP………………….1mg Chlorhexidine Hydrochloride BP (as preservative) ………….0.1 mg | For vaginal symptoms due to Estrogen deficiency in menopause. | 11.04.2022 |
| Finerenone 10mg/20mg film coated tablets | Finerenone 10mg/20mg film coated tablets | Indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 Diabetes (T2D). | 11.04.2022 |
| Betahistine dihydrochloride Orodispersible film 8mg/16mg/24mg (Additional Strength) | Each Orodispersible Contains: Betahistine dihydrochloride …8mg/16mg/24mg | Indicated in the treatment of Menier’s syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss. | 12.04.2022 |
| Linezolid Sustained Release Tablets 1200 mg (Additional Dosage Form & Strength) | Each film coated sustained release tablet contains: Linezolid IP……………..1200mg | For the treatment of complicated/uncomplicated skin & skin structure infection, community acquired pneumonia & osteomyelitis in adults You are required to conduct PMS study in adequate number of patients. Accordingly, submit protocol to this office within six months of launch of product in Indian market. | 12.04.2022 |
| Ripasudil Hydrochloride Hydrate eq. to Ripasudil………0.4% w/v Timolol Maleate IP eq. to Timolol……………….0.5% w/v Benzalkonium chloride IP….0.01%w/v ( Eye Drops) | Ripasudil Hydrochloride Hydrate eq. to Ripasudil………0.4% w/v Timolol Maleate IP eq. to Timolol……………….0.5% w/v Benzalkonium chloride IP….0.01%w/v | It is indicated for the treatment of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension. | 18.04.2022 |
| Sugammadex sodium bulk and Sugammadex injection 100mg/ml (single dose vial for bolus injection, IV) | Sugammadex sodium bulk and Sugammadex injection 100mg/ml (single dose vial for bolus injection, IV) | Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults undergoing surgery. | 18.04.2022 |
| Nirmatrelvir bulk and Combipack of Nirmatrelvir 300mg tablets (2x150mg tablets) and Ritonavir tablets 100mg | Nirmatrelvir bulk and Combipack of Nirmatrelvir 300mg tablets (2x150mg tablets) and Ritonavir tablets 100mg | For treatment of adult patients with COVID-19, with SpO2 >93% and who have high risk of progression of the disease including hospitalization or death, in light of Covid 19 outbreak for restricted emergency use in the country | 21.04.2022 |
| Aviptadil bulk and Aviptadil injection | Each ml vial contains: Aviptadil 15 mcg | For treatment of patients with severe COVID-19 with Acute Respiratory Distress Syndrome (ARDS), in light of Covid 19 outbreak for restricted emergency use in the countr0079. | 29.04.2022 |
| Empagliflozin Tablets 10/25mg (Additional Indication) | Each Film coated tablets contains: Empagliflozin ……………… 10/25mg | To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure subject to condition that the drug should be prescribed only to the patients with eGFR more than 30ml/min/1.73m2. | 05.05.2022 |
| Tofacitinib Extended Release Tablets 11mg (Additional Strength) | Each film-coated extended release tablets contains: Tofacitinib Citrate equivalent to Tofacitinib…...11mg | Rheumatoid Arthritis: Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers. Psoriatic Arthritis: Indicated for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers. Ulcerative Colitis: Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers The firm should conduct the Active PMS Study. Accordingly, the firm should submit Active PMS Study protocol within 03 months after approval of the product "WARNING: To be sold by retail on the prescription of a Rheumatologist, Gastroenterologist, Hepatologist or Specialist in Internal Medicine only” | 09.05.2022 |
| Clozapine Extended Release Capsules 12.5mg/25mg/50mg/100mg/200mg (Additional Dosage Form) | Each Extended Release Capsules contains: Clozapine …………………… 12.5mg/25mg/50mg/100mg/200mg | Indicated in the management of schizophrenic patients "WARNING: To be sold by retail on the prescription of Psychiatrist only” | 09.05.2022 |
| Each Orodispersible tablet contains: Bilastine……..10mg Montelukast Sodium IP Eq. to Montelukast….4mg (Additional Dosage Form) | Each Orodispersible tablet contains: Bilastine……..10mg Montelukast Sodium IP Eq. to Montelukast….4mg | For the treatment of allergic rhinitis | 09.05.2022 |
| Bempedoic acid bulk and Bempedoic acid tablet 180 mg | Bempedoic acid bulk and Bempedoic acid tablet 180 mg | Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Limitation of use: The effect of the drug on cardiovascular morbidity and mortality has not been established. | 09.05.2022 |
| rdESAT-6 bulk; rCFP-10 bulk and rdESAT-6 and rCFP-10 (Cy-Tb) injection Each vial (10 dose vial, single dose of 0.1ml) contains: rdESAT-6:0.05 mcg; rCFP-10: 0.05 mcg | rdESAT-6 bulk; rCFP-10 bulk and rdESAT-6 and rCFP-10 (Cy-Tb) injection - Each vial (10 dose vial, single dose of 0.1ml) contains: rdESAT-6:0.05 mcg; rCFP-10: 0.05 mcg | For detection of Latent TB for population of 18 years and above | 09.05.2022 |
| Magnesium Sulphate Intravenous Infusion 4% w/v (Additional Strength) | Each 100 ml contains: Magnesium Sulphate Heptahydrate…...4g (equivalent to 32.5 mEq of Magnesium) Excipients…………qs Water for injection………………...qs to 100ml | Indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively "WARNING: To be sold by retail on the prescription of a Gynecologist only” | 11.05.2022 |
| Sacubitril + Valsartan Tablet (Additional Indication) | Each Film Coated Tablet Contains: 1. Sacubitril + Valsartan……..50mg (24mg+26mg) (as sodium salt complex) 2. Sacubitril + Valsartan…..100mg (49mg+51mg) (as sodium salt complex) 3. Sacubitril + Valsartan…..200mg (97mg+103mg) (as sodium salt complex) | To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with Left Ventricular Ejection Fraction (LVEF) below normal. LVEF is a variable measure, so use clinical judgment in deciding whom to treat | 11.05.2022 |
| Each uncoated sublingual tablet contains: Naloxone Hydrochloride IP eq. to Naloxone …………..0.25mg Buprenorphine Hydrochloride IP eq. to Buprenorpohine…..1mg (Additional Strength) | Each uncoated sublingual tablet contains: Naloxone Hydrochloride IP eq. to Naloxone …………..0.25mg Buprenorphine Hydrochloride IP eq. to Buprenorpohine…..1mg (Additional Strength) | For the treatment of patients with opioid dependence | 17.05.2022 |
| Metformin Hydrochloride Sustained Release Tablets 500/850/1000mg (Additional Indication) | Metformin Hydrochloride Sustained Release Tablets 500/850/1000mg | Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with Impaired Glucose Tolerance and/or Impaired Fasting Glucose, and/or increased HbA1C who are: o At high risk for developing overt type 2 diabetes mellitus and o Still progressing towards type-2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months. Treatment with metformin SR must be based on a risk score incorporating appropriate measures of glycaemic control and including evidence of high cardiovascular risk. Lifestyle modifications should be continued when metformin is initiated, unless the patient is unable to do so because of medical reasons. | 17.05.2022 |
| Vardenafil Oral Jelly 20mg/5g Sachet (Pineapple Flavour) (Additional Dosage Form) | Each sachet (5g) contains: Vardenafil Hydrochloride Trihydrate equivalent to Vardenafil……20mg | For the treatment of erectile dysfunction "WARNING: To be sold by retail on the prescription of a Urologist/Endocrinologist/Psychiatrist/Cardiologist only | 17.05.2022 |
| Sodium Dichloroisocynaurate / Sodium Troclosene / NaDCC Tablets 0.5 gm, 2.5 gm and 5.0 gm (Additional Strength & Indication) | Each uncoated effervescent disinfectant Tablets contains: Sodium Dichloroisocynaurate / Sodium Troclosene / NaDCC ……………….0.5 gm/ 2.5 gm/ 5.0gm Excipients:….…….qs | Cleaning , Cleaning of work surfaces, Cleaning of Hospital Surfaces | 17.05.2022 |
| Levothyroxine Sodium Tablets 125mcg/137mcg/150mcg (Additional Strength) | Each uncoated tablet contains: Thyroxine Sodium Eq. to anhydrous Thyroxine sodium .……….125mcg/137mcg/150mcg | For the treatment of hypothyroidism | 18.05.2022 |
| Thyroxine Sodium Tablets 62.5mcg (Additional Strength) | Each uncoated tablet contains: Thyroxine Sodium Eq. to anhydrous Thyroxine sodium ……….62.5mcg | For the treatment of hypothyroidism | 18.05.2022 |
| Ropivacaine Solution for Infusion 2 mg/ml (250ml) in Administration System (Additional Dosage Form) | 1ml solution for infusion contains ropivacaine hydrochloride monohydrate, equivalent to 2 mg ropivacaine hydrochloride. 1 dispensing device (Ropivacaine 2 mg/ml Solution for Infusion in Administration System) contains 250ml ropivacaine hydrochloride monohydrate solution for infusion, equivalent to 500mg ropivacaine hydrochloride | For acute, postoperative pain management in adults. It is used to maintain a continuous peripheral nerve block via a continuous infusion and for continuous wound infiltration “WARNING: To be sold by retail on the prescription of Anesthesiologist only” | 18.05.2022 |
| Pralsetinib Capsule 100mg | Pralsetinib Capsule 100mg | • Indicated for the treatment of adult patients with metastatic rearranged during transfection (RET)fusion-positive non-small cell lung cancer.,. • Indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy. Indicated for the treatment of adult and pediatric patients 12years of age and older with ladvanced or metastatic RET-fusion positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). | 26.05.2022 |
| Each Film Coated Tablet contains: - Tenofovir Alafenamide Fumarate 28mg eq. to Tenofovir Alafenamide ….25mg Lamivudine USP………………300mg Dolutegravir Sodium eq. to Dolutegravir…………………….50mg | Each Film Coated Tablet contains: - Tenofovir Alafenamide Fumarate 28mg eq. to Tenofovir Alafenamide ….25mg Lamivudine USP………………300mg Dolutegravir Sodium eq. to Dolutegravir…………………….50mg | As a complete regimen for the treatment of HIV 1 infection in adults and pediatric patients weighing at least 25kg. | 02.06.2022 |
| Liposomal Amphotericin B Injection 50 mg/vial (Lyophilized) (Additional Indication) | Each vial contains: Amphotericin B……………...50 mg (intercalated into Liposomal Membrane) | Febrile Neutropenia in cancer patients. For the treatment of invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin-B therapy. For the treatment of visceral leishmaniasis The Firm should conduct active post marketing surveillance studies in at least 250 patients. Accordingly, you should submit the protocol for approval. The data of safety monitoring shall be submitted on monthly basis | 02.06.2022 |
| Nitisinone Capsules 2/5/10 mg and bulk | Nitisinone Capsules 2/5/10 mg and bulk | Indicated for the treatment of herediatry tyrosinemia type -1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. | 09.06.2022 |
| Pantoprazole Powder for Oral Suspension (Sodium Bicarbonate as Buffer) 40mg per sachet (Additional Dosage Form) | Each sachet contains: Pantoprazole sodium IP Equivalent to Pantoprazole………..40mg (sodium Bicarbonate as buffer) | For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and Gastro-Esophageal reflux disease | 14.06.2022 |
| Dexamethasone Intravitreal Implant 0.7mg (Additional Indication) | Each Intravitreal Implant contains: Dexamethasone………….0.7mg (in solid polymer drug delivery system) | For the treatment of diabetic macular edema The firm should conduct active post marketing surveillance study in 500 patients with follow up period of six months. The protocol for active post marketing surveillance study should be submitted to CDSCO within three months of approval of the drug “WARNING: To be sold by retail on the prescription of Ophthalmologist only” | 15.06.2022 |
| Carbetocin injection 100 mcg/ml (Pre Filled Syringes) | Each ml of solution for injection in vial contains: Carbetocin…………….100mcg Excipients…………q.s. Water for injections………………………….q.s. to 1.0ml | Prevention of postpartum haemorrhage due to uterine atony Firm should submit the Phase IV clinical trial protocol within 3 months of approval of the product "WARNING: To be sold by retail on the prescription of a Gynecologist and obstetrician only” | 17.06.2022 |
| Colchicine Tablets USP 0.6mg (Additional Strength) | Each tablets contains: Colchicine…...0.6mg | For treatment and prohpylaxis of acute gout. It is also indicated for the treatment of familial Mediterranean fever | 17.06.2022 |
| Calcium-3-Methyl-2-Oxo-Valerate (α-Ketoanalogue to Isoleucine Calcium salt) IH 67.0mg + Calcium-4-Methyl-2-Oxo-Valerate (α-Ketoanalogue to Leucine Calcium Salt) IH 101.0mg + Calcium-2- Oxo-3-Phenylpropionate (α-Ketoanalogue to Phenylalanine Calcium Salt) IH 68.0mg + Calcium-3-Methyl-2- Oxo-Butyrate (α-Ketoanalogue to Valine Calcium Salt) IH 86.0mg + Calcium-DL-2-hydroxy-4 (methylthio) Butyrate (α-Ketoanalogue to methionine Calcium Salt) IH 59.0mg + L-Lysine acetate USP 105.0mg + L-Threonine USP 53.0mg + L-Tryptophan USP 23.0mg + Histidine Hydrochloride Monohydrate BP eq. to Histidine 38 mg + L-Tyrosine USP 30.0mg per 10ml Oral suspension (Additional Strength) | Calcium-3-Methyl-2-Oxo-Valerate (α-Ketoanalogue to Isoleucine Calcium salt) IH 67.0mg + Calcium-4-Methyl-2-Oxo-Valerate (α-Ketoanalogue to Leucine Calcium Salt) IH 101.0mg + Calcium-2- Oxo-3-Phenylpropionate (α-Ketoanalogue to Phenylalanine Calcium Salt) IH 68.0mg + Calcium-3-Methyl-2- Oxo-Butyrate (α-Ketoanalogue to Valine Calcium Salt) IH 86.0mg + Calcium-DL-2-hydroxy-4 (methylthio) Butyrate (α-Ketoanalogue to methionine Calcium Salt) IH 59.0mg + L-Lysine acetate USP 105.0mg + L-Threonine USP 53.0mg + L-Tryptophan USP 23.0mg + Histidine Hydrochloride Monohydrate BP eq. to Histidine 38 mg + L-Tyrosine USP 30.0mg per 10ml Oral suspension (Additional Strength) | revention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40g/day or less (adult). Usually this applies to patients whose glomerular filtration rate (GFR) is less than 25mL/min | 22.06.2022 |
| Each hard gelatin capsules contains: Mirabegron (as extended release tablet) + Solifenacin Succinate (as immediate release tablet) (25mg + 5mg & 50mg + 5mg) (Additional Strength) | Each hard gelatin capsules contains: Mirabegron (as extended release tablet) + Solifenacin Succinate (as immediate release tablet) (25mg + 5mg & 50mg + 5mg) | It is indicated for the treatment of overactive bladder (OAB) | 22.06.2022 |
| Each uncoated bilayered tablet contains: Efonidipine Hydrochloride Ethanolate…………...40mg Chlorthalidone IP……12.5mg | Each uncoated bilayered tablet contains: Efonidipine Hydrochloride Ethanolate…………...40mg Chlorthalidone IP……12.5mg | In the management of hypertension | 23.06.2022 |
| Gabapentin Oral solution 250mg/5ml (Additional Dosage Form) | Each Oral solution contains: Gabapentin …………………………….250mg/5ml | For the treatment of neuropathic pain and as adjunctive therapy in the treatment of partial seizures with or without secondary generalization in adults | 27.06.2022 |
| Each film coated tablet contains: Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin + Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin (50mg+5mg & 100mg+10mg) | Each film coated tablet contains:- Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin + Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin (50mg+5mg & 100mg+10mg) | It is indicated for the treatment of type 2 diabetes mellitus inadequately controlled on metformin monotherapy | 30.06.2022 |
| Each film coated tablet contains: Gabapentin IP…….200mg Nortriptyline Hydrochloride IP eq. to Nortriptyline……….10mg | Each film coated tablet contains: Gabapentin IP…….200mg Nortriptyline Hydrochloride IP eq. to Nortriptyline……….10mg | For the treatment of Neuropathic pain | 06.07.2022 |
| Each capsule contains: Fluticasone Furoate + Vilenterol Trifenatate eq. to Vilenterol (100mcg + 25mcg & 200mcg + 25mcg) | Each capsule contains: Fluticasone Furoate + Vilenterol Trifenatate eq. to Vilenterol (100mcg + 25mcg & 200mcg + 25mcg) | Treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroids) is appropriate: Patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting beta 2-agonists. Patients already adequately controlled on both inhaled corticosteroid and long-acting beta 2-agonist. | 06.07.2022 |
| Each film coated tablet contains: Gabapentin IP + Nortriptyline Hydrochloride IP eq. to Nortriptyline (100mg +10mg & 200mg +10mg) (Additional Dosage form) | Each film coated tablet contains: Gabapentin IP + Nortriptyline Hydrochloride IP eq. to Nortriptyline (100mg +10mg & 200mg +10mg) | For the treatment of Neuropathic pain | 23.07.2022 |
| Cisatracurium Besylate Injection 20mg/10ml (Additional Indication) | Each ml contains: Cisatracurium Besylate USP Equivalent to Cisatracuriu……2 mg Benzyl Alcohol IP 0.09% (As Preservative) Water for Injection IP……………qs | Indicated for in-patients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU The firm should conduct Phase IV clinical trial for the indication to provide skeletal muscle relaxation during mechanical ventilation in the ICU. Accordingly, you should submit the Phase IV clinical trial within 3 months after approval for further review "WARNING: To be sold by retail on the prescription of Specialist only” | 25.07.2022 |
| Fosfomycin Sodium for Injection 4 gm (Powder for solution for infusion) (Additional Dosage Form) | Each vial contains: Fosfomycin Sodium EP equivalent to Fosfomycin………………4gm Excipients……………...q.s | For the treatment of uncomplicated urinary tractinfections (acute cystitis) in women due to susceptible strains of E. Coli and Enterococcus faecalis | 26.07.2022 |
| FDC of Amino Acid and Carbohydrate Injection with Electrolytes and Vitamin B1- (Brand Name: BFLUID) 1. Upper chamber contains (500ml): Acetyl cysteine JP 0.202gm + Glycine JP 0.885gm + L-Alanine USP 1.200gm + L-Arginine USP 1.575gm + L-Aspartic acid BP 0.150gm + L-Glutamic acid BP 0.150gm + L-Histidine USP 0.750gm + L-Isoleucine JP 1.200gm + L-Leucine JP 2. 100gm + L-Lysine Hydrochloride JP 1.965gm + L-Methionine JP 0.585gm + L-Phenylalanine JP 1.050gm + L-Proline USP 0.750gm + L-Serine USP 0.450gm + L-Threonine JP 0.855gm + L-Tryptophan JP 0.300gm + L-Tyrosine USP 0.075gm + L-Valine JP 1.200gm + Dibasic Potassium Phosphate USP 0.501gm + Dibasic Sodium Phosphate Hydrate JP 0.771gm + Sodium Citrate Hydrate JP 0.285gm + Sodium L-Lactate solution (60%) (as Sodium L-Lactate) USP 1.145gm Lower chamber contains (500ml): Calcium Chloride Hydrate JP 0.184gm + Glucose USP 37.499gm + Magnesium Sulfate Hydrate JP 0.308gm + Potassium chloride JP 0.317gm + Thiamine Chloride Hydrochloride JP 0.96mg + Zinc sulphate Hydrate JP 0.70mg 2. Upper chamber contains (1000ml): Acetyl cysteine JP 0.404gm + Glycine JP 1.770gm + L-Alanine USP 2.400gm + L-Arginine USP 3.150gm + L-Aspartic acid BP 0.300gm + L-Glutamic acid BP 0.300gm + L-Histidine USP 1.500gm + L-Isoleucine JP 2.400gm + L-Leucine JP 4.200gm + L-Lysine Hydrochloride JP 3.930gm + L-Methionine JP 1.170gm + L-Phenylalanine JP 2.100gm + L-Proline USP 1.500gm + L-Serine USP 0.900gm + L-Threonine JP 1.710gm + L-Tryptophan JP 0.600gm + L-Tyrosine USP 0.150gm + L-Valine JP 2.400gm + Dibasic Potassium Phosphate USP 1.002gm + Dibasic Sodium Phosphate Hydrate JP 1.542gm + Sodium Citrate Hydrate JP 0.570gm + Sodium L-Lactate solution (60%) (as Sodium L-Lactate) USP 2.290gm Lower chamber contains (1000ml): Calcium Chloride Hydrate JP 0.368gm + Glucose USP 74.998gm + Magnesium Sulfate Hydrate JP 0.616gm + Potassium chloride JP 0.634gm + Thiamine Chloride Hydrochloride JP 1.920mg + Zinc sulphate Hydrate JP 1.400mg | FDC of Amino Acid and Carbohydrate Injection with Electrolytes and Vitamin B1- (Brand Name: BFLUID) 1. Upper chamber contains (500ml): Acetyl cysteine JP 0.202gm + Glycine JP 0.885gm + L-Alanine USP 1.200gm + L-Arginine USP 1.575gm + L-Aspartic acid BP 0.150gm + L-Glutamic acid BP 0.150gm + L-Histidine USP 0.750gm + L-Isoleucine JP 1.200gm + L-Leucine JP 2. 100gm + L-Lysine Hydrochloride JP 1.965gm + L-Methionine JP 0.585gm + L-Phenylalanine JP 1.050gm + L-Proline USP 0.750gm + L-Serine USP 0.450gm + L-Threonine JP 0.855gm + L-Tryptophan JP 0.300gm + L-Tyrosine USP 0.075gm + L-Valine JP 1.200gm + Dibasic Potassium Phosphate USP 0.501gm + Dibasic Sodium Phosphate Hydrate JP 0.771gm + Sodium Citrate Hydrate JP 0.285gm + Sodium L-Lactate solution (60%) (as Sodium L-Lactate) USP 1.145gm Lower chamber contains (500ml): Calcium Chloride Hydrate JP 0.184gm + Glucose USP 37.499gm + Magnesium Sulfate Hydrate JP 0.308gm + Potassium chloride JP 0.317gm + Thiamine Chloride Hydrochloride JP 0.96mg + Zinc sulphate Hydrate JP 0.70mg 2. Upper chamber contains (1000ml): Acetyl cysteine JP 0.404gm + Glycine JP 1.770gm + L-Alanine USP 2.400gm + L-Arginine USP 3.150gm + L-Aspartic acid BP 0.300gm + L-Glutamic acid BP 0.300gm + L-Histidine USP 1.500gm + L-Isoleucine JP 2.400gm + L-Leucine JP 4.200gm + L-Lysine Hydrochloride JP 3.930gm + L-Methionine JP 1.170gm + L-Phenylalanine JP 2.100gm + L-Proline USP 1.500gm + L-Serine USP 0.900gm + L-Threonine JP 1.710gm + L-Tryptophan JP 0.600gm + L-Tyrosine USP 0.150gm + L-Valine JP 2.400gm + Dibasic Potassium Phosphate USP 1.002gm + Dibasic Sodium Phosphate Hydrate JP 1.542gm + Sodium Citrate Hydrate JP 0.570gm + Sodium L-Lactate solution (60%) (as Sodium L-Lactate) USP 2.290gm Lower chamber contains (1000ml): Calcium Chloride Hydrate JP 0.368gm + Glucose USP 74.998gm + Magnesium Sulfate Hydrate JP 0.616gm + Potassium chloride JP 0.634gm + Thiamine Chloride Hydrochloride JP 1.920mg + Zinc sulphate Hydrate JP 1.400mg | Provision of amino acids, electrolytes, vitamin B1, and water via a peripheral vein to patients with mild hypoproteinemia or mild malnutrition due to inadequate oral intake, and before and after gastrointestinal surgery. | 02.08.2022 |
| Tepotinibe film coated tablet 250 mg | Tepotinibe film coated tablet 250 mg | Each film coated tablet contains Tepotinibe hydrocholridehydrate 250 mg equiv. to Tepotinibe 225 mg | 12.08.2022 |
| Olaparib film coated Tablets 100mg and 150mg (Additional Indication) | Each film-coated tablets contains: Olaparib……………….. 100mg / 150mg | As monotherapy for the adjuvant treatment of adult patients with BRCA-mutated HER2- negative high risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy “WARNING: To be sold by retail on the prescription of Oncologist only” | 17.08.2022 |
| Rifapentine film-coated tablets 300mg (Additional Strength) | Each film-coated tablets contains: Rifapentine …………………..300mg | For the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph). Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. Rifapentine Tablets must always be used in combination with isoniazid as a 12 week once weekly regimen for the treatment of latent tuberculosis infection This drug should be available only through National Programme (NTEP) in the treatment of LTBI Phase IV clinical trial shall be conducted by the firm through the programme, for which protocol should be developed in consultation with the programme expert & submitted to CDSCO "WARNING: for the use in revised National Tuberculosis elimination Programme (NTEP) only” | 18.08.2022 |
| Ruxolitinib tablets 5mg, 10mg, 15mg and 20mg (Additional Indication) | RuxolitiniEach tablet contains: Ruxolitinib……………5mg/10mg/15mg/20mgb tablets 5mg, 10mg, 15mg and 20mg | Ruxolitinib is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies “WARNING: To be sold by retail on the prescription of Oncologist only” | 18.08.2022 |
| Ozenoxacin Lotion 2% w/v (New Dosage Form) | Ozenoxacin ………………….2% w/v | For the treatment of superficial skin infections and Acne "WARNING: To be sold by retail on the prescription of a Medical Specialist only” | 01.09.2022 |
| Each Chewable uncoated tablet contains: Magnesium Hydroxide IP…….165mg Calcium Carbonate IP………....800mg Femotidine IP………………….10mg | Each Chewable uncoated tablet contains: Magnesium Hydroxide IP…….165mg Calcium Carbonate IP………....800mg Femotidine IP………………….10mg | For the treatment of conditions where neutralization of gastric acid and a controlled reduction of gastric secretion is required, such as acid indigestion, heartburn, sour or upset stomach | 08.09.2022 |
| Each film coated tablet contains: Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin + Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin (50mg + 10mg & 100mg + 5mg) | Each film coated tablet contains: Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin + Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin (50mg + 10mg & 100mg + 5mg) | It is indicated for the treatment of type 2 diabetes mellitus inadequately controlled on metformin monotherapy | 16.09.2022 |
| Each film coated tablet contains: Vildagliptin………….50mg Pioglitazone Hydrochloride IP eq. to Pioglitazone…………15mg | Each film coated tablet contains: Vildagliptin………….50mg Pioglitazone Hydrochloride IP eq. to Pioglitazone…………15mg | For the treatment of type 2 diabetes mellitus inadequately controlled on metformin monotherapy | 16.09.2022 |
| Each Film Coated tablet contains: Alpha Lipoic Acid USP……….200mg Mecobalamin IP………………1500mcg Myo-Inositol BP……………...100mg Folic Acid IP……………….....1.5mg Pyridoxine Hydrochloride IP…...3mg Chromium Picolinate USP eq. to elemental Chromium………....200mcg Benfotiamine…………………200mg | Each Film Coated tablet contains: Alpha Lipoic Acid USP……….200mg Mecobalamin IP………………1500mcg Myo-Inositol BP……………...100mg Folic Acid IP……………….....1.5mg Pyridoxine Hydrochloride IP…...3mg Chromium Picolinate USP eq. to elemental Chromium………....200mcg Benfotiamine…………………200mg | For the treatment of diabetic neuropathic | 16.09.2022 |
| Each film coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate IP eq. to Sitagliptin + Metformin Hydrochloride IP (as an extended release form) (10mg + 100mg + 500mg & 10mg + 100mg + 1000mg) | Each film coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate IP eq. to Sitagliptin + Metformin Hydrochloride IP (as an extended release form) (10mg + 100mg + 500mg & 10mg + 100mg + 1000mg) | It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | 16.09.2022 |
| Paracetamol Injection (Intramuscular ), 2ml (Additional Route & Additional Strength) | Each ml contains: Paracetamol………….250mg Absolute Alcohol IP……..30%v/v Water for injection IP………..q.s. | For the short term treatment of moderate pain especially following surgery and for the short term treatment of fever, when administration by parenteral route is clinically justified Package Insert (PI) of the product should clearly mention the Warning that the product is for Intramuscular use only and not for Intravenous use | 16.09.2022 |
| Tranexamic acid spray 10% w/v (New Dosage Form) | Each ml Contains: Tranexamic Acid IP……………………100mg | To reduce or prevent hemorrhage and reduce the need of replacement therapy during accidental and domestic injury | 19.09.2022 |
| Each film coated tablet contains: Rosuvastatin Calcium IP eq. to Rosuvastatin…………40mg Bempedoic acid…….180mg | Each film coated tablet contains: Rosuvastatin Calcium IP eq. to Rosuvastatin…………40mg Bempedoic acid…….180mg | For the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C | 19.09.2022 |
| Each film coated tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin …………80mg Bempedoic acid…….180mg | Each film coated tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin …………80mg Bempedoic acid…….180mg | It is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established artherosclerotic cardiovascular disease who required additional lowering of LDL C. | 24.09.2022 |
| Tofacitinib Sustained Release Tablets 22mg (Additional Strength) | Each film-coated sustained release tablets contains: Tofacitinib Citrate equivalent to Tofacitinib………………….22mg | Indicated for the treatment of adult patients with moderately to severely active Ulcerative Colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers "WARNING: To be sold by retail on the prescription of a Gastroenterologist, Hepatologist or Specialist in Internal Medicine only” | 26.09.2022 |
| Each Film Coated Tablet contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin IP + Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin (20mg + 5mg & 20mg + 10mg) | Each Film Coated Tablet contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin IP + Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin (20mg + 5mg & 20mg + 10mg) | For the treatment of patients with type 2 diabetes mellitus inadequately controlled on Metformin monotherapy. | 06.10.2022 |
| Sildenafil Citrate Oro-Dispersible Granules 50 mg and 100mg (Additional Dosage Form) | Each Stick Pack Contains: Sildenafil citrate IP equivalent to Sildenafil …………50mg/100mg Excipients…………q.s. | For the treatment of Erectile Dysfunction "WARNING: To be sold by retail on the prescription of an Urologist, Psychiatrist and Endocrinologist only” | 07.10.2022 |
| Abemaciclib Tablets 50 mg, 100mg 150mg & 200mg (Additional Indication) | Each film coated tablet Contains: Abemaciclib ………………….. 50mg/100mg/150mg/200mg | Early Breast Cancer: In combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence. In pre or postmenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinizing hormone releasing hormone agonist “WARNING: To be sold by retail on the prescription of oncologist only” | 11.10.2022 |
| Each Film Coated Tablet contains: Ezetimibe IP………….10mg Rosuvastatin Calcium IP eq. to Rosuvastatin…………..20mg (In additional Strength) | Each Film Coated Tablet contains: Ezetimibe IP………….10mg Rosuvastatin Calcium IP eq. to Rosuvastatin…………..20mg | For the treatment of patients with primary hypercholesterolemia | 14.10.2022 |
| Each 20ml vial contains: Ceftazidime pentahydrate equivalent to Ceftazidime …… 2gm Avibactam Sodium equivalent to Avibactam ……0.5gm (In additional Indication) | Each 20ml vial contains: Ceftazidime pentahydrate equivalent to Ceftazidime …… 2gm Avibactam Sodium equivalent to Avibactam ……………………0.5gm | Treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options | 14.10.2022 |
| Tofacitinib Tablets (Additional Indication) | Tofacitinib Tablets | Treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy The firm should conduct Phase IV clinical trial for the proposed indication. Accordingly, the firm should submit Phase IV clinical trial protocol before marketing. "WARNING: To be sold by retail on the prescription of a Rheumatologist or Specialist in Internal Medicine only” | 17.10.2022 |
| Each actuation delivers: Indacaterol Maleate eq. to Indacaterol…………75mcg Budesonide IP…….200mcg | Each actuation delivers: Indacaterol Maleate eq. to Indacaterol…………75mcg Budesonide IP…….200mcg | Indicated for treatment of patients with moderate to severe COPD. | 21.10.2022 |
| Each actuation delivers: Vilanterol Trifenatate eq. to Vilanterol + Fluticasone Furoate (12.5mcg + 50mcg & 12.5mcg + 100mcg) | Each actuation delivers: Vilanterol Trifenatate eq. to Vilanterol + Fluticasone Furoate (12.5mcg + 50mcg & 12.5mcg + 100mcg) | Indicated in the patients with persistent asthma aged 18 years and older. | 21.10.2022 |
| Nimesulide Granules for oral suspension 100mg (Additional Dosage Form) | Each Sachet Contains: Nimesulide ………….100mg | For short-term treatment of inflammatory conditions including joint disorders such as rheumatoid arthritis, post-traumatic and postoperative painful conditions and fever Label should contain “Not for children below 12 years” The drug product should be available only under prescription of a Registered Medical Practitioner. The prescription should contain clearly displayed Medical Council Registration No. of the Physician The firm should conduct Phase IV clinical trial. Accordingly, the firm should submit phase IV clinical trial protocol to CDSCO within 3 months of approval of the product "WARNING: To be sold by retail on the prescription of a Medical Specialist only” | 25.10.2022 |
| Capecitabine Dispersible Tablets 150mg/500mg/1000mg (Additional Dosage Form & Additional Strength) | Each Dispersible Tablets Contains: Capecitabine ………………….150mg/500mg/1000mg | 1. For the treatment of patients with metastatic colorectal cancer. 2. For the treatment of metastatic breast cancer after failure of paclitaxel and anthracycline containing chemotherapy regimen | 25.10.2022 |
| Each uncoated bilayered tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin 40mg + Clopidogrel Sulphate IP eq. to Clopidogrel 75mg (In additional Strength) | Each uncoated bilayered tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin 40mg + Clopidogrel Sulphate IP eq. to Clopidogrel 75mg | For the treatment of dyslipidemia associated with artherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease. | 31.10.2022 |
| Each capsule contains: Indacaterol Maleate eq. to Indacaterol + Budesonide IP (75mcg + 200mcg & 150mcg + 400mcg) | Each capsule contains: Indacaterol Maleate eq. to Indacaterol + Budesonide IP (75mcg + 200mcg & 150mcg + 400mcg) | In patients with chronic obstructive pulmonary disease | 31.10.2022 |
| Each Film Coated Tablet contains: Bisoprolol Fumarate IP + Telmisartan IP (2.5mg + 40mg & 5mg+40mg) | Each Film Coated Tablet contains: Bisoprolol Fumarate IP + Telmisartan IP (2.5mg + 40mg & 5mg+40mg) | For the treatment of stage 1 and stage 2 hypertension | 02.11.2022 |
| Biapenem for Injection 300mg and Sodium Chloride Injection IP 0.9% w/v 100ml-Dual Chamber bag (Additional Packing (Dual Chamber Bag)) | Each Dual Chamber Bag contains: (A) Biapenem for Injection 300mg Each Bag Contains: Biapenem IP (Sterile)……300mg (B) Sodium Chloride Injection IP 0.9% w/v 100ml Each ml contains: Sodium Chloride IP 0.9% w/v Water for Injection IP. …….q.s. to 100ml | Complicated urinary tract infections (cUTI) "WARNING: to be sold by retail on the prescription of Specialist only” | 02.11.2022 |
| Each film coated bilayered tablets contains: Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin + Metformin Hydrochloride IP (as sustained release) + Pioglitazone Hydrochloride IP (20mg + 500mg + 15mg & 20mg + 1000mg + 15mg) | Each film coated bilayered tablets contains: Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin + Metformin Hydrochloride IP (as sustained release) + Pioglitazone Hydrochloride IP (20mg + 500mg + 15mg & 20mg + 1000mg + 15mg) | As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control | 04.11.2022 |
| Each capsule contains: Mometasone Furoate eq. to 136mcg of Mometasone Furoate IP 160mcg + Glycopyrronium Bromide eq. to 46mcg of Glycopyrronium Ph. Eur. 63mcg + Indacaterol Acetate eq. to 114mcg of Indacaterol IH 173mcg | Each capsule contains: Mometasone Furoate eq. to 136mcg of Mometasone Furoate IP 160mcg + Glycopyrronium Bromide eq. to 46mcg of Glycopyrronium Ph. Eur. 63mcg + Indacaterol Acetate eq. to 114mcg of Indacaterol IH 173mcg | Indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of long acting beta 2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in a previous year. | 07.11.2022 |
| Each uncoated bilayered tablet contains: Desvenlafaxine Succinate USP eq. to Desvenlafaxine (as extended release form) ..................50mg Clonazepam IP ……0.25mg (In additional Strength) | Each uncoated bilayered tablet contains: Desvenlafaxine Succinate USP eq. to Desvenlafaxine (as extended release form) ..........50mg Clonazepam IP ……0.25mg | For the treatment of depression | 07.11.2022 |
| FDC of Bempedoic Acid 180mg + Ezetimibe 10mg film coated tablet | FDC of Bempedoic Acid 180mg + Ezetimibe 10mg film coated tablet | It is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established artherosclerotic cardiovascular disease who required additional lowering of LDL C. | 09.11.2022 |
| Sterile dehydrated Human Amnion Chorion Membrane | Each unit contains: Sterile dehydrated Human Amnion Chorion Membrane (Patch size 5 x 5 cm2) | Indicated for the treatment of acute and chronic non-healing wounds | 15.11.2022 |
| Sterile dehydrated Human Amnion Chorion Membrane with Polyhexamethylene Biguanide 0.5% | Each unit contains: Sterile dehydrated Human Amnion Chorion Membrane with Polyhexamethylene Biguanide (PHMB) …………………….0.5% (Patch size 12 x 6 cm2) | Indicated for the treatment of acute and chronic non-healing wounds | 15.11.2022 |
| Each uncoated bilayered tablet contains: Vildagliptin 100mg (as sustained release) + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg + Metformin Hydrochloride IP (as sustained release) 1000mg | Each uncoated bilayered tablet contains: Vildagliptin 100mg (as sustained release) + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg + Metformin Hydrochloride IP (as sustained release) 1000mg | For the treatment of patients with Type 2 Diabetes Mellitus | 18.11.2022 |
| Loratadine Orally Disintegrating Tablets USP 10mg (Additional Dosage Form) | Each Orally Disintegrating Tablets Contains: Loratadine ……………10mg | Indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children | 22.11.2022 |
| Desidustat Tablets 100mg (Additional Strength) | Each uncoated tablet contains: Desidustat …………100mg Excipients………………………q.s | Treatment of Anemia in Adult Patients with Chronic Kidney Disease (CKD) not on Dialysis and on Dialysis "WARNING: To be sold by retail on the prescription of a Nephrologist/ Internal Medicine specialist” | 23.11.2022 |
| Dapagliflozin tablets 10mg (Additional Indication) | Each film-coated tablets contains: Dapagliflozin propanediol monohydrate equivalent to Dapagliflozin……………..10 mg | To reduce the risk of sustained eGFR and kidney disease, cardiovascular death, and hospitalization for heart failure in adult with chronic kidney disease at risk of progression” with condition that: - It is indicated in adults for the treatment of patients of chronic Kidney disease (CKD) upto eGFR of greater than or equal to 25 ml/min/1.73m2 .Below this, initiation of the treatment is not recommended, however the patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF “WARNING: To be sold by retail on the prescription of Nephrologist only” | 23.11.2022 |
| Each 5ml oral liquid contains: Chlorpheniramine Maleate IP + Noscapine IP (2mg + 7mg & 4mg + 15mg) | Each 5ml oral liquid contains: Chlorpheniramine Maleate IP + Noscapine IP (2mg + 7mg & 4mg + 15mg) | For the treatment of dry, irritating cough associated with running nose | 25.11.2022 |
| Naproxen Sodium Tablets USP 275mg & 550mg (Additional strength for new indication) | Each Uncoated Tablet Contains: Naproxen Sodium USP …………. 275mg/550mg | In Adult: Rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhea and acute gout. In Children: Juvenile rheumatoid arthritis | 29.11.2022 |
| Paracetamol Oral Solution (Taste Masked) 125mg/5ml (Additional Dosage Form) | Each 5ml contains: Paracetamol IP…………………….125mg In a flavoured vehicle base………q.s. | For symptomatic relief of Pain and fever | 06.12.2022 |
| Paracetamol Oral Solution (Taste Masked) 250mg/5ml (Additional Dosage Form) | Each 5ml contains: Paracetamol IP…………………….250mg In a flavoured vehicle base………q.s. | For symptomatic relief of Pain and fever | 06.12.2022 |
| Nicotine Transdermal Patch 14.5 mg (7mg/24 hr), 29 mg (14 mg/24 hr) and 43.5 mg (21mg/24 hr) (Additional Dosage form) | 1. Nicotine Transdermal patch Each transdermal Patch contains Nicotine USP…….14.5mg (7mg/24hr) Excipients……q.s 2. Nicotine Transdermal patch Nicotine USP…….29 mg (14mg/24hr) Excipients……q.s 3. Nicotine Transdermal patch Nicotine USP…….43.5mg (21mg/24hr) Excipients……q.s | To relieve and/or prevent cravings and nicotine withdrawal symptoms associated with tobacco dependence | 09.12.2022 |
| Brivaracetam Sustained Release Tablets 200mg (Modified Dosage Form) | Each Film Coated Sustained Release Tablets Contains: Brivaracetam …………………200mg | As adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy Firm should conduct active PMS study after marketing of the drug product | 12.12.2022 |
| Inosine Pranobex Tablets 1000mg (Additional Strength) | Each uncoated Tablet Contains: Inosine Pranobex ……… 1000mg | A. As add-on therapy for treatment of Mild Covid-19 patients with Co-Morbidities and Moderate Covid-19 Patients. B. Mucocutaneous infections due to herpes simplex virus (Type1 and/or Type II), Genital warts and adjunctive therpy to podophyllin or carbon dioxide laser, Subacute sclerosing panencephalitis, Influenza and other acute respiratory viral infections The firm should conduct active PMS study with minimum of 100 subjects and submit study data to CDSCO after marketing the drug product "WARNING: To be sold by retail only under prescription of Medical Specialists” | 12.12.2022 |
| Loteprednol etabonate ophthalmic suspension 1% (Additional Strength) | Each ml Contains: Loteprednol Etabonate……………1.0% w/v Benzalkoninum chloride IP….0.01% w/v (As Preservative) Sterile Aqueous Vehicle……...q.s | It is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery "WARNING: to be sold by retail on the prescription of Ophthalmologists only” | 12.12.2022 |
| Esomeprazole Dual-Release Gastro-Resistant Tablets 80mg (Additional Dosage Form) | Each Dual-Release Gastro-Resistant Tablets Contains: Esomeprazole ……………80mg | Indicated for the treatment of moderate to severe refractory gastro-esophageal reflux disease (GERD) for 4 weeks only | 16.12.2022 |
| Loperamide Hydrochloride Orally Disintegrating 2mg tablets (Additional Dosage Form) | Each Orally Disintegrating Tablets Contains: Loperamide Hydrochloride ……………………. 2 mg | Indicated for the Symptomatic treatment of acute diarrhea in adults | 03.01.2023 |
| Nitisinone Capsules 2mg/5mg/10mg/20mg (Additional Strength) | Nitisinone Capsules 2 mg: Each hard-gelatin capsule contains 2 mg of Nitisinone. Nitisinone Capsules 5 mg: Each hard-gelatin capsule contains 5 mg of Nitisinone. Nitisinone Capsules 10 mg: Each hard-gelatin capsule contains 10 mg of Nitisinone. Nitisinone Capsules 20 mg: Each hard-gelatin capsule contains 20 mg of Nitisinone | Nitisinone Capsules is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine "WARNING: To be sold by retail on the prescription of a Neonatologist Pediatrician/Endocrinologist only” | 09.01.2023 |
| Chlorhexidine Gluconate 2% w/v Wet Wipes (Additional Dosage Form & Additional Indication) | Each wipe contains: Chlorhexidine Gluconate Solution IP Equivalent to Chlorhexidine Gluconate …………..2% w/v | Chlorhexidine Gluconate Wet Wipes are disposable antibacterial towels that provide rinse-free bathing for patients at hospitals protecting them from nosocomial infection, the product is intended to use on all exposed skin | 09.01.2023 |
| Meropenem Injection IP 125 mg (Additional Strength) | Each vial contains: Meropenem IP Equivalent to anhydrous Meropenem……125 mg Sodium as Sodium carbonate IP…... 11.28 mg | Meropenem injection is indicated in children for treatment of the following infections caused by single or multiple bacteria sensitive to Meropenem: Pneumonia and Nosocomial Pneumonia, Urinary Tract Infections, Intra-abdominal Infections, Skin and Skin Structure infections, Meningitis, Septicemia. Meropenem has been proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infection The firm should submit the PMS data generated in Children with Meropenem Injections | 09.01.2023 |
| Dabrafenib Capsules 50mg and 75mg (Additional Indication) | Each hard gelatin capsule contains: Dabrafenib Mesylate equivalent to Dabrafenib ………. 50mg/75mg | Dabrafenib is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresctable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Limitation of use: Dabrafenib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Babrafenib is not indicated for treatment of patients with wild-type BRAF solid tumors “WARNING: To be sold by retail on the prescription of Oncologist only” | 10.01.2023 |
| Trametinib tablets 0.5mg and 2 mg (Additional Indication) | Each film coated tablet contains: Trametinib Dimethyl Sulfoxide equivalent to Trametinib ……0.5mg/2 mg | Trametinib is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 6 years of age and older with unresectablet or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.” Limitation of use: Trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition “WARNING: To be sold by retail on the prescription of Oncologist only” | 10.01.2023 |
| Vitamin E Capsules USP 400mg (Additional Dosage form) | Each hard gelatin capsule contains: Tocopheryl acetate IP……………… 400mg | For the prevention and treatment of Vitamin E deficiency | 13.01.2023 |
| Mercaptopurine Powder for Oral Suspension 10mg/mL (Additional Dosage Form) | Each ml of reconstituted Suspension Contains: Mercaptopurine (as monohydrate) IP………………………. 10mg | Treatment of Acute Lymphoblastic Leukemia (ALL) The firm should conduct Phase IV Clinical Trial. Accordingly, the firm should submit Phase IV study protocol within 1 year after marketing. "WARNING: To be sold by retail on the prescription of an Oncologist only” | 24.01.2023 |
| Iron.sorbitol citric acid complex | 2ml (50mgFe+++) | Haematinic.Parentral iron (Colloidal iron complex). | May,1962 |
| Irsogladine Maleate Tablet 2mg /4mg | Each uncoated tablet contains: Irsogladine maleate.2mg, 4mg | For gastric ulcers, improvement of gastric mucosal lesion (erosion, hemorrhage, redness and edema) caused by acute gastritis and acute exacerbation stage of chronic gastritis. | 10.05.2010 |
| Isapterl.II | Prepared from granulated Plantago ovata(Isapgol) seed husk (IP) and effervescent powder | March,1981 | |
| Isepamicin injection | Each ml contains: isepamicin sulfate eq.to 100mg,250mg of isepamicin. | LRTI, intra abdominal infection, UTI, skin & soft tissue infection and septicemia. | 26.12.1997 to 26.12.1999 |
| ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) | ISMN 30mg SR + Atenolol 50mg tablets | Same as Approved. | 19.03.2008 |
| ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength) | ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets | Same as Approved | 02.01.2008 |
| ISMN 60mg Sr + Atenolol 50mg/100mg | ISMN 60mg Sr + Atenolol 50mg/100mg | For angina pectoris | 23.03.2007 |
| ISMN SR 30mg + Aspirin75/150mg tablet (Additional Strength) | ISMN SR 30mg + Aspirin75/150mg tablet | Same as approved. | 20.07.2006 |
| ISMN SR 60mg + Metoprolol Succinate ER 25/50mg | Each film coated ER tablet contains: Diluted isosorbide mononitrate BP eq.to isosorbide mononitrate.60mg(SR), metoprolol succinate USP eq.to metoprolol tartrate.25mg, 50mg(ER) | For the treatment of patients suffering from angina & Hypertension. | 10.08.2006 |
| Isocarboxacid | Tabs 10 mg | Anti.depressant. | June,1962 |
| Iso.dihydo.ethaverine chloride | Iso.dihydo.ethaverine chloride | Antispasmodic | April,1965 |
| Isoflupredone AcetateSuspension for Injection (2mg per ml) ( For Veterinary) | Isoflupredone AcetateSuspension for Injection (2mg per ml) ( For Veterinary) | For the glucocorticoid, anti.inflammatory or supportive therapy to cattle suffering from conditions such as: (1) Overwhelming infections with severe toxicity. (2) Bovine ketosis. (3) Musculoskeletal conditions. (4) Shock. (5) Parturient paresis (supportive stress therapy for milk fever). | 03.10.2009 |
| Isoflurane | Isoflurane | Used for induction and maintenance of general anaesthesia. | July,1999 |
| Isometamidium Chloride | Isometamidium Chloride | Indicated in treatment of cardiac arrhythmias including atrial fibrillation, ventricular tachycardia, arrhythmia. | January,1977 |
| isoniazid + Ethambutol + Vitamin B6 | Each tablet contains: Isoniazid.300mg, ethambutol.800mg, vitamin B6.10mg | Anti.TB fide | 21.01.2000 |
| Isopregnenone, dydrogestrone | 5 mg tabs | Oral progesterone agent. | August,1962 |
| Isopropamide iodide | 5mg to 10mg | Anticholinergic | March,1961 |
| Isopropamide phenylpropanolamine Hcl. | Isopropamide phenylpropanolamine Hcl. | Symptomatic relief of common cold, vasoconstrictor and antisecretary agent. | February,1967 |
| Isopropyl thioimidazolidine | Each tablet contains: Isopropyl thioimidazolidine. 5mg | December,1972 | |
| Isoptin hydrochloride | Each 2mL contains: Isoptin Hydrochloride.5mg | September,1974 | |
| Isosorbibe 20 mg + Hydralazine 37.5 mg tablets | Isosorbibe 20 mg + Hydralazine 37.5 mg tablets | For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status. | 18.09.2009 |
| Isosorbid.5.mononitrate (SR) + aspirin hard gelatin caps. | Each hard gelatin capsule contains: isosorbid.mononitrate (as SR pellets).60mg, aspirin.75mg | By cardiologists. for prophylaxis of angina and prevention of myocardial infarction. | 16.07.2002 |
| Isosorbide dinitrate | 10mg & 5 mg | Coronary vasodilators. | October,1967 |
| Isosorbide mononitrate tablets | Each tablet contains: isosorbide mononitrate.20mg,40mg, 10mg (sun pharma, 9.8.89) | Cardiac drug. Indicated in the treatment of coronary heart disease prophylaxis of angina pectoris follow up treatment of myocardial infarction, pulmonary hypertension. | August,1985 |
| Isosorbide.5 mononitrate | Each SR Tablet contains: Isosorbide.5.mononitrate.50mg,25mg, 40mg(Nicholas 3.11.97) | Indicated in prophylaxis of angina pectoris, CHD post NI, therapy pulmonary hypertension. | May,1991 |
| Isotretinoin 0.05% + Erythromycin 2% gel | Isotretinoin 0.05% + Erythromycin 2% gel | For acne | 08.06.2007 |
| Isotretinoin cap. USP & bulk import | Each soft gelatin capsule contains: Isotretenoin USP.10mg,20mg | Dermatologists only. cystic & conglobate acne, severe nodular acne unresponsive to antibiotic therapy. | 21.06.2002 |
| isotretinoin topical gel (0.05% w/w) | Each gm of gel contains: isotretinoin USP.0.5mg | By dermatologist. for the treatment of acne vulgaris. | 13.10.2004 |
| Isoxsuprine | 10mg | Peripheral vasodilator. | March,1961 |
| Isoxsuprine Hcl | Each sustained release tablet contains: Isoxsuprine Hcl eq to 40mg of Isoxsuprine | May,1979 | |
| Itopride 150mg capsule (S.R) | Each capsule contains: Itopride Hcl 150mg (SR) | For gastrointestinal symptoms caused by reduced gastro intestinal motility like feeling of gastric fullness, upper abdominal pain, anorexia, heartburn, nausea & vomiting in non.ulcer dyspepsia or chronic gastritis. | 22.05.2006 |
| Itopride hcl tab & bulk | Each film coated tab contains: Itopride hch.50mg | G.I symptoms caused by reduced G.I motility (like feeling of gastric fullness, upper abdominal pain, anorexia, heart burn, nausea & vomiting in non.ulcer dyspepsia or chronic gastritis. | 09.05.2002 |
| Itraconazole capsules | Each capsule contains: Itraconazole.100mg | Systemic aspergillosis and candidas cryptococcosis, sporotrichosis, paracoccidioidomycosis, blastomycosis and other rarely occuring systemic or tropical mycoses. | 20.07.1993 |
| Itrolan 190, 240, 300 injection. | Itrolan 190.1ml contains:0.406g of itrolan, Itrolan 240.1ml contains:0.513g of itrolan Itrolan 300.1ml contains; 0.641g of itrolan. | Contrast media | 23.10.1992 |
| Ivabradine (Hcl.) 5mg/7.5mg Tablets | Each film coated tablet contains: ivabradine Hcl eq.to ivabradine.5mg, 7.5mg | For the treatment of chronic stable angina pectoris in patients with normal sinus rhythm who have a contraindication or intolerance for Beta.blockers. | 03.07.2008 |
| Ivabradine Hcl Tablets 5/7.5mg (Additional Indication) | Ivabradine Hcl Tablets 5/7.5mg | For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta.blockers in patients inadequately controlled with an optimal beta.blocker dose and whose heart rate is >60bpm. | 10.02.2010 |
| Ivabradine HCL Tablets 5mg/7.5mg (Additional indication) | Ivabradine HCL Tablets 5mg/7.5mg | Additional indication of "treatment of chronic heart failure in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is > 75 bpm, in combination with standard therapy including beta.blocker therapy or when beta.blocker therapy is contraindicated or not tolerated”. | 19.12.2013 |
| Ivabradine Tablets 5mg/7.5mg (Additional Indication) | Ivabradine Tablets 5mg/7.5mg | For Symptomatic Treatment of Chronic Stable Angina Pectoris in Coronary Artery Disease Patients with Normal Sinus Rhythm, Indicated in Combination with Beta.Blockers in Patients Inadequately Controlled with an Optimal Beta.Blocker Dose and Whose Heart rate is >60bpm. | 05.05.2011 |
| Ivermectin (6mg) tablets | 6mg | June,2004 | |
| Ivermectin concentrate solution/injection | Ivermectin concentrate solution.10% w/v, ivermectin injection.1% w/v. | Anthelmintic. Indicated for the control of various helminthic infestations such as round worm, lung worm of sheep, cattle, horse, swine, sucking lice, mange of pigs, dogs, ticks of sheep & cattle. | October,1985 |
| Ixabepilone lyophilized powder (Additional Indication) | Ixabepilone lyophilized powder | As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to cytotoxic chemotherapy. Previous therapy should have included as anthracycline, a taxane, and capecitabine. | 09.10.2008 |
| Ixabepilone lyophilized powder inj. 15mg/45mg per vial | Each vial contains: Ixabepilone.15mg, 45mg | In combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. | 15.09.2008 |
| Kanamycin sulphate | 1 g daily | Antibiotic for cases resistant to other antibiotic, urinary tracks staphylococcus infections. | December,1961 |
| Ketamine hydrochloride | Ketamine hydrochloride | Anaesthetic agent | August,1971 |
| Ketoconazole 2% + Zinc Pyrithone 1% Lotion | Ketoconazole 2% + Zinc Pyrithone 1% Lotion | For the treatment of pityriasis and dandruff of the scalp. | 23.02.2009 |
| Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution | Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution | For the treatment of dandruff. | 09.02.2009 |
| Ketoconazole tablets/suspension | Tablets.200mg each, suspension.20mg/ml | Oral anti fungal agent. Indicated in the treatment of systemic fungal infections, candidiasis, chronic mucocutaneous candidiasis, vaginal candidiasis, oral rush candiduria etc. | October,1986 |
| Ketoprofen | 50mg | Non steroidal anti. inflammatory agent. Indicated in the treatment rheumatoid arthritis, Osteroarthritis, ankylosing spondylites, gout. | April,1981 |
| Ketoprofen controlled release capsules | Each cotrolled release capsule contains: ketoprofen BP.100mg | July,1989 | |
| Ketoprofen Plaster ( Size . 7cm x 10 cm) | Ketoprofen Plaster ( Size . 7cm x 10 cm) | For the Relief of Musculoskeletal pain and Inflammation. | 09.03.2011 |
| Ketoprofen plaster 30 mg (7cm X 10 cm) | Ketoprofen plaster 30 mg (7cm X 10 cm) | For the relief of musculoskeletal pain & inflammation. | 11.12.2009 |
| Ketoprofen Plaster 30mg (7cm X 10cm) | Ketoprofen Plaster 30mg (7cm X 10cm) | For the relief of musculoskeletal pain and inflammation. | 18.04.20112 |
| Ketoprofen transdermal patches | Each patch contains: ketoprofen.30mg | For the relief of musculoskeletal pain & inflammation. | 17.05.1999 |
| Ketorolac ODS 10mg (Additional Dosage form) | Ketorolac ODS 10mg | For the treatment of short.term management of post.operative pain and musco.skeletal pain. | 29.04.2015 |
| Ketorolac sterile ophthalmic solution 0.5% | Ketorolac tromethamine .0.5% | For the relief of occular itching due to seasonal allergic conjunctivitis only. | 01.03.1996 |
| Ketorolac Tromethamine 0.4% (Eye drops) (Additional Strength) | Ketorolac Tromethamine 0.4% Eye drops | Ophthalmic. | 20.09.2005 |
| Ketorolac Tromethamine 0.4% w/v + Moxifloxacin 0.5% w/v Opthalmic solution (Additional Lower Strength) | Ketorolac Tromethamine 0.4% w/v + Moxifloxacin 0.5% w/v | Additional Lower Strength | 21.09.2010 |
| Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops | Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops | For the reduction of post operative inflammatory conditions of the eye. | 24.07.2008 |
| Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops | Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops | Ophthalmic | 07.12.2005 |
| Ketorolac tromethamine Gel | Each mg of gel contains; ketorolac tromethamine USP. 20mg | For the treatment of muscle, joint and post.traumatic stress. | 01.04.2009 |
| Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solution | Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg | For the treatment of seasonal allergic conjunctivitis in adults only. | 21.11.2011 |
| Ketorolac Tromethamine Ophthalmic Solution 0.45% | Ketorolac Tromethamine Ophthalmic Solution 0.45% | Indicated for the treatment of pain and inflammation following cataract surgery. | 10.02.2010 |
| Ketorolac tromethamine tablet/injection | Each film coated tablet contains: ketorolac tromethamine.10mg, ampoule.30mg/ml, 15mg/ml (i.m inj. Cadila 13.5.92) | Non steroidal analgesic anti inflammatory. Indicated in the treatment of short term management of post operative pain and musculo.skeletal pain. | 21.04.1992 |
| Ketotifen fumerate | Each ml contains: ketotifen fumerate eq.to ketotifen.0.25mg | For temporary prevention of itching of the eyes due to allergic conjuctivitis. | 05.05.2000 |
| KFD Vaccine (Kyasanur forest disease) | KFD Vaccine (Kyasanur forest disease) | March,1989 | |
| Kiltix collar | Every 10gm of collar contains: propoxur.1000gm, flumethrin.0.225gm | For protection and control of ticks and fleas on dogs. | 03.02.1997 |
| Kit for preparation of Medronate (Sn) MTC injectable | Each vial contains: (on reconstitution) medronic acid.10mg, stannous chloride, 2H2O.1mg | Diagnosis and study of primarily cancer metastatic bone lesion and other bone diseases. Paget's disease osteomylitis fractures. | 23.02.1999 |
| Kitotifen fumerate | Each tablet contains: kitotifen fumerate eq.to .1mg base, Each 5ml syrup contains; kitotifen fumerate eq.to.1mg, Ketotifen nasal drop* | Anti asthmatic drug. Indicated in prophylactic treatment of bronchial asthma, symptomatic improvement of allergic conditions including rhinitis and conjunctivitis. | May,1991 |
| korsolex concentrated instrument disinfectant | korsolex concentrated instrument disinfectant | 20.05.1992 | |
| L. Lysine Hcl Ointment (150mg/gm) | L. Lysine Hcl Ointment (150mg/gm) | For wounds of various etiology. | 08.08.2006 |
| Labetolol hydrochloride | Labetolol hydrochloride | Anti hypertensive agent. Indicated in the treatment of all forms of hypertension (except hypertension of pregnancy) | December,1986 |
| Labetolol tablets | Each tablet contains: labetolol hydrochloride.50mg,100mg,200mg | January,1987 | |
| Lacidipine tablets | Each film coated tablet contains: lacidipine.2mg,4mg | Mild to moderate hypertension. | 06.05.1997 to 05.05.1999 |
| Lacosamide film coated tablet 50mg /100mg /150mg /200mg | Each film coated tablet contains: lacosamide.50mg, 100mg, 150mg, 200mg | As an adjunctive treatment of partial onset seizures in patients > 17 years of age. | 10.06.2010 |
| Lacosamide Injection 10mg/ml | Lacosamide Injection 10mg/ml | As an adjunctive treatment of partial onset seizures in patients>17 years of age. | 19.10.2012 |
| Lacosamide Syrup15mg/ml (Additional Dosage Form) | Lacosamide Syrup15mg/ml | Same as approved | 02.05.2011 |
| Lacti syn conc. Amps | Lacti syn conc. Amps | June,1965 | |
| Lactic acid with lactoserum (for topical use) | Lactic acid.0.1% w/v=1.00% w/v, lactoserum.0.9% w/v | 06.11.1995 | |
| Lactilol monohydrate Syrup 66.67/100ml | Each 100ml syrup contains: lactilol monohydrate BP.66.67gm | For the treatment of constipation. | 16.05.2007 |
| Lactitol Sachet (10gm/20gm) | Each sachet contains: lactitol monohydrate eq.to lactitol.10gm, 20gm | For the treatment of constipation. | 21.11.2005 |
| Lactobacillus brevis CD2 Lozenges 100mg (corresponding to not less than 1 billion) of live, lyophilised, lactic acid bacteria, Lactobacillus brevis CD2. (Additional Indication) | Lactobacillus brevis CD2 Lozenges 100mg (corresponding to not less than 1 billion) of live, lyophilised, lactic acid bacteria, Lactobacillus brevis CD2. | Prevention of radiotherapy and chemotherapy induced oral mucositis in cancer patients. | 09.08.2014 |
| Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules | Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules | For the treatment of acute diarrhoea in children. | 04.11.2009 |
| Lactobacillus sporogenes | Each tablet contains: lacbon.50 million, 100 million. | October,1971 | |
| Lactulose Enema (20%) | For constipation & hepatic encepthalopathy. | 28.03.2006 | |
| Lactulose oral powder 10gm | Each dose contains: lactulose BP.10gm | For the treatment of constipation, hepatic encephalopathy. | 08.02.2007 |
| Lactulose powder for oral solution | Each pouch contains: lactulose B.P.10gm,20gm | Constipation | 03.09.2001 |
| Lamivudine (40mg) + Stavudine (10mg/5ml) reconstituted solution | Lamivudine (40mg) + Stavudine (10mg/5ml) reconstituted solution | For HIV infection. | 08.04.2005 |
| Lamivudine + zidovudine tablets | Lamivudine.150mg, zidovudine.300mg | For the treatment of HIV infection | 26.11.1999 |
| Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet | Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet | Anti HIV | 11.08.2006 |
| Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Strength) | Lamivudine 20mg + Stavudine 5mg dispersible tablets | Same as Approved. | 01.04.08 |
| Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet | Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet | For pediatric patients with HIV infection. | 14.06.2005 |
| Lamivudine 30mg + Zidovudine 60mg +Nevirapine 50mg Oral Suspension (Tablets for oral Suspension) | Lamivudine 30mg + Zidovudine 60mg +Nevirapine 50mg Oral Suspension | For the treatment of HIV patients. | 23.02.2009 |
| Lamivudine 40mg + Stavudine 10mg dispersible tablet. | Lamivudine 40mg + Stavudine 10mg dispersible tablet. | For HIV infection. | 12.07.2006 |
| Lamivudine oral solution | 25mg/5ml | For the treatment of chronic hepatitis B virus infection. | 30.12.1999 |
| Lamivudine tablet/oral solution/bulk | i).Each uncoated tab contains: lamivudine.150mg, 100mg (for chronic hepatitis on 25.10.99), ii).Each 5ml contains; lamivudine.50mg, 25mg(30.12.99, cadila) | As an adjunct to other anti retroviral agents in prgressive HIV infection and chronic hepatitis B virus (HBV). | 27.03.1998 |
| Lamivudine(40mg) + Nevirapine(70mg) + Stavudine(10mg) (in5ml) Powder for suspension | Lamivudine(40mg) + Nevirapine(70mg) + Stavudine(10mg) (in5ml) | Anti HIV | 28.01.2005 |
| Lamotrigin 200mg tablet (Additional Strength) Dispersible tablet (5mg/50mg/100mg/200mg | Lamotrigin 200mg tablet Dispersible tablet (5mg/50mg/100mg/200mg | Anti.epileptic. | 08.06.2006 |
| Lamotrigine | Each tab contains: Lamotrigine.50mg,100mg | 21.01.2000 | |
| Lamotrigine 25mg Modified Release Tablet (Additional Strength) | Lamotrigine 25mg Modified Release Tablet | Same as Approved | 05.04.2010 |
| Lamotrigine ER Tablet 25mg/50mg/100mg/200mg | Lamotrigine ER Tablet 25mg/50mg/100mg/200mg | Add.on therapy for partial and secondary generalised tonic.clonic seizures. | 06.08.2012 |
| Lamotrigine MR Tablets 150mg (Additional Strength) | Lamotrigine MR Tablets 150mg | Same as approved. | 03.10.2009 |
| Lamotrigine MR Tablets 50/100mg (Additional Indication) | Lamotrigine MR Tablets 50/100mg | For the treatment of bipolar I disorder. | 17.12.2008 |
| Lamotrigine Orodispersible Tablet 12.5 mg (Additional Strength) | Lamotrigine Orodispersible Tablet 12.5 mg | Same as Approved | 20.03.2010 |
| Lamotrigine SR tablets | Each SR tablet contains: lamotrigine.50mg,100mg,200mg. | By neurologists.as add on therapy for partial and secondry generalized tonic.clonic seizures in adults not below 16 years of age. | 27.08.2004 |
| Lamotrigine tab | Lamotrigine tab | Deletion of box warning on label/carton stating "the drug is contraindicated in children below 16 years of age" | 05.03.2002 |
| Lamotrigine tablets | Each scored tablet contains: lamotrigine.25mg | Add on therapy for partial and secondry generalised tonic.clonic seizures in adults not below 16 years of age. | 14.05.1998 |
| Lansoprazole capsules | Each capsule contains: lansoprazole.30mg(as enteric coated granule), lansoprazole(as enteric coated granule).15mg(31.7.96) | For the treatment of duodenal ulcer, gastric ulcer, reflux oesophagitis, zollinger.ellison syndrome. | 16.12.1994 |
| Lansoprazole for injection 30mg/vial | Each vial contains: lansoprazole.30mg | For short term treatment of errosive esophagitis when patients are unable to take the oral formulation. | 28.04.2008 |
| Lanthanum Carbonate Chewable tablet (250mg/500mg) | For the treatment of hyperphosphatemia. | 09.11.2005 | |
| Lapatanib tablet 250mg (Additional indication) | Lapatanib tablet 250mg | Lapatinib in combination with trastuzumab, indicated for the treatment of patients with hormone receptor. negative metastatic breast cancer whose tumours overexpress HER2/neu (ErbB2) and who have progressed onprior trastuzumab therapy in combination with chemotherapy in the metastatic setting. | 22.12.2014 |
| Lapatinib (as Ditosylate) (250mg) Tablet | Each film coated tablet contains: lapatinib ditosylate eq.to lapatinib.250mg | Lapatinib In combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumour overexpress HER2+/neu and who have received prior therapy including trastuzumab. | 24.07.2007 |
| Lapatinib Ditosylate Tablets 250mg (Additional indication) | Lapatinib Ditosylate Tablets 250mg | In combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. | 10.05.2010 |
| L.Asparaginase | L.Asparaginase | Anticancer | May,1973 |
| Latanoprost + timolol maleate (Eye Drops) | Each ml contains: latanoprost.50mcg, timolol maleate eq.to timolol.50mg (5.0mg ??) | Reduction of intraocular pressure in patients with open angle glaucoma & ocular hypertension. | 02.08.2002 |
| Latanoprost 50mcg/ml Ophtalamic Solution (Additional indication) | Latanoprost 50mcg/ml Ophtalamic Solution | For the Reduction of Elevated Intraocular Pressure in Paediatric Patients with Elevated Intraocular Pressure and Paediatric Glaucoma. | 02.06.2011 |
| Latanoprost (Eye Drops) | Each ml of eye drop contains: latanoprost.50mg | In the treatment of glaucoma and ocular hypertension. | 12.05.1998 |
| L.carnitine (tabs of l.carnitine 330mg was appr.in May.92) | Each single dose 5ml ampoule contains: levo.carnitine.1gm. | 31.03.2000 | |
| L.carnitine capsule/tab/oral solution | Each L.carnitine capsule contains: levo carnitine.330mg, tablets.250mg, oral solution.10ml of oral liquid contains l.carnitinr.1gm | Carnitine deficiency. | May,1990 |
| L.dihydroxyphenylalanine | Each tablet/capsule contains:L.dihydroxyphenylalanine.500 mg. | May,1971 | |
| Lecithin Liquid (each 5 ml contains lecithin 500mg equivalent to essential phospholipids 250mg) | Each 5ml contains: lecithin USP 500mg eq.to essential phospholipid.250mg | For the treatment of alcoholic liver disease and drug induced hepatitis. | 14.05.2008 |
| Ledipasvir (90mg) + Sofosbuvir (400mg) tablets | Each film coated tablet contains: ledipasvir.90mg, sofosbuvir.400mg | For the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. | 08.12.2015 |
| Leflunomide (10mg/20mg/100mg) | 10mg,20mg,100mg | For additional indication; "active psoriatic arthritis in adults only" subject to all condition of 4.136/04 dt. 30.08.2004. | 29.11.2004 |
| Leflunomide film coated tablets | Leflunomide film coated tablet.10mg | For additional indication. active psoriatic arthritis in adults only. | 30.08.2004 |
| Leflunomide tab | Each film coated tab contains; leflunomide.10mg,20mg,100mg | For active rheumatoid arthritis in adults only. | 01.10.2001 |
| Lenalidomide capsule (5mg/10mg /15mg/25mg) | Each capsule contains: lenalidomide.5mg, 10mg, 15mg, 25mg | For the treatment of patients with transfusion dependent anemia due to low or intermediate.1.risk myalodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. | 16.05.2007 |
| Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication) | Lenalidomide Capsule 5mg/10mg/15mg/25mg | In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. | 22.04.08 |
| Lenograstim 263 mcg/vial (HAS free) | 263mcg/vial | This product without (HAS free) was approved vide file of even no. dated 7.05.1997 | 29.03.2001 |
| Leprosy immunomodulator vaccine (based on Mw) | Leprosy immunomodulator vaccine (based on Mw) | 09.02.1999 | |
| Lercanidipine hcl | Each film coated tablet contains: lercanidipine hcl.10mg | By cardiologists. for mild to moderate hypertension. | 07.05.2002 |
| Letrozole | 2.5mg | For first line therapy in post menopausal women with Advanced Breast cancer | 11.02.2002 |
| Letrozole tabs | Each film coated tab contains: letrozole.2.5mg | Second line treatment of advanced breast cancer in women. | 12.03.1998 |
| Leuprolide acetate (3 months) depot | 11.25mg/vial injection | For additional indication; "advanced prostatic cancer", subject to all condition of MF 1447/04 dated 26.05.2004. 3 months depot, 11.25mg/vial, injection. | 03.12.2003 |
| Leuprolide acetate depot inj. | Leuprolide acetate depot inj. | For additional indicatio; of endometriosis & uterine leiomyomata in women. | 17.07.2001 |
| Leuprolide acetate sepot for inj. | Each vial contains: leuprolide acetate.3.75mg | Indicated for the treatment of prostatic cancer only. | 10.12.1997 to 10.12.1999 |
| Levamisole + Mebendazole tablets | Each tablet contains: levamisole.50mg, mebendazole.200mg | September,1984 | |
| Levamisole + Oxyclozanide suspension | Levamisole.1.5%,& oxyclozanide.3.0% | 29.09.1993 | |
| Levamisole Hydrochloride | Levamisole Hydrochloride.15% w/w & 30% w/v Injection.Levamisole.18.2% w/v | July,1980 | |
| Levetiracetam (1000mg) tablet (Additional Strength) | Levetiracetam (1000mg) tablet | May,2005 | |
| Levetiracetam (250mg,500mg,750mg) tablets | Each film coated tablet contains: levetiracetam.250mg, 500mg, 750mg | By neurologists. As adjunctive therapy in treatment of partial onset of seizures in adults with epilepsy. | 05.04.2005 |
| Levetiracetam Oral Solution (100mg/ml) | Each 1ml solution contains: levetiracetam.100mg | As adjuvant therapy in treatment of partial onset seizures in adults with epilepsy when oral tablets cannot be swallowed by patients. | 04.10.2005 |
| Levetiracetam Oral Solution (100mg/ml). | Anti.epileptic. | 24.02.2006 | |
| Levetiracetam Oral Solution 100mg/ml (Additional Indication) | Levetiracetam Oral Solution 100mg/ml | As Adjunctive Therapy in the Treatment of Partial Onset Seizures With or Without Secondary Generalisation in Adults, Children and Infants from 1 Month of Age with Epilepsy. | 05.05.2011 |
| Levetiracetam SR Tablet 500/750/1000mg | Levetiracetam SR Tablet 500/750/1000mg | Same as approved. | 02.05.2009 |
| Levetiracetam Tablet (Additional Indication) | Levetiracetam Tablet | (i) As monotherapy in partial onset seizures with or without secondary generalisation in patients with 16 years of age with newly diagnosed epilepsy. (ii) As adjunctive therapy in myoclonic seizures in adults and adolescents from 12 years of age with Juvenile myoclonic epilepsy. In primary generalised tonicclonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. | 09.10.2007 |
| Levobetaxolol HCl Opthalmic Suspension 0.5% | Each ml contains: levobetaxolol hydrochloride 5.6mg eq.to levobetaxolol.5.0mg (free base) | For lowering of intraoccular pressure in patients with chronic open.angle glaucoma or occular hypertension. | 19.01.2010 |
| Levobunolol hydrochloride ophthalmic solution | Each ml contains: levobunolol hcl USP.2.5mg,5.0mg. | For the control of intra.ocular pressure in chronic open angle glaucoma and ocular hypertension. | 16.05.1996 |
| Levocetirizem 2Hcl. Dispersible tablet (2.5mg) | For allergic rhinitis & chronic urticaria. | 08.05.2007 | |
| Levocetirizine Di.HCl mouth dissolving tablets (5mg) (New Dosage Form) | Each uncoated tablet contains: levoceterizine di.HCl.5mg | For the treatment of allergic rhinitis and chronic urticaria. | 27.07.2007 |
| Levocetirizine Di.HCl syrup (2.5mg/5ml) (for use in children 2 years and above) | Levocetirizine Di.HCl syrup (2.5mg/5ml) (for use in children 2 years and above) | As approved. | 26.09.2007 |
| Levocetirizine Di.HCl Syrup2.5mg/5ml (Additional Indication) | Levocetirizine Di.HCl Syrup2.5mg/5ml | For the Treatment of Allergic Rhinitis and Chronic Urticaria in Children from 6 months of Age. | 05.05.2011 |
| Levocetirizine dihydrochloride 2.5mg + Montelukast 5mg Dispersible tablet (Additional Strength) | Levocetirizine dihydrochloride 2.5mg + Montelukast 5mg Dispersible tablet | Additional strength | 13.10.2010 |
| Levocetirizine ODS 2.5mg /5mg (Additional Dosage Form) | Levocetirizine ODS 2.5mg /5mg | For allergic rhinitis and chronic urticaria. | 14.10.2015 |
| Levocetirizine Syrup (2.5mg/5ml) | Levocetirizine Syrup (2.5mg/5ml) | For allergic rhinitis & urticaria | 13.01.2005 |
| Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup | Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup | For productive cough. | 20.07.2006 |
| Levocetrizine 2Hcl + Pseudoephedrine hcl SR tablets | Each uncoated tablet contains: levocetrizine 2Hcl.2.5mg,5mg, pseudoephedrine hcl SR.120mg | By RMP. for the treatment of seasonal allergic rhinitis. | 29.01.2004 |
| Levocetrizine 2HCl syrup | Each 5ml of liquid syrup contains: levocetrizine 2HCl.2.5mg | By RMP | October,2004 |
| Each tablet contains : Levocetrizzine Dihydrochloride IP (IR)…............5mg Ambroxol Hydrochloride (SR)….......................75mg | Each tablet contains : Levocetrizzine Dihydrochloride IP (IR)…............5mg Ambroxol Hydrochloride (SR)….......................75mg | For the symptomatic relief of productive cough associated with allergic rhinitis, when both anti- histamine and mucolytic agents are desired. | 29.05.2006 |
| Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage Form) | Levocetrizine Di HCl Dispersible tablet 5mg/10mg | For allergic rhinitis & chronic urticaria. | 28.01.2008 |
| Levocetrizine tablets | Each film coated tablet contains: levocetrizine 2hcl.5mg | RMP. for treatment of allergic rhinitis & chronic urticaria. | 12..12.2002 |
| Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules | Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules | For SAR, PAR & Chronic idiopathic urticatia. | 09.08.2006 |
| Levocloperastine (as Fendizoate) Suspension eq. to Levocloperastine Hcl 20mg / 5ml. | Each 5ml of suspension contains: levocloperastine fendizoate 35.4mg eq.to levocloperastine Hcl.20mg | For the treatment of non productive cough in adult patients | 29.09.2010 |
| Levodopa & carbidopa CR tablet | Each CR tablet contains: carbidopa (anhydrous).50mg, levodopa.200mg | 19.10.1994 | |
| Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg) + Entacapone (200mg) tablet | Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg) + Entacapone (200mg) tablet | For Parkinson’s disease. | 25.07.2005 |
| Levodopa + Benserazide capsules | Each capsule contains: levodopa.100mg,200mg, benserazide.25mg,50mg | Parkinsonism. To be used only in the manufacture of capsules containing this drug in combination with levodopa for the treatment of Parkinson's disease. | November,1985 |
| Levodopa + Carbidopa tablets | Levodopa + Carbidopa tablets | Parkinsonism.for the treatment of Parkinson's disease. | December,1983 |
| Levodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving tablet | Levodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving tablet | For the symptomatic symptoms of idiopathic Parkinson's Disease. | 04.03.2009 |
| Levodopa 200mg + Carbidopa 50mg C.R. tablet | Levodopa 200mg + Carbidopa 50mg C.R. tablet | For Parkinson's Disease. | 08.01.2008 |
| Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup | Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup | For the treatment of non.productive cough. | 06.07.2009 |
| Levodropropizine oral syrup (30mg/5ml) | Each 5ml contains: levodropropizine Hcl.30mg | By RMP. Symptomatic treatment of non.productive cough in adults. | 25.02.2005 |
| Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml (Eye Drops) | Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml | For post.operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists. | 11.07.2007 |
| levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet | levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet | For lower respiratory tract infection in adult. | 08.02.2007 |
| Levofloxacin 0.5% (Ear Drops) | Levofloxacin 0.5% | For otitis media. | 27.06.2006 |
| Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Additional Strength) | Levofloxacin Oph. Solu. (1.5%) 15mg/ml. | Ophthalmic | 16.12.2005 |
| Levofloxacin Ophthalmic Solution (0.5%) | Each ml ophthalmic solution contains: levofloxacin hemihydrate eq.to levofloxacin.5mg | For the treatment of susceptible bacterial conjunctivitis. | 04.03.2005 |
| Levofloxacin oral Solution | Each 240ml bottle contains: levofloxacin hemihydrate eq.to levofloxacin.25mg/ml | For the treatment of adult patients (≥18 years of age) with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, complicated and uncomplicated UTI, skin and soft tissue infections, chronic bacterial prostatitis and acute pyelonephritis. | 22.11.2007 |
| Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.) | Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.) | Antibiotic (For adult use only). | 07.03.2007 |
| Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For Additional Indication) | Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml | Additional indication; in treatment of prostatitis. | 21.09.2006 |
| Levofloxacin tabs | Levofloxacin.750mg | For the treatment of complicated skin and skin structure infections only | 20.06.2003 |
| Levofloxacin tabs and infusion | Each film coated tab 250mg,500mg. Infusion 5mg/ml (in 50ml & 100ml) | In treatment of acute mailliary sinusitis, acute bacterial excerbation, chronic bronchitis, community acquired pneumoniae, skin & soft tissue infection, complicated urinary tract infection or acute pyelonephritis. | 23.07.1999 |
| Levofloxaxin inj. | Levofloxacin.750mg | 17.09.2003 | |
| Levonorgesterel 100mcg + Ethniyl estradiol IP 20mcg tablet (Additional indication) | Levonorgesterel 100mcg + Ethniyl estradiol IP 20mcg tablet | (Additional indication) For the treatment of moderate acne vulgaris in women more than 18 years of age who have no therapy contraindications to oral contraceptive therapy, desire contraceptiopn, and have achieved menarche. | 13.10.2010 |
| Levonorgestrel + ethinyl estradiol | Levonorgestrel.0.25mg, ethinyl estradiol.0.05mg | For emergency contraception in women, only till such time the newer option like levonorgestrel (0.75mg) is available in market. | 07.06.2001 |
| Levonorgestrel + Ethinyloestradiol | Triquilar (Calender pack contains 21 tablets): 6 tablets.Each tablet containing: Levonorgestrel.0.05mg, Ethinyloestradiol.0.03mg, 5 tablet.Each containing Levonorgestrel.0.075mg, Ethinyloestradiol.0.04mg, 10 tablets.Each contains Levonorgestrel.0.125mg, Ethinyloestradiol.0.03mg, Triquilar ED containing; 7 inactive tablets + 5 extra. | August,1981 | |
| Levonorgestrel 0.03mg tablet | Levonorgestrel 0.03mg tablet | For control of fertility | 23.07.2007 |
| Levonorgestrel 1.5mg tablets | Levonorgestrel 1.5mg tablets | For emergency contraceptive | 07.02.2007 |
| Levonorgestrel releasing intrauterine system | Each sterile IUS contains: levonorgestrel.52mg | By RMP. contraception, menorrhagia & endometrial hyperplasia during estrogen replacement therapy in women. | 13.09.2000 |
| Levonorgestrel tabs | Each tab.in packs of 2 tabs contain: levonorgestrel.0.75mg | Emergency contraception in women. | 06.09.2001 |
| Levosalbutamol (as sulphate) inhalation solution | Each 2.5ml contains: levosalbutamol (as sulphate) 0.63mg/1.25mg | By RMP. for treatment or prevention of bronchospasm in adults and adolescents with reversible obstructive airway disease. | 04.06.2001 |
| Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler (100mcg/capsule) (New Dosage Form) | Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler (100mcg/capsule) | As approved. | 16.03.2007 |
| Levosalbutamol syrup/tabs. | Tablets.1mg,2mg, syrup.1mg/5ml | For treatment of bronchospasm in patients above 6 years with reasonable obstructive airway disease. | 16.07.2004 |
| Levosimendan Injection 2.5mg / ml | Each ml contains: levosimendan.2.5mg | For the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient and in cases where inotropic support is considered appropriate. | 04.05.2010 |
| Levosulpiride 75/150/200 mg (Additional Strength) | Levosulpiride 75/150/200 mg | 75 mg tablet: For the treatment of gastro intestinal problem like fanatical dyspepsia, nausea, vomiting and diabetic gastroperisis. 150/200mg: For the treatment of depression and schizophrenia in adults. | 09.12.2014 |
| Levosulpiride Inj. 25mg/ml, 2ml | Levosulpiride Inj. 25mg/ml, 2ml | For the treatment of depression and schizophrenia in adults when oral therapy is not possible. | 26.09.2008 |
| Levosulpiride tablet (25mg) | Each uncoated tablet contains: levosulpiride.25mg | For the treatment of different G.I. problem like fanatical dyspepsia, nausea, vomiting and diabetic gastroparesis. | 10.05.2007 |
| Levosulpiride Tablet (50mg/100mg) (Additional Strength For Additonal Indication) | Levosulpiride Tablet (50mg/100mg) | For depression and schizophrenia in adults. | 12.06.2007 |
| Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule | Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule | For the treatment of Gastrooesophageal Reflux Disease (GERD) | 19.08.2011 |
| Levosulpride ER Tablet 100/150/200mg | Levosulpride ER Tablet 100/150/200mg | For the treatment of depression and schizophrenia in adults. | 27.10.2009 |
| Levosulpride Injection 25mg/2ml (Additional Strength) | Levosulpride Injection 25mg/2ml | For the treatment of different Gastro intestinal problems like functional dyspepsia, nausea, vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults. | 17.12.2008 |
| Levovist | Levovist 4gm and 2.5gm granules per 20ml vial, 1gm granules contains; galactose.999mg, palmetic acid.1mg | Contrast media.One and two dimensional doppler senographic blood flow in aging in patients when there is an insufficient dopler. signal intensity and for B mode contrast echo.cardiography. | 28.11.1997 to 28.11.1999 |
| Lidocaine 2% + prilocaine 2.5% w/w cream | Lidocaine.2% w/w, prilocaine.2.5%w/w | As a topical anaesthetic for use on normal intact skin for local anaesthetic | May,1999 |
| Lidocaine 2.5% w/w + Prilocaine 2.5% w/w Gel (Additional higher Strength) | Lidocaine 2.5% w/w + Prilocaine 2.5% w/w Gel | Additional higher Strength | 26.03.2010 |
| Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml | Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml | Indicated for ocular surface anaesthesia during ophthalmologic procedures. | 30.07.2010 |
| Lidocaine Lozenges 100mg (Additional Strength) | Lidocaine Lozenges 100mg | Same as Approved | 15.07.2010 |
| Lidocaine Lozenges 200/300mg | Lidocaine Lozenges 200/300mg | For single agent anesthesia in upper gastro intestinal endoscopy. | 26.02.2009 |
| Lidocaine Lozenges 200/300mg (Additional Indication) | Lidocaine Lozenges 200/300mg | For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract. | 19.08.2009 |
| Lidocaine Patch 350mg (Additional Pack Size) | Lidocaine Patch 350mg | For the relief of pain associated with post.herpetic neuralgia. It should be applied only to intact skin. | 17.06.2010 |
| Lidocaine patch 5% | Each adhesive patch contains: lidocaine.700mg in an aqueous base (50mg per gram adhesive) | For the relief of pain associated with post.herpetic neuralgia. It should be applied only to intact skin. | 31.03.2009 |
| Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive) | Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive) | For the relief of pain associated with post.herpetic neuralgia. It should be applied only to intact skin. | 26.03.2009 |
| Lidocaine7.5mg + Prilocaine2.5mg per acutation spray | Lidocaine7.5mg + Prilocaine2.5mg per acutation spray | For the treatment of adult male patients with premature ejaculation. | 12.03.2010 |
| Lidoflazine | Each tablet contains: Lidoflazine.60mg (1 tablet daily for 1st week,2 tablets for 2nd week, 3 tablets for 3rd week) | Coronary Vasodilator. Indicated in the treatment as Ischaemic heart disease and prophylaxis after treatment of myocardial infarction. | August,1974 |
| Lignocaine cream (10 & 25gm tube) | Lignocaine (base).2%, silver sulphadiazine.1%, chlorhexidine glyconate.02% | Temporary pain relief & to prevent infection in cuts & burn, wounds, nick, scrapes, scratches, abrasion, heppes zoster, bed sores. | 18.06.1996 |
| Lignocaine IP + Aluminium Hydroxide IP + Magnesium Hydrochloride IP + Activated Dimethicone.20 NF | Each tablet contains & each 5ml suspension contains: Lignocaine IP.50mg, Aluminium Hydroxide IP.300mg, Magnesium Hydrochloride IP.100mg, Activated Dimethicone.20, NF.50mg | September,1978 | |
| Linagliptin film coated Tablet 5mg | Each film coated tablet contains: linagliptin.5mg | As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important limitations of use: 1. Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 2. Has not been studied in combination with insulin. | 23.01.2012 |
| Lincomycin + Neomycin + Methyl prednisolone | Each 10ml contains: lincomycin hcl monohydrate eq.to 200mg base, neomycin sulphate eq.to 200mg base, methyl prednisolone.5mg | March,1989 | |
| Lincomycin + Spectinomycin sterile solution | Each ml contains: Lincomycin hcl.50mg, spectinomycin sulphate.100mg | October,1988 | |
| Lincomycin Hcl + Lincomycin base | Each 5mL contains: Lincomycin Hcl eq. to Lincomycin base.250mg | June,1973 | |
| Lincomycin Hydrochloride | Each capsule contains: Lincomycin hydrochloride.500mg | December,1972 | |
| Linezolid dry powder for suspension | Each 5ml reconstituted suspension contains: linezolid.100mg | Bt RMP.for the treatment of complicated/uncomplicated skin and skin structure infection and community acquired pneumonia. | 05.01.2004 |
| Linezolid IV inj. | Each ml contains: linezolid.2mg, dextrose.5% | Complicated/uncomplicated skin & skin structure infections/community acquired pneumonia. | 01.04.2002 |
| Linezolid tablets | Each tablet containg: linezolid.600mg | For additional indication. By RMP. osteomyelitis in adults. | 30.05.2004 |
| Linezolid tabs & bulk & oral susp. | Each film coated tab contains: linezolid.400mg, 600mg, Each 5ml of reconstituted oral suspension contains; linezolid.100mg | Complicated/uncomplicated skin & skin structure infection, community acquired pneumonia. | 04.10.2001 |
| Lipid Based Amphotericin.B Gel 0.1% | Indicated in the treatment of cutaneous and mucocutaneous mycotic infections caused by candida (Monilia) species. | 05.02.2010 | |
| Lipoproteins extracted from human placenta | Lipoproteins extracted from human placenta.50% | January,1989 | |
| Liposomal doxorubicin hcl | Liposomal doxorubicin hcl pegylated inj. 2mg/ml | Additional indication.for the treatment of metastatic carcinoma of the ovary in patients with diseases, refractory to both paclitaxel and platinum based chemotherapy. | 29.11.2000 |
| Liquid paraffin 6% + White soft paraffin 15% w/v Cream | Liquid paraffin 6% + White soft paraffin 15% w/v Cream | For symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis. | 29.04.2010 |
| Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate3.33mg per 5ml | Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate3.33mg per 5ml | For symptomatic treatment of constipation in adults. | 29.01.2009 |
| Lisinopril | Each tablet contains: lisinopril dihydrate eq. to 10mg,20mg of lisinopril, 2.5mg,5mg approved vide letter dated 22.11.91 | Essential hypertension and inpatients with congestive heart failure. | November,1991 |
| Lisinopril + Hydrochlorthiazid | Each uncoated tab contains: lisinopril.10mg,20mg,5mg, Hydrochlothiazide.12.5mg,25mg,12.5mg | 23.11.1995 | |
| Live freeze.dried lactic acid bacteria and bifidobacteria capsules | Live freeze.dried lactic acid bacteria and bifidobacteria capsules | For the treatment of irritable bowel syndrome. | 10.04.2008 |
| Livetiracetam conc. for infusion 100mg/ml (New Dosage Form) | Livetiracetam conc. for infusion 100mg/ml | As adjunctive therapy in partial onset seizures in adults with epilepsy when oral administration is temporarily not feasible. | 21.05.2007 |
| Lixisenatide pre.filled solution for injection 10mcg/20mcg | Each dose (0.2ml) contains: 10mcg lixisenatide (3ml cartridge in a green pre.filled pen, 0.05mg/ml), Each dose (0.2ml) contains; 20mcg lixisenatide (3ml cartridge in a burgundy pre.filled pen, 0.1mg/ml) | For the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in patients who are not controlled on existing therapy: In combination with the following oral antibiotics Metformin, a sulphonyl urea, or a combination of these agents, In combination with a basal insulin: alone, in combination with metformin, or in combination with sulphonyl urea. | 15.01.2015 |
| L.Lysine hydrochloride cream | Each gm contains: L.Lysine HCl USP.150mg | For the treatment of wounds of various etiology. | 03.12.2007 |
| Lofepramine tablet | Each tablet contains: lofepramine.35mg,70mg | Tricyclic anti depressants. Indicated in the treatment of depressive condition only. | January,1990 |
| Lomefloxacin Eye Drops | Each ml contains: lomefloxacin hcl.3mg | Bacterial infection of the eye. | 22.07.1998 |
| Lomefloxacin tablet | Each tablet contains: lomefloxacin.400mg | In the treatment of mild to moderate infections caused by susceptible starins of designated micro.organism in RTI uncomplicated and complicated UTI. | 20.05.1994 |
| Lomustine | Each capsule contains: 10mg, 40mg & 100mg of Lomustine | Anticancer | August,1980 |
| Loperamide | Loperamide | Anti diarrhoeal agent. indicated in the treatment of acute diarrhoea due to food poisoning, viral infections. | December,1976 |
| Loperamide | Loperamide | 1978.October | |
| Lopinavir + Ritonavir | Lopinavir + Ritonavir | 16.01.2004 | |
| Lopinavir + Ritonavir (100 + 25mg) Tablets (Additional Strength) | Lopinavir + Ritonavir (100 + 25mg) Tablets | For the treatment of patients with HIV infection. | 08.09.2008 |
| Lopinavir 200mg + Ritonavir 50mg Tablet (Additional Strength) | Lopinavir 200mg + Ritonavir 50mg Tablet | Anti.HIV | 08.06.2006 |
| Loratidine + pseudoephedrine suphate in ER form | Each film coated tab contains: pseudo ephedrine sulphate (ER).180mg, loratidine.10mg | Allergic & seasonal rhinitis only | 17.09.1999 |
| Loratidine + Pseudoephedrine tab | Each tab contains: loratidine.5mg, pseudoephedrine.120mg(ER) | For the relief of symptoms of seasonal allergic rhinitis. | 21.08.1996 |
| Loratidine nasal spray | Each 0.05ml actuation delivers 200mcg loratidine. | 2004 | |
| Loratidine tablets | Each tablet contains: loratidine 10mg. | Long acting anti histaminic. In treatment of allergic rhinitis, acute coryza, chronic idiopathic urticaria. | 19.06.1992 |
| Lorazepam Orodispersible Tablet 1mg/2mg (Additional Dosage Form) | Lorazepam Orodispersible Tablet 1mg/2mg | For the management of anxiety disorders or for the short term relief of symptoms of anxiety or anxiety associated with depressive symptoms. | 29.05.2015 |
| Lornoxicam 12 mg SR (Additional Strength) | Lornoxicam 12 mg SR | Same as approved. | 26.06.2009 |
| Lornoxicam 4mg + Eperisone 50mg tablet | Lornoxicam 4mg + Eperisone 50mg tablet | For the improvement of myotonic conditions caused by neck shoulder arm syndrome, scapulumeral periarthiritis and low back pain in adult patients only. | 13.09.2010 |
| Lornoxicam 4mg + Paracetamol 500mg film coated tablets | Lornoxicam 4mg + Paracetamol 500mg film coated tablets | For the short term use in acute painful & inflammatory conditions in adults. | 05.02.2009 |
| Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets | Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets | For the treatment of patients with acute painful musculoskeletal conditions. | 12.02.2010 |
| Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets (Additional Higher Strength) | Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets | Additional higher strength | 23.03.2010 |
| Lornoxicam ER Tablet 8 mg (Additional Strength) | Lornoxicam ER Tablet 8 mg | Same as approved | 11.12.2009 |
| Lornoxicam injection | Each 2ml vial contains: lornoxicam.8mg | For short term treatment of mild to moderate pain when oral administration is inappropriate (e.g. Afetr dental surgery). | 10.12.2007 |
| Lornoxicam SR 16mg Tabs | Lornoxicam SR 16mg Tabs | For the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis. | 25.04.2009 |
| Lornoxicam tablet 4mg/ 8mg | Each film coated tablet contains: lornoxicam.4mg, 8mg | For symptomatic treatment of pain and inflammation in patients of osteoarthritis and rheumatoid arthritis. | 21.05.2007 |
| Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets | Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets | For the treatment of mild to moderate hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy. | 15.09.2008 |
| Losartan + Hydrochlorthiazide (100 mg + 25 mg) Tablets (Additional Strength) | Losartan + Hydrochlorthiazide (100 mg + 25 mg) Tablets | Additional Strength. | 10.11.2008 |
| Losartan + ramipril tabs | Each tablet contains: losartan potassium.50mg, ramipril BP.2.5mg,5mg | RMP. mild to moderate hypertension. | 10.09.2003 |
| Losartan 100mg + Hydrochlorthiazide 25 mg tablet (Additional Higher Strength) | Losartan 100mg + Hydrochlorthiazide 25 mg tablet | Additional higher strength. | 16.03.2009 |
| Losartan potassium + Hydrochlorothiazide | Each film coated tab contains: Losartan potassium.50mg, Hydrochlorthiazide.12.5mg | 08.06.2009 | |
| Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength) | Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets | Same as Approved. | 14.05.2008 |
| Losartan potassium tablets | Each film coated tab contains: losartan potassium.25mg,50mg,100mg | Mild to moderate hypertension. | 16.06.1998 |
| Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) (Eye drops) | Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) | For post.operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists. | 12.07.2007 |
| Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension | Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension | For the treatement of post operative steriod responsive inflammatory ocular infections or risk of bacterial ocular infections exists. | 01.12.2009 |
| Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution | Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution | For steroid responsive inflammatory ocular condition. | 14.02.2007 |
| Loteprednol etabonate Nasal spray 0.1% | Loteprednol etabonate. 0.1% w/v | For prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis. | 03.02.2009 |
| Loteprednol etabonate ophthalmic solution & bulk (0.2% & 0.5%) | Each ml contains: loteprednol etabonate.2mg,5mg | 0.2% suspension shall be indicated in treatment of seasonal allergic conjuctivitis & 0.5% suspension is indicated for treatment of post.operative inflammation following ocular surgery. | 15.03.2002 |
| Loteprednol etabonate ophthalmic suspension | Each ml contains: loteprednol etabonate.2mg,5mg | 2% suspensionshall be indicated in treatment of seasonal allergic conjuctivitis and 0.5% suspension is indicated for treatment of post operative inflammation following ocular surgery. | 15.03.2002 |
| Lovastatin | Each tab contains: lovastatin.10mg,20mg,40mg. | Reduction of total LDL cholestrol in patients of primary hypercholesterolemia (type.IIa & IIb hyperlipoproleinemia) | 05.10.1995 |
| Lovastatin + Niacin | Each film coated tab contains: lovastatin USP.20mg, niacin IP.500mg(ER form). | By RMP. for the treatment of primary hyperlipidemia & mixed dyslipidimia in patients treated with i).lovastatin who require further TG lowering or HDL raising or ii).with niacin who are require further LDL lowering. It is not indicated for initial therapy. | 24.12.2004 |
| Loxapine | Each capsule contains;: loxapine succinate.5mg,10mg,20mg,50mg of base, loxapine oral concentration solution eq.to 25mg/ml. | Anti depressant. For the management of the manifestation of psychotic disorders. | September,1990 |
| Loxoprofen Sodium tablet (60mg) | Each tablet contains: loxoprofen sodium.60mg | For the symptomatic treatment of pain and inflammation condition in patients with osteoarthritis. | 14.08.2008 |
| Lubiprostone soft gelatin capsules 8mcg / 24 mcg | Each soft gelatin capsule contains: lubiprostone.8mcg, 24mcg | 1. For the treatment of chronic constopation in adults. 2. For the treatment of irritable bowel syndrome with constipation (IBS.C) in women > 18 years old. | 19.10.2010 |
| Luliconazole Cream 1% | Each gram contains: luliconazole.10mg | For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris. | 03.06.2009 |
| Lumiracoxib Tablet (100/200/400mg) | Lumiracoxib Tablet (100/200/400mg) | For OA, RA acute pain & primary dysmenorrhoea. | 01.08.2006 |
| Luprostiol | Each vial contains: Luprostiol.7.5mg | Prostaglandin. Indicated in the treatment of corpora lutea, induction of abortion etc. | June,1986 |
| Lymecycline | Lymecycline | Antibiotic. | October,1962 |
| Lynestranol.2.5 mg + Ethinyloestradiol.50 mcg | Lynestranol.2.5 mg + Ethinyloestradiol.50 mcg | Oral contraceptive | September,1970 |
| Lynestrenol | Lynestrenol | Progesterone hormone | January,1964 |
| Lynestrenol + Ehinylestradiol | Each tablet contains: Lynestrenol.0.75mg, Ehinylestradiol.37.5mcg | Oral contraceptive | April,1979 |
| Lynestrenol 2.5mg & Mestranol 0.075mg | 100 mg tabs (22 tablets) | Oral contraceptive | April,1967 |
| Lynestrenol B.P. | Each tablet contains: Lynestrenol B.P.0.5mg | March,1975 | |
| Maduramicin 1% premix | Each kg of 1% premix contains: maduramicin amonium.10gm, maduramicin amonium.0.5% | As an acid for the prevention of coccidiosis in broiler chickens. | 07.07.1993 |
| Magestrol acetate | 4mg tab+0.05 ethionyl estradiol | Progestational | April,1964 |
| Magnesium Valporate Prolonged release tablet 600mg | Magnesium Valporate Prolonged release tablet 600mg | I) For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. II) For prophylaxis of migraine headache in adults. III) For the treatment of manic episodes associated with bipolar disorders. | 04.06.2009 |
| Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (Additonal Strength) | Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg | Same as Approved | 26.03.2010 |
| Magnesuim Valproate Tablet 200mg/400mg | Each enteric coated tablet contains: magnesium valproate.200mg, 400mg | I) For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. II) For prophylaxis of migraine headache in adults. III) For the treatment of manic episodes associated with bipolar disorders. | 05.12.2008 |
| Malathion | Malathion.0.5% | For treatment of pediculosis only. | September,1975 |
| Malathion 1% DustiPowder | Malathion 1% DustiPowder | for Pedicular | December,1973 |
| Marantel Tartrate | Marantel Tartrate | August,1973 | |
| Maraviroc Tablets 150mg/300mg | Each film coated tablet contains: maraviroc.150mg, 300mg | For the treatment of patients infected with CCR5. trophic HIV.1. | 26.11.2009 |
| Marcaine adrenaline | marcaine.0.25% with & without adrenaline, marcaine.0.5% with or without adrenaline | September,1972 | |
| Marek's disease vaccine | Marek's disease vaccine | July,1972 | |
| Marek's disease vaccine T.H.U Living | Marek's disease vaccine | April,1972 | |
| Measles (Edmoustan zagreta strain) mumps and rubella vaccine | Marek's disease vaccine | December,1987 | |
| Measles mumps & rubella vaccine | Marek's disease vaccine | February,1983 | |
| Measles vaccine | Each 0.5ml dose contains measles virus (CAM.70 strain) not less than 1000 CCID50 | Active immunization against measles. | 02.04.2002 |
| Measles virus vaccine live attenuated | Measles virus vaccine live attenuated | Prophylactic | April,1965 |
| Mebendazole | Each 5mL contains: Mebendazole.100mg | December,1978 | |
| Mebendazole | Each tablet contains: Mebendazole.100mg | Broad spectrum anthelmentic. For the treatment of enterobiasis as carriasis, trichuriasis ancyclostomiasis, strongylodiasis (pin warm, large round warm, whip warm, hooks warm and thread warm. | December,1974 |
| Mebendazole Active Substance | Mebendazole Active Substance | December,1974 | |
| Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet | Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet | For IBS. | 12.12.2006 |
| Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. | Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. | For symptomatic relief of Irritable bowel syndrome in adults. | 06.07.2006 |
| Mebeverine HCl prolonged release capsule (200mg) | Each SR capsule contains; mebeverine hydrochloride.200mg | For the symptomatic treatment of irritable bowel syndrome in adults. | 20.06.2007 |
| Mebhydroline Napadisylate | 50mg tabs | Antihistaminic | February,1964 |
| Mecobalamin 0.5mg + Alpha Lipoic Acid 100mg + Benfotiamin100mg + Pyridoxine 50mg tablets | Mecobalamin 0.5mg + Alpha Lipoic Acid 100mg + Benfotiamin100mg + Pyridoxine 50mg tablets | For the treatment of diabetic neuropathy. | 03.07.2008 |
| Mecobalamin 0.5mg + Pyridoxine 50mg + Benfotiamine 100mg capsule | Mecobalamin 0.5mg + Pyridoxine 50mg + Benfotiamine 100mg capsule | For the treatment of diabetic Neuropathy. | 29.11.2007 |
| Mecobalamin 1000mcg + Alpha Lipoic Acid 200mg + vitamin B6 3mg + Folic Acid 1.5mg + Inositol 100mg + Benfotiamine 100mg capsule | Mecobalamin 1000mcg + Alpha Lipoic Acid 200mg + vitamin B6 3mg + Folic Acid 1.5mg + Inositol 100mg + Benfotiamine 100mg capsule | For the treatment of diabetic neuropathy. | 19.03.2008 |
| Mecobalamin 1500mcg + Alpha Lipoic Acid 100mg + Benfothiamine 15mg + B6 3mg + Calcium Pantothenate 25mg + Folic Acid 1.5mg + Zinc oxide 22.5mg + Chromium picolinate 65mcg + Inositol 10mcg + Lutein 5mg capsule | Mecobalamin 1500mcg + Alpha Lipoic Acid 100mg + Benfothiamine 15mg + B6 3mg + Calcium Pantothenate 25mg + Folic Acid 1.5mg + Zinc oxide 22.5mg + Chromium picolinate 65mcg + Inositol 10mcg + Lutein 5mg capsule | For Vitamins and Minerals deficiency states in adult patients. | 30.01.2008 |
| Mecobalamin 500mcg + Alpha Lipoic Acid 200mg + Benfotiamin 10mg + Pyridoxine 3mg + Biotin 5mg + Folic acid 1.5mg capsule | Mecobalamin 500mcg + Alpha Lipoic Acid 200mg + Benfotiamin 10mg + Pyridoxine 3mg + Biotin 5mg + Folic acid 1.5mg capsule | For Vitamins deficiency states in adult patients. | 30.01.2008 |
| Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets | Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets | For the treatment of diabetic neuropathy in adults. | 16.03.2010 |
| Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets | Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets | For the treatment of diabetic neuropathy. | 27.10.2009 |
| Mecobalamine | Each ml ampoule contains: mecobalamine.500mcg | Treatment of peripheral neuropathies & megaloblastic anemia caused by vit.B12 deficiency. | 14.02.2002 |
| Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5/1.5mg + Chromium Polynicotinate 65mcg/200mcg + Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule | Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5/1.5mg + Chromium Polynicotinate 65mcg/200mcg + Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule | For Vitamins and Mineral deficiency states in adult patients. | 11.07.2007 |
| Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule | Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule | For diabetic neuropathy | 02.04.2007 |
| Mecobalamine E.R. Tablet (1500mcg) | Mecobalamine E.R. Tablet (1500mcg) | For neuropathic pain. | 19.07.2005 |
| Medicated dressing wash proof | Each perforated fresh coloured self adhesive plaster strip contains: medicated pad with cetylpyridinium chloride.0.3% w/w | 06.10.1994 | |
| Medroxy progesterone acetate | Medroxy progesterone acetate | Gynaecological disorders. Indicated in the treatment of secondry amenorrhea and functional uterine bleeding of hormonal imbalance only. | June,1986 |
| Medroxyprogesterone acetate suspension for injection s.c . Single dose container with 104mg Medroxyprogesterone acetate in 0.65 ml suspension for injection (SAYNA PRESS) (Additional Route/ Strength/Indication) | Medroxyprogesterone acetate suspension for injection s.c . Single dose container with 104mg Medroxyprogesterone acetate in 0.65 ml suspension for injection (SAYNA PRESS) | Indicated for the management of endometriosis.associated pain. | 18.12.2014 |
| Medrysone | Medrysone USP.1% | July,1980 | |
| Mefanamic acid | Mefanamic acid | Analgesic with Anti inflammatory properties. indicated in the treatment of acute & chronic pain post operative and postpartum pain, headaches, traumatic pain, muscular pain. | January,1976 |
| Mefenamic acid + tizanidine | Mefenamic acid.500mg, tizanidine.2mg | By RMP | 12.07.2002 |
| Mefloquine hcl tabs | Each film coated tab contains: mefloquine hcl eq.to mefloquine.250mg | Used in severe malaria including cerebral malaria and as a second line chloroquine resistant malaria cases only. | 03.03.1997 |
| Megaldrate tablets/Chewable/Suspension | Tablet (megaldrate.400mg), Chewable(megaldrate.400mg, simethicone.60mg), Suspension (megaldrate.400mg, simethicone.60mg per 5ml) | November,1982 | |
| Megestrol acetate 4mg & Ethinyloestradiol 0.05 mg | 20 tabs | Oral contraceptive | April,1967 |
| Megestrol Acetate Oral Suspension 400mg per 10ml (10 & 20mg Sachet) | Megestrol Acetate Oral Suspension 400mg per 10ml (10 & 20mg Sachet) | For the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of cancer or acquired immunodeficiency syndrome (AIDS). | 05.12.2012 |
| Meglumine gadoterate soln.for i.v inj | Each 100ml contains: gadoteric acid.27.932gm, meglumine.9.76gm | Magnetic imaging diagnostic investigation including MR angiography. | 23.10.2002 |
| Meglumine iocarmate | Meglumine iocarmate | X.ray contrast media. | February,1974 |
| Meglumine Iothalamate | Meglumine Iothalamate | Angiography | August,1965 |
| Meglumine ioxaglate sodium + sodium ioxaglate i.v inj. | Meglumine ioxaglate sodium + sodium ioxaglate i.v inj. | Urography, angiography, arthrography, G.I examination, hysterosalpingography, sialography. | 16.08.2001 |
| Meglumine salt of Loxitalamic acid | Telebrix 38.Each 20mL ampoule contains: Sodium salt of loxitalamic acid.5.13gm, Meglumine salt of loxiralamic acid.10.26gm, Vasobrix 32.Meglumine & sodium salt of loxitalanic acid.62.5% | X.ray contrast media. for cerebral angiography & urography. | September,1977 |
| Melagenina lotion | Melagenina lotion | For leucoderma. Indicated in repigmenting treatment of skin in depigmented areas of patients suffering from vertigo. | May,1988 |
| Melatonin tablets | Each tab contains: melatonin.3mg | For sleep disorders Jet lag and regulation of circadium rhytham disorders. | 12.03.1998 |
| Melitracen + Flupenthixol tablets | Each sugar coated tab contains; flupenthixol dihydrochloride eq.to flupenthixol.0.5mg, meltracen hcl eq.to melitracen.10mg | Psychogenic depression, depressive neurosis, marked depression and psychosomatic affections accompanied by anxiety and apathy. | 28.10.1998 |
| Meloxicam | Each uncoated tablet contains: 7.5mg,15mg | For the treatment of rheumatoid arthritis and soteoarthritis. | 16.02.1999 |
| Meloxicam gel (1% w/w) | Each gm contains: meloxicam.10mg | For acute painful/inflammatory musculoskeletal painful conditions. | 09.04.2001 |
| Meloxicam inj. | Each vial contains: meloxicam.5mg/ml | Painful inflammatory conditions including arthritis in animals as well as pyrexia. | 02.04.2002 |
| Meloxicam ODT 7.5mg/15mg (Additional Dosage Form) | Meloxicam ODT 7.5mg/15mg | Non.steroidal anti.inflammatory. | 23.02.2015 |
| Melphalan | Melphalan | Anti.cancer drug. | October,1964 |
| Memantine 5mg /10mg + Donepezil 5mg Tablets | Memantine 5mg /10mg + Donepezil 5mg Tablets | For moderate to severe Alzheimer's disease. | 31.01.2008 |
| Memantine ER Tablet 7mg/14mg/21mg. (Additional Strength) | Memantine ER Tablet 7mg/14mg/21mg. | Same as approved | 17.12.2010 |
| Memantine HCl ER Tablet 28mg | Memantine HCl ER Tablet 28mg | In the treatment of moderate to severe Alzheimer's disease | 06.09.2010 |
| Memantine hcl tabs. | Each film coated tablet contains: memantine hcl.5mg,10mg | By neurologists only. for the treatment of moderate to severe dementia of Alzheimer's type. | 22.07.2004 |
| Menadione sodium bisulphate | 1mg/0.5ml | 06.08.1999 | |
| Mepartricin tablet | Each enteric coated tablet contains: mepatricin.50000units | Functional disorders in benign prostatic hypertrophy. | 28.05.1993 |
| Mepenzolate methylbromite | 25 mg | Anticholinergic | March,1961 |
| Meropenem Injection IP 500mg/1.0g (Additional Indication) | Meropenem Injection IP 500mg/1.0g | For Treatment, in Children, of the following Infections Caused by Single or Multiple Bacteria Sensitive to Meropenem: Pneumonias and Nosocomial Pneumonias, Urinary Tract Infections, Intra.abdominal Infections, Gynaecological Infections Such as Endometriatis and Pelvic Inflammatory Disease, Skin and Skin Structure Infections, Meningitis, Septicaemia. Meropenem has been Proved Efficacious alone or in Combination with other Antimicrobial agents in the Treatment of Polymicrobial Infections. | 20.05.2011 |
| Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection | Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection | For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only. | 15.03.2011 |
| Meropenem powder for i.v inj. | Each vial contains: meropenem trihydrate eq.to anhydrous meropenem.500mg, 1000mg | For treatment of pneumonia, nonocomial pneumonia, UTI, intra.abdominal infection, gynaecological infection, skin & soft tissue infection, meningitis, septicaemia & empiric treatment of presumed infection in adult patients with febrile neutropenia. | 08.01.2002 |
| Mesalamine PR Tablets 1.2gm | Mesalamine PR Tablets 1.2gm | For the induction of remission in patients with active, mild to moderate ulcerative colitis. | 30.03.2009 |
| Mesalazine (5.Amino salicylic acid) tablets | Each enteric/resin coated tablet contains: mesalazine.250mg,400mg, 5.amino salicylic acid rectal suspension enema contains; 5.ASA.4gm/60ml | Ulcerative colitis. | June,1989 |
| Me.salicylate 30% + Menthol 10% + camphor 4% Cream | Me.salicylate 30% + Menthol 10% + camphor 4% Cream | For temporary relief from pain, swelling & inflammation due to musculoskeletal disorder. | 29.11.2007 |
| Mesna (Sodium.2.mercapto.ethane sulphonate) | Mesna (Sodium.2.mercapto.ethane sulphonate) | Urotoxic agent. for prevention of urotoxic side effects associated with the treatment of malignant tumours by oxazaphosphorines. | December,1981 |
| Mesna oral tablets | Each film coated tab contains: mesna.400mg,600mg | By oncologist. for the prevention of urothelical toxicity including haemorrhagic cyctitis, microhaematuria and macrohaematuria in patients with ifosfamide and cyclophosphamide in doses considered to be urotoxic. | 05.05.2004 |
| Metadoxine hcl bulk & tabs | Each uncoated tablet contains: metadoxine (as hcl).500mg, each 1ml of iv/im injection meta doxine.60 mg. | specialist only. for the treatment of fatty liver due to alcoholism, acute and chronic intoxication of alcohol. | 24.10.2003 |
| Metaraminol bitartarate | 2.10mg im/sc, 0.5.5mg iv | Sympathomimetic (adrenergic) urgent vasopressor. | January,1964 |
| Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet | Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet | For acute painful musculoskeletal condition in adult. | 22.02.2005 |
| Metaxolone tab & bulk | Each tab contains: metaxolone.400mg | As an adjunct to rest, physical therapy & other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. | 08.10.2002 |
| Methenolone | 1mg and 5 mg tab., Injection | Anabolic agent | June,1962 |
| Methenolone acetate | i).Tablet.each contains: metenolone acetate.5mg, ii).Depot.each 1ml of solution contains; metenolone enanthate.100mg | July,1970 | |
| Metformin (ER )1000mg/500mg + Saxagliptin 2.5 mg/5mg Tablets | Metformin (ER )1000mg/500mg + Saxagliptin 2.5 mg/5mg Tablets | As an Adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate. | 19.09.2011 |
| Metformin + rosiglitazone tabs | Each uncoated tab contains: rosiglitazone maleate eq.to rosiglitazone.2mg, metformin IP.500mg | Patients with type.2 diabetes mellitus when diet exercise and the single agent do not result in adequate glycemic control. | 11.10.2001 |
| Metformin 1000 mg SR tablets | 1000mg | 2002 | |
| Metformin 500/500mg + Repaglinide 1/2mg | Metformin 500/500mg + Repaglinide 1/2mg | Indicated as an adjunct to diet and excersice to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide & metformin or who have inadequte glycemic control on a meglotinide alone or metformin. | 20.08.2010 |
| Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional Indication) | Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg | A) FDC is indicated as triple combination therapy with a PPARy agonist (i.e a thiazolidinedione) as an adjunct to diet and exercise in patients inadequtely controlled on their maximal tolerated dose of metfomin and a PPARy agonist. B) FDC is also indicated as add.on to insulin(i.e triple combination therapy) as an adjucnjt to diet and exercise to improve glycemic contrl in patients when stable dosage of insulin and metformin alone do not provide adequte control. | 02.08.2010 |
| Metformin ER tablet 750mg (Additional strength) | Metformin ER tablet 750mg | As an adjunct to diet and exercise to improve glycemic control in adult patients with Type II Diabetes. | 25.09.2014 |
| Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet | Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet | For the treatment of Type.II diabetes associated with mixed dyslipidemia. | 25.01.2008 |
| Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet | Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet | For the treatment of patients with diabetic polyneuropathy. | 05.01.2011 |
| Metformin Hcl. | 0.5gm | Oral hypoglycemic agent. | September,1961 |
| Metformin Oral Solution (100mg/ml) | Each 1ml oral solution contains: metformin Hcl.100mg | As an adjunct to diet & excercise to improve the glycemic control in patients with type.II diabetes mellitus. | 04.03.2005 |
| Metformin SR (500mg) tablets | Each tablet contains: metformin hcl.500mg | For type II diabetes. | 09.11.2001 |
| Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets | Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets | As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control. | 28.05.2010 |
| Methacycline Hcl. | Methacycline Hcl. | Antibiotic | December,1966 |
| Methadone syrup and tablets | i) Each ml of syrup contains: methadone hydrochloride IP.5mg,10mg, ii) Each tablet contains; methadone hydrochloride IP.5mg,10mg,20mg,40mg | For the treatment of opioid dependence and for maintainence treatment for opioid dependence. | 01.06.2009 |
| Methandienone + Benzylalcohol | Each ml contains: Methandienone B.P.25mg, Benzylalcohol in sterile oily sol..9% w/v | January,1970 | |
| Methaqualone hydrochloride | 150 mg | A new non.barbiturate Hypnotic. | April,1961 |
| Methdilazine | 8mg, thrice daily. | New long acting Antihistaminic. | March,1961 |
| Methicillin Sodium | Methicillin Sodium | Antibiotic. indicate in the treatment of infections due to pencillinase producing staphylococa. | July,1980 |
| Methimazole Tablet (5mg/10mg) | Methimazole Tablet (5mg/10mg) | For hyperthyroidism. | 22.12.2005 |
| Methocarbamol | 1gm to 1.5gm (Max. 4gm/day) | Skeletal muscle relaxant. | February,1961 |
| Methohexital sodium | 500mg amp, 12.5 g vials | Anesthetic (ultra short). | April,1964 |
| Methophenazine | Methophenazine | Tranquiliser (Major) | April,1965 |
| Methotrexate 0.25% topical gel | Each gm contains: methotrexate IP 0.25% w/w in hydroxy gel base. | Topical treatment of psoriasis. | 21.08.2002 |
| Methotrexate Topical gel (1%) (Additional Strength) | Methotrexate Topical gel (1%) | Psoriasis. | 25.11.2005 |
| Methotrimeprazine (acid maleate) | tab.5mg, 25mg,100mg, amp. 25mg/cc | 1964,January | |
| Methoxsalen USP.20mg Tablet | Methoxsalen USP.20mg Tablet | 1) For repigmentation of idiopathic vitiligo alongwith phototherapy. 2) For symptomatic control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy. | 07.03.2008 |
| Methoxyflurane | Methoxyflurane | Inhalation anaesthetic. | 1963,October |
| Methychlothiazide | 2.5 to 5mg | Oral diuretic agent Longest duration: more sodium excretion less potassium loss. | 1961, February |
| Methyl cobalamine 500mcg + folic acid 1.5mg + B5.5mg + Zn.sulphate 25mg + Cr.Polynicotinate 200mcg + selenium 65mcg + inositol 1.5mg + alpha lipoic acid 100mg capsule | Methyl cobalamine 500mcg + folic acid 1.5mg + B5.5mg + Zn.sulphate 25mg + Cr.Polynicotinate 200mcg + selenium 65mcg + inositol 1.5mg + alpha lipoic acid 100mg capsule | For Vitamins and mineral deficiency states. | 31.10.2007 |
| Methyl cobalamine 500mcg + folic acid 1.5mg + B6.3mg + Zn.sulphate 61.8mg + Ca.Pantothenate 10mg + Niacinamide.50mg + chrimium.50mcg capsule | Methyl cobalamine 500mcg + folic acid 1.5mg + B6.3mg + Zn.sulphate 61.8mg + Ca.Pantothenate 10mg + Niacinamide.50mg + chrimium.50mcg capsule | For Vitamins and mineral deficiency patients. | 29.11.2007 |
| Methyl Dopa | 250 mg | Antihypertensive | 1963,March |
| Methylphenedate Hcl E.R Tablet | Each extended release contains :methylphenedate Hcl USP.18mg, 36mg, 54mg. | By psychiatrists.for the treatment of attention deficit hyperactivity disorders (ADHD) | 08.12.2004 |
| MethylPhenidate ER Tablet 10/20/30mg | MethylPhenidate ER Tablet 10/20/30mg | For the treatment of Attention Deficit Hyperactivity Disorder (ADHD). | 10.07.2009 |
| Methyl Prednisolone Aceponate Cream (0.1%) | Each gm of cream contains: Methyl prednisolone acetate 1mg | For treatment of Atopic dermatitis (exzema) inflammatory & allergic skin reaction. | 15.06.2006 |
| Methyl prednisolone aceponate.1mg + salicylic acid.50mg ointment | Methyl prednisolone aceponate.1mg + salicylic acid.50mg ointment | For treatment of psoriasis. | 19.11.2007 |
| Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule | Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule | For diabetic neuropathy. | 31.07.2007 |
| Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D.Panthenol IP 50mg per 2 ml of injection | Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D.Panthenol IP 50mg per 2 ml of injection | For peripheral neuropathy. | 31.03.2008 |
| Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets (Additional strength) | Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets | Additional strength | 04.11.2009 |
| Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule | Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule | For the treatment of diabetic Neuropathy. | 04.07.2008 |
| Methylcobalamin 1500mcg + Folic acid 0.7mg +Niacinamide 12mg injection | Methylcobalamin 1500mcg + Folic acid 0.7mg +Niacinamide 12mg injection | For the treatment of diabetic neuropathy in adults. | 23.06.2010 |
| Methylcobalamin 1500mcg + Pyridoxine 100mg + Nicotinamide 100mg injection | Methylcobalamin 1500mcg + Pyridoxine 100mg + Nicotinamide 100mg injection | For the treatment of diabetic neuropathy in adults. | 23.06.2010 |
| Methylcobalamin 500mcg + beta carotine 10.33mg + alpha lipoic acid 100mg + B6 1.5mg + B1 2mg & Cr.polynicotinate | Methylcobalamin 500mcg + beta carotine 10.33mg + alpha lipoic acid 100mg + B6 1.5mg + B1 2mg & Cr.polynicotinate | For adult patients with diabetic neuropathy. | 18.10.2007 |
| Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule | Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg +Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule | For Vitamins and Minerals deficiency states in adult patients. | 11.01.2011 |
| Methylcobalamin orally disintegrating strips 1500mcg (Additonal Dosage Form/Indication) | Methylcobalamin orally disintegrating strips 1500mcg (Additonal Dosage Form/Indication) | For the treatment of peripheral neuropathy and diabetec neuropathy. | 17.12.2014 |
| Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules | Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules | For the treatment of vitamin deficiency states in adults. | 14.01.2009 |
| Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules | Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules | For the treaetment of painful diabetic neuropathy in adults only. | 05.03.2010 |
| Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate (200mg) tablet | Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) + Calcium Picolinate (200mg) tablet | For diabetic neuropathy. | 16.10.2007 |
| Methylcobalamine 1500mcg oral tablets | Each ER tablet contains: mecobalamine JP.1500mcg | For peripheral neuropathies and megaloblastic anaemia caused by vitamin B12 deficiency. | 21.07.2005 |
| Methylcobalamine 500mcg + folic acid 1.5mg + alpha lipoic acid 100mg + B6.3mg + Thiamine 10mg capsule | Methylcobalamine 500mcg + folic acid 1.5mg + alpha lipoic acid 100mg + B6.3mg + Thiamine 10mg capsule | For diabetic neuropathy | 29.11.2007 |
| Methylcobalamine 500mcg + folic acid 1.5mg + alpha lipoic acid 300mg + Benfothiamine 50mg Capsule | Methylcobalamine 500mcg + folic acid 1.5mg + alpha lipoic acid 300mg + Benfothiamine 50mg Capsule | For diabetic neuropathy. | 13.11.2007 |
| Methylcobalamine 500mg + Alpha lipoic acid 100mg | Communicated that no such FDC yet appr.by this dtc. | 13.12.2005 | |
| Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + Calcium pantothenate 25mg + Nicotinamide 50mg + Folic acid 0.75mg capsule | Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + Calcium pantothenate 25mg + Nicotinamide 50mg + Folic acid 0.75mg capsule | For Vitamins and Minerals deficiency states in adult patients. | 30.01.2008 |
| Methyldopa + Hydrochlorothiazide | Methyl dopa.250 mg, Hydrochlorthiazide.15 mg | 1969,February | |
| Methylhydroxy propyl cellulose | Methylo hydroxy propyl cellolose.0.3% | By RMP. for temporary relief of discomfort due to minor irritation of the eye from exposure to wind sun or other irritants for use as a protectant against further irritation or to relief dryness of then eyes. | 05.07.2000 |
| Methylmercadone (Nifuratel) | 200mg tabs & 250mg vaginal tabs. | Urinary tract infection by leucohhea and vulvo vaginitis. | 1967, December |
| Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w | Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w | For short term treatment of chronic wounds including stage III & IV pressure sores, leg ulcers. | 06.07.2010 |
| Methylprednisolone | Methylprednisolone | Corticosteroids. Indicated for conditions requiring glucocorticoid activity including collagen disease, allergic disease, hypersensitivity reactions. | 1978,March |
| Methylprednisolone aceponate.1mg + Mupirocin.20mg cream | Methylprednisolone aceponate.1mg + Mupirocin.20mg cream | For the treatment of atopic dermatitis. | 21.11.2007 |
| Methylprednisolone acetate | 40 mg/ml | Corticosteroid | 1962, November |
| Methylprednisolone Acrponate topical solution 0.1% | Each ml contains: methylprednisolone aceponate.1mg | For the treatment of atopic dermatitis (eczema) inflammatory and allergic skin reaction. | 09.04.2007 |
| Methylprednisolone Tablet 8mg | Each tablet contains: methylprednisolone. 8mg | Indicated for conditions require glucocorticoid activity including collagen disease, allergic disease, hypersensitivity reactions. | 01.09.2009 |
| Metifex drages | Each dragee contains: ethacridine lactate.100mg,200mg. | June,1983 | |
| Metoclopramide (as HCl) 200mg/400mg per ml Intranasal Solution | Metoclopramide (as HCl) 200mg/400mg per ml Intranasal Solution | For the treatment of nausea and vomiting. | 09.09.2009 |
| Metoclopramide C.R Tab. | Each tablet contains: metoclopramide hcl IP eq.to 15mg of the anhydrous substance. | To restore normal coordination and tone the upper digestive trac and relieve symptoms of gastro.duodenal dysfunction including heart burn,dyspepsia,nausea and vomiting associated with such conditions as reflux oesophagitis,gastritis,duodenitis and hiatus hernia. | 13.04.1992 |
| Metoclopromide Monohydrochloride | Each tablet contains; Metoclopromide Monohydrochloride.10mg, Each 2mL contains; Metoclopromide Monohydrochloride.10mg | Anti.emetic. | December,1976 |
| Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg) | Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg) | For the treatment of oedema associated with congestive heart failure, cirrhosis and nephritic syndrome. | 25.08.2008 |
| Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets | Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets | For hypertension in patients whose blood pressure is not adequately controlled in monotherapy. | 28.05.2008 |
| Metolazone 2.5mg + Ramipril 2.5mg/5mg | Metolazone 2.5mg + Ramipril 2.5mg/5mg | For essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy. | 28.05.2008 |
| Metolazone tab USP | Each uncoated tab contains: metolazone USP.2.5mg,5mg,10mg | For treatment of hypertension & oedema accompaying CHF & renal failure. | 23.04.2003 |
| Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (Additional Strength) | Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg | As approved | 10.04.2007 |
| Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet (For Additional Indication) | Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet | Angina pectoris in adults. | 20.02.2007 |
| Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg | Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg | Essential hypertension. | 26.02.2007 |
| Metoprolol + Hydrochlorthiazide tablets | Each tablet contains: metoprolol.50mg, hydrchlorthiazide.12.5mg | June,1989 | |
| Metoprolol 50/50/25 mg + Atorvastatin20/10/10 mg + Ramipril 10/5/2.5 mg capsules | Metoprolol 50/50/25 mg + Atorvastatin20/10/10 mg + Ramipril 10/5/2.5 mg capsules | As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti.hypertensive with lipid lowering agent. | 01.07.2009 |
| Metoprolol ER + Amlodipine tablets (Additional Indication) | Metoprolol ER + Amlodipine tablets | For coronary artery disease/ischaemic heart disease. | 16.07.2008 |
| Metoprolol injection | Each ml contains: metoprolol tartrate.1mg | August,1985 | |
| Metoprolol succinate 25mg /50mg ER + Hydrochlorthiazide 12.5mg | Metoprolol succinate 25mg /50mg ER + Hydrochlorthiazide 12.5mg | Anti hypertensive. | 30.11.2006 |
| Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg | Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg | For hypertension. | 07.02.2006 |
| Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 10mg tablets | Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 10mg tablets | For the treatment of patient with both essential hypertension and hypercholesterolemia. | 28.01.2008 |
| Metoprolol succinate ER 12.5mg/25mg/50mg tablet | Each ER film coated tablet contains: s(.) metoprolol succinate eq.to s(.) metoprolol tartrate.12.5mg, 25mg, 50mg | For the treatment of essential hypertension in adults. | 01.08.2007 |
| Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg | Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg | For the treatment of essential hypertension. | 16.07.2010 |
| Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg | Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg | For the treatment of essential hypertension. | 19.07.2010 |
| Metoprolol succinate ER tablets | Metoprolol succinate.25mg,50mg,100mg,200mg | Additional indication; i).functional heart disorders, ii).migraine prophylaxis, iii).cardiac arrhythmias, iv).prevention of cardiac death and reinfarction after the acute phase of myocardial infarction v).stable symptomatic CHF | 29.11.2004 |
| Metoprolol succinate SR tablets | Each tablet (SR) contains: metoprolol succinate eq.to metoprolol tartrate.25mg,50mg,100mg,200mg | By RMP. For essential hypertension & angina pectoris only. | 30.10.2002 |
| Metoprolol tartrate | Metoprolol tartrate | Antihypertensive agent. Indicated in the treatment of hypertension. | March,1982 |
| Metoprolol tartrate bulk drug | Metoprolol tartrate bulk drug | September,1982 | |
| Metoprolol Tartrate ER Tablet 75mg (Additional Strength) | Metoprolol Tartrate ER Tablet 75mg | Same as approved. | 03.10.2009 |
| Metoprolol tartrate tablets | Metoprolol tartrate.50mg,100mg | May,1982 | |
| Metoprolol tartrate tablets 50 mg (Additional Indication) | Metoprolol tartrate tablets 50 mg | Adjunct to the treatement of Hyperthyroidism. | 14.01.2009 |
| Metoprolol with hydrochlorthiazide tablets | Each tablet contains: metoprolol tartrate.100mg, hydrochlorthiazid.12.5mg | October,1982 | |
| Metronidazole (skin ointment) gel | Metronidazole.1% w/w | 19.07.1993 | |
| Metronidazole + benzocaine topical gel | Each gm of gel contains: metronidazole (as benzoate).10mg, benzocaine.200mg | RMP. for treatment of gingivitis | September,2003 |
| Metronidazole + Furazolidone + Kaolin + Pectin | Each 5mL contains: Metronidazole.40mg, Furazolidone.30mg, Kaolin.1gm, Pectin.20mg | October,1977 | |
| Metronidazole + Spiramycin tablets | Each film coated tablet contains;: spiramycin.0.75 MIU,1.50MIU, metronidazole.125mg,250mg | 15.03.1994 | |
| Metronidazole colon drug delivery system | Each tab contains: metronidazole.400mg | New formulation. for treatment of intestinal amoebiasis & giardiasis in adult patients. | 14.05.2002 |
| Metronidazole CR tablet 600mg | Metronidazole CR tablet 600mg | For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis. | 21.02.08 |
| Metronidazole tab | Metronidazole tab | Removal of warning of carcinogenicity in rodents. | 07.02.2002 |
| Mexiletine capsule/injection | Each capsule contains: mexiletine hcl.50mg,150mg, Each ampoule of 10ml contains; mexiletine hcl.250mg | Anti arrhythmic agent. Indicated in the treatment of existing or anticipated ventricular arrhythmias and ectopic beats such as those found after myocardial infarction and in ischaemic heart disease for arrhythmias induced drugs and for idiopathic arrhythmic effects. | August,1985 |
| MI cu 250 | MI cu 250 | Intra.uterine device | May,1979 |
| Mianserin hydrochloride | Each tablet contains: mianserin hcl.10mg,20mg,30mg | Anti depressant. Indicated in the treatment of endogenous reactive depression anxiety, agitation and insomnia where associated with depressive illness. | August,1985 |
| Micafungin (as sodium) Powder for solution for infusion 50mg/vial | Each vial contains: micafungin sodium eq.to micafungin.50mg | For the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT) | 04.02.2009 |
| Micafungin sodium for injection 100mg/vial (Additional Strength) | Micafungin sodium for injection 100mg/vial | Treatement of patient with candidemia,acute Disseminated Candidiasis, Candida Peritonitis and abscesses.Treatment of patients with Esophageal Candidiasis,Prohylaxis of Candidia and Aspergillus Infections in patients undergoing Hemopoeitic stem cell transplantaion.Treatment of patient with Fungemia, Respiratory mycosis, Gastrointestinal mycosis caused by Aspergillus sp. | 02.05.2014 |
| Micafungin sodium for Injection 10mg per vial/50mg per vial (Additional Indication) | Micafungin sodium for Injection 10mg per vial/50mg per vial | 1) Prophylaxis of Aspergillus Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation. 2) Treatment of Patients with Fungemia, Respiratory mucosis, Gastrointestinal mycosis caused by Aspergillus sp. | 05.12.2011 |
| Miconazole Active Substance | Miconazole Active Substance | Topical antifungal and anti bacterial agent. for the treatment of onychomycosis, dermatophytosis and vulvovaginitis. | December,1974 |
| Miconazole Cream | Miconazole.2% | December,1974 | |
| Miconazole eye drops/ophthalmic suspension/ointment | Miconazole.1% | For fungal infection of eye. | July,1989 |
| Miconazole Nitrate | Miconazole Nitrate.2% | March,1979 | |
| Microgynen | Microgynen | November,1974 | |
| Micronised Purified Flavonoid 1000mg (MPFF) | Each film coated tablet contains: Diosmin 90% and Hesperidine 10% of Micronised Purified Flavonoid fraction 1000mg (MPFF) | Acute hemorrhoid piles | 28.11.2013 |
| Micronised Purified Flavonoid Fraction of Rutacea 1000mg (MPFF) (Amendment) | Each film coated tablet contains: Diosmin 90% and Hesperidine 10% of Micronised Purified Flavonoid Fraction of Rutaceae 1000mg (MPFF) | Acute hemorrhoid piles. | 20.12.2013 |
| Acetyl Cysteine Eye Drops 5% w/v | Acetyl Cysteine Eye Drops 5% w/v | Indicated the relief of Dry eye symptoms associated with defecient tear secretion, impaired or abnormal mucus Production. | 14.12.2010 |
| Luliconazole lotion 1 % W/V (New Dosage Form) | Luliconazole lotion 1 % W/V (new Dosage Form) | Same as approved | 19.12.2011 |
| "Hyperox" peracetic acid + hydrogen peroxide liquid | Composition; Peracetic acid, hydrogen peroxide (NLT 24.0%), Peracetic acid (NLT 4.5%) | Disinfections of farms for livestock species. | September, 2004 |
| 1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg | (Each Co.pack contains : 1 capsule of Atazanavir 300mg 1 Tablet of Ritonavir 100mg 1 Tablet of FDC of Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg) | For the treatment of HIV infections in adults. | 19.07.2010 |
| 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of Nevirapine 200mg combipack | 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of Nevirapine 200mg combipack | For the treatment of HIV infection in adults. | 23.06.2010 |
| 1.(2.tetrahydrofuryl).5.Fluorouracil | 1.(2.tetrahydrofuryl).5.Fluorouracil | Anticancer drug. indicated in the treatment of cancer of stomach, colon, rectum, breast and lung. | June,1977 |
| 1,2.dimethyl.3 hydroxypyrid.4.one caps | Each capsule contains: 1,2.dimethyl.3 hydroxypyrid.4.one.250mg, 500mg. | 07.12.1994 | |
| 1. PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii 2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides …. 100mg 3. PROBIO & PREBIO (D) Each sachet (1.3g) contains: Probio (CMP 5) Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides...1000mg | 1. PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii 2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides …. 100mg 3. PROBIO & PREBIO (D) Each sachet (1.3g) contains: Probio (CMP 5) Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides...1000mg | For the treatment of rotavirus diarrhoea. | 09.06.2011 |
| 17β.estradiol intranasal spray | Each spray (0.07ml) delivers;: 17.β.estradiol hemihydrate.150mcg | For treatment of oestrogen deficiency symptoms in post.menopausal women. | 18.06.2003 |
| 1.Nicotinylamine.1,2.diphenylethane | 1.Nicotinylamine.1,2.diphenylethane | June,1969 | |
| 2.Bromo.2.nitropropan.1,3.diol | 2.Bromo.2.nitropropan.1,3.diol | Preservative | September,1972 |
| 2.Bromo.2.nitropropan.3.diol | 2.Bromo.2.nitropropan.3.diol | April,1975 | |
| 2.Sulphanilamide.5.methyl pyrimidine | 0.5 g tablets | Sulpha drug | January,1970 |
| 3 chamber bags of glucose solution, amino acid solution & fat emulsion for .v infusion | 3 chamber bags of glucose solution, amino acid solution & fat emulsion for .v infusion | By RMP. for parenteral nutritions where oral or enteral nutrition is impossible or impracticable. | March,2005 |
| 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack | 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack | Additional strength | 28.05.10 |
| 3,5 . Dinitro.O.toluamide | 3,5 . Dinitro.O.toluamide | January,1972 | |
| 3.Phenylazo.2,6.diaminopyridine | 3.Phenylazo.2,6.diaminopyridine | May,1969 | |
| Abacavir Sulfate Tablet 60mg | Abacavir Sulfate Tablet 60mg | For the treatment of HIV.1 infection in combination with other antiretroviral agents. | 01.08.2009 |
| Abacavir sulphate + zidovudine+lamivudine tabs | Each tab contains: lamivudine.150mg Zidovudine.300mg Abacavir(as sulphate).300mg | By RMP. alone or in combination with other antiretroviral agents for treatment of HIV.1 infection. | 03.10.2003 |
| Abacavir sulphate oral solution | Each 1ml oral solution contains: Abacavir (as sulphate).20mg | By RMP only. for the treatment of HIV infection in combination with other anti retroviral drugs. | 20.09.2004 |
| Abacavir Sulphate syrup 20mg/ml | Each ml contains: Abacavir sulphate IP eq.to abacavir.20mg | For the treatment of patients with HIV Infection. | 29.08.2006 |
| Abacavir sulphate tablets & bulk | Each tablet contains: Abacavir sulphate eq.to abacavir.300mg | HIV infection in combination with other antiretroviral agent. | 22.03.2002 |
| Abatacept Injection 250mg/vial (Additional Indication) | Abatacept Injection 250mg/vial | For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARD's such as MTX. | 10.04.2009 |
| Abatacept Injection 250mg/vial (Additional Indication) | Abatacept Injection 250mg/vial | In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists. | 20.02.2009 |
| Abatacept powder for injection 250mg/vial | Each vial contains: Abatacept.250mg | For the treatment of adult patients with severe active rheumatoid arthritis, who had an inadequate response to one more DMARDs such as methotrexate or TNF antagonists. | 22.07.2008 |
| Abciximab injection | Each 5ml vial contains: Abciximab.10mg | 02.05.1997 | |
| Abiraterone acetate Tablet 250 mg (Additional Indication) | Abiraterone acetate Tablet 250 mg | For the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated, with prednisone or prednisolone. | 27.03.2015 |
| Abiraterone Acetate Tablets 250mg | Each tablet contains: Abiraterone acetate.250mg | In combination with prednisone for the treatment of patients with metastatic castration.resistant prostrate cancer who have received prior chemotherapy containing docetaxel. | 16.12.2011 |
| Acamprosate calcium tabs/bulk | Each enteric coated tab contains: Acomprosate calcium.333mg | As therapy to maintain abstinence unalcohol dependent patients. It should be combined with counselling. | 30.10.2002 |
| Acarbose tablets | Each tab contains: Acarbose.50mg,100mg | Insulin dependent (type.II) diabetes inadequately controlled by diet/or oral hypoglycaemic agent. | 06.03.1997 |
| Acebrophylline capsules 100mg | Each capsule contains: Acebrophylline. 100mg | For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma. | 29.05.2008 |
| Acebrophylline SR Tablet 200 mg | Acebrophylline SR Tablet 200 mg | For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma. | 23.11.2010 |
| Acebrophylline Syrup | Each ml of syrup contains: Acebrophylline.10mg | For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma. | 13.01.2009 |
| Acebrophylline Syrup 10mg/ml (Additional Indication) | Acebrophylline Syrup 10mg/ml | For the treatment of children (age 6 to 12 years) with chronic obstructive pulmonary disease(COPD) and bronchial asthma. | 30.03.2009 |
| Acebutolol capsules/injection | Each capsule contains:: Acebutolol hcl eq.to 100mg,200mg,400mg Acebutolol Each ml contains; eq.of 5mg of Acebutolol. | Anti hypertensive agent. Indicated in the management of all grades of hypertension, angina pectoris and control of tachyarrhythmias. | December,1985 |
| Acebutolol hcl + Hydrochlorthiazide tablets | Acebutolol hcl.200mg, hydrochlorthiazide.12.5mg | August,1986 | |
| Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. (New Dosage Form) | Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained released pellets) 8mg/16mg Capsules. | For the treatment of acute inflammation conditions associated with spasm in adults only. | 04.01.2012 |
| Aceclofenac + Paracetamol tablets | Each tablet contains: Aceclofenac.100mg, Paracetamol.500mg | RMP. for acute painful conditions in adults only. | 08.07.2004 |
| Aceclofenac 1% w/w + Menthol 5% Spray | Aceclofenac 1% w/w + Menthol 5% Spray | For the treatment of acute painful inflammatory conditions in adults only. | 28.05.2010 |
| Aceclofenac 100mg + Tizanidine 2mg film coated tablets | Aceclofenac 100mg + Tizanidine 2mg film coated tablets | For the treatment of acute low back pain in adult patients only. | 23.02.2009 |
| Aceclofenac 100mg Tablet | Each tablet contains: Aceclofenac.100mg | For the treatment of pain & inflammation in patients with osteoporosis, rheumatoid arthritis and ankylosing spondylitis. | 05.04.2007 |
| Aceclofenac 200mg (S.R) tablet | Aceclofenac 200mg (S.R) tablet | NSAID | 22.02.2006 |
| Aceclofenac dispersible tablet 100mg (New Dosage Form) | Aceclofenac dispersible tablet 100mg | As Approved. | 21.12.2006 |
| Aceclofenac gel 1.5% along with linseed oil, menthol, Salicylate, Capsaicin | Aceclofenac BP (1.5% w/w) also contains linseed oil,menthol, methyl salicylate and capscicin. | For the treatment of pain, swelling and inflammation due to musculo skeletal disorder viz., sprains, strains, tensonitis, bursitis, head, neck, shoulder pain, sciatica muscle stiffness, joint pain, backache, lumbago. | 14.06.2005 |
| Aceclofenac Inj. (150mg/ml) | Aceclofenac Inj. (150mg/ml) | For pain in post operative & post traumatic cases. | 28.09.2006 |
| Aceclofenac Inj. 50mg/ml (Additional Strength) | Aceclofenac Inj. 50mg/ml | As Approved. | 01.12.2006 |
| Aceclofenac injection (150mg/3ml) | Aceclofenac injection (150mg/3ml) | For short term treatment of pain due to post operative and post traumatic cases. | 19.02.2007 |
| Aceclofenac injection 150mg/ml | Aceclofenac injection 150mg/ml | For short term treatment of pain due to post operative and post traumatic cases. | 23.01.2008 |
| Aceclofenac Roll . On 1% | Aceclofenac Roll . On 1% | For the treatment of acute musculoskeletal pain in patients. | 24.10.2008 |
| Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets | Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets | For the treatment of acute inflammation conditions associated with spasm in adults only. | 03.08.2009 |
| Aceclofenac(100mg) + Thiocolchicoside (4 mg) tablets (Additional strength) | Aceclofenac(100mg) + Thiocolchicoside (4 mg) tablets | For the treatment of acute inflammation conditions associated with spasm in adults only. | 11.08.2009 |
| Acesulfame Potassium | Acesulfame Potassium | As sweetener in pharmaceutical preparation. | 05.04.2005 |
| Acetyl salicylic acid + Aluminium Hydrochloride + Magnesium Hydrocloride | Each tablet contains: Acetyl salicylic acid.350mg Aluminium Hydrochloride.90mg Magnesium Hydrocloride.90mg | November,1981 | |
| Acetyl salicylic acid + calcium carbonate + anhydrous citric acid | Each tablet contains: ASA.100mg,CC.30mg,ACA.10mg | September,1991 | |
| Acetyl salicylic acid Injection | Acetyl salicylic acid Injection | October,2005 | |
| Acetylcystein | Acetylcystein | Antimycolytic enzyme. | March,1966 |
| Acipimox Capsules 250mg. | Each capsule contains: Acipimox.250mg | As adjunctive therapy to diet in the treatment of hyperlipidaemias of type IIa, IIb and IV. | 01.12.2009 |
| Acitretin | Each hard gelatin capsule contains: Acitretin.10mg, 25mg | For the treatment of severe psoriasis in adults patients (excluding female of child bearing potentials) with 7 points of warning | 09.09.2005 |
| Aclarubicin hydrochloride injection | Aclarubicin hydrochloride injection | Anti cancer. Indicated in the treatment of acute leukaemia, malignant lymphoma, stomach, lung cancer etc. | March,1988 |
| Acrivastine Capsules 8mg | Each capsule contains: Acrivastine.8mg | For the symptomatic relief of allergic rhinitis. | 26.09.2011 |
| Actarit 100mg Tablets | Each film coated tablet contains: Actarit.100mg | For the treatment of rheumatoid arthritis patients. | 22.07.2008 |
| Activated Dimethicone 50mg + Magnesium Hydroxide 250mg + Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution | Activated Dimethicone 50mg + Magnesium Hydroxide 250mg + Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution | For treatment of symptoms of hyperacidity (e.g. heartburn, epigastric discomfort, or their equivalents) that are often associated with dyspepsia, peptic ulcers, gastritis, peptic esophagitis and indicated for relief of flatulence. | 28.05.2010 |
| Activated Methylpolysiloxane + Magnesium Hydroxide + Aluminium Hydroxide | Each 5mL contains: Activated Methylpolysiloxane.125mg Magnesium Hydroxide.100mg Aluminium Hydroxide.5mg | June,1973 | |
| Acyclovir 50g + Hydrocortisone 10mg Cream | Acyclovir 50g + Hydrocortisone 10mg Cream | For the early treatment of recurrent cold sores in adult patients to reduce likelihood of ulcerative cold sores and to shorten the lesion healing time. | 30.08.2011 |
| Acyclovir SR Tablet 1200 mg | Acyclovir SR Tablet 1200 mg | For the treatment of uncomplicated Herbis Zoster in immunocompetent patients. | 11.09.2010 |
| Acyclovir tablets/cream/ointment/ophthalmic ointment/suspension | Tablets.200mg, cream/ointment.5%, ophthalmic ointment.3%, suspension.400mg/5ml (30.7.91) | Anti viral agent. Indicated in the treatment of Herpes simplex virus infections of the skin including initial & recurrence genital herpes, herpes labiales, herpes simplex keratites. | October,1987 |
| Adapalene + clindamycin gel | Each gm gel contains: Adapalene.1mg Clindamycin phosphate eq.to clindamycin.10mg | For treatment of acne vulgaris | 01.05.2003 |
| Adapalene 0.1% + Benzoyl Peroxide 2.5% gel | Each gram contains: Hydrous benzoyl peroxide eq.to anhydrous benzoyl peroxide.25mg Adapalene.1.0mg | For the treatment of acne vulgaris. | 31.10.2008 |
| Adapalene 0.1% w/w | Each 15gm tube contains: Adapalene.0.1% w/w | By RMP. for topical treatment of acne vulgaris. | 15.03.2001 |
| Adefovir dipivoxil (Tab/bulk) | Each tablet contains: Adefovir dipivoxil.10mg | For treatment of chronic hepatitis B infection, in adults with evidences of active viral replication either evidences of persistent elevation of serum aminotransferases or histologically active disease. | 04.03.2004 |
| Ademetionine enteric coated Tablets ..200mg/400mg | Each enteric coated tablet contains: Ademetionine.1,4 butanedisulfonate eq.to ademetionine.200mg, 400mg | For the management of intrahepatic cholestasis and liver disease. | 01.09.2010 |
| Adenosine injections | Each 2ml ampoule contains: Adenosine.6mg | Conversion to sinus rhythm of paroxysmal supraventricular tachycardia, including that associated with accessory by pass tracts (wolf.parkinson.white syndrome) when clinically advisable appropriate vagal maneuvers should be attempted prior to adenosine administration. | 08.07.1997 to 08.07.1999 |
| Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet | Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet | For the treatment of iron deficiency anaemia in adults only. | 21.03.2011 |
| Adrenochrome monosemicarbazone | Adrenochrome monosemicarbazone | March,1969 | |
| Afatinib Tablet 20, 30, 40 mg | Each film coated tablet contains: afatinib.20mg, 30mg, 40mg, 50mg (free base) corresponding to afatinib dimaleate 29.56mg, 44.34mg, 59.12mg, 73.9mg | For “treatment of locally advanced or metastatic non.small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutation” | 30.12.2014 |
| Agomelatine Tablets 25mg | Each film coated tablet contains: Agomelatine.25mg | For the treatment of major depression in adult patients aged 18 – 65 years only with normal liver functions. | 10.09.2012 |
| Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg + Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets | Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg + Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets | For the treatment of hypertension: a) As initial therapy in the patient likely to need multiple drugs to achieve blood pressure control. B) In the patients whose blood pressure is not adequately controlled with the Aliskiren alone or Amlodipine (or another dihydropyridine calcium channel blocker) alone. C) As replacement therapy in patients already receiving Aliskiren and Amlodipine from separate tablets at the same dose level. | 12.10.2011 |
| Albendazole | Albendazole.2.5% w/v, 10% w/v | Anthelmetic. indicated in the control of Gastro.intestinal roundworm, lungworm, tapewarm & adult liver flukes in cattle, sheep. | October,1979 |
| Albendazole 400 mg + Ivermectin 6 mg tablet | Albendazole 400 mg + Ivermectin 6 mg tablet | For the treatment of intestinal helminthes and suppression of microfilaraemia especially with bancrofti infections. | 25.04.2009 |
| Albendazole tablet 400mg and suspension 400mg/10ml (Additional Indication) | Albendazole tablet 400mg and suspension 400mg/10ml | For the treatment of systemic helminth infections 1. Neurocysticerosis 2. Echinococcosis | 28.11.2011 |
| Albendazole tablets/suspension | Suspension.200mg/5ml, Tablet.200mg, 400mg | Anthelmintic | February,1986 |
| Alclometasone dipropionate cream/ointment | Alclometasone dipropionate.0.05% | Topical corticosteroid. Indicated for the relief of the inflammatory & pruritic manifestations of corticosteroid responsive dermatosis. | July,1987 |
| Alendronate sodium | Each uncoated tablet contains: Alendronate sodium trihydrate.35mg, 70mg (as alendronic acid) | By RMP. for treatment & prevention of osteoporosis in post menopausal women. | 16.05.2001 |
| Alendronate sodium (earlier approved 10mg) | 5mg | Based on expert comments | 06.03.2000 |
| Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet | Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet | For osteoporosis. | 01.02.2006 |
| Alendronate sodium tablets | Each uncoated tab contains: Alendronate sodium.10mg (as alendronic acid) | Post menopausal osteoporosis only. | 18.09.1997 to 18.09.1999 |
| Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet | For BPH in men with enlarged prostate. | 14.06.2007 | |
| Alfuzocin hcl. OD(10mg) tablets | Each extended release film coated tablet contains: Alfuzocin hcl ER.10mg | By urologists only. for the treatment of sign & symptoms of BPH. | 14.05.2004 |
| Aliskiren 150/150/300/300mg + Hydrochlorthiazide 12.5/25/12.5/25mg tablets | Aliskiren 150/150/300/300mg + Hydrochlorthiazide 12.5/25/12.5/25mg tablets | For the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy. | 08.05.2008 |
| Aliskiren 150/160 mg + Valsartan 300/320 mg tablets | Aliskiren 150/160 mg + Valsartan 300/320 mg tablets | For the treatment of hypertension. | 19.01.2010 |
| Aliskiren Tablet 150mg/300mg | Aliskiren Tablet 150mg/300mg | For hypertension | 08.06.2007 |
| Allergen Extracts | Allergen Extracts | Contact allergic conditions. to be supplied to clinics & physician having facilities to conduct such test and prescription from the specialist. | January,1979 |
| Allergens | Allergens | September,1978 | |
| Allopurinol | Each tablet contains: 100mg of allopurinol | In the treatment of gout and secondary hyperuricaemia. | March,1969 |
| Allopurinol SR caps | Each SR cap contains: Allopurinol.250mg | For treatment & prophylaxis of gout. | 22.11.2002 |
| Allyloestrenol | 5mg tab | Progestational compound | January,1964 |
| Almotriptan Tablet 6.25mg/12.5mg | Each film coated tablet contains: Almotriptan malate eq.to almotriptan.6.25mg, 12.5mg | For acute treatment of migraine attacks with a history of migraine with or without aura in adults. Important limitation: Use only after a clear diagnosis of migraine has been established. Not intended for prophylactic therapy of migraine. Not indicated for the treatment of cluster headache. | 05.10.2012 |
| Aloe Ext. | Aloe Ext. | Russian pharmacopoeia drugs | April,1965 |
| Alogliptin Tablet 6.25 mg/12.5 mg/ 25 mg | Each film coated tablet contains: Alogliptin.6.25mg, 12.5mg, 25mg | "To improve glycemic control in combination with other glucose lowering medicnial products including insulin when these together with diet and exercise, do not provide adequated glycemic control or as monotherpy as adjunct to diet and exercise to improve glycemid control in adults aged 18 years or older with type 2 Diabetic mellitus." | 27.08.2014 |
| Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets | Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets | For the treatment of Diabetic neuropathy. | 10.08.2011 |
| Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. To Chromuim 200mcg Capsule | Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. To Chromuim 200mcg Capsule | For the treatment of diabetic neuropathy. | 03.01.2011 |
| Alphachymotrypsin + ethyl nicotinate | Each 20g contains: Alpha chymotrypsin 60 mg, Ethyl nicotinate 200 mg | September,1971 | |
| Alprazolam Dispersible Tab. 0.125 mg/0.25 mg/0.50 mg | Alprazolam Dispersible Tab. 0.125 mg/0.25 mg/0.50 mg | For anxiety | 20.09.2006 |
| Alprazolam SR 0.25 mg + Sertraline (As Hcl) 25 mg/50 mg tablet | Each uncoated bilayered tablet contains: Alprazolam IP.0.25mg (SR), Sertraline hydrochloride eq.to sertraline 25 mg, 50 mg | For the treatment of Panic disorder with or without agoraphobia. | 07.08.2005 |
| Alprazolam SR 0.5mg tablet | Each SR tablet contains: Alprazolam.0.5mg | Short.term treatment of anxiety disorder, anxiety associated with depression and panic disorders. | 01.08.2007 |
| Alprazolam SR tab (1.5mg) | SR tablets.............1.5mg | Short term symptomatic treatment of anxiety including anxious patients with symptoms of depressions. | |
| Alprazolam sublingual tablets 0.5mg/1mg (New dosage form) | Alprazolam sublingual tablets 0.5mg/1mg | In the treatment of anxiety associated with depression and for the treatment of panic disorder. | 27.10.2011 |
| Alprazolam tablets | Each tablet contains: Alprazolam.0.25mg,0.5mg,1mg | Anxiolytic agent. Indicated in the treatment of anxiety associated with depression. | June,1988 |
| Alprostadil for injection | Each single dose syringe contains: Alprostadil USP.10mcg,20mcg | Treatment of erectile dysfunction in men. Endocrinologists/urologists/psychiatrists/venereologists only | 09.05.2002 |
| Altretamine caps 50mg | 50mg | For palliative treatment of patients with persistent or recurrent ovarian cancer, following first line therapy with cisplatin and/or alkylating agent based combination. | 29.03.1995 |
| Aluminium salicylate | Aluminium salicylate | Anti.diarrhoeial, antiseptic. | February,1965 |
| Aluminium sodium silicate, magnesium hydroxide, methyl polysiloxane | 1 mg, 10 tablets | In the treatment of peptic ulcer gastric hyperacidity, heart burn and flatulence. | June,1967 |
| Amantadine Hydrochloride | Amantadine Hydrochloride | Parkinsonism | December,1972 |
| Ambodryl + Aspirin + Phenacitin + Caffeine + Phenylephrine hcl + Aluminium hydroxide | Each Tablets contains: Ambodryl 10 mg, Aspirin 190 mg Phenacitin 65 mg Caffeine 15 mg Phenylephrine hcl.10 mg Aluminium hydroxide gel. 100 mg | Upper respiratory tract infections | November,1970 |
| Ambrisentan film coated Tablets 5 mg / 10mg | Each film coated tablet contains: Ambrisentan.5mg, 10mg | For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening. | 28.05.2010 |
| Ambroxol + Guaiphenesin | Each 5ml contains: guaiphenesin.100mg, ambroxol hcl.15mg ethanol 95% eq.to ethanol.5% v/v | By RMP. for treatment of cough | 18.08.2000 |
| Ambroxol + Guaiphenesin + Menthol + Pseudoephedrine | Ambroxol.30mg, guaiphenesin.100mg, menthol.01mg, pseudoephedrine.60mg | Cough congestion | 29.10.1999 |
| Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml) | Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml) | For the treatment of productive cough. | 18.08.2008 |
| Ambroxol + Pseudoephedrine + Chlorpheniramine maleate tabs/suspension/syrup | Ambroxol + Pseudoephedrine + Chlorpheniramine maleate tabs/suspension/syrup | 26.02.1998 | |
| Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup | Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup | Additional strength | 27.10.2009 |
| Ambroxol 30mg + Levosalbutamol 1mg + Guiphenesin 50mg /5ml syrup | Ambroxol 30mg + Levosalbutamol 1mg + Guiphenesin 50mg /5ml syrup | For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis. | 19.03.2009 |
| Ambroxol CR tabs | 75mg | ||
| Ambroxol hcl + salbutamol + guaiphenesin + menthol | Each 5ml contains: Ambroxol hcl.15mg, Salbutamol.1mg, Guaiphenesin.50mg, Menthol.1mg | Cough expectorant | 16.06.1999 |
| Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup | Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup | For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis. | 26.03.2008 |
| Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. | Each capsule contains: Ambroxol Hcl (SR pellets).75mg, Desloratidine.5mg | For symptomatic relief of productive cough associated with allergic rhinitis, when both antihistamine and mucolyte agents are desired. | 11.11.2005 |
| Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrup | Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrup | For symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis. | 26.03.2008 |
| Ambroxol tablet/liquid/drops | i).Each tab contains; ambroxol hcl.30mg, ii).Each 5ml liquid contains; ambroxol hcl.30mg, iii).Each ml drop contains; ambroxol hcl.7.5mg | Antitussive. acute and chronic disease of the respiratory tract associated with abnormal bronchial secretions in particular acute attacks of chronic bronchitis, asthmatic bronchitis, bronchial asthma. | 01.12.1995 |
| Ambroxyl hcl SR+ Doxycycline hcl | Each tab contains: Ambroxol (as hcl) SR.75mg Doxycycline hcl.100mg | Acute and chronic illness of RT with pathological inspissation of mucous (in case of acute attacks of chronic bronchitis, inflammation of the para nasal sinuses) caused by doxycycline sensitive actiological agents. | 23.08.2001 |
| Amifostine | Amifostine | NOC issued for additional indication; for use in association with standard fractionated radiation therapy to protec aganst acute and late xeroxtomia in hand and neck cancer. | 06.11.2000 |
| Amifostine sterile lyophillised powder for injection | Each vial contains: Amifostine.500mg | Indicated as a chemoprotective agent against the serious toxicities associated with intensive regimens of platinum and alkylating agent chemotherapy (on reconstitution each ml will contains 50mg amifostine). | 21.03.1996 |
| Amikacin injection | Each vial contains: Amikacin sulphate eq.to 100mg,250mg,500mg of amikacin | Antibiotic. Indicated in the treatment of serious infections due to amikacin sensitive organisms. | June,1986 |
| Amiloride + Frusemide tablets | Each tablet contains: Amiloride...........5mg/5mg Frusemide..................20mg,40mg | June,1989 | |
| Amiloride + Hydrochlorothiazide | Amiloride 5mg, Hydrochlorothiazide 50mg | Diuretic antihypertensive. Marketed in combination with hydrochlorothiazide indicated in the treatment of oedema and hypertension. | September,1979 |
| Amineptine tablets | Each tablet contains: Amineptine hcl 100mg | Anti depressant. Indicated in the treatment of all types of depression. | January,1988 |
| Amino acid 5% (w/v) IV infusion with & without electrolytes | 5% w/v | For parenteral nutrition in patients with protein depletion condition. | 07.02.2001 |
| Amino acid 5% inj. | Each 100 ml contains: L-isoleucine 0.353 g, L-leucine 0.500 g, L-valine 0.380 g, L-lysine 0.550 g, L-methionine 0.120 g, L-phenylalanine 0.210 g, L-threonine 0.125 g, L-tryptophan 0.100g, L-arginine 0.420g, L-histidine 0.190 g, L-alanine 0.400 g, L-aspartic acid 0.300 g, L-cysteine 0.095 g, L-glutamic acid 0.500 g, Aminoacetic acid IP 0.200 g, L-proline.0.150 g, L-serine.0.200 g, L-tyrosine 0.045 g, L-ornithine hcl 0.144 g, taurine.0.030 g, WFI.q.s | For prophylaxis & therapeutic treatment of protein depletion in children where oral/enternal nutrition is impossible/impracticable. | 23.04.2002 |
| Amino acid injection | Amino acid injection | As parenteral nutrition, when oral, enteral nutrition is impossible, insufficient or contraindicated. | 18.08.2008 |
| Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion) | Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion) | Indicated to meet daily requirement of nitrogen (amino acids), energy (glucose) for patients needing parentral nutrition. | 08.07.2008 |
| Amino acids 10% inj. | Each 100ml contains: L-isoleucine 0.670 g, L-leucine 1.000 g, L-valine 0.760 g, L-lysine 1.100 g, L-methionine 0.240 g, L-phenylalanine 0.120 g, L-threonine 0.370 g, L-tryptophan 0.200 g, L-arginine 0.840 g, L-histidine 0.380 g, L-alanine 0.800 g, L-aspartic acid 0.600 g, L-cysteine 0.189 g, L-glutamic acid 1.000 g, glycine IP 0.100 g, L-proline 0.300 g, L-serine 0.400 g, L-tyrosine 0.045 g, L-ornithine hcl 0.318 g, taurine 0.060 g, WFI.q.s | For prophylaxis & therapeutic treatment of protein depletion in children where oral/enternal nutrition is impossible/impracticable. | 19.01.2004 |
| Aminoglutethimide tablets | Anti cancer. In the treatment of metastatic breast cancer. | August,1985 | |
| Aminomix.2 | Solution A.500ml, solution B.500ml | By.RMP. for complete parentral nutrition | 04.07.2000 |
| Aminophylline CR 225/350mg | Asthma, COPD, Bronchitis. | 21.03.2007 | |
| Aminosidine Sulphate | Each vial contains: Ammosidine sulphate.500mg | Antibiotic. indicated in the treatment of staphylococcus sepsis, infection of the respiratory tract due to staphylococcus and pneumococcus, infections of the urinary tract due to E.coli, P.vulgaris, Gonococci infection resistant to other antibiotics. | June,1976 |
| Amiodarone hcl | Each tab contains: 100mg,200mg, Each 3ml ampoule (inj.) contains: Amiodarone hcl.150mg | In the treatment of control of ventricular and supraventricular arrhythmia where other drug cannot be used, arrhythmia associated with wolf.white syndrome. | April,1990 |
| Amiodarone Injection (Additional Indication) | Amiodarone Injection | For cardiopulmonary resuscitation in the event of cardiac arrest related to ventricular fibrilation resistant to external electric shock. | 05.10.2007 |
| Amisulpiride 300mg tablets (Additional Strength) | Amisulpiride 300mg tablets | Same as Approved. | 20.03.2008 |
| Amisulpiride SR Tablet 100 mg | Amisulpiride SR Tablet 100 mg | Same as approved | 27.11.2009 |
| Amisulpiride Tablet (50/100/200mg) | Amisulpiride Tablet (50/100/200mg) | For schizophrenic disorder. | 01.08.2006 |
| Amisulpride 400mg tablet (Additional strength) | Amisulpride 400mg tablet | As Approved. | 01.12.2006 |
| Amisulpride 50/100/200 and 400mg Tablets | Each tablet contains: Amisulpride.50mg, 100mg, 200mg and 400mg | For acute and chronic schizophrenic disorders, in which positive and negative symptoms are prominent, including patients characterised by predominant negative symptoms, schizophrenic disorder. | 12.03.2010 |
| Amisulpride S.R.Bilayered tablet 200/400mg | Amisulpride S.R.Bilayered tablet 200/400mg | For acute and chronic schizophrenic disorders, in which positive symptoms and or negative symptoms are prominent, including patients characterised by predominant negative symptoms. | 03.11.2008 |
| Amitraz 2%w/v pour on solution | For the control of ticks on cattle and ostriches | 12.06.2010 | |
| Amitraz emulsifiable concentrate | Each ml emulsifiable concentrate contains: Amitraz BP.50mg,125mg | 06.08.1996 | |
| Amitriptyline hydrochloride | tabs 10 & 25 mg, inj. 10mg/cc | Anti.depressant. | August,1962 |
| Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. | Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. | For the treatment of patients suffering from neuralgia | 13.10.2010 |
| Amitryptylline Hcl | Each tablet contains: Amitryptylline Hcl.25mg | October,1978 | |
| Amlexanox Oral Paste (5%) | Each gram of paste contains: Amlexanox.50mg | For the treatment of apthous ulcers in people with normal immune system | 16.05.2007 |
| Amlodipine (5mg) + Nebivolol (5mg) tablet (Additonal Strength) | Amlodipine (5mg) + Nebivolol (5mg) tablet | As approved | 06.09.2007 |
| Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (Additonal Strength) | Amlodipine (As besylate) 10mg + Perindopril 8mg tablets | As approved | 07.05.2007 |
| Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Additonal Strength) | Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet | For hypertension | 30.11.2005 |
| Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet | Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet | For hypertension | 24.04.2006 |
| Amlodipine (as besylate) 5mg + Losartan Pot. 50mg | Amlodipine (as besylate) 5mg + Losartan Pot. 50mg | For hypertension | 08.12.2005 |
| Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (Additonal Strength) | Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg | As approved | 14.02.2007 |
| Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. | Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. | For hypertension | 05.06.2006 |
| Amlodipine (As besylate) 5mg/10mg + Perindopril 4mg tablet | Amlodipine (As besylate) 5mg/10mg + Perindopril 4mg tablet | For hypertension | 23.02.2007 |
| Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet | Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet | Essential hypertension | 21.02.2007 |
| Amlodipine + benazepril hcl tabs/caps | Each cap contains: Amlodipine (as besylate).2.5mg,5mg, Benazepril.10mg,20mg | Hypertension | 22.03.2002 |
| Amlodipine + Enalapril maleate tabs | Each tab contains: Amlodipine.5mg,2.5mg, Enalapril maleate.5mg,2.5mg | 16.11.1995 | |
| Amlodipine + Lisinopril tabs | Each tab contains: Amlodipine besylate eq.to amlodipine.5mg,2.5mg, lisinopril eq.to lisinopril anhydrous.5mg,2.5mg | Mild to moderate hypertension | 27.03.1997 |
| Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets | Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets | Additional Lower Strength | 10.11.2008 |
| Amlodipine + Ramipril tablets | Each hard gelatin capsule contains: Amlodipine.5mg Ramipril.2.5mg | 04.10.2004 | |
| Amlodipine 10mg/10mg + Telmisartan 40mg/80mg Tablets (Additional Strength) | Amlodipine 10mg/10mg + Telmisartan 40mg/80mg Tablets | Same as approved | 31.05.2011 |
| Amlodipine 25mg + Metoprolol 25mg (Additional lower strength) | Amlodipine 25mg + Metoprolol 25mg | 01.11.2006 | |
| Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets | Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets | For the treatment of essential hypertension | 24.11.2009 |
| Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet | Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet | Additional strength | 21.09.2010 |
| Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg Tablet (Additional Strength) | Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg Tablet | For the treatment of mild to moderate hypertension | 02.01.2013 |
| Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet | Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet | For the treatment of mild to moderate hypertension | 05.01.2011 |
| Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 8mg Tablets (Additional Strength) | Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 8mg Tablets. (Additional Strength). | For the treatment of mild to moderate hypertension in adults only and or treatment of stable coronary artery disease in patients already controlled with Perindopril & Amlodipine given concurrently at same dose level. | 20.12.2011 |
| Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + Olmesartan Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet | Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + Olmesartan Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet | For the treatment of essential hypertension. | 23.11.2011 |
| Amlodipine besylate + Atorvastatin tablets | Each uncoated tablet contains: Amlodipine besylate eq.to amlodipine.5mg, Atorvastatin calcium eq.to atorvastatin.10mg | By RMP. for the treatment of coexisting essential hypertension and hyperlipidaemia. | 11.02.2004 |
| Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet | Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet | For the treatment of essential hypertension. | 12.10.2010 |
| Amlodipine besylate tablets | Each tablet contains: Amlodipine besylate eq.to active amlodipine besylate.5mg,10mg,2.5mg(8.11.94, TPL) | Indicated in hypertension, angina pectoris. | 19.05.1993 |
| Amlodipine Tablets 5mg/10mg (Additional Indication) | Amlodipine Tablets 5mg/10mg | 1. To reduce of fatal coronary heart disease and non.fatal myocardial infarction, and to reduce the risk of stroke. 2. To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease. | 02.05.2009 |
| Amlodipine5mg + Ramipril10mg/5mg Tablets (Additional strength) | Amlodipine5mg + Ramipril10mg/5mg Tablets | For the treatment of hypertension only. | 10.03.2010 |
| Ammoidin & Ammidin | Ammoidin & Ammidin | In treatment of leucoderm and depigment action. | July,1967 |
| Ammonium Lactate Cream 12% w/w | Ammonium Lactate Cream 12% w/w | Indicated For the treatment of Dry,scaly skin(xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these condition. | 03.12.2010 |
| Amorolfine nail lacquer & cream | Each ml of nail lacquer contains: Amorolfine hcl eq.toamorolfine.50mg, Each gm of cream contains: Amorolfine hcl eq.to amorolfine.2.5mg | By Dermatologists. nail lacquer:for oncomycosis caused by dermatophytes yeasts & moulds. Cream:for treatment of dermatomycosis caused by dermatophytes cutaneous candidiasis and pityriasis versicolor. | 25.11.2003 |
| Amoscanate bulk/tablets | Each tablet contains: Amoscanate.250mg | Indicated in treatment of adult hookworm infestation only. | November,1985 |
| Amoxapine tablets | Each tablet contains: Amoxapine.25mg,50mg,100mg,150mg | Anti depressant. Indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depression, depression accompanied by anxiety and agitation. | November,1985 |
| Amoxicillin + Carbocisteine | Each capsule contains: Amoxicillin.250mg,500mg, carbocisteine.150mg, Each 5ml syrup contains: Amoxicillin.125mg Carbocisteine75mg. | For respiratory infection characterized by excessive or viscous mucus, contraindicated in pregnancy. | April,1991 |
| Amoxicillin 250mg + Lacto. Bacillus 1.7 billion Spores | Amoxicillin 250mg + Lacto. Bacillus 1.7 billion Spores | For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea. | 31.01.2008 |
| Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores | Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores | For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea. | 30.01.2008 |
| Amoxycillin | Amoxycillin | Antibiotic. indicated in the treatment of urinary tract infections, respiratory, genito.urinary, ENT and soft tissue infections. | December,1978. |
| Amoxycillin + Clavulanic acid | Amoxycillin.250mg, clavulanic acid.125mg | 13.12.1999 | |
| Amoxycillin + Clavulanic acid injections | 600mg vial.each contains: Amoxycillin.500mg, Clavulanic acid.100mg, 1.2gm vials.each contains: Amoxycillin.1g, Clavulanic acid.200mg | 1987.May | |
| Amoxycillin + Clavulanic acid tablets | Each tablet contains: Potassium clavulanate eq.to 125mg of clavulanic acid, Amoxycillin trihydrate eq.to 250mg, 500mg, 875mg(27.1.99) of amoxycillin | 1987.February | |
| Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC Tablets | Amoxycillin + Clavulanic acid (1gm + 62.5mg ) FC Tablets | For the treatment and management of patients with community acquired pneumonia or acute bacterial sinusitis due to beta lactamase producing pathogens. | 25.11.2008 |
| Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet | Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet | Antibiotic | 08.06.2006 |
| Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules) | Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules) | For the treatment of respiratory tract infection, skin and soft tissue infections & antibiotics associated diarrhoea in adult patients. | 31.01.2008 |
| Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsule | Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsule | For the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in adult patients prone to antibiotic associated diarrhoea. | 30.01.2008 |
| Amoxycillin 250mg + Dicloxacillin 250mg cap. | Each capsule contains: Amoxicillin trihydrate BP eq.to amoxicillin.250mg, Dicloxacillin sodium BP eq.to dicloxacillin.250mg | For the treatment of RTI, UTI, otitis media, dental abscess, septicaemia, soft tissue, infections and other bacterial infections due to beta.lactamase producing organism. | 28.Aug.2006 |
| Amoxycillin 3H2O dispersible tablets | Each dispersible tablet contains: 200mg,400mg | 26.05.2000 | |
| Amoxycillin Oral Suspension 200/400 mg per 5ml | Amoxycillin Oral Suspension 200/400 mg per 5ml | In the treatment of infections due to susceptible strains of the designated micro.organisms in the condition of E.N.T infection, skin & skin structure infection, lower respiratory tract infection, genitourinary tract infection, gonorrhea, acute uncomplicated (anogenital & urethral) infections. | 9.08.2010 |
| Amoxycillin sodium + Sulbactum sodium inj. (i.m/i.v) | Each vial contains: sterile amoxycillin sodium eq.to amoxycillin.500gm,1gm and sterile sulbactum sodium eq.to sulbactum.250mg,500mg. | 21.06.1996 | |
| Amoxycillin Trihydrate | Each dispersible tablet contains: Amoxycillin Trihydrate eq to 125mg of amoxycillin | March,1980 | |
| Amoxycillin trihydrate bolus | Each bolus contains: Amoxycillin trihydrate.750mg | 16.10.1996 | |
| Amphotericin B Emulsion 5mg/ml (Additional Indication) | Amphotericin B Emulsion 5mg/ml | Febrile Neutropenia in cancer patients. | 18.07.2009 |
| Amphotericin B emulsion injection | Each ml of the emulsion contains: Amphotericin B IP.5mg | Indicated for the treatment of visceral leishmaniasis. | 29.08.2003 |
| Amphotericin B lipid complex inj. | Each 10ml, 20ml injection contains: Amphotericin B (USP).5mg/ml | By RMP. for the treatment of invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin.B therapy. | 12.07.1996 |
| Amphotericin B Lipid suspension 50mg/ vial (Additional Strength) | Amphotericin B Lipid suspension 50mg/ vial | Additional Strength. | 12.12.2008 |
| Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension | Each vial contains: Amphotericin B IP 25mg with Lipid suspension & excipients q.s | For invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin B therapy. | 04.06.2008 |
| Ampicillin | Oral synthetic penicillin. | August,1965 | |
| Ampicillin + Probenecid | Each single dose vial contains: Ampicillin.3.5gm, Probenecid.1.0g | February,1983 | |
| Ampicillin 250mg + Dicloxacillin 250mg tablet | Ampicillin 250mg + Dicloxacillin 250mg tablet | Antibiotic. | 13.12.2006 |
| Amrinone injection | Each ml contains: Amrinone lactate eq.to 5mg amrinone base. | Inotropic agent. Indicated for the short term management of congestive heart failure. | May,1988 |
| Amsacrine injection | Amsacrine injection | Anti cancer. | 26.02.1992 |
| Amtolmetin Guacil tablets 600mg | Amtolmetin Guacil tablets 600mg | For the treatment of osteoarthritis & rheumatoid arthritis. | 07.03.2008 |
| Amylase + cellulose + protinase + pancreatic enzyme + lipase | Each capsule contains: Amylase, cellulose, protinase, pancreatic enzyme, lipase | December,1971 | |
| Amylobarbitone & Trifluoperazine dihydrochloride | Amylobarbitone & Trifluoperazine dihydrochloride | Psychoneurotics, tranquilizer & sedative. | February,1967 |
| Anastrozole tab (finished formulation import) | Each film coated tab contains: Anastrozole.1mg | For the treatment of advanced breast cancer in post menopausal women. | 10.02.2003 |
| Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial | Each vial contains: Anidulafungin.50mg, 100mg | For the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients. | 26.02.2009 |
| Anti.rabies vaccine (Killed virus) | Anti.rabies vaccine (Killed virus) | Vaccine against rabies. | March,1989 |
| Apixaban Tablets 2.5/5mg (Additional Indication) | Apixaban Tablets 2.5/5mg | Treatment of deep vein thrombosis (DVT) and pulmonary Embolism (PE), and prevention of Recurrent DVT and PE in adult patients. | 29.05.2015 |
| Apixaban Tablets 2.5mg | Each film coated tablet contains: Apixaban.2.5mg | Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. | 03.08.2012 |
| Apixaban tablets 2.5mg/5mg (Additional Strength & Additional Indication) | Apixaban tablets 2.5mg/5mg | Prevention of stroke and systemic embolism in adult patients with non.valvular artrial fibrillation (NVAF), including those with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age≥75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class≥II). Compared to warfarin apixaban also results in less bleeding, including intracranial hemorrhage. | 16.05.2014 |
| Apomorphine HCL 2mg Sublingual tablet | Each sublingual tablet contains: Apomorphine hydrochloride.2mg | For the treatment of erectile dysfunction in adult men. | 11.12.2007 |
| Apomorphine HCL 2mg/3mg Sublingual tablet | For erectile dysfunction in adult men. | 12.11.2007 | |
| Apraclonidine ophthalmic solution | Each ml contains: Apraclonidine hcl USP 0.575%w/v, 1.15% w/v eq.to Apraclonidine 0.5%w/v, 1%w/v | Solution is indicated in control of intra ocular pressure following anterior segment laser surgery, 0.5% solution is indicated for short term adjuncture treatment of chronic glaucoma. | 15.03.2002 |
| Apramycin sulphate | 50 gm in each 100 gm | Bacterial enteritis cellibacllosis, salmonellosis in poultry. | 22.07.1997 |
| Aprepitant 40mg capsules (Additional strength) | Aprepitant 40mg capsules | Prevention of post.operative nausea & vomiting (Additional indication). | 24.04.2007 |
| Aprepitant cap (80mg/125mg) | Aprepitant cap (80mg/125mg) | For chemotherapy induced nausea & vomiting. | 30.08.2006 |
| Arformoterol (as Tartrate) 15mcg/2ml Inhalation Solution | Each 2ml contains; arformoterol tartrate eq.to arformoterol.15mcg | For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. | 29.05.2009 |
| Aripiprazole tab | Each uncoated tab contains; Aripiprazole.10mg,15mg,20mg,30mg | For the treatment of schizophrenia. | 11.06.2003 |
| Aripiprazole tablets | Each uncoated tablet contains: Aripiprazole.5mg | Psychiatrist only. for the treatment of schizophrenia. | 23.Feb.04 |
| Armodafinil uncoated tablet 50/150/250mg | Each uncoated tablet contains: Armodafinil 50mg, 150mg, 250mg | To improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy. | 23.04.2010 |
| Arsenic trioxide inj | Each ml contains: Arsenic trioxide.1mg | For induction of remission and consolidation in patients with acute promyelocytic leukemia. | 12.06.2003 |
| Arteether injection 150mg/mL | Indicated for the treatment of severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only. | 03.12.2010 | |
| Arteether injection i.m | Each ampoule contains: Arteether 150mg | Same as artesunate (Antimalarial) | 14.01.1997 |
| Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup | Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup | For the treatment of chloroquine resistant/multidrug resitant on complicated malaria. | 30.09.2008 |
| Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg (Additional Strength) | Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg | Same as Approved. | 05.08.2008 |
| Artemether + Lumifantrine | Each tablet contains: Artemether.20mg lumefantrine.120mg | For hospital use only. for treatment of p.falciparum malaria cases resistant to both chloroquine and sulphadoxine pyrimethamine combination. | 26.12.2002 |
| Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (Additional Strength) | Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets | Same as Approved. | 24.06.2008 |
| Artemether injection | Each ampoule contains: Artemether.80mg, Each cap contains: Artemether.40mg | Promoted for use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only. | 02.08.1996 |
| Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets | Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets | For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups. | 01.09.2009 |
| Artesunate inj. | Each ampoule contains: Artesunate.60mg | Promoted for use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only. | 02.09.1996 |
| Artesunate injection (Additional strength) | Each combipack contains: Artesunate for injection 120mg Each vial contains Artesunate IP 120mg), Sodium bicarbonate injection IP 5%w/v (Each 2ml ampoule contains: Sodium Bicarbonate IP 5% w/v), Sodium chloride Injection IP 0.9% w/v (Each 10ml ampoule contains: Sodium chloride IP 0.9% w/v) | Promoted for use in severe malaria including cerebral malaria and as a second line in chloroquine resistant malaria cases only. | 13.11.2013 |
| Artesunate powder for injection 60mg/vial alongwith 6ml ampoule of phosphate buffer solution (pH 8.0;0.30M) | Artesunate powder for injection 60mg/vial alongwith 6ml ampoule of phosphate buffer solution (pH 8.0;0.30M) | For the treatment of severe Falciparum malaria in areas where there is evidence if quinine resistance. | 02.07.2014 |
| Artesunate tabs | Each tab contains: Artesunate.50mg | 07.10.1996 | |
| Articaine hydrochloride | Articaine hydrochloride | Local anaesthetic agent. Indicated for spinal infiltration, dental surgical & epidural anaesthesia. | August,1986 |
| Ascerbine | Ascerbine | For burns. | December,1970 |
| Asenapine Maleate Sublingual Tablets 5mg/10mg | Each sublingual tablet contains: Asenapine maleate eq.to asenapine.5mg, 10mg | For acute treatment of schizophrenia in adults only. | 07.04.2011 |
| Asiaticoside | Asiaticoside | For Expert only | November,1976 |
| Aspirin (EC Tablets) 75mg/75mg/150mg + Rosuvastatin (Granules) 5mg/10mg/10mg Capsules | Aspirin (EC Tablets) 75mg/75mg/150mg + Rosuvastatin (Granules) 5mg/10mg/10mg Capsules | For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease. | 30.03.2011 |
| Aspirin + dipyridamole ER cap | Each hard gelatin cap contains: Aspirin IP.25mg, Dipyridamole BP.200mg (ER) | For reduction of risk of stroke in patients who had transient ischemia of the brain of complete ischemic stroke due to thrombosis. | 27.02.2003 |
| Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (Additional Strength) | Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet | As loading dose for prevention of in.stent restenosis in PCI. | 22.06.2006 |
| Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet | Each tablet contains: i) aspirin IP.75mg + glycine.37.5mg, ii) aspirin IP.150mg + glycine IP.75mg | For primary & secondry prevention of acute coronary syndrome in patients with CAD, in prophylaxis against stroke and patients with risk of vascular thrombosis. | 10.08.2006 |
| Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg Tablets | Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg Tablets | For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate. | 01.06.2010 |
| Aspirin Bolus (Vet.) 6gm/bolus) | Aspirin Bolus (Vet.) 6gm/bolus) | For Veterinary use. | 21.11.2005 |
| Aspirin delayed release tablets | Each (aspirin) delayed release tablet contains: Aspirin.325mg, 500mg | 06.09.1993 | |
| Aspirin DL lysine | Each vial contains: Aspirin DL Lysine.900mg | April,1986 | |
| Astemizole suspension | Astemizole.5mg/5ml | August,1988 | |
| Astemizole tablets | Each tablet contains: Aztemizole.10mg | Anti allergic. Indicated in the treatment of allergic rhinitis allergic conjunctivitis, chronic urticaria and other allergic conditions. | February,1988 |
| Atazanavir (100/150/200mg) | Atazanavir (100/150/200mg) | Anti.HIV in adults. | 24.04.2006 |
| Atazanavir + Ritonavir(300mg + 100mg) FC Tablets | Atazanavir + Ritonavir(300mg + 100mg) FC Tablets | For the treatment of patients with HIV infection. | 04.11.2008 |
| Atazanavir 150mg + Ritonavir 50mg capsules | Atazanavir 150mg + Ritonavir 50mg capsules | Anti HIV. | 12.12.2006 |
| Atazanavir 300mg capsules (Additional Strength) | Atazanavir 300mg capsules | Same as approved. | 08.01.2008 |
| Atenolol (25mg, 50mg) + Hydrochlorthiazid (12.5mg) | Atenolol (25mg, 50mg) + Hydrochlorthiazid (12.5mg) | Anti.Hypertensive | 13.01.2005 |
| Atenolol + Amlodipine besylate tabs | Each uncoated tab contains: Amlodipine besylate eq.to amlodipine.5mg, Atenolol.50mg | 20.05.1996 | |
| Atenolol 25mg/50mg + Indapamide SR 1.5mg | Atenolol 25mg/50mg + Indapamide SR 1.5mg | For essential hypertension. | 21.05.2007 |
| Atenolol 50mg + HCTZ 25mg (Additional Strength) | Atenolol 50mg + HCTZ 25mg | For hypertension. | 03.02.2006 |
| Atenolol bulk | Atenolol bulk | January,1986 | |
| Atenolol tablets | Each tablet contains: Atenolol.50mg,100mg | Anti arrhythmic agent. Indicated in the treatment of hypertension, angina pectoris, cardiac arrhythmias. | September,1985 |
| Atomoxetine (as HCl) Sachet (10/18 /25/40mg) | Atomoxetine (as HCl) Sachet (10/18 /25/40mg) | For ADHD. | 15.12.2005 |
| Atomoxetine 60mg capsule (Additional Strength) | Atomoxetine 60mg capsule | For ADHD | 27.02.2006 |
| Atomoxetine hcl capsules | Each hard gelatin capsule contains: Atomoxetine hcl eq.to atomoxetine.10mg,18mg,25mg,40mg. | By psychiatrist. for the treatment of attention deficit hyperactivity disorders. .Patients requiring long term therapy should be monitored & consideration should be given to interrupting therapy in patients who are not growing or gaining weight satisfactorily. .Atomoxetine hcl should also be given with caution in patients with hypertension, tachycardia or cardiovascular or cerebro.vascular disease as it can increase B.P & heart rate. | 09.11.2004 |
| Atorvastatin | Each film coated tablet contains: Atorvastatin.5mg | As an adjunct to diet to reduce elevated total cholestrol & triglyceride level in patients with primary hypercholesterolemia & mixed dysbetalipoprotenimia (Type IIa & IIb) | 30.10.2001 |
| Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (Additional Strength) | Atorvastatin (40mg) + Ezetimibe (10mg) Tablet | As approved | 30.07.2007 |
| Atorvastatin + Ezetimibe tabs. | Each tablet contains: Atorvastatin.10mg,20mg, Ezetimibe.10mg | 13.08.2004 | |
| Atorvastatin + Fenofibrate | Each film coated tablet contains: Atorvastatin calcium eq.to atorvastatin.10mg, Fenofibrate BP (micronised).160mg | By RMP. for the treatment of combined hyperlipidemia in patients with normal hepatic and renal function. | 24.12.2004 |
| Atorvastatin + Metformin(10mg + 500mg SR) Tablets | Atorvastatin + Metformin(10mg + 500mg SR) Tablets | As adjunctive therapy to diet and exercise in patients with diabetic dyslipidemia. | 04.12.2008 |
| Atorvastatin 10mg + Aspirin 75/150mg Capsules | Atorvastatin 10mg + Aspirin 75/150mg Capsules | For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease. | 18.01.2008 |
| Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) | Atorvastatin 10mg + Fenofibrate 80mg tablet | For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions. | 25.01.2008 |
| Atorvastatin 10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules | Atorvastatin 10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules | For secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate. | 05.04.2010 |
| Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules | Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules | Additional higher strength | 17.03.2010 |
| Atorvastatin 5mg + Fenofibrate 160mg (Additional strength) | Atorvastatin 5mg + Fenofibrate 160mg | As Approved. | 01.12.2006 |
| Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet | Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet | For treatment of patients with both hypertension and hypercholesterolemia. | 15.10.2007 |
| Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (Addl. strength) | Atorvastatin Calcium (10mg) + Fenofibrate (145mg) | As Approved | 30.10.2007 |
| Atorvastatin calcium (amorphous) | Atorvastatin calcium (amorphous) | 27.05.2005 | |
| Atorvastatin calcium 5mg/10mg/20mg/40mg/80mg (Additional Dosage Form) | Atorvastatin calcium 5mg/10mg/20mg/40mg/80mg | 1) As an Adjunct to Diet to Reduce Elevated Total Cholesterol and Triglyceride Levels in Patients with Primary HyperCholesterolemia and Mixed Dyalipidemia (Type IIa and IIIb). 2) In adult patients with type II diabetes and without clinically evident coronary heart disease to reduce the risk of myocardial infarction and stroke. 3) To reduce the risk of stroke in adult patients without clinically evident coronary heart disease but multiple risk factors for coronary heart disease. | 20.04.2011 |
| Atorvastatin Calcium 80mg tablets (Additional Strength) | Atorvastatin Calcium 80mg tablets | Additional Strength (it should not be used routinely because of increased risk of adverse events. It should be reserved for patients who are considered to be at higher risk after careful risk assessment). | 25.02.2008 |
| Atorvastatin calcium tablets | Each film coated tablet contains: Atorvastatin calcium eq.to atorvastatin.10mg, 20mg, 40mg | As an adjunct diet to reduce elevated total cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia (type IIa & IIb) | 17.09.1999 |
| Atosiban Acetate Injection 6.75mg/0.9 ml, 1 ml & 5 ml Vial | Each 0.9ml and 5ml contains: Atosiban acetate eq.to atosiban.6.75mg/0.9ml and 37.5mg/5ml respectively | “Indicated to delay imminent pre.term birth in pregnant adult women with: .regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes . a cervical dilation of 1 to 3 cm (0.3 for nulliparas) and effacement of ≥ 50% . a gestational age from 24 until 33 completed weeks . a normal foetal heart rate.” | 16.09.2015 |
| Atricurium dibesylate injection | Atricurium dibesylate injection | Muscle relaxant. Indicated for use in anaesthesia to relax muscle during surgical procedures and to facilitate controlled ventillation. | January,1986 |
| Atropine sulphate + hyoscyamine sulphate + scopolamine hcl + phenobaribotol | Atropine sulphate.0.06mg,hyoscyamine sulphate.0.30mg, scopolamine hcl.0.035mg, phenobaribotol.64.8mg | December1969 | |
| Auranofin capsules | Each capsule contains: Auranofin.3mg | Anti rheumatic. Indicated in the treatment of rheumatoid arthritis and in children with juvenile rheumatoid arthritis. | December,1987 |
| Autolysate of B.subtilis and B.megatherium | Autolysate of B.subtilis and B.megatherium | Anti allergic. indicated in the treatment of bronchial asthma recurrent inflammation of the broncho.phyrinx, tonsils in children, rheumatic disease. | July,1975 |
| Axitinib Tablet 1mg/5mg | Each film coated tablet contains: Axitinib.1mg, 5mg | For the “ treatment of advanced renal cell carcinoma after failure of one prior systemic therapy”. | 18.09.2014 |
| Azabiperidol bulk | Azabiperidol bulk | Neroleptic agent. Indicated in the treatment of acute & chronic schizophrenia, anxiety, depressive, psychosis & hyperkinetic children. | September,1981 |
| Azacitidine for injection 100 mg/vial | Each vial contains: Azacitidine.100mg | For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome. | 29.04.2014 |
| Azacitidine Injection 100mg/vial | Each single dose vial conatins: Azacitidine.100mg | For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome. | 01.09.2015 |
| Azatadine Maleate | Each tablet contains: Azatadine maleate.1mg | Anti.allergic. indicated for the symptomatic relief of allergic conditions such as hay fever, vasomotor rhinitis, urticaria, pruritus of allergic origin. | November,1980 |
| Azathioprine | Each tablet contains: Azathioprine.50mg & 100 mg | For facilitating the survival and function of organ transplants. | July,1969 |
| Azathioprine 25mg Tablets | Azathioprine 25mg Tablets | Additional Strength. | 19.12.2008 |
| Azelaic acid (20% w/w) cream | Each gm of cream contains: Azelaic acid.0.2gm | By RMP only. for the topical treatment of mild to moderate inflammatory acne vulgaris. | 08.07.2003 |
| Azelaic acid Cream (15%) | Each gm of cream contains: Azelaic acid.0.15gm (15% w/w) | For topical treatment of mild to moderate inflammatory papules and pustules of mild to moderate rosacea. | 23.02.2005 |
| Azelastine eye drops | 0.5mg/ml | 05.05.2000 | |
| Azithromycin + Dexamethasone (10mg + 1mg) (Eye Drops) | Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops | For post operative steroid responsive inflammatory ocular condition when bacterial ocular infections or a risk of bacterial ocular infections exists. | 21.10.2008 |
| Azithromycin 500mg + Ambroxol S.R (75mg) Tablet | Azithromycin 500mg + Ambroxol S.R (75mg) Tablet | For RTI caused by susceptible organisms in adults. | 05.07.2007 |
| Azithromycin caps/suspension/inj. | i).Each capsule contains: Azithromycin dihydrate eq.to 250mg of base, ii).Each 5ml contains; azithromycin.200mg,50mg | For susceptible infections including community acquired pneumonia pelvic inflammatory disease. | 13.05.1994 |
| Azithromycin eye drops 1% | Azithromycin eye drops 1% | Conjunctivitis | 06.06.2007 |
| Azithromycin SR Granules for Oral Suspension 1gm (Additional Strength) | Azithromycin SR Granules for Oral Suspension 1gm | Same as Approved | 05.04.2010 |
| Azithromycin SR Granules for oral suspension 2000mg | Azithromycin SR Granules for oral suspension 2000mg | for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/skin structure, non gonococcal urethritis, cervicitis. | 26.06.2009 |
| Azithromycin Tablet 250mg/500mg | Azithromycin Tablet 250mg/500mg | For the treatment in uncomplicated multidrug resistant enteric fever only. | 06.03.2013 |
| Aztreonam inj. & bulk | Each vial contains: Aztreonam USP eq.to anhd. Aztreonam.0.5gm,1gm,2gm | Urinary tract infection, lower respiratory tract infection, septicemia, skin & skin structure infections, intra abdominal infections, gynecological infections. | 01.11.2002 |
| Bacampicillin tablets | Each tablet contains: Bacampicillin hcl eq.to 400mg of bacampicillin | Antibiotic. Indicated in the treatment of upper & lower respiratory tract infections, urinary tract infections, skin infections, gonorrhea, sinusitis, tonsilitis, acute & chronic bronchitis, otitis media, post.operative infections. | October,1985 |
| Bacillocid special | Bacillocid special | 20.05.1992 | |
| Bacillus calmette and geurin vaccine (immucyst, BCG therapeutics) | 27mg dry weight per vaccine | Anti cancer. To be indicated for intravesical use in the treatment of primary and relapse carcinoma in.situ of the urinary bladder. | 22.06.1992 |
| Bacillus calusii spores suspension (2billion/5ml vial) | Each vial of oral suspension contains: spores of Bacillus clausii 2 billions/5ml | RMP. For the treatment of the alteration of intestinal bacterial flora. | 28.01.2005 |
| Bacillus Clausii Spores (2 Billion) Capsules (Additional Dosage Form) | Bacillus Clausii Spores (2 Billion) Capsules | Same as Approved. | 23.07.2008 |
| Baclofen E.R capsule (30mg) | Each ER capsule contains: Baclofen USP 30mg | For the symptomatic treatment of neuronal spasticity due to multiple sclerosis, spinal chord, pathology & injury. | 01.08.2006 |
| Baclofen ER (GRS) Capsule 45mg/60mg (Additional strength) | Baclofen ER (GRS) Capsule 45mg/60mg | As approved. | 22.02.2007 |
| Baclofen ER Capsule 10 mg/50 mg. (Additional Strength) | Baclofen ER Capsule 10 mg/50 mg. | Same as approved | 17.02.2011 |
| Baclofen tablets | Each tab contains: Baclofen USP.10mg, 25mg. | In the treatment of spasticity of the skeletal muscle in multiple sclerosis, spastic conditions occuring in spinal cord diseases of infections, degenerative, traumatic neoplastic of unknown spinal paralysis, amyotrophic lateral sclerosis, syrengomelia, transverse nyetitis, traumatic paraplegia or para.paralysis, compression of spinal cord muscle spasm of cerebral origin, especially where due to infantile cerebral poly cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease. | 29.09.1995 |
| Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate | Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate | For use as an intra ocular irrigation solution during intraocular surgical procedures involving perfusion of the eyes. | 29.04.2005 |
| Balofloxacin Tablet 100mg | Each tablet contains: Balofloxacin.100mg | For the treatment of uncomplicated urinary tract infectins (such as cystitis or urethritis) | 23.12.2009 |
| Balsalazide disod.cap & bulk import | Each hard gelatin cap contains: Balsalazide disod.dihydrate.750mg | Mild to moderately active ulcerative colitis. | 12.11.2002 |
| Bambuterol hcl (bulk locally) (D.F 22.4.94) | Bronchospasm in asthma, reversible air ways disease. | 13.12.1999 | |
| Bambuterol hcl oral solution | Each ml of oral suspension contains: Bambuterol hcl.1mg. | By RMP. for bronchospasm in asthma reversible airway disease for children > age of 2 years. | 27.09.2000 |
| Bambuterol hcl tablets | i).Each uncoated tab contains: Bambuterol hcl BP.10mg,20mg, ii).Each ml of oral suspension contains: Bambuterol hcl.1mg (appr. On 27.9.2000) | Bronchodilator. | 13.12.1999 |
| Banoxinate hcl. | Banoxinate hcl. | Indicated for use as an anaesthesia of cornea and conjuctivit for ophthalmic procedure. | 24.11.1992 |
| Basiliximab inj. | Basiliximab inj. | For the prophylaxis of acute organ rejection in de.novo transplantation & is to be used concomitantly with cyclosporin for microemulsion & corticosteroid immuno suppression. | 28.05.1999 |
| Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream | Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream | For the topical treatment of bacterial and fungal infections. | 30.01.2008 |
| Beclomethasone Dipropionate B.P. | Beclomethasone Dipropionate B.P. | Topical corticosteroid. | February,1973 |
| Beclomethasone dipropionate inhaler | Each canister contains: beclomethasone dipropionate.50mcg,100mcg,250mcg | By RMP. for treatment of asthma. | 21.12.2000 |
| Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate IP 0.5% w/w cream | Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate IP 0.5% w/w cream | Additional lower strenth | 15.09.2010 |
| Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler | Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler | For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate. | 05.01.2011 |
| Beclotiamine hydrochloride & Beclotiamine napadisylate | Beclotiamine hydrochloride & Beclotiamine napadisylate | Treatment of coccidiosis in poultry. | December,1970 |
| Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). | Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). | For deep vein thrombosis. | 08.06.2006 |
| Benazepril hcl + Hydrochlorthiazide tabs | Each tab contains: Benazepril hcl.5mg,10mg,20mg, Hydrochlorthiazide.6.25mg,12.5mg,25mg | For the treatment of mild to moderate hypertension. | 21.05.1998 |
| Benazepril hcl tabs | Each tab contains: Benazepril hcl.5mg,10mg,20mg | Essential hypertension and congestive heart failure. | 22.04.1996 |
| Bendamustine Hydrochloride Injection 100mg/vial (Additional Indication) | Bendamustine Hydrochloride Injection 100mg/vial | For the use in Indolent B.cell NonHodgkin's Lymphoma (NHL) that has Progressed During or Within Six months of Treatment with Rituximab or a Rituximab containing Regimen. | 18.05.2011 |
| Bendamustine Hydrochloride lyophilised injection 25mg (Additional strength) | Bendamustine Hydrochloride lyophilised injection 25mg | Treatment of patients with chronic lymphocytic leukemia. | 19.09.2014 |
| Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial | Each vial contains: Bendamustine Hcl.100mg | For the treatment of patients with chronic lymphocytic leukemia. | 19.05.2009 |
| Benidipine hcl tabs | Each film coated tab contains: Benidipine hcl.4mg,8mg | Hypertension and long term prophylactic management of angina pectoris. | 12.Aug.1996 |
| Benorylate | Tablet Each tablet containing 250mg of Benorylate, Suspension. Each 5mL contain 2gm of Benorylate. | Analgesic & antipyretic. treatment of headache, bodyache, fever, rhinitis, sinutitis. | December,1978 |
| Benziquinone guanyl hydrazone thiosemi carbazone | 10 mg | Powerful oral and pharyngeal disinfectant. | March,1961 |
| Benzoyl peroxide + Precipitated sulphur | Each 20 gm contains: Benzoyl peroxide.10%w/w, Precipitated sulphur.5% w/w | August,1975 | |
| Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solution) | Each textured pad contains: benzoyl peroxide treatment.4.5%, 6.5%, 8.5% | For the topical treatment of acne vulgaris. | 14.05.2008 |
| Benzydamine topical cream | Benzydamine hcl.3% | Topical analgesic. Indicated in the treatment of musculo.skeletal pain only. | May,1988 |
| Bepotastine besilate ophthalmic solution 1.5% w/v | Each ml contains: Bepotastine besilate.15.0mg, Benzalkonium chloride IP.0.01% w/v (as preservative), sterile aqueous vehicle.q.s | For the treatment of itching associated with allergic conjunctivitis. | 08.06.2016 |
| Beractant intratracheal suspension (sterile) | Each ml contains: Phospholipids.25mg, Sodium chloride.9mg | Indicated for the prevention and treatment of respiratory distress syndrome in prematute infants. | 02.10.2000 |
| Beriplast (fibrin adhesive glue) | Beriplast (fibrin adhesive glue) | Tissue adhesion, suture support, haemostasis, wound care, sealing of body cavities and subarachnoid space only. | 19.06.1996 |
| Besifloxacin Ophthalmic Suspension 0.6% w/v | Each ml contains: Besifloxacin.6mg | For the treatment of bacterial conjunctivitis. | 31.05.2011 |
| Betahistine Di hydrochloride CR capsule 24/32/48mg | Betahistine Di hydrochloride CR capsule 24/32/48mg | Indicated in the treatment of Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss. | 17.12.2009 |
| Betahistine dihydrochloride | Betahistine dihydrochloride | Indicated in the treatment as Meniere's syndrome characterised by unilatered or bilatered tinnitus, vertigo usually accompanied by sensory neural hearing loss. | April,1975 |
| Betahistine Dihydrochloride SR Tablets 24mg/32mg/48mg | Betahistine Dihydrochloride SR Tablets 24mg/32mg/48mg | For the symptomatic treatment of peripheral vertigo. | 14.03.2013 |
| Betahistine hcl | Each tablet contains; 16mg | 20.01.2000 | |
| Betahistine mesilate Tablet | Each tablet contains: Betahistine mesilate.6mg, 12mg | For the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo. | 24.02.2009 |
| Betamethasone | 0.5mg | A corticosteroid. | August,1961 |
| Betamethasone + gentamycin sulph. Lotion | Each ml contains: Betamethasone diprop. USP.0.064mg, gentamycin sulph.eq.to gentamycin.1mg | Treatment of infected dermatosis, infection. Eczema & contact dermatitis topical | 25.09.2002 |
| Betamethasone 0.05% + Miconazole 2% Cream | Betamethasone 0.05% + Miconazole 2% Cream | For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin. | 12.03.2008 |
| Betamethasone Benzoate | Betamethasone Benzoate | August,1978 | |
| Betamethasone diprop.+ salicylic acid lotion | Each ml contains: Betamethasone diprop..0.064%, Salicylic acid.3% | New formulation. for treatment of keratosis, ichthysis, lichen planus & dry scaly conditions of skin. | 14.05.2002 |
| Betamethasone Dipropionate | Each gm contains: 0.64 mg of Betamethasone dipropionate eq to 0.5mg of Betamethasone, (0.05%). | Topical corticosteroid. Indicated in the treatment of psoriosis, contact dermatitis, atopic dermatitis neurodermatitis, senile pruritus. | October,1979 |
| Betamethasone Sodium Phosphate + Gentamicin Sulphate | Each mL contains: Betamethasone Sodium Phosphate.1mg, Gentamicin Sulphate eq to 1mg of Gentamicin. | November,1977 | |
| Betamethasone.17.Benzoate | Topical anti.inflammatory steroid. | December,1973 | |
| Betamethyl Digoxin | Each tablet contains: Betamethyl Digoxin.0.1mg & 0.5mg, Liquid: Betamethyl Digoxin.0.6mg, Injection: Betamethyl Digoxin.0.1mg | March,1978 | |
| Beta.Methyl Digoxin | Beta.Methyl Digoxin | Cardiac glycoside | December,1977 |
| Betaxolol ophthalmic gel forming solution | Each ml contains: Betaxolol hcl BP eq.to betaxolol.2.5mg,5mg | New formulation (once daily administration). for reduction of elevated intraocular pressure in patients with ocular hypertension & chronic open angle glaucoma. | 25.10.2002 |
| Betaxolol ophthalmic solution | Wach 5ml vial contains: Betaxolol 0.5% w/v (as betaxolol hcl). | Ocular hypertension and chronic open angle glaucoma. | 01.05.1992 |
| Bezafibrate retard tablet | Each film coated retard tab contains: Bezafibrate.400mg | 02.04.1993 | |
| Bezafibrate tablets | Each tablet contains: Bezafibrate.200mg | Lipid lowering agent. Indicated in all forms of hyperlipoproteinaemia. | .January,1988 |
| B.Hydroxytheophylline | B.Hydroxytheophylline | February,1969 | |
| Bicalutamide Tablet 150 mg. (Additional Strength and Indication) | Bicalutamide Tablet 150 mg. | Indicated either alone or as adjuvant to radical Prostatetomy or radiotherapy in Patients with Locally advanced Prostate cancer at High risk for disease Progression. | 05.01.2011 |
| Bicalutamide tabs/bulk | Each film coated tab contains Bicalutamide.50mg | Advanced prostatic cancer in combination with LHRH analogue on surgical castration. | 07.03.2002 |
| Biclotymol | Each 100ml syrup contains: Biclotymol (adult.0.198g, children.0.150g), Glyceryl galacolate (adult.0.200g, children.0.200g), Pholocodine (adult.0.133g, children..0.100g), Chlorphenamine (adult.0.0133g, children. 0.010g) | Respiratory tract infections, bronchitis, coughs and *tracheobronchitis. | May,1986 |
| Bifonazole cream/solution/powder | 1 gm of cream/powder contains: bifonazole.0.01gm, 1ml of solution contains; bifonazole.0.01gm | Skin mycosis caused by dermatophytes, yeast moulds, other fungi. | 28.11.1997 to 28.11.1999 |
| Bimaprost ophthalmic soln 0.03% | Each ml contains Bimaprost.0.3mg | For reduction of elevated IOP in patients with open angle glaucoma or ocular hypertension. | 08.01.2002 |
| Bimatoprost 300mg + Timolol (as maleate) 5mg/ml (Eye Drops) | Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops | For reduction of IOP. | 05.07.2006 |
| Bimatoprost Eye Drps 0.1mg/ml | Bimatoprost Eye Drps 0.1mg/ml | For the treatment of hypotrichosis of the eye.lashes by increasing their growth including length, thickness & darkness. | 05.08.2010 |
| Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength) | Bimatoprost Ophthalmic Solution 0.01% w/v | Same as approved. | 09.10.2010 |
| Bimatoprost Opthalmic solution 0.03% | Bimatoprost Opthalmic solution 0.03% | For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. | 30.03.2009 |
| Bioceramic composite materials | Each glass vial contains: Hydroxyapatite 100% granules, Each glass vial contains; hydroyapatite 90%+beta tri calcium phosphate 10% as granules, Each vial contains: Hydroxyapatite paste as 30% & 18% suspension | For acute cases of bone deformities only as bone grafting material | 22.11.2002 |
| Biomesh' GTR barrier (biodegradable) | Biomesh' GTR barrier (biodegradable) | An aid to promote regeneration and integration of peridontal tissue components after surgical procedure. | 01.12.1999 |
| Biomycin (of tetracycline) | Biomycin (of tetracycline) | Russian pharmacopoeia drugs | April,1965 |
| Biperiden Hydrochloride | Biperiden Hydrochloride | Parkinsonism | July,1972 |
| Biperiden lactate | Each ml contains: Biperiden lactate.5 mg | Parkinsonism | October,1972 |
| Biphenyl acetic gel | Each 15gm tube contains: Biphenyl acetic.3.00% w/w | For the relief of symptems of soft tissue injuries, extra articular rheumatic or inflammatory conditions, acute inflammatory manifestations of osteoarthritis of knee joint pain, and swelling following injury. | 27.04.1998 |
| Bisacodyl | Bisacodyl | Laxative. | June,1962 |
| Bismuth aluminate | Bismuth aluminate | New bismuth salt (antacid). | April,1962 |
| Bisoprolol | 2.5mg tablets | NOC issued for the additional indication of congestive heart failure (CHF). | 19.01.2001 |
| Bisoprolol fumerate 2:1 + hydrochlorthiazide | Bisoprolol fumerate (2:1).2.5mg,5mg, hydrochlorthiazide.6.25mg | Mild to moderate hypertension. | 13.05.1999 |
| Bisoprolol fumerate tab. | Each film coated tablet contains: Bisoprolol fumerate (2:1). 5mg,10mg | Anti hypertensive. Hypertension, coronary heart disease (angina pectoris). | 27.02.1992 |
| Bitoscanate | Bitoscanate | Anthelmintic | April,1970 |
| Bivaluridin Injection (250mg/vial) | Each vial contains: Bivaluridine.250mg | For use as an Anti.coagulant in patients with unstable angina undergoing percutaneous transluminal coronary angiography (PTCA). | 25.08.2005 |
| Bleomycin oil suspension for injection | Bleomycin oil suspension for injection | Anti cancer. Indicated in the treatment of neck & head cancer malignant. | September,1985 |
| Bleomycin.S ointment | Each 1 gm ointment contains: 5mg of bleomycin sulphate | For malignant skin tumour | 11.10.1999 |
| Blonanserin Tablet 2mg/4mg/8mg | Blonanserin Tablet 2mg/4mg/8mg | For the treatment of Schizophrenia in adult patients when first line treatment is ineffective. | 24.04.2012 |
| Boplant | Boplant | June,1965 | |
| Bortezomib 2mg/vial (Additional pack size) | Bortezomib 2mg/vial | As approved | 28.03.2007 |
| Bortezomib for injection (3.5mg/vial) | Bortezomib for injection (3.5mg/vial) | For the treatment of myeloma patients. | 18.05.2005 |
| Bortezomib for injection 3.5mg (Subcutaneous route of administration as an alternate to intravenous route) (Additional route of administration) | Bortezomib for injection 3.5mg (Subcutaneous route of administration as an alternate to intravenous route) | Same as already approved | 28.01.2014 |
| Bortezomib inj.3.5mg/vial (Additional Indication) | Bortezomib inj.3.5mg/vial | Treatment of patients with multiple myeloma. | 09.10.2008 |
| Bortezomib Injection (Additional indication) | Bortezomib Injection | For the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. | 05.09.2007 |
| Bosentan (as monohydrate) Tablets 62.5mg/125mg | Each film coated tablet contains: Bosentan monohydrate eq.to bosentan.62.5mg, 125mg | For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve excercise ability and decrease the rate of clinical worsening. | 23.06.2009 |
| Boswellia Serrata 0.05gm/gm of Cream | Boswellia Serrata 0.05gm/gm of Cream | For the treatment of mild to moderate psoriasis. | 28.03.2008 |
| Botulinum toxin type A 50 Units/Vial and 100 Units/Vial (Additional Indication) | Botulinum toxin type A 50 Units/Vial and 100 Units/Vial | For the prophylaxis of headaches in adults with chronic migraine. | 02.06.2011 |
| Botulinum toxin type.A i.m injection | Each vial contains: clostridium botulinum toxin type A.hemagglutinin complex 100 units, human serum albumin.0.5mg, NaCl.0.9mg | For the treatment of blepharospasm hemifacial spasm associated focal dystonias. | 13.01.1994 |
| Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml | Ophthalmic | 25.11.2005 | |
| Brimonidine tartrate ophthamic solution | Brimonidine tartrate.0.2% eq.to brimonidine base.0.13% | For lowering intraocular presuure in patients with open angle glaucoma or ocular hypertension. | 18.05.1999 |
| Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.005%) (Additional strength) | Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.005%) | For lowering of IOP in patients with open angle glaucoma occular hypertension. | 07.03.2008 |
| Brimonidine topical gel 0.33% (Add. Dosage form/indication) | Brimonidine topical gel 0.33% | For the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older. | 18.06.2015 |
| Brinzolamide Ophthalmic Suspension 1%w/v | Each ml contains: brinzolamide.10mg | For the treatment of elevated intraocular pressure in patients with ocular hypertension or open.angle glaucoma. | 26.05.2011 |
| Bromelin + Pancratin + Ox bile | Enzyme | Indicated for Pancreatic insufficiency. | May ,1977 |
| Bromfenac Sodium Eye Drop (0.09%) | Each ml contains Bromfenac sodium 1.035mg eq.to 0.9mg bromfenac free acid. | For the treatment of postoperative inflammation & reduction of postoperative ocular pain in patients who have undergone cataract extraction. | 19.08.2008 |
| Bromhexine Hcl | Each tablet contains: Bromhexine Hcl 8mg, Elixir.Each 5mL contain Bromhexine Hcl 4mg | Mucolytic agent. indicated in the treatment of brochitis and other conditions where sputum is troublesome. | September,1979 |
| Bromocriptine Mesylate Tablet IP 0.8mg, (Additional Indication) | Bromocriptine Mesylate Tablet IP 0.8mg, | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | 22.10.2009 |
| Bromocriptine tablets | Each tablet contains: Bromocriptine (as mesylate).2.5mg,5mg,10mg | Gynaecological disorders. Indicated in the treatment of prolactin dependent menstrual cycle disorders, female infertility, pre.menstrual syndrome, hyper prelactinaemia in men. | July,1987 |
| Bromonaphthol | 250 mg tabs | Anthelmintic.in hookwarm infection only. | February,1963 |
| Broncho vaxom capsules | Each capsule contains: lyophillized bacterial lysate.7mg made up of D.pneumoniae, H.influenzae, Klb.pneumoniae, S.aureus, streptococcus pyogens, neisseria catarrhalis | RMP. As adjuvant therapy in acute and chronic bronchitis for adults only. | 12.02.2001 |
| Broxyquinoline & Brobenzoxa lidine | 250 mg, 200 mg tabs | Intestinal antiseptic, antiamoebic. | May,1963 |
| Buclizine Hcl 25mg Tablet (Additional Indication) | Buclizine Hcl 25mg Tablet | For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness. | 16.01.2010 |
| Buclizine HCl tablet (25mg) & Syrup 6mg/5ml | Buclizine HCl tablet (25mg) & Syrup 6mg/5ml | As appetite stimulant. | 28.06.2006 |
| Budesonide | Each CR capsule contains: Budesonide (CR). 3mg | For the treatment of ulcerative colitis. | 17.06.2008 |
| Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication) | Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder | Indicated in the regular treatment of patients with moderate to severe COPD with frequent symptoms and a history of exacerbations. | 17.10.2008 |
| Budesonide controlled release capsule | Eacg CR capsule contains: Budesonide.3mg | For the treatment of ulcerative colitis. | 30.08.2005 |
| Budesonide enema | Each tablet for enema contains: Budesonide.2.3mg | For the treatment of ulcerative colitis involving rectal & rectosigmoid diseases. | 05.08.2005 |
| Budesonide inhaler | Each metered inhaler supplies: Budesonide.200mcg. | Anti asthmatic. Indicated in the treatment of bronchial asthma. | February,1988 |
| Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Indication) | Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension | In the regular treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with frequent symptoms and a history of exacerbations. | 04.01.2012 |
| Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength) | Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. | For the treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is appropriate. | 21.11.2011 |
| Bulaquine compound 80/53 (local bulk mfg),(D.A.R 25.5.87) | For vivax malaria only. | 21.12.1999 | |
| Bumetanide + Potassium chloride tablets | Each tablet contains: Bumetanide.0.5mg, Potassium chloride. 523mg | February,1983 | |
| Bumetinide | Each tablet contains: Bumetidine.1mg, Each mL contains: Bumetidine.0.25mg | Diuretic indicated in the treatment of oedema associated with congestive heart failure, coronary oedema, hepatic ascites and renal disease including nephrotic syndrom | August,1980 |
| Buparvaquone | Buparvaquone solution for injection contains: 5% w/v buparvaquone. | Indicated in the treatment of bovine theileriosis. | April,1991 |
| Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet | Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet | For opioid dependence. | 06.04.2005 |
| Buprenorphine (old drug) new strength 0.4mg/2mg as sublingual | Each uncoated tablet contains: Buprenorphine hcl eq.to 0.4mg, 2mg. | For opioid de.addiction. | 10.03.1999 |
| Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets | Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets | Additional Lower Strength. | 02.12.2008 |
| Buprenorphine hcl + Naloxone sublingual tablets | Each sublingual tab contains:B uprenorphine hcl eq.to bprenorphine.2mg, Naloxone hcl eq.to naloxone.0.5mg | August,2004 | |
| Buprenorphine hydrochloride | Each ml contains: Buprenorphine hydrochloride eq.to 0.3mg of buprenorphine | Narcotic analgesic | April,1986 |
| Buprenorphine sublingual tablets | Each tablet contains: Buprenorphine hcl.eq.to 0.2mg of buprenorphine. | December,1987 | |
| Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm², 12.5cm², and 25cm²contains: Buprenorphine…5mg/10mg/20 mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively (over a period of 7 days). | Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm², 12.5cm², and 25cm²contains: Buprenorphine…5mg/10mg/20 mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively (over a period of 7 days). | For the treatment of severe opioid responsive painconditions which are not adequately responding to non.opioid analgesics.For Hospital supply only. | 03.09.2009 |
| Bupropion hcl | Each SR tablet contains: Bupropion hcl.150mg | Indicated as an aid to smoking cissation treatment. | 10.04.2001 |
| Buserelin acetate injection | Each ml contains: Buserelin acetate 4.2mcg eq.to 4mcg of buserelin. | Lueitinising hormone. Indicated in the treatment of infertility of ovarian origin for the induction of ovulation and improvement of conception rate in cows, mares & rabbits | April,1986 |
| Buserelin Acetate injection 1mg/ml (Additional Indication) | indicated for the palliative (initial & maintenance treatment) of patients with hormone.dependent advanced carcinoma of the Prostate gland (Stage D). | 08.09.2010 | |
| Buspirone hcl | Each tablet contains: 5mg,10mg of base | Anxiolytic. Indicated in the treatment of anxiety and tension states. | October,1990 |
| Butafosfane + Cyanocobalamin injection | Each 100ml solution contains: Butafosfane.10gm, Cyanocobalamine.0.005gm | 04.03.1998 | |
| Butarphenol tartrate 10mg/ml nasal spray | Butarphenol tartrate 10mg/ml nasal spray | For management of pain in patients using opioid analgesics. | 26.11.2007 |
| Butenafine + betamethasone dipropionate cream | Each gm of cream contains: Butenafine hcl.10mg, Betamethasone dipropionate eq.to betamethasone.0.5mg | Superficial fungal infections, dermatophytes infections. | 15.03.2002 |
| Butorphanol tartrate inj. & bulk import | Each ml contains: Butorphanol tartrate USP.1mg, 2mg | Management of pain where use of opiod analgesics is appropriate | 11.09.2002 |
| Butorphanol tartrate nasal spray | Each ml of solution contains: Butorphanol tartrate B.P.10mg, Each actuation delivers: butorphanol tartrate USP.1mg | For the management of pain when the use opioid analgesic is appropriate. | 26.11.2007 |
| Cabazitaxel Injection 60mg / 1.5ml | Each 1.5ml contains: Cabazitaxel.60mg, Diluent.5.7ml of 13% (w/w) ethanol in water for injection. | In combination with prednisone for treatment of patients with hormone.refractory metastatic prostrate cancer previously treated with a docetaxel.containing treatment regimen. | 16.11.2011 |
| Cabergoline 1mg tablet (Additional strength) | Cabergoline 1mg tablet | For Hyperprolactinemia. | 06.03.2007 |
| Cabergoline 1mg Tablets (Additional indication) | Cabergoline 1mg Tablets | For the treatment of hyperprolactinemia and inhibition of lactation. | 01.10.2008 |
| Cabergoline tab | Each tab (uncoated) contains: cabergoline.0.5mg | For hyperprolactinemia, inhibition of lactation & suppression of lactation. | 05.09.2002 |
| Caffeine + Ergotamine tartarate + Analgin + Trifluperazine Hcl | Each capsule contains: Caffeine.100mg, Ergotamin e tartarate.1mg , Analgin.250mg, Trifluperazine Hcl.1mg | Poison E,H & Z drug | March,1976 |
| Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form) | Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution | Same as approved. | 18.07.2009 |
| Caffeine citrate oral solution | Each ml contains: caffeine citrate USP.20mg (eq.to 10mg caffeine base) | For the short treatment of apnoea of prematurity in infants between 28 and <33 weeks gestational age. | 21.07.2009 |
| Calamine 8% + Liquid Paraffin10% lotion | Calamine 8% + Liquid Paraffin10% lotion | As antipruritic and smoothening agent. | 26.02.2009 |
| Calcipotriol Gel 0.005% (additional dosage form) | Calcipotriol Gel 0.005% | For the treatment of moderate plaque psoriasis in adults. | 03.10.2009 |
| Calcipotriol scalp solution and cream | i) Each ml of scalp solution contains: calcipotriol.50mcg (30ml total pack), ii) Each gm of cream contains:calcipotriol.5mcg | For the treatment of psoriasis vulgaris. | 12.05.2005 |
| Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules | Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules | For the treatment of hypocalcaemia and/or osteoporosis. | 04.11.2008 |
| Calcitriol injection (finished formulation) | Each ml contains: calcitriol.1mcg,2mcg | 19.03.1994 | |
| Calcitriol oint. | Each gm contains calcitriol.0.003mg (3mcg) | For treatment of mild to moderately severe plaque psoriasis (psoriasis vulgaris) | 14.05.2003 |
| Calcitriol soft gelatin caps (Finished Formulation) | Each soft gelatin capsule contains: calcitriol.0.5mcg,0.25mcg | For the treatment of metabolic bone disease. | 27.08.1993 |
| Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets | Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets | For the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing Children) | 30.09.2008 |
| Calcium acetate 435mg + Magnesium carbonate 235mg tablets | Calcium acetate 435mg + Magnesium carbonate 235mg tablets | For the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis). | 05.03.2010 |
| Calcium and Magnesium 24% (Veterinary) injectable solution | Each ml of injectable solution contains: Calcium gluconate.190mg, calcium glucoheptone.45mg, butaphosphan.4.0mg, magnesium chloride hexahydrate.60mg | For the treatment of milk fever, hypocalcaemia tetanies and disorders of calcium metabolism in dairy cattle. | 16.09.2008 |
| Calcium carbonate 600mg + Simethicone 80mg Chewable tablet | Calcium carbonate 600mg + Simethicone 80mg Chewable tablet | To relive the uncomfortable symptoms of acid indigestion, heart burn, gas or sour stomach. | 28.05.2010 |
| Calcium citrate malate (bulk) | Calcium citrate malate (bulk) | 24.02.2009 | |
| Calcium citrate maleate Eq. to elemental calcium 250mg + Vitamin D3 IP 200 IU tablet | Calcium citrate maleate Eq. to elemental calcium 250mg + Vitamin D3 IP 200 IU tablet | For the treatment of calcium and Vitamin D deficiency states | 13.10.2010 |
| Calcium dobesilate caps | Each cap contains; calcium dobesilate.500mg | Chronic venous insufficiency of lower limbs only. | 22.09.1997 to 22.09.1999 |
| Calcium gluconate + isothipendyl + acetylsalicylic acid + Caffeine | Each dragee contains: Calcium gluconate.50mg, Isothipendyl hcl.4mg, Acetylsalicylic acid.200mg, Caffeine.30mg | June,1972 | |
| Calcium Hypochlorite 4gm Sachet (Calcium Hypochlorite 0.542% Other Ingredients: 99.458%) | Each 4g sachet contains: Calcium hypochlorite.0.542%, other ingredients.99.458% | For purification of contaminated ground water sources. | 20.11.2008 |
| Calcium Pidolate equivalent to Calcium 500mg + Vit.D3250 IU | Calcium Pidolate equivalent to Calcium 500mg + Vit.D3250 IU | For osteoporosis and calcium deficiency state. | 23.10.2007 |
| Calcium Polycarbophil (500mg) Tablet | For additional indication: for 500mg oral tablets | i) for relieving diarrhoea, ii) for improving irritable bowel syndrome | 13.07.2005 |
| Calcium polycarbophil rablets | Each film coated tablet contains: Calcium polycarbophil eq.to polycarbophil.500mg | December,2004 | |
| Calcium polystyrene sulphonate | Each container contains: Calcium polystyrene sulphonate.300gm | By RMP. for treatment hyperkalemia associated with oligurea, anurea or dialysis. | 05.02.2001 |
| Calcium succinate & Iron edetate sodium | October,1969 | ||
| Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml | Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml | (a). As a prophylaxis therapy for premature infants <29 weeks of gestational age at significant risk for Respiratory Distress Syndrome (RDS). (b). For the treatment of infants <72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotrachteal intubation. | 17.02.2011 |
| Calfactant intratracheal suspension | Each ml of suspension contains: total phospholipids.35mg (containing 26mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine), protein.0.65mg (including 0.26mg of surfactant associated proteins B) | i) As a prophylaxis therapy for premature infants < 29 weeks of gestational age at significant risk for respiratory distress syndrome (RDS). Ii) For the treatment of infants ≤ 72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotrachteal intubation. | 16.12.2010 |
| Camostat Mesylate tablets 100mg | Camostat Mesylate tablets 100mg | For remission of acute symptoms of chronic pancreatitis and post.operative reflux esophagitis. | 29.01.2008 |
| Canagliflozin, 100 & 300 mg Tablet | Each film coated tablet contains: Canagliflozin.100mg, 300mg | “Indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type.2 Diabetic Mellitus”. | 17.11.2014 |
| Candesartan cilexetil | Each tablet contains: Candesartan cilexetil.4mg,8mg,16mg | By RMP. for mild to moderate essential hypertension only. | 31.08.2000 |
| Candesartan cilexetil & hydrochlorothiazide tab | Each tab contains: Candesartan cilexetil.16mg, hydrochlorthiazide.12.5mg | Essential hypertension (not for initial therapy) | 03.01.2002 |
| Candur P. Parvovirus vaccine | Inactivated cannine parvovirus | Indicated in active immunization of dogs against parvovirus infection. | 09.07.1992 |
| Candur.R (purified chick emryo cell rabies vaccine) | Candur.R (purified chick emryo cell rabies vaccine) | 13.08.1993 | |
| Canine distemper killed canine hepatitis leptorpira parvo virus vaccine | Canine distemper killed canine hepatitis leptorpira parvo virus vaccine | Vaccine against canine distemper parvo viru, infectious canine hepatitis and leptospirosis. | November,1986 |
| Cape aloes + podophyllum resin + licorice powder | Each tablet contains: Cape aloes IP 16mg, podophyllum resin IP 4.2mg, licorice powder IP 5.462mg | October,1972 | |
| Capecitabin Tablet (150mg/500mg) (forAdditional indication) | Capecitabin Tablet (150mg/500mg) | (i). First line treatment of advanced gastric cancer in combination with platinum based regimen. (ii). Treatment of patients with locally advanced or metastatic breast cancer in combination with docetaxel following failure of cytotoxic chemotherapy. | 16.07.2007 |
| Capecitabine 150/500mg Tablets (Addl. Indication) | Capecitabine 150/500mg Tablets | For the treatment of patients with metastatic colorectal cancer. | 02.09.2008 |
| Capecitabine tablets (Already approved) | Capecitabine tablets | For additional indication; first line treatment in patients with metastatic colorectal carcinoma | 14.03.2001 |
| Capecitabine tablets (finished formulation import) | Each film coated tablet contains: Capecitabine.150mg,500mg | By cancer specialists. for treatment of metastatic breast cancer after failure of paclitaxel and anthracycline containing chemotherapy regimen. | 12.10.2000 |
| Captopril + Hydrochlorthiazide tablets | Each tablet contains: Captopril.25mg,50mg, Hydrochlorthiazide.15mg,25mg | July,1989 | |
| Captopril tablets | Each tablet contains: Captopril.25mg,50mg | Anti hypertensive agent. Indicated in the treatment of hypertension only. | October,1985 |
| Carbadox | Carbadox | Antibiotic. indicated in the treatment of swine dysentry and bacterial enteritis. | July,1975 |
| Carbamazepine C R tablets | Each C.R film coated tablet contains: Carbamezepine.200mg,400mg | 17.05.1993 | |
| Carbazochrome salicylate | Each ml contains: Carbazochrome salicylate eq.to 5mg of adrenochrone monosemicarbazone | July,1969 | |
| Pentazocine Lactate | Each ml contains: Pentazocine Lactate.30mg | October,1977 | |
| Pentosan polysulfate Sodium Capsules 100mg | Each capsule contains: Pentosan polysulfate sodium.100mg | For the relief of bladder pain or discomfort associated with interstitial cystitis. | 11.05.2010 |
| Pentoxifylline 400 dragees | Each dragee contains: pentoxifylline.400mg | March,1986 | |
| Pentoxyphylline SR | Each pentoxyphylline SR tablet contains: pentoxyphylline.400mg | Indicated for the same purpose as for plane conventional dosage. | March,1990 |
| Peopleomycin injection | Peopleomycin injection | Anti cancer. Indicated in the treatment of prostatic carcinoma, breast cancer, malignant lymphoma, melanoma and carcinomas of the head, neck and lungs. | February,1987 |
| Perflutren liquid microsphere injectable suspension | Perflutren liquid microsphere injectable suspension | For diagnostic use. | 31.05.2006 |
| Pergolide tablets | Each tablet contains: pergolide mesylate eq.to pergolide base.50mcg,250mcg,1000mcg | By neurologists. adjunctive treatment to levodopa in management of the signs & symptoms of parkinson's diasease. | 11.10.2000 |
| Perindopril | Each tablet contains: perindopril.2mg,4mg | Anti hypertensive. Indicated in the treatment of hypertension. | 16.09.1991 |
| Perindopril + Indapamide tabs | Each tab contains: Perindopril.2mg,4mg, indapamide.0.625mg,1.25mg. | Mild to moderate essential hypertension. | 24.03.1998 |
| Perindopril arginine 2.5mg/5mg/10mg film coated tablet | Perindopril arginine 2.5mg/5mg/10mg film coated tablet | For the treatment of arterial hypertension, congestive heart failure and coronary artery disease. | 16.05.2009 |
| Perindopril arginine tablet | Each film coated tablet contains: perindopril arginine.2.5mg, 5mg, 10mg | For the treatment of arterial hypertension, congestive heart failure and coronary artery disease. | 19.05.2009 |
| Permethrin cream 5% | Each (30gm tube contains) gm contains: permethrin.(50mg) 5% | Infestation with sarcopyto scabies. | 06.03.1995 |
| Petoxyfyline | Petoxyfyline | August,1977 | |
| Phenelzine dihydrogen sulphate | Phenelzine dihydrogen sulphate | Anti.depressant. | November,1961 |
| Pheniramine maleate | Each retard tablet contains: Pheniramine maleate. | November,1971 | |
| Phenosulf inj. | Each ml contains: 25mg of phenylmethylamine.p.amino benzene sulphonate. | July,1969 | |
| Phenprobamate | 400 mg | Muscle relaxant & tranquiliser. | March,1964 |
| Phenyl propanolamine + isopropamide + diphenyl pyralline hcl | Each phenylpropanolamine hcl.50mg, isopropamide.2.5mg, diphenyl pyralline hcl.5mg | September,1971 | |
| Phenylbutazone + Propyphenazone | Each tablet contains: Phenylbutazone.125mg, Propyphenazone.125mg | February,198 | |
| Phenylbutazone calcium | 200mg & 50 mg tabs | Anti.inflammatory, anti.rheumatic. | May,1963 |
| Phenylbutazone sodium | Phenylbutazone sodium | August,1963 | |
| Phenyl.dimethyl isopropyl Pyrazolone + Diethyl.dioxotetrahydro pyridine + Paracetamol + Caffeine | Phenyl.dimethyl isopropyl Pyrazolone.150mg, Diethyl.dioxotetrahydro pyridine.50mg, Paracetamol.250mg Caffeine(Anhydrous).46.75mg | November,1980 | |
| Phenylephrine 2.5% (Eye drops) | Phenylephrine 2.5% | Ophthalmic | 02.12.2005 |
| Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 60mg + Menthol 1mg (per 5ml) Syrup | Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 60mg + Menthol 1mg (per 5ml) Syrup | For the treatment of common cold and cough associated with fever. | 31.01.2008 |
| Phenylmethylamine.p.amino benzene sulphonate | Phenylmethylamine.p.amino benzene sulphonate | July,1969 | |
| Phenylmethylamine.p.amino benzene sulphonate.15mg, phenylmethylamine Hcl.10 mg | Each tablet contains: Phenylmethyl amine.p.amino benzene sulphate.15mg, Phenylmethyl amine hcl. 10mg. Ointment.phenylmethyl amine.p.amino benzene sulphate.1.5% w/w, Phenylmethyl amine hcl.1.5% w/w | Anti.leprosy drug | July,1969 |
| Phenyramidol HCl tablet 400mg | Each film coated tablet contains: phenyramidol Hcl.400mg | For the treatment of lumbago, integumental pain, musculoskeletal pain. | 18.11.2008 |
| Phenyramidol hydrochloride | 200 mg tabs | Analgesic.muscle relaxant. | August,1962 |
| Phenytoin Sodium (300mg) tablet | Each film coated tablet contains: Phenytoin sodium.300mg | By neurologists. | 05.08.2005 |
| Phenytoin Sodium E.R (300mg) | Phenytoin Sodium E.R (300mg) | For control of generalised tonic clonic (grand.mal) and prevention and treatment of seizures occuring during or following neurosurgery. | 14.06.2007 |
| Phenytoin sodium ER capsules (300mg) (New dosage form) | Each ER capsule contains: phenytoin sodium.300mg | For the control of generalized tonic.clonic (grand mal) and complex partial seizures and prevention & treatment of seizures occurring during or following neurosurgery. | 13.06.2007 |
| Pholcodiene Syrup (4mg/5ml) | Each 5ml contains: Pholcodine.4mg | For symptomatic relief of dry, ticklish and unproductive coughs in children above 1 years. | 10.07.2007 |
| Pidotimod tablet & oral solution | i) Each film coated tablet contains: pidotimod.400mg, 800mg, ii) Each 7ml oral solution contains; pidotimod.400mg, 800mg | For infections of the respiratory system in secondry and primary immunodeficiency with alteration in maturation of T cells in adults only. | 15.12.2010 |
| Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml | Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml | For infections of the respiratory system in secondary and primary immunodeficiency with alteration in maturation of T cells in adults only. | 11.02.2011 |
| Pilocarpine gel | Each gm contains: pilocarpine hcl.40mg | For the management of intraocular pressure in glaucoma | 24.06.1999 |
| Pilocarpine hcl tab | Each film coated tab contains: Pilocarpine hcl BP.5mg | For treatment of radiation induced xerostomia in patients undergoing radiotherapy of head & neck cancer and in patients with sjogren's syndrome. | 13.03.2003 |
| Pimaricin | Oint.20mg/gm, Vag tab.50mg | Anti fungal antibiotic for "Streptomyces natalensis". | December,1961 |
| Pimecrolimus 1% cream | Each gm contains: pimecrolimus.10mg | By dermatologists only. for the treatment of mild to moderate atopic dermatitis in patients above 3 months of age and above. | 22.07.2004 |
| Pimozide Active Substance | Pimozide Active Substance | December,1974 | |
| Pinaverium bromide | Each film coated tablet contains: pinaverium bromide.50 mg | In the treatment of spastic colon, irritable bowel syndrome, billiary dyskinesia and for radiological investigation. | April,1990 |
| Pindolol | Each tablet contains: Pindolol.5mg | β.Blocker | November,1973 |
| Pioglitazone + metformin (OD) | Each uncoated tab contains: Pioglitazone.15mg, metformin (OD).500mg | By RMP. for second line therapy in type.II diabetes. | 18.10.2002 |
| Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (Additional Strength) | Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet | As approved | 23.01.2007 |
| Pioglitazone hcl | Each uncoated tablet contains: pioglitazone hcl eq.to 15mg, 30mg, 45mg of pioglitazone. | As an adjunct to diet and exercise to improve glycemic control in patients with type.II diabetes (NIDDM) | 17.10.2000 |
| Pioglitazone hcl + glimepiride tab | Each tab contains: Pioglitazone hcl eq.to pioglitazone.15mg, glimepiride.1mg,2mg | Treatment of type.II diabetes as 2nd line therapy when diet exercise & initial therapy with glitazone or sulphonylurea do not result in adequate glycemic control. | 25.10.2002 |
| Pipazethate | Dragee.20mg, drops.40mg/ml | Antitussive. | September,1961 |
| Pipecuronium bromide inj. | Each vial contains: freeze dried pipecuronium bromide.4mg. | Non depolarising muscle relaxing agent. In the treatment of as an adjunct to general anesthesia to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgical procedure of medium and large duration. | 03.11.1992 |
| Pipenzolate methylbromide | 5 mg | Anticholinergic | March,1961 |
| Piperacillin + Tazobactum i.v inj. | Each vial contains: Piperacillin sod.eq.to piperacillin.4gm,2gm+Tazobactum sod.eq.to tazobactum.500mg,250mg | In the treatment of LRTI/UTI/Intra abdominal infections, skin and skin structure infections, bacterial septicemic polymicrobic infections. | 13.08.1999 |
| Piperacillin sodium injection | Each vial contains: piperacillin (as sodium salt).1gm,2gm, (19.2.90).3gm,4gm | Antibiotic. Indicated in the treatment of systemic and local infections, peri.operative infections, prophylaxis & obstructive and gynae infections, UTI, neonatal and life threatening paediatric infections. | August,1989 |
| Piperidolate hydrochloride | 50 mg | Anticholinergic | March,1961 |
| Pirarubicin hcl inj. | Pirarubicin hcl inj. | Anti cancer. | May,1991 |
| Pirfenidone film coated tablet ...200mg | Each film coated tablet contains: Pirfenidone.200mg | For the treatment of idiopathic pulmonary fibrosis. | 14.09.2010 |
| Piribedil SR Tablets | Each SR coated tablet contains: Piribedil.50mg | Of imapired attentiveness and/or memory or feelings of giddiness in elderly, painfull symptoms of arterial disease, idiopathic parkinson disease. | 27.09.1993 |
| Piroxicam 20mg tab & Paracetamol 500mg tab combikit | Piroxicam 20mg tab & Paracetamol 500mg tab combikit | For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes. | 19.01.2010 |
| Piroxicam betacyclodextrin tabs | Each tablet contains: Piroxicam betacyclodextrin eq.to 20mg piroxicam. | Pain and inflammation associated with rheumatoid arthritis, osteoarthritis, acute musculo.skelital pain, tendinitis, bursitis, post traumatic disorders, post operative pain, primary dysmenorrhoea. | 25.03.1996 |
| Piroxicam capsules | Each capsule contains: Piroxicam.10mg | Anti inflammatory agent. Indicated in the treatment of rheumatoid arthritis, ankylosing spondylitis and other musculoskeletal disorders. | August,1986 |
| Piroxicam gel | Piroxicam gel.0.5% | In the treament of musculo.skeletal inflammatory disorders. | March,1990 |
| Piroxicam injection i.m | Each ml contains: Piroxicam USP.20mg | Indicated in the treatment of musculoskeletal disorders, acute gout, pain after operative intervention following acute trauma and in primary dysmenorrhoea (12 years age or older) | August,1991 |
| Piroxicam sublingual tablet 20mg (Additional Dosage Form) | Piroxicam sublingual tablet 20mg | In the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, cervical spondylitis and other musculoskeletal disorder. | 27.12.2011 |
| Piroxicam transdermal patch | Each patch contains: Piroxicam 48mg | Osteoarthritis pain due to musculoskeletal disorder. | 16.03.2000 |
| Pitavastatin (1mg/2mg) Tablet | Each film coated tablet contains: Pitavastatin calcium eq.to pitavastatin.1mg, 2mg | By RMP. for the treatment of familial hypercholesterolaemia. | 14.01.2005 |
| Pitavastatin Tablet 4mg | Pitavastatin Tablet 4mg | An adjunctive therapy to diet to reduce elevated total cholesterol (TC), low.density lipoprotein cholesterol (LDL.C), apolipoprotein B (Apo B), triglyceride TG), and to increase high.density lipoprotein cholesterol (HDL.C) in patients with primary hyperlipidemia or mixed dyslipidemia. | 23.10.2012 |
| Pivazide | 50mg, 1.2 tab t.i.d | Cardiac drug.reduces intensity & frequency of anginal attacks. | September,1961 |
| Plerixafor Injection 20mg/ml | Plerixafor Injection 20mg/ml | In combination with Granulocyte Colony Stimulating Factor (G.CSF) to enhance mobilisation of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous hematopoeitic stem cells transplantation in patients with non.Hodgkin’s lymphoma and multiple myeloma whose cells mobilise poorly. | 31.01.2012 |
| Podophyllotoxin topical solution | Each 3.5ml contains: Podophyllotoxin.0.5% | Anogenital warts, non genital warts only | 05.05.1995 |
| Policresulen + Cinchocaine ointment | Each gm of ointment contains: Policresulen.50mg, cinchocaine.10mg | 07.07.1995 | |
| Polio virus vaccine live (oral) | 0.1 ml | Prophylactic, immunological | November,1962 |
| Pollidacanol injection | Pollidacanol injection | Anti sclerosis. Indicated in the treatment of sclerosation of various cutaneous veins and oeseophageal varicose haemorhoids and haemangiomas. | March,1987 |
| Polonosetron (As Hcl.) For Injection 0.25mg/5ml | Polonosetron (As Hcl.) For Injection 0.25mg/5ml | Chemotherapy induced nausea & vomiting. | 20.03.2007 |
| Polyestradiol phosphate injection | Polyestradiol phosphate injection | Anti cancer drug. Indicated in the treatment of prostatic carcinoma. | July,1986 |
| Each vial contains: Polythylene Glycol 400 ................... % w/v Propylene Glycol ............................ % w/v Eye drops | Each vial contains: Polythylene Glycol 400 ................... % w/v Propylene Glycol ............................ % w/v Eye drops | For temporary relief of burning and irritation due to dryness of the eye. | 14.11.2011 |
| Polyethylene Glycol 400 (0.4%) + Propylene Glycol (0.3%) | Each vial contains: Polyethylene glycol 400 NF.0.4% w/v, propylene glycol USP.0.3% w/v. | For temprory relief of dryness, irritation burning, stinging, grittiness or foreign body sensation caused due to environmental factors. | 24.09.2007 |
| Polyglycolic acid sutures | Polyglycolic acid sutures | Sutures | 1973. May |
| Polysachharide pneumococcal vaccine (pneumo 23) | Polysachharide pneumococcal vaccine (pneumo 23) | Marketed for the prevention of pneumococcal pneumonia and pneumococcal systemic infections caused by the serotypes included in the vaccine. | 09.07.1996 |
| Polythiazide | 2.4 mg daily | Non.mercurial oral diuretic & hypotensive. | February,1962 |
| Polyvidone eye drops 5% | Each ml contains: Polyvidone.50mg | Symptomatic treatment of dry eye conditions including kerato.conjunctivitissicca. | 30.04.1997 |
| Polyvinyl alcohol + Povidone + Chlorbutanol (Eye Drops) | Each ml contains: Polyvinyl alcohol.14mg, povidone.6mg, chlorbutanol.5mg | For relief from burning, irritation and discomfort due to dryness of the eye. | 11.01.1996 |
| Polyvinyl alcohol ophthalmic solution | Each ml contains: Polyvinyl alcohol.14mg,30mg, Benzalkonium chloride.8.05mg | 16.05.1996 | |
| Polyvinyl pyrrolidone iodine | Polyvinyl pyrrolidone iodine | Antiseptic/Germicidal. | September,1970 |
| Ponderax sustained release tablets | Each sustained release tablet contains: fenfluramine hydrochloride.60mg | September,1984 | |
| Poractant alpha | Each 1.5ml & 3ml vial contains: Phospholipid fraction from porcine lung.120mg,240mg | For respiratory distress syndrome in preterm babies. | 24.12.2002 |
| Posaconazole oral suspension 40 mg/ml (Additional Indication) | Posaconazole oral suspension 40 mg/ml | Zygomycosis in patients with disease refractory to other therapy, or patients who are intolerant of other therapy. | 20.12.2011 |
| Posaconazole Oral Suspension 40mg/ml | Posaconazole Oral Suspension 40mg/ml | For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severly immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft.versus.host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. | 18.07.2009 |
| Povidone Iodine | i) Betadine solution containing.10% Povidone Iodine, ii)Betadine gargle containing.0.5% of Povidone iodine, iii)Betadine ointment containing.10% Povidone iodine. | November,1972 | |
| Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg) | Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg) | As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental infections, and halitosis. | 25.08.2008 |
| Povidone iodine sterile ophthalmic prep solution | Each ml contains: Povidone iodine IP.5.0% w/v | For prepping of the periocular region and irrigation of the ocular surfaces. | 22.11.1996 |
| Povidone Iodine USP | Povidone Iodine USP.4% (Scrub), Povidone Iodine USP.5%(Solution & oitment) | September,1978 | |
| P.Piperidinoethoxy.O.Carbomethoxy Benzophenone Hydrochloride | 5mg to 10mg | Antispasmodic and analgesic. | February,1961 |
| Practolol | Practolol | Cardiac Drug. | November,1973 |
| Practolol | Each tablet contains: Practolol BP.100mg | 1974 | |
| Pralidoxime chloride | Pralidoxime chloride | Antidote for poisoning. | March,1966 |
| Pralidoxime iodide | Pralidoxime iodide | Antidote for poisoning | March,1966 |
| Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg | Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg | For the treatment of the sign and symptoms of idiopathic parkinsons disease. | 13.03.2010 |
| Pramipexole Di.hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg) | Each tablet contains: Pramipexole dihydrochloride monohydrate.0.125mg, 0.25mg, 0.5mg, 1mg, 1.5mg | For the treatment of the signs and symptoms of idiopathic Parkinson’s disease. | 25.07.2005 |
| Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg. | Each film coated tablet contains: prasugrel hydrochloride eq.to prasugrel.5mg, 10mg | To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: • Patients with unstable angina (UA) or non.ST.elevation myocardial infarction (NSTEMI). • Patients with ST.elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. | 28.05.2010 |
| Pravastatin 40mg tablet (Additional Strength) | Each tab contains: Pravastatin sod. phEur. 40mg | As an adjunct to diet to reduce elevated total cholesterol, LDL.C, Apo.B TG levels and to increase HDL.C in patients with primary hypercholesterolaemia and mixed dyslipidaemia. | 09.08.2006 |
| Pravastatin tabs | Each uncoated tablet contains: Pravastatin sodium.10mg, 20mg, 40mg | By RMP. primary hypercholesterolemia type IIa, IIb and prevention of cardiovascular events in adults only. | 20.12.2000 |
| Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets | Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets | For the treatment of mixed infections with roundworms and tapeworms in dogs. | 30.03.2010 |
| Prazocin GITs tablets | 2.5mg | In additional indication of B.P.H | 14.09.1999 |
| Prazosin hcl (GITS) tablets | Prazosin hcl (GITS) tablets | 21.06.1995 | |
| Prazosin hydrochloride | Each tablet contains: Prazosin hcl eq.to 1mg,2mg,5mg, (0.5mg for sun pharma.14.11.90) | All grades of essential primary hypertension and all grades of hypertension. | May,1990 |
| Prazosin mesylate | Mild to moderate hypertension only | 11.03.1999 | |
| Prednicarbate cream | Each gram of cream contains: Prednicarbate.2.5mg | Skin diseases where treatment with topical corticosteroid is appropriate. | 06.08.1997 to 06.08.1999 |
| Prednimustine tablets | Prednimustine tablets | Anti cancer drug. Indicated in the treatment of chronic lymphocytic leukaemia, non.hodgkin's lymphoma and breast cancer. | July,1986 |
| Prednisolone | Each retard tablet contains: Prednisolone IP.10 mg | December,1971 | |
| Prednisolone + Ofloxacin | Prednisolone + Ofloxacin | 2003 | |
| Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg | Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg | Indicating for condition required Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction. | 26.11.09 |
| Pregabalin 150mg/75mg + Methylcobalamin 750mcg + Alpha lipoic acid 100mg + Pyridoxine 3mg + Folic acid 1.5mg capsule | Pregabalin 150mg/75mg + Methylcobalamin 750mcg + Alpha lipoic acid 100mg + Pyridoxine 3mg + Folic acid 1.5mg capsule | For the treatment of painful diabetic neuropathy in adults only. | 12.10.2010 |
| Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength) | Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules | Same as Approved. | 08.05.2008 |
| Pregabalin capsule (75/150/300 mg) | Pregabalin capsule (75/150/300 mg) | For neuropathic pain. | 25.11.2005 |
| Pregabalin Capsule 25/50/100/200mg (Additional Strength) | Pregabalin Capsule 25/50/100/200mg | Same as approved. | 19.05.2006 |
| Pregabalin capsules (Additional Indication) | Pregabalin capsules | Management of fibromyalgia syndrome. | 29.04.2008 |
| Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets | Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets | For the treatment of adult patients with peripheral neuropathy. | 09.02.2010 |
| Pregabalin SR Tablet 150/300mg | Pregabalin SR Tablet 150/300mg | For the treatment of peripheral neuropathic pain in adults. | 16.05.2009 |
| Pregabalin SR Tablet 75mg (Additional Strength) | Pregabalin SR Tablet 75mg | Same as approved | 30.01.2010 |
| Pregabalin.75mg/150mg + Methylcobalamine 500mcg cap | Pregabalin.75mg/150mg + Methylcobalamine 500mcg cap | For the treatment of adult patients with peripheral neuropathy. | 12.10.2007 |
| Premetrexed(Disodium) powder For solution For Inj. 500mg/vial | Premetrexed(Disodium) powder For solution For Inj. 500mg/vial | Anti Cancer. | 21.08.2006 |
| Premetrxed disodium injection 100mg/vial (Additional Strength) | Premetrxed disodium injection 100mg/vial (Additional Strength) | Same as Approved. | 12.03.2008 |
| Prenoxdiazine hcl. | Each tab contains: Prenoxdiazine hcl.100mg | Anti tussive agent. Indicated in relief of cough of bronchial origin. | July,1990 |
| Prenylamine lactate | Coronary vasodilator. | October,1964 | |
| Prenylamine Lactate | Prenylamine Lactate.60mg | June,1973 | |
| Primaquine Tablet 45mg (Additional Strength) | Primaquine Tablet 45mg | Used as Gametocytocidal drug in P. falciparum infections to prevent transmission of falciparum malaria particularly in area where there is potential for re.introduction of malaria. | 05.05.2011 |
| Primoxan tablets | Each tablet contains: Metoclopramide.5mg, dimethylpolysiloxane.250mg | August,1985 | |
| Procarbazine Hydrochloride USP | Indicated in the treatment of Hodgkins disease | April,1981 | |
| Prochlorperazine maleate | Each buccal tab contains: Active drug.3 mg. | For treatment of nausea, vomiting, post operative emesis & migrains. | 09.08.1999 |
| Progesterone micronized soft gelatin caps. | Progesterone micronized soft gelatin caps. | 21.06.1995 | |
| Progesterone pessary | Each pessary contains: progesterone B.P.100mg,200mg,400mg | Supplementation of insufficient secretion of progesterone in women participating in fertilisation programme. | 25.10.2001 |
| Promegestone tabs | Each tab contains: Promegestone.0.125mg,0.250mg,0.500mg | Gynaecological conditions characterized by luteal insufficiency, menstrual irregularities due to ovulation disorders, dysmenorrhea, premenstrual syndrome, mastodynia, dysfunctional uterine bleeding menorrhagia due to fibromyomas, menopausal syndrome. | 23.09.1996 |
| Propafenone hydrochloride | Propafenone hydrochloride | Anti arrhythmic agent. Indicated in the treatment of ventricular extra systoles supra ventricular tachycardia etc. | November,1986 |
| Propafenone tablets/injection | Tablets.propafenone.150mg,300mg, injection.each 20ml ampoule contains: Propafenone.70mg | .January,1987 | |
| Propanol 1.ol 18gm + Ethanol 100% 45gm/100ml solution | Propanol 1.ol 18gm + Ethanol 100% 45gm/100ml solution | For hygenic and surgical hand disinfection. | 18.01.2010 |
| Propanol 50gm + povidone iodine.1gm in 100ml solution | Propanol 50gm + povidone iodine.1gm in 100ml solution | For surgical & hygenic hand disinfection. | 19.11.2007 |
| Propanol.18 gm + Ethenol(100%).45gm in 100ml solution | Propanol.18 gm + Ethenol(100%).45gm in 100ml solution | For surgical & hygenic hand disinfection. | 19.11.2007 |
| Propionyl.L.Carnitine HCl Tablet (500mg) & injection 300mg/vial | Propionyl.L.Carnitine HCl Tablet (500mg) & injection 300mg/vial | Chronic congestive heart failure. | 22.03.2006 |
| Propofol (1% w/v) with medium chain triglycerides (MCT) | Advice to FDA for amendment of existing permission to include MCT (BP) as excepient with the condition of 2yrs PMS data to be submitted. | 02.09.2005 | |
| Propofol 1% for injection (Additional Indication) | Propofol 1% for injection | 1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care. | 05.11.2009 |
| Propofol 10 mg + Lignocaine 2.5 mg per ml injection (Additional Strength) | Propofol 10 mg + Lignocaine 2.5 mg per ml injection | Additional strength | 27.10.2009 |
| Propofol 10mg + Lignocaem 1mg per ml injection | Propofol 10mg + Lignocaem 1mg per ml injection | For induction of anesthesia | 04.04.2007 |
| Propofol 2% w/v Injection (Additional Strength) | Propofol 2% w/v Injection | Same as Approved | 27.02.2010 |
| Propofol clear soln for i.v inj. | Each ml of clear soln for inj.contains: Propofol.50mg,200mg,400mg | For induction in veterinary practise only | 10.01.2003 |
| Propofol inj. | Each ml contains: propofol 10mg in vehicle containing soybeen oil and purified egg lecithin and glycerol. | Induction and maintenance of general anaesthesia. | 18.05.1998 |
| Propoxyphene napsylate BP + Paracetamol IP | Propoxyphene napsylate BP.100mg, Paracetamol IP.650mg | November,1978 | |
| Propranolol + Hydrallazine | Each tablet contains: Propranolol.40mg, Hydrallazine.25mg | February,1980 | |
| Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules | Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules | For the prophylaxis of migraine. | 16.03.2010 |
| Propranolol hcl sustained release tablets | Each tablet contains;: Propranolol hcl eq.to 80mg,160mg | September,1985 | |
| Propranolol sustained release capsules | Each sustained release capsule contains: Propranolol hcl.80mg | December,1987 | |
| Propranolol with bendrofluazide capsules | Each capsule contains: Propranolol hydrocloride.80mg, bendrofluazide.2.5mg | October,1982 | |
| Propranolol with hydroflumethazide tablets | Each tablet contains: propranolol hydrochloride.40mg, hydroflumethazide.25mg | October,1982 | |
| Propyl docetrizoate | Propyl docetrizoate | Contrast medium in bronchography | May,1962 |
| Proresid | Proresid | June,1965 | |
| Protein derived from soya bean | Each 150gm contains Protein derived from soya bean.33.2gm | June,1978 | |
| Proternol | Proternol | January,1965 | |
| Prothionamide | Prothionamide | Anti T.B Drug | September,1970 |
| Prothionamide B.P | Each tablet contains: Prothionamide.125 mg | Anti T.B. | June,1972 |
| Prothionamide B.P. | Prothionamide B.P. | Anti T.B. | June,1972 |
| Prothipendyl hydrochloride | 40.120 mg/day | Psycho sedative & Tranquiliser.relaxes the autonomas system. | January,1962 |
| Protokylol hydrochloride | Solution: inhaler.1:100, Injection.0.5mg, Tablet.2mg | Bronchodilator | July,1961 |
| Protriptyline Hcl. | 5mg & 10 mg | Anti.depressant. | February,1969 |
| Protryptyline hydrochloride | Protryptyline hydrochloride.5mg, 10 mg | June,1969 | |
| Prulifloxacin (600mg) Tablet | Prulifloxacin (600mg) Tablet | For acute uncomplicated lower urinary tract infection (simple cystitis), complicated lower UTI, acute exacerbation of chronic bronchitis. | 30.10.2007 |
| Pseudoephedrine hcl + Ibuprofen tablet | Each tablet contains: Ibuprofen.200mg,400mg, pseudoephedrine hcl.30mg,60mg. | For the relief of nasal congestion, headache, fever, bodyache and pains associated with sinusitis, flu and common cold. | 28.09.1992 |
| Psoralen + copper sulphate | Each tablet contains: Psoralen.10mg, copper sulphate.2mg | October,1971 | |
| Purified chick embryo cell (PCEC) rabies vaccine (HEP flury virus strain) | Purified chick embryo cell (PCEC) rabies vaccine (HEP flury virus strain) | Vaccine. Indicated for treatment after exposure to rabies and for pre.exposure prophylaxis. | November,1988 |
| Purified Vi.capsular polysaccharide of salmonella typhi (vaccine against typhoid fever) | One vaccinating dose of 0.5ml: purified vi.capsular polysaccharide of salmonella typhi.0.025mg, phenol.1.250mg, isotonic buffer solution qs.0.5ml | 12.02.1993 | |
| PVP/VA Resin + Benzalkonium Chloride + Lignocaine Hcl + D.anthanol DAB.700R | Each aerosol pack of 85gm PVP/VA Resin.5%, Benzalkonium Chloride.0.10%, Lignocaine Hcl.0.25%, D.anthanol DAB.7DDR.2% | September,1977 | |
| Pygeum africanum soft gelatin caps & bulk import | Each cap.contains: Pygeum africanum extract.50mg | Benign prostate hypertrophy | 30.07.2002 |
| Pyrantel embonate with fabental suspension | Each ml of suspension contains: Pyrantel embonate.14.4mg, febental.15mg | For treatment of infestation caused by round worms, ascarids, hook worms, whip worm in puppies & young dogs. | 23.04.2001 |
| Pyrantel Pamoate USP | Pyrantel Pamoate USP | Anthelmitic | July,1972 |
| Pyrantel tartrate | Pyrantel tartrate | In the treatment if infestation with G.I round worm in sheep, cattle & swine (Broad spectrum anthelmintic) | April,1969 |
| Pyrazinamide | Pyrazinamide | Anti.tuberculosis. | September,1964 |
| Pyrazinamide dispersible tabs | Each dispersible tab contains: Pyrazinamide.250mg | Short course treatment of tuberculosis in the paediatric age group. | 06.06.1997 |
| Pyridine 3.carboxylic acid hydroxy methylamide + choline bitartrate | Each tablet contains: PCAHM.0.125g, cholie bitartrate.0.125g | July,1971 | |
| Pyridoxine hcl CR tablet | Each C.R tablet contains: Pyridoxine hcl.100mg. | Deficiency of vit.B6 caused by usage of oral contraceptive pill/drug induced pyridoxine deficiency. | 07.05.1992 |
| Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet | Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet | For Mineral & Vitamins deficiency states in adult patients. | 23.12.2010 |
| Pyritinol | Pyritinol | Cerebral stimulant | April,1965 |
| Pyrvinium pamoate | Pyrvinium pamoate | Anthelmintic | October,1962 |
| Quetiapen fumarate Sustained Release Tablets 50mg and 100mg (Additional Strength) | Quetiapen fumarate Sustained Release Tablets 50mg and 100mg | Same as approved | 05.04.2011 |
| Quetiapine (As fumarate) SR 400mg tablet (Additional Strength) | Quetiapine (As fumarate) SR 400mg tablet | As approved. | 05.03.2007 |
| Quetiapine fumarate SR tablets | Quetiapine fumarate SR tablets | For the additional indication "acute manic episode associated with bipolar disorder". | 21.02.2008 |
| Quetiapine fumerate tablets | Each film coated tab contains: Quetiapine fumerate eq.to quetiapine 25mg,50mg (Additional Strength on 28.10.2002),100mg,200mg,300mg | For the management of the manifestation of of psychotic disorders (schizophrenia) | 03.06.2002 |
| Quetiapine S.R tablet 200/300mg | Each oral SR tablet contains: Quetiapine fumarate eq. to quetiapine 200mg/300mg | For the management of manifestation of psychotic disorders (Schizophrenia). | 01.08.2006 |
| Quetiapine SR Tablets 50mg (Additional Strength) | Quetiapine SR Tablets 50mg | As approved | 10.04.2007 |
| Quinapril + Hydrochlorthiazide tab | Each film coated tab contains: Quinapril hcl eq.to quinapril.10mg,20mg, Hydrochlorthiazide IP.12.5mg | For treatment of mild to moderate hypertension. | 10.02.2003 |
| Quinapril 20mg + Hydrochlorthiazide 25mg film coated tablet | Quinapril 20mg + Hydrochlorthiazide 25mg film coated tablet | For the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion. | 26.02.2009 |
| Quinapril tab & bulk | Each tab contains: Quinapril hcl eq.to quinapril.5mg,10mg,20mg | Mild to moderate hypertension & adjunct to cardiac glycoside in congestive heart failure. | 19.09.2002 |
| Quinapyramine Sulphate (bulk drug) | Quinapyramine Sulphate/Chloride (bulk drug) | August,1980 | |
| Quinestrol | 25mcg tablets daily for 2 months | Oestrogenic steroid | July,1971 |
| Quinethazone | 50 mg tabs | Diuretic (oral) | January,1964 |
| Quinidine phenylethyl barbiturate | 0.1 g | March,1969 | |
| r Hu erythropoietin injection | Each lyophillised 2ml vial contains; r hu erythropoietin.2000iu,4000iu, mannitol.40mg, NaCl.7mg, monobasic sod.phosphate.2.8mg, diabesic sod.phosphate.8mg, human albumin.5mg | In the treatment of anaemia due to chronic renal failure and end stage renal disease. | 27.01.1993 |
| r human erythropoeitin | r Hu Epo inj.1000 IU/ml,2000 IU/ml, 3000 IU/ml, 4000 IU/ml, 10000 IU/ml | For additional indication of perisuregry. First approval on 27.1.93 vide no.12.67/88.DC | 19.06.2000 |
| R(.) Ondansetron oral Solution (1mg/5ml) | Each 5ml of oral solution contains; R(.) ondansetron Hcl eq.to R(.) ondansetron.1mg | For Chemotherapy induced nausea and vomiting. | 27.05.2005 |
| R(.) salbutamol i.e levosalbutamol rotacaps & inhalers | Each actuation delivers R(.) salbutamol sulphate eq.to R(.) salbutamol.50mcg,100mcg. | By RMP only. for the treatment of bronchospasm in patients with reversible obstructive airway diseases. | October,2004 |
| R(+) Ondansetron (2mg/4mg) tablet | Each tablet contains; R(+) ondansetron Hcl.2H2O eq.to R(+) ondansetron.2mg, 4mg | For the treatment of chemotherapy induced nausea and vomiting. | 15.04.2005 |
| Rabbit anti human thymocyte immunoglobulin | Rabbit anti human thymocyte immunoglobulin | May,1991 | |
| Rabeprazole + Mosapride SR | Rabeprazole.20mg, mosapride.15mg | 27.07.2004 | |
| Rabeprazole 20mg (EC) + Itopride SR 150mg | Rabeprazole 20mg (EC) + Itopride SR 150mg | For GERD. | 28.11.2006 |
| Rabeprazole sodium | Each enteric coated tablet contains: Rabeprazole sodium.10mg,20mg | Gastroesophageal reflux disease, deodenal ulcer & zollinger ellision syndrome. | 27.12.2001 |
| Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tablets | Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tablets | For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD. | 28.04.2008 |
| Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer | Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer | For Duodenal ulcer, G.U, Z.E.S. & GERD. | 26.02.2007 |
| Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) | Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) | Same as Approved. | 16.04.2008 |
| Rabeprazole sodium injection | Each vial contains; lyophillized powder of rabeprazole sodium.10mg,20mg for i.v injection | By RMP. for the treatment of gastritic & deodenal ulcer, gastroesophagal reflux disease (GERD) as an alter native to oral therapy in patients who are unable to take oral proton pump inhibitor. | 19.05.2004 |
| Rabeprazole Sodium Powder oral suspension (sachet of 20 mg) (Additional Dosage Form) | Rabeprazole Sodium Powder oral suspension (sachet of 20 mg) | Same as approved | 03.12.2010 |
| Rabies vaccine inactivated (Verocell) | Rabies vaccine inactivated (Verocell) | Indicated for treatment after exposure to rabies and for pre.exposure prophylaxis. | November,1988 |
| Rabies veterinary vaccine inactivated | Rabies veterinary vaccine inactivated | November,1987 | |
| Racecadotril caps | Each cap contains: Racecadotril.100mg | For the treatment of acute diarrhoea in adults only. | 10.10.2001 |
| Racecadotril dispersible tablet (10mg/30mg) (New Dosage Form) | Racecadotril dispersible tablet (10mg/30mg) | For diarrhea. | 15.12.2006 |
| Racecadotril sachet | 10mg, 30mg | By RMP | 19.05.2004 |
| Raloxifene hcl | Each film coated tab contains: Raloxifene hcl.60mg | For the treatment and prevention of post menopausal osteoporosis in women. | 04.05.2001 |
| Raltegravir (as Potassium) film coated Tablets 400mg | Each film coated tablet contains: Raltegravir potassium 434.4mg eq.to raltegravir.400mg | In combination with other anti retroviral agents for the treatment of human immunodeficiency virus (HIV.1) infection in treatment experienced patients with evidence of HIV.1 replication despite ongoing retroviral therapy. | 27.01.2010 |
| Ramelteon film coated tablets 8mg | Each film coated tablet contains: Ramelteon.8mg | For the treatment of insomnia characterized by difficulty with sleep onset. | 21.12.2010 |
| Ramipril | Each cap. Contains: Ramipril.1.25 mg,2.5mg,5mg,10mg. | ACE inhibitor. Indicated in the treatment of hypertension, cardiac failure. And also for myocardial infarction (29.11.94). | August,1991 |
| Ramipril (5mg) + Telmisartan (40mg) tablet | Ramipril (5mg) + Telmisartan (40mg) tablet | For Hypertension. | 11.05.2005 |
| Ramipril + candesartan cilexatil tabs | Each uncoated bilayered tab contains: Ramipril BP.2.5mg,5mg, candesartan cilexatil eq.to candesartan.8mg | By RMP. for mild to moderate essential hypertension and congestive heart failure (CHF) | |
| Ramipril + Hydrochlorthiazide tabs | Each tab contains: Ramipril.2.5mg,5mg, Hydrochlorthiazide.12.5mg,25mg | Mild to moderate hypertension in patient (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion. | 26.08.1996 |
| Ramipril + S(.) amlodipine tab | Each tab/cap contains: Ramipril.2.5mg, S(.) amlodipine besylate eq.to S(.) amlodipine.2.5mg | For treatment of essential hypertension. | 11.02.2003 |
| Ramipril 1.25/ 2.5/5/10mg (Additional Indication) | Ramipril 1.25/ 2.5/5/10mg | For the treatment ofnon.diabetic overt glomerular or incipient nephropathy. | 24.05.2010 |
| Ramipril 10mg + HCTZ 12.5mg tablet (Additional Strength) | Ramipril 10mg + HCTZ 12.5mg tablet | As approved. | 20.02.2007 |
| Ramipril 5mg + Hydrochlorthiazide 12.5mg tablets (Additional Strength) | Ramipril 5mg + Hydrochlorthiazide 12.5mg tablets | Same as Approved. | 20.02.2008 |
| Ramipril MR capsule 10mg | Ramipril MR capsule 10mg | For the treatment of hypertension/ cardiac failure and myocardial infarction. | 30.07.2009 |
| Ramipril MR Capsules 2.5/5 mg (Additional Strength) | Ramipril MR Capsules 2.5/5 mg | Same As Approved | 03.07.2010 |
| Ramipril tablets | 1.25mg, 2.5mg, 5mg, 10mg | For additional indication: Reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularization, procedures in diabetic patients 55 yrs of age or more with one or more of the following rosk factors, syst. B.P >160mmHg or diastol. BP>90mmHg, total cholesterol >5.2mMol/L HDL cholesterol < 0.9mMol/L etc. | 2005 |
| Ramipril tablets/capsules (Additional Indication) | Ramipril tablets/capsules | Additional indication | December,2004 |
| Ramosetron Dispersible Tablet 0.1mg | Ramipril tablets/capsules | For the prevention and treatment of gastrointestinal symptoms (nausea and vomitting) associated with ematogenic cancer chemotherapy. | 12.06.2010 |
| Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg/2ml | 1) Each tablet contains: ramosetron hydrochloride.2.5mcg, 5mcg, 0.1mg. 2) Each 2ml injection contains; ramosetron hydrochloride.0.3mg | 1) Tablets 0.1mg & Injection 0.3mg/2ml.for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer chemotherapy. 2) Tablets 2.5mcg & 5mcg.for the treatment of adult patients with diarrhoea predominant irritable bowel syndrome. | 12.11.2009 |
| Ranitidine injection | Each 2ml contains: Ranitidine hydrochloride eq.to 50mg of ranitidine. | February,1986 | |
| Ranitidine syrup | Each 10ml contains: Ranitidine hcl eq.to ranitidine.150mg | February,1990 | |
| Ranitidine tablets | Each tablet contains: Ranitidine hcl eq.to 150 mg of ranitidine. | Anti ulcer. Indicated in the treatment of duodenal ulcer, benign gastric ulcer, post operative ulcer, reflux oesophagitis, zollinger ellison syndrome. | August,1985 |
| Ranolazine 1000mg ER Tabs (Additional Strength) | Ranolazine 1000mg ER Tabs | Same as approve | 31.01.2009 |
| Ranolazine ER 500mg Tablet | Each film coated ER tablet contains: Ranolazine.500mg | For the treatment of chronic angina. | 04.06.2007 |
| Ranolazine ER Tablet 375mg/750mg (Additional Strength) | Ranolazine ER Tablet 375mg/750mg | Same as approved | 11.08.2011 |
| Ranolazine ER Tablets 750mg (Additional Strength) | Ranolazine ER Tablets 750mg | Same as Approved | 24.04.2010 |
| Rasagiline (as mesylate ) Tablet 0.5mg/1mg | Each tablet contains: Rasagiline mesylate eq.to rasagiline.0.5mg, 1mg | For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa. | 31.01.2009 |
| Raubasine + Almitrine bismesylate | Each film coated tablet contains: Almitrine bismesylate.30mg, raubasine.10mg | For RMP. for the corrective treatment of symptoms due to abnormal mental deficiency and age related hypoxia in elderly patients (viz. Cerebral muscular insufficiencies) | 11.08.2003 |
| rDNA hepatitis B vaccine (10mcg) | 10mcg | At a dose of 10mcg up to an age of 19 years approved. | 15.09.2000 |
| Rebamipide tablets | Each film coated tab contains: Rebamipide.100mg | By gastroenterologists.for the treatment of gastric intestinal ulcers in adults only. | 29.07.2004 |
| Reboxetine tab | Each uncoated tab contains: Reboxetine methane sulphonate eq.to reboxetine.2mg,4mg | Mild to moderate depression in adults only. | 31.12.2002 |
| Recombinant human Erythropoeitin inj. | Each vial contains: R Human erythropoeitin.2000IU, 4000IU | For hospitals/institutions & prescription of cancer specialist for anemia due to chronic renal failure, anemia associated with cancer & cancer chemotherapy, HIV infected patients on zidovudine, adult surgery patients in autologus pre.donation program and peri.surgery patients without blood dontion. | 08.11.2000 |
| Recombinant human erythropoietin | Recombinant human erythropoietin | For addition indication of autologous blood donation in case of anaemia due to chronic renal failure and anemia associated with cancer. | 07.02.2000 |
| Recombinant human erythropoietin rHuEPO | Recombinant human erythropoietin rHuEPO | For additional indication; anemia associated with cancer to conditions of letter (even no.dated 27.1.1993) | 12.07.2000 |
| Recombinant human tissue type plasminogen activation infection (Actilyse) | 20mg, 50mg per vial | For fibrinolytic therapy in acute thrombotic coronary artery occlusion. | July,1989 |
| Regorafenib Tablet | Each film coated tablet contains: Regorafenib.40mg | For the “treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine., oxaliplatin. and irinotecan.based chemotherapy, an anti.VEGF therapy, and, if KRAS wild type, an anti.EGFR therapy”. | 01.07.2014 |
| Renolazine Extend Release tablet (500mg) | Renolazine Extend Release tablet (500mg) | For Chronic Angina. | 14.06.2007 |
| Repreterol tablets/syrups | Each tablet contains: Pepreterol.20mg, Each 5ml contains; repreterol.10mg. | January,1987 | |
| Reproterol hydrochloride | Reproterol hydrochloride | Bronchodilator. Indicated in the treatment of conditions involving reversible airways obstruction viz bronchial asthma, bronchitis etc. | September,1986 |
| Reproterol respirator solution/aerosol/injection | Respirator solution.10mg/ml, Aerosol.each metered dose.0.50mg, Injection.0.09mg/ml (Reproterol hcl) | October,1987 | |
| Reproterol tablet/elixir | Tablet.reproterol hcl.20mg, Elixir.reproterol hcl.10mg/5ml | October,1987 | |
| Residronate sodium (35mg) once weekly | 35mg | 19.03.2004 | |
| Resperidone E.R. (long.acting) injection (12.5mg/vial) (Additional Strength) | Resperidone E.R. (long.acting) injection (12.5mg/vial) | As approved. | 25.09.2007 |
| Resperidone long acting injection | Each long acting injection vial resperidone.25mg,37.5mg,50mg | By psychiatrists. for the treatment of schozophrenia. | 26.08.2004 |
| Resperidone Tablet & Syrup (Additional Indication) | Resperidone Tablet & Syrup | Acute mania & mixed episode in bipolar.I disorder. | 04.04.2006 |
| Resperidone tabs | i).Each film coated tablet contains: resperidone.1mg,2mg,3mg,4mg ii).resperidone liquid.each ml contains;resperidone.1mg(14.5.97) | Acute and chronic schizophrenic psychosis and other psychotic conditions in which +ve symptoms and .ve symptoms are prominent. | 03.04.1997 |
| Retapamulin Ointment 1% | Each gram contains: Retapamulin.10mg | For the topical treatment of bacterial skin and skin structure infections:. Primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses. | 28.04.2009 |
| Revaprazan tablet | Each film coated tablet contains: Revaprazan.100mg, 200mg | For the short term treatment of gastric ulcer, duodenal ulcer and for improvement of mucosal lesion in acute and chronic gastritis. | 26.09.2011 |
| r.follicle stimulating hormone (FSH) | r.follicle stimulating hormone (FSH) | NOC issued for additional strength of 37.5IU | 19.08.1999 |
| r.follinotropin beta soln for inj.in cartridges (Additional Strength) | Each cartridge contains: r.follinotropin beta.300Iu,600IU | Additional strength. | 21.02.2002 |
| r.hu.coagulation factor VII (a) inj. | Each vial contains: r.hu.coagulation factor VII (a); 60KIU (1.2mg), 120KIU(2.4mg),240 KIU (4.8mg) | Treatment of bleeding episodes and prevention of excessive bleeding associated with surgery in patients with inherited or acquired hemophilia with inhibitors to coagulation factor VIII or IX | 14.01.2003 |
| r.human interferon beta 1a soln for inj. | Each prefilled syringe of 0.5ml soln contains: r.human interferon beta 1a. 22mcg (6m iu/0.5ml), 44mcg (12m iu/0.5ml) | For treatment of patients with relapsing/remitting multiple sclerosis ch characterised by at least 2 recurrent attacks with neurological symptoms over the preceding 2 years. | 18.01.2002 |
| Ribavirin | Each capsule contains: ribavirin.100mg,200mg, Each 5/ml syrup contains; ribavirin.50mg | Anti viral agent. Acute hepatitis, viral respiratory and herpes infection. | November,1990 |
| Ribavirin Capsules 200mg (Additional Strength) | Ribavirin Capsules 200mg | Indicated in combination with peg interferon alpha.2b for the treatment of naïve adult patients with chronic hepatitis C with clinically stable HIV co.infection. | 24.12.2009 |
| Rice based O.R.S | Rice based ORS citrate containing each sachet NaCl.3.5g, KcL.1.5g, sodi.citrate.2.9g, extruded rice.50g Rice based ORS electrolytes containing each sachet Nacl.1.25g, kcl.1.50g, sodi.citrate.2.90g, extruded rice.50g | 09.12.1993 | |
| Rifabutin Capsule (150mg) | Each capsule contains: Rifabutin USP.150mg | For treatment of pulmonary T.B only in patients co.infected with HIV. (It should never be used as a substitute to Rifampicin in T.B patients without HIV co.infection). | 19.07.2007 |
| Rifampicin + Isoniazid | Rifampicin.300mg+INH.200mg, Rifampicin.450mg+INH.300mg, Rifampicin.600mg+INH.300mg | June,1983 | |
| Rifampicin + Isoniazid + Piperine (200mg + 300mg + 10mg ) Capsules | Rifampicin + Isoniazid + Piperine (200mg + 300mg + 10mg ) Capsules | For the treatment of adult patients with pulmonary tuberculosis. | 11.12.2008 |
| Rifampicin + Piperine (200mg + 10mg ) Capsules | Rifampicin + Piperine (200mg + 10mg ) Capsules | For the treatment of adult patients with pulmonary tuberculosis. | 11.12.2008 |
| Rifampicin syrup | Rifampicin syrup | June,1983 | |
| Rifaximin 400mg (Additional Indication) | Rifaximin 400mg | For the treatment of hepatic encephalopathy. | 18.07.2009 |
| Rifaximin Dispersible Tablet 200mg | Rifaximin Dispersible Tablet 200mg | For infections diarrhoea in adults. | 26.11.2009 |
| Rifaximin Oral Suspension 100mg/5ml (New Dosage Form) | Each 5ml suspension contains: Rifaximin 100mg | Treatment of Infectious Diarrhoea in Adult and Children (>2years of age and above). | 09.06.2011 |
| Rifaximin Tablet 550 mg (Additional strength and Additional Indication) | Rifaximin Tablet 550 mg | For Reduction in Risk of Overt Hepatic Encephalopathy (HE) Recurrence in Patients ≥ 18 years of Age. | 18.08.2011 |
| Rifaximine 200mg tab | Rifaximine 200mg tab | For infections diarrhea in adults. | 28.08.2006 |
| Rilmenidine tablets | Each tablet contains: Rilmenidine dihydrogen phosphate eq.to 1mg of rilmenidine (base). | Mild to moderate hypertension. | 21.02.1995 |
| Riluzole tablets | Riluzole tablets | In the treatment of patients with amyotrophic later sclerosis (motor neurone disease). | 17.10.1997 to 17.10.1999 |
| Rimonabant tablet 20mg | Rimonabant tablet 20mg | For Obese Patients BMI≥ 30kg/m2 or overweight patients BMI≥ 27kg/m2 with Associated risk factors such As type.I diabetes or dyslipidemia. | 11.05.07 |
| Ripaglinide | Each tablet contains: 0.25mg,0.5mg,1.0mg,2mg | Treatment of type.II diabetes (NIDDM) whose hyperglycemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. | 23.03.2000 |
| Risedronate Sodium 150mg Tablet (Additional Strength) | Risedronate Sodium 150mg Tablet | As already approved. | 16.09.08 |
| Risedronate Sodium tablet (35mg) (Additional Indication) | Risedronate Sodium tablet (35mg) | For osteoporosis in men at high risk of fracture. | 08.10.2007 |
| Risperidone long acting injection (Additional Indication) | Risperidone long acting injection | Indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of Bipolar.1 disorder. | 29.08.2009 |
| Risperidone prolonged release suspension for injection (Deep Intramuscular Deltoid route using appropriate safety needle) (Additional route of administration) | Risperidone prolonged release suspension for injection (Deep Intramuscular Deltoid route using appropriate safety needle) (Additional route of administration) | Same as already approved | 19.12.2013 |
| Ritodrine hcl tablet | Each tablet contains: Ritodrine hcl.10mg, Ritodrine hcl injection Contains; ritodrine hcl.USP 10mg (appr.on 10.3.95) | Premature labours, acute foetal distress, prevention of preterm labours after operations. | 21.02.1995 |
| Ritonavir + Lopinavir capsules & oral suspension | Each soft gelatin capsule contains: ritonavir.33.3mg, lopinavir.133.3mg, Each ml of oral solution contains: ritonavir.20mg, lopinavir.80mg | By RMP. in treatment of HIV infection in combination with other retroviral agents. | 18.01.2001 |
| Ritonavir caps | Each capsule contains: ritonavir.100mg | In the treatment of advanced HIV infection.by qualified physician not below the age of 12 years to administer. | 08.09.1997 to 08.09.1999 |
| Rituximab (Finished Formulation Import) | Each vial of rituximab.10mg/ml | By cancer specialist.for the treatment of patients with relapsed or chemo resistant indolent B cell non.hodgkins lymphomas. | 10.07.2000 |
| Rivaroxaban Tablet | Each film coated tablet contains: Rivaroxaban.10mg | For the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. | 03.02.2010 |
| Rivaroxaban tablet 15/20mg (Additional Strength/Indication) | Rivaroxaban tablet 15/20mg | 1. Treatment of deep vein thrombosis and for prevention of recurrent DVT and pulmonary embolism. 2. For the prevention of stroke and systemic embolism in patient with non.valvular arterial fibrillation. | 02.09.2014 |
| Rivaroxaban tablet 2.5mg (Additonal Strength) | Rivaroxaban tablet 2.5mg | Rivaroxaban 2.5mg tablet, co.administered with Acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. | 13.07.2015 |
| Rivastigmine caps | Each hard capsule contains: Rivastigmine as the hydrogen tartrate salt.0.5mg,1mg,1.5mg,3mg,4mg,5mg,6mg | Treatment of patients with mild to moderate dementia of Alzheimer type. | 31.07.1998 |
| Rivastigmine capsules 1.5/3.0/4.5/6.0mg | Each capsule contains: 1.5mg, 3.0mg, 4.5mg, 6.0mg | For the treatment of mild to moderately severe dementia associated with Parkinson's disease. | 17.04.2006 |
| Rivastigmine transdermal patch (each patch of 5m2 10m 2,15m 2& 20m2 contain Rivastigmine base 9/18/27/36mg respectively) | Rivastigmine transdermal patch (each patch of 5m2 10m 2,15m 2& 20m2 contain Rivastigmine base 9/18/27/36mg respectively) | For the treatment of patients with mild to moderately severe dementia of the Alzheimer type and dementia associated with Parkinson's disease. | 28.01.2008 |
| Rivastigmine transdermal patch. (Additional Indication) | Each Transtermal patch of 15cm2 contains: Rivastigmine 27mg | For the treatment of patients with severe dementia of the Alzheimer's type. | 28.10.2014 |
| Rizatriptan Benzoate orally disintegrating tablet 10mg (Additional Dosage Form) | Rizatriptan Benzoate orally disintegrating tablet 10mg | Same as Already approved | 24.05.2010 |
| Rizatriptan tab & bulk locally | Each uncoated tab contains: rizatriptan benzoate eq.to rizatriptan.5mg,10mg | For acute treatment of headache phase of migraine with or without aura in adults only. | 27.02.2003 |
| Rocuronium bromide inj. | Rocuronium bromide inj..50mg/5ml, 100mg/10ml | As an adjuvant to general anaesthesia to facilitate endotracheal incubation to provide skeletal muscle relaxation during surgery. | 18.06.1996 |
| Rofecoxib + paracetamol fdc tabs | Each tab contains: Rofecoxib.25mg, paracetamol.500mg | By RMP. for the management of acute pain in adults only. | October,2003 |
| Rofecoxib gel | Each gm of gel contains: Rofecoxib.10mg | For acute musculo skeletal pain in adults. | 18.10.2001 |
| Rofecoxib inj. | Each ml contains: Rofecoxib.12.5mg | For short term treatment of acute post.operative pain in adults only. | 11.02.2003 |
| Rofecoxib suspension (oral) | Each 5ml suspension contains: Rofecoxib.12.5mg,25mg. | Not to be used in children | 25.09.2000 |
| Roflumilast Tab 500 mcg | Each film coated tablet contains: Roflumilast.500mcg | For the "maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post.bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. | 17.07.2014 |
| R.Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection | R.Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection | Chemotherapy induced nausea & vomiting. | 12.01.2007 |
| Ropinirole 6mg ER Tablets (Additional Strength) | Ropinirole 6mg ER Tablets | Same as approved | 06.02.2010 |
| Ropinirole ER Tablet 1 mg. (Additional Strength) | Ropinirole ER Tablet 1 mg. | Same as approved | 04.01.2011 |
| Ropinirole ER tablet 2/4/8mg | Ropinirole ER tablet 2/4/8mg | for the treatment of signs & symptoms of idiopathic Parkinson's disease. | 03.12.2009 |
| Ropinirole hcl bulk & tab | Each film coated tablet contains: Ropinirole hcl eq.to ropinirole.0.25mg, 0.5mg, 1mg, 2mg, 5mg | Monotherapy or as an adjunct to levodopa in idiopathic parkinsons' disease. | 03.12.2001 |
| Ropivacaine HCl Inj. 2mg/5mg/7.5mg/10mg | Each ml contains: Ropivacaine Hcl USP.2mg, 5mg, 7.5mg, 10mg | For the production of local or regional anasthesia for surgery and for acute pain management. | 20.03.2009 |
| Rosaxacin | Each capsule contains: Rosoxacin.150mg | Oral anti.gonococcal agent. Indicated in the treatment of gonorrheal urethritis | July,1982 |
| Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg table | Each film coated tablet contains: glibenclamide IP.5mg, metformin Hcl IP.500mg, Rosiglitazone maleate eq.to rosiglitazone.2mg | As 3rd line treatment of type.II diabetes mellitus when diet, excercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control. | 08.08.2006 |
| Rosiglitazone + glimepiride tab | Each film coated tab contains: Rosiglitazone maleate eq.to rosiglitazone.2mg, glimepiride.1mg | Type.II diabetes mellitus where diet, exercise & single agent do not result in adequate glycemic control. | 14.11.2002 |
| Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (Additional Strength) | Rosiglitazone 1mg + Metofmin Hcl 500mg tablet | As approved | 08.02.2007 |
| Rosiglitazone maleate tablets | Each film coated tablet contains: Rosiglitazone maleate eq.to 1mg,2mg,4mg,8mg of rosiglitazone. | By RMP. for treatment of type.II diabetes mellitus as mono therapy & adjunct to diet. | 28.06.2000 |
| Rosiglitazone tablets | Each tablet contains: rosiglitazone.2mg,4mg,8mg | For additional indication of "in combination with suphonyl urea or metformin when diet,exercise and rosiglitazone alone or diet, exercise plus the single agent do not results in adequate glycemic control". | 14.07.2000 |
| Rosuvastatin 5/10/20mg + Fenofibrate 67/145/160mg | Rosuvastatin 5/10/20mg + Fenofibrate 67/145/160mg | For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function. | 23.08.2010 |
| Rosuvastatin calcium | Rosuvastatin calcium | 2003 | |
| Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets (Additional Strength) | Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets | Additional Strength | 24.08.2011 |
| Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet (Additional Strength) | Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet | Additional strength | 29.12.2010 |
| Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. (Additional Strength) | Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. | For the treatment of patients with primary hypercholesterolemia. | 05.12.2011 |
| Rosuvastatin Calcium Tablet (Additional Indication) | Rosuvastatin Calcium Tablet | Risk reduction of MI stroke and arterial evascularisation procedure in patients without clinically evident CHD but with multiple risk factor. | 24.05.2010 |
| Rosuvastatin Calcium tablets 5/10/20/40mg (Additional Indication) | Rosuvastatin Calcium tablets 5/10/20/40mg | 1) As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 2)As an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total.C and LDL.C to target levels. | 08.11.2008 |
| Rosuvastatin Calcium Tablets 5/10/20mg (Additional Indication) | Rosuvastatin Calcium Tablets 5/10/20mg | 1. As adjunct to diet to reduce Total.C, LDL.C, and ApoB levels in adolesent boys and girls, who are at least one year post.menarche, 10.17 years of age with heterozygous hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL.C> 190mg/dL or > 160mg/dL and there is a positive family history of premature cadiovascular disease (CVD) or two or more other CVD risk factors. 2. As an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). | 05.04.2011 |
| Rowachol capsules | Each cap. Contains: pinene.17mg,camphene.5mg,cineol.2mg,methone.6mg,menthol.32mg, borneol.5mg,olive oil.33mg | For hepato.billiary disorders. | September,1991 |
| Roxatidine acetate hcl | Each SR Tablet contains: Roxatidine acetate nhcl.75mg | Anti ulcer. Disorders in the upper gastric intestinal region i.e duodenal ulcer, benign gastric ulcers. | May,1991 |
| Roxithromycin | Each film coated tablet contains: roxithromycin.150mg, 300mg(20.8.93, Roussel), roxithromycin kid tab.50mg (30.3.94.Alembic), roxithromycin dispersible tab.50mg(Torrent), roxithromycin dry syrup.50mg/5ml (26.4.96 Alembic) | Antibiotic. Sensitive strain infections of ENT, bronchopulmonary tract infection, genital except for gonococcal infections, prophylaxis of meningococcal meningitis in exposed subjects. | 27.03.1992 |
| Roxithromycin ER Tablets | Each extended release tablet contains: Roxithromycin.300mg | Additional indication.skin & soft tissue infection. | 08.03.2004 |
| Roxithromycin tablets | 75mg | For paediatric use. | 15.05.2000 |
| R.Sibutramine Capsule (2.5mg/5mg) | R.Sibutramine Capsule (2.5mg/5mg) | As an adjunctive therapy for the management of obesity including weight loss and maintenance of weight loss in pateints whose BMI is 30Kg/m2 or higher. | 26.09.2007 |
| Rupatadine (10mg) tablet | Each tablet contains: Rupatadine fumerate eq.to rupatadine.10mg | For the symptomatic treatment of seasonal perinial allergic rhinitis. | 05.04.2005 |
| Rupatadine 10 mg + Montelukast 10 mg Tablets | Rupatadine 10 mg + Montelukast 10 mg Tablets | For the management of seasonal allergic rhinitis (SAR). | 10.11.2009 |
| Rutin + viit. C + vit. K + dicalcium phosphate + carbazochrome | Tablet: Rutin 0.1g, vit. C. 0.1g, vit. K1. 2.5 mg, dicalcium phosphate.0.1g, carbazochrome.1 mg, Injection: vit. K1.5 mg, calcium lactuonate.100mg, carbazochrome.2.5mg, phenol.0.5%, lignocaine hcl..1% | July,1969 | |
| Ruxolitinib 10mg tablet (Additional Strength) | Ruxolitinib 10mg tablet | 1. For the treatment of patients with myelofibrosis including primary myelofibrosis, post.polycythemia vera myelofibrosis or post.essential thrombocythemia myelofibrosis. 2.Treatment of patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. | 29.05.2015 |
| Ruxolitinib Tablet 5mg/15mg/20mg | Each tablet contains: Ruxolitinib.5mg, 15mg, 20mg | For the treatment of patients with myelofibrosis including primary myelofibrosis, post.polycythemia vera myelofibrosis or post.essential thrombocythemia myelofibrosis. | 28.01.2013 |
| Ruxolitinib Tablet 5mg/15mg/20mg (Additional Indication) | Treatment of patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. | 23.02.2015 | |
| S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets | S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets | For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. | 25.11.2009 |
| S (+) Etodolac 300mg + Thiocolchicoside 8mg Tablet | S (+) Etodolac 300mg + Thiocolchicoside 8mg Tablet | For the treatment of patients with acute painful musculoskeletal conditions. | 05.01.2011 |
| S(.) amlodipine (5mg) + atenolol(50mg) tab | Each tablet contains: S(.) amlodipine.5mg, atenolol.50mg | By RMP. for the treatment of essential hypertension & angina pectoris. | 09.07.2003 |
| S(.) amlodipine + Atorvastatin | Each uncoated tablet contains: s(.) amlodipine besylate eq.to s(.) amlodipine.2.5mg, atorvastatin calcium eq.to atorvastatin.10mg | By RMP. for the treatment of coexisting essential hypertension and hyperlipidaemia in adults. | 10.02.2004 |
| S(.) amlodipine + Hydrochlorthiazide tablets | Each uncoated tablet contains: s(.) amlodipine besylate eq.to s(.) amlodipine.2.5mg, 5mg, Hydrchlorthiazide.12.5mg | By RMP. for the treatment of mild to moderate hypertension. | 14.04.2004 |
| S(.) amlodipine + lisinopril tab | Each tab contains: S(.) amlodipine.2.5mg, lisinopril.5mg | For treatment of mild to moderate hypertension. | 12.03.2003 |
| S(.) amlodipine + losartan pot.tab | Each tab contains: S(.) amlodipine.2.5mg, losartan pot..25mg,50mg, S(.)amlodipine.5mg+losartan.50mg(appr.on 17.4.02) | Mild to moderate hypertension | 17.10.2002 |
| S(.) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets | S(.) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets | For the treatment of high risk hypertensives who need anti.platelet therapy especially for prophylaxis of artherothrombotic events in patients with a history of recent stroke or established peripheral arterial disease. | 22.09.2011 |
| S(.) atenolol + Hydrochlorthiazide tablets | S(.) atenolol + Hydrochlorthiazide tablets | 2004 | |
| S(.) Metoprolol (As succinate) 25mg + S(.) Amlodipine (As besylate) 2.5/5mg | S(.) Metoprolol (As succinate) 25mg + S(.) Amlodipine (As besylate) 2.5/5mg | For essential hypertension | 16.05.2007 |
| S(.) Metoprolol Succinate ER Eq. to S (.) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tablet | S(.) Metoprolol Succinate ER Eq. to S (.) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tablet | For the treatment of essential hypertension who need antiplatelet therapy especially for prophylaxis of atherombotic event. | 07.10.10 |
| S(.) Metoprolol Succinate S.R. Tablets (equivalent to S(.) Metoprolol Tartrate 12.5mg/25mg/50mg) | Each extended release tablet contains: s(.) metoprolol succinate eq.to s(.) metoprolol tartrate.12.5mg, 25mg, 50mg | For the treatment of essential hypertension in adults. | 15.04.2005 |
| S(.) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet | Each capsule contains; S(.) pantoprazole sodium eq.to S(.) pantoprazole.20mg (enteric coated), domperidone BP (SR).30mg | For the treatment of GERD not responding to S(.) pantoprazole alone. | 30.08.2006 |
| S(.) Pantoprazole (as Sodium) Inj. 20mg/vial | Each vial contains: S(.) pantoprazole sodium eq.to S(.) pantoprazole.20mg | For the treatment of patients with peptic ulcer, GERD & Zollinger Ellison Syndrome. | 31.08.2005 |
| S(.)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets | S(.)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets | For the treatment of patients with both essential hypertension and hypercholesterolemia. | 01.04.2010 |
| S(.)Pantoprazole (10mg/20mg/40mg) tablet | Each enteric coated tablet contains: S(.) pantoprazole sodium eq.to S(.) pantoprazole.10mg,20mg,40mg | For the treatment of gastric ulcer, duodenal ulcer & GERD. | 20.05.2005 |
| S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/w | S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/w | For the painful & inflammatory conditions associated with joint, tendons, ligaments and muscles. | 05.08.2010 |
| S(+) Etodolac ER tablets 200mg/300mg | Each ER film coated tablet contains: S(+) etodolac. 200mg, 300mg. | For the relief of pain and inflammation in patients with rheumatoid arthritis and osteoarthritis. | 02.06.08 |
| Saccharomyces boulardii (caps/sachets) | i).lyophillized S.boulardii.282.5mg sachet, ii).lyophillized S.boulardii.282.5mg caps | i).For irritable bowel syndrome, ii).antibiotic associated diarrhoea, iii).diarrhoea due to enternal feeding in adults only. | 18.12.1997 to 18.12.1999 |
| Saccharomyces Cerevisiae | Each capsule contains: Dried yeast powder.250 mg, saccharamyces cervisiae containing not less than 10 million living cells. | January,1971 | |
| Salazopyrin | Each enteric coated tablet contains: salazopyrin.500mg | For rheumatoid. | November,1990 |
| Salbutamol sulphate | Each tablet contains: Salbutamal sulphate.4mg | February,1973 | |
| Salbutamol sulphate B.P | Salbutamol sulphate B.P | Bronchial asthma | September,1971 |
| Salcatonin | Salcatonin | Synthetic Salmon calcitonin.polypeptide hormone. | July,1978 |
| Salicylazosulphapyridine | 0.5 mg tablets | Ulcerative colotis, regional enteritis, non.secific colitis. | August,1967 |
| Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion | Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion | For the treatment of scaly dermatoses. | 18.12.2008 |
| Salicylic Acid + Coal Tar (3% + 1%) Solution | Salicylic Acid + Coal Tar (3% + 1%) Solution | For scaling of seborrhea, seborrheic dermatitis, psoriasis of scalp. | 17.11.2008 |
| Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment | Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment | For the treatment of psoriasis and fungal skin infection. | 17.11.2008 |
| Salicylic acid 10mg/20mg (Foaming facewash solution) | Salicylic acid 10mg/20mg (Foaming facewash solution) | For the treatment of acne vulgaris. | 28.01.2008 |
| Salinomycin bulk | Salinomycin bulk | January,1989 | |
| Salinomycin premix | Salinomycin sodium.6% | Prevention of coccidiosis. | December,1988 |
| Salmeterol + fluticasone propionate inhaler | Each actuation delivers: salmeterol (as xinofoate).25mcg, fluticasone propionate BP.50mcg,125mcg,250mcg | Bronchial asthma where use of bronchodilator & an inhaled corticosteroid are appropriate. | 05.07.2001 |
| Salmeterol inhaler/rotacap | Each actuation delivers: salmeterol xinafoate.25mcg, Each rota caps contains; salmeterol xinafoate eq.to salmeterol.50mcg | Long term regular treatment of reversible airway obstruction in asthma, and chronic bronchitis. | 01.12.1993 |
| Salmeterol xinafoate + fluticasone propionate | Each single actuation delivers: salmeterol xinafoate eq.to salmeterol.25mcg, fluticasone propionate.50mcg, 125mcg, 250mcg | By RMP. for regular treatment of bronchial asthma where the use of a bronchodilator and an inhaled cortocosteroid are appropriate. | 09.11.2000 |
| Salmon calcitonin injection | Each ampoule contains: salmon calcitonin.100 IU/ml, Each vial contains; salmon calcitonin.400 IU/2ml | Hypercalcaemia pain associated with advanced metastic bone cancer, paget's disease, post menopausal osteoporesis. | 03.08.1995 |
| Salmon calcitonin nasal spray | Each metered dose delivers: synthetic salmon calcitonin.50IU,100IU,200IU | By RMP. in post menopausal osteoporosis, bone pain associated with osteolysis and/or osteopenia paget's disease. | 18.07.2000 |
| S.amlodipine tab/bulk | Each uncoated tab contains: s.amlodipine besilate eq.to s.amlodipine.2.5mg | Essential hypertension and angina pectoris. | 16.08.2002 |
| Sapindus saponin (Reetha saponin) (Cream) | Sapindus saponin (Reetha saponin) | May,2005 | |
| Saquinavir (500mg) tablet (Additonal Strength) | Saquinavir (500mg) tablet | Anti.AIDS | 20.03.2006 |
| Saquinavir (as mesylate) 500mg Tablet (Additonal Strength) | Saquinavir (as mesylate) 500mg Tablet | Addl.Strength. | 25.07.2005 |
| Saquinavir caps | Saquinavir caps | In the treatment of advanced HIV infection | 26.08.1997 to 26.08.1997 |
| Sarcolysin | Sarcolysin | Russian pharmacopoeia drugs | April,1965 |
| Sarcolysin I.P. | Sarcolysin I.P. | Anti cancer | June,1972 |
| Saroglitazar 2mg/4mg Tablets | Each uncoated tablet contains: Saroglitazar 2mg, 4mg. | For the treatment of diabetic dyslipidemia and hypertriglyceridemia with type.2 diabetes mellitus not controlled by statin therapy. | 25.02.2013 |
| Sarpogrelate Hydrochloride film coated Tablets 100mg | Each film coated tablet contains: Sarpogrelate hydrochloride.100mg | For the improvement of ischemic symptoms including ulcer, associated with chronic arterial occlusion. | 19.01.2010 |
| Satranidazole (300mg) + Ofloxacin (200mg) Tablet | For diarrhoea of mixed infection in adults. | 18.10.2007 | |
| Satranidazole tablets/bulk | Each tablet contains: Satranidazole.150mg | November,1985 | |
| Saxagliptin (as HCl) 2.5mg/ 5mg Tablets | Each film coated tablet contains: Saxagliptin hydrochloride eq.to saxagliptin.2.5mg, 5mg | As an adjunct to diet and exercise to improve glycemic control in adults with type.2 diabetes mellitus (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings). | 26.10.2009 |
| S.Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per ml | For surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block. | 28.04.2011 | |
| Secnidazole tablet | Each tablet contains: secnidazole.500mg, Each film coated tablet contains; secnidazole.1gm(20.5.94), Each 15ml suspension contains; secnidazole.500mg(19.2.98) | Intestinal amoebiasis, amoebic hepatitis, trichomonial vaginitis, bacterial vaginitis and giardiasis. | 13.05.1993 |
| Selamectin Tropical solution (for verterinary use) 60mg/120mg per ml | salamectin.60mg, 120mg | (I) For the treatement and lasting prevention of flea infestations,treatment and control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs and cats. (II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs. | 14.01.2009 |
| Selegiline hcl | Each uncoated tablet contains: Selegiline hcl.5mg. | Parkinsonism. Indicated in the treatment of Parkinson's disease. | August,1991 |
| Semduramicin sodium 5% premix | Each kg of premix contains: Semduramicin.50gm (eq.to semduramicin sod.) | 04.03.1998 | |
| Septopal beads and chains | Septopal beads and chains | Indicated for the treatment of bone and soft tissue infections. | January,1985 |
| Seratrodast tablets 40mg/80mg | Each tablet contains: Seratrodast.40mg, 80mg | As add.on therapy in bronchial asthma. | 30.11.2012 |
| Serenoa repens caps. | Each soft gelatin cap contains: 160mg lipid extract of serenoa repens. | For BPH. | 12.09.1997 to 12.09.1999 |
| Serratio peptidase tablets | Each tablets contains: Serratio peptidase.5mg | Oral enzyme. Indicated for the remission of various inflammatory disorders including post.operative inflammation and traumatic injury. | September,1985 |
| Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo | Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo | For the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp. | 05.03.2010 |
| Sertaconazole Nitrate Cream 2%, | Sertaconazole Nitrate Cream 2%, | For the topical treatment of the superficial mycosis like dermatophytosis. | 31.01.2008 |
| Sertaconazole Nitrate Vaginal Tab.500mg | Each vaginal tablet contains: Sertaconazole nitrate.500mg | For the treatment of vulvovaginal candidiasis in women. | 13.10.2008 |
| Sertanidazole.300mg + Ofloxacin.200mg tablet | Sertanidazole.300mg + Ofloxacin.200mg tablet | For treatment of diarrhoea of mixed infection in adults patients. | 29.11.2007 |
| Sertraline (For Additional Indication) | 50mg, 100mg | For additional indication | 12.02.2004 |
| Sertraline hcl | Each film coated tablet contains: Sertraline hcl eq.to sertraline.50mg,100mg | By psychiatrist only. for the treatment of i).pre menstrual dysphoric depression, ii).social anxiety disorders. | 23.02.2004 |
| Sertraline tab | Each film coated tab contains: Sertraline hcl eq.to 50mg,100mg sertraline and also 25mg (30.11.99 for panic disorder, unichem) | Major depressive disorders, obsessive compulsion disorders (OCD), panic disorders. | 09.06.1998 |
| Sevelamer (400mg/800mg) tablet | Each film coated tablet contains: Sevelamer Hcl.400mg, 800mg | For the control of serum phosphorus in patients with chronic kidney disease on hemodialysis. | 20.05.2005 |
| Sevelamer Carbonate (Additional Indication) | Sevelamer Carbonate | For control of serum phosphorus in patients with chronic kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl. | 26.11.2009 |
| Sevelamer Carbonate 400mg/800mg tablets & sachet 400mg/800mg | 1) Each film coated tablet contains: sevelamer carbonate.400mg, 800mg, 2) Each sachet contains:sevelamer carbonate.400mg, 800mg | For the control of serum phosphorus in patients with chronic kidney disease on dialysis. | 28.04.2008 |
| Sevelamer hydrochloride tablet | Each film coated tablet contains: sevelamer hydrochloride eq.to sevelamer.800mg | For the control of serum phosphorus in patients with chronic kidney disease on hemodialysis. | 10.07.2007 |
| Sevoflurane inhalation | Sevoflurane inhalation | For induction and maintenance of general anaesthesia in all procedures and patients types. | 09.07.1996 |
| Sheep pox vaccine | Sheep pox vaccine | April,1991 | |
| Sibutramine hcl monohydrate (D.A.R 15.4.97) | Each capsule contains: Sibutramine hcl monohydrate.5mg,10mg,15mg | Adjunct therapy for the management of obesity including weight loss and maintenance of weight loss in patients whose BMI is 30kg/m2 or higher. | 23.12.1999 |
| Sildenafil citrate | Each film coated tablet contains: Sildenafil citrate.25mg, 50mg, 100mg | By urologist, psychiatrist, endocrinologist.for treatment of erectile dysfunction in men. | 08.01.2001 |
| Sildenafil Citrate 20mg Tablet | Each film coated tablet contains: Sildenafil citrate eq.to sildenafil.20mg | For the treatment of pulmonary arterial hypertension (WHO group I) to improve excercise ability. | 23.01.2007 |
| Sildenafil Citrate Injection 0.8mg/ml | Sildenafil Citrate Injection 0.8mg/ml | For the treatment of pulmonary arterial hypertension (PAH) (WHO Group.1) to improve exercise ability and delay clinical worsening. | 05.12.2012 |
| Sildenafil Citrate Orally Disintegrating Strips. 25mg/50mg (Additional Dosage Form) | Sildenafil Citrate Orally Disintegrating Strips. 25mg/50mg | For the treatment of erectile dysfunction. | 05.07.2013 |
| Silodosin Capsules2mg/4mg/8mg | Each capsule contains: Silodosin.2mg, 4mg, 8mg | For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only. | 23.06.2011 |
| Silodosin Tablets 4mg | Silodosin Tablets 4mg | For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only. | 10.04.2012 |
| Silver Sulphadiazine | Silver Sulphadiazine.1%w/w | Antibacterial agent. indicated in the treatment of burn & wound infections. | September,1979 |
| Silver sulphadiazine ophthalmic ointment | Silver sulphadiazide.1% | April,1988 | |
| Silver Wound Dressing | Dressing contains; Silver sodium hydrogen zirconium phosphate.15±5%, nylon fiber.53±3%, polyester fiber.16±3%, polyurethane binder.4±2%, elastomer (Lycra) fiber.12±5%. | As an antimicrobial barrier for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions and Stage I.IV dermal ulcers (vascular, venous, pressure and diabetic). | 16.04.2008 |
| Silymarin tablets | Each sugar coated tab contains: Silymarin.70mg, also 140mg (Aug.1995, Ranbaxy,Microlab) | For supportive treatment in chronic liver disease and cirrhosis. | 22.06.1995 |
| Simethicone | 5 ml Gel & Tabs. | Gastric hyper acidity, heart burn, over indulgence. | July,1967 |
| Simethicone (methyl polysiloxane) | Simethicone (methyl polysiloxane) | October,1964 | |
| Simethicone Orally disintegrating strip 62.5mg | Simethicone Orally disintegrating strip 62.5mg | For the treatment of flatulance and as adjuvant in hyperacidity. | 14.11.2010 |
| Simvastatin (10/20mg) + Ezetimibe (10mg) Tab | Each film coated tablet contains: Simvastatin USP.10mg, 20mg, Ezetimib.10mg | For the treatment of patients with primary Hypercholesterolemia. | 11.05.2005 |
| Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules | Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules | For secondary prevention of coronoryheart disease/stroke in patients where use of such combination is appropriate. | 21.07.2009 |
| Simvastatin tab | Each tab contains: Simvastatin.5mg,10mg,20mg,40mg | Primary hypercholesterolemia, type Iia & Iib alone or in association with CAD | 25.09.1997 to 25.09.1999 |
| Sirolimus oral soln. | Each ml of soln.contains: Sirolimus.1mg/ml | Prophylaxis of organ rejection in patients receiving renal transplants. | 13.07.2002 |
| Sirolimus tab | Each uncoated tab contains: Sirolimus.1mg | For prophylaxis of organ rejection in patients receiving renal transplant along with the regimens of cyclosporins & corticosteroids. | 31.12.2002 |
| Sisomicin sulfate | Sisomicin sulfate | Aminoglycoside antibiotic. Indicated in the treatment of the systemic and local infections of the kidney, genitourinary tract, lower respiratory tract infections, septicemia, soft tissue infections, gastrointestinal tract infections, infections of the CNS peritonitis or pelvic. | April,1981 |
| Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets | Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets | As an adjunct to diet & exercise to improve glycemic control in patients with type.two diabetes mellitus. | 28.04.2008 |
| Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication) | Sitagliptin Phosphate 25/50/100 mg Tablet | (i) Use of Sitagliptin Phosphate in combination with Metformin and a PPARγ agonist as an adjunct to diet & exercise in adult patients with type.2 Diabetes mellitus who are inadequately controlled on combination therapy with Metformin and a PPARγ agonist. (ii) Use of Sitagliptin Phosphate in combination with insulin, alone or in combination with Metformin. | 03.07.2010 |
| Sitagliptin Tablet (25mg/50mg/100mg) | Each film.coated tablet contains: Sitagliptin.25mg, 50mg, 100mg | As adjunct to diet and exercise to improve glycemic control in patients with type.II diabetes. | 31.10.2007 |
| Nitroxazepine Hydrochloride | Each 2mL contains; Sitamil.25mg(Nitroxazepine Hydrochloride), Each tablet contains; Sitamil.25mg(Nitroxazepine Hydrochloride) | Developed in India. | September/ October,1973 |
| Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets | Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets | For the treatment of acute migraine. | 22.01.2008 |
| S.Metoprolol Succinate Oral Solution (Each Ml contains: S.Metoprolol Succinate 9.5mg equal to S.Metoprolol Tartrate 10mg) | Each Ml contains: S.Metoprolol Succinate 9.5mg equal to S.Metoprolol Tartrate 10mg | For the treatment of haemodynamically stably patients with definite or suspected acute Myocardial Infarction to reduce cardio.vascular mortality. | 19.08.2008 |
| Sodium and maglumine iothalamate | Meglumine iothalamate 52% w/v, sodium iothalamate 26% w/w | Contrast medium | July,1969 |
| Sodium chloride + Hypertonic saline | Sodium chloride.20%, Hypertonic saline | For intra amniotic use | October,1975 |
| Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L.malic acid 0.67gm in 1000ml solution for infusion | Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L.malic acid 0.67gm in 1000ml solution for infusion | Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present. | 11.02.2010 |
| Sodium Chloride IP + Sodium Acetate NF + Calcium Chloride USP + Magnesium Chloride BP + Potassium Chloride IP | (Mount mettur).Each 100ml contains: Sodium Chloride IP.20.047gm, Sodium Acetate NF.19.047gm, Calcium Chloride USP.0.859gm, Magnesium Chloride BP.0.366gm, Potassium Chloride IP.0.522gm, (Elys Hjekt). Sodium Chloride IP.20.475gm, Sodium Acetate NF.19.054gm, Calcium Chloride USP.0.972gm, Magnesium Chloride BP.0.534gm, Potassium Chloride IP.0.783gm | November,1978 | |
| Sodium chloride+ Potassium chloride+ Magnesium chloride+Calcium chloride dihydrate+20/6molar sodium lactate+ Dextrose anhydrous | Each 100mL contains: Sodium chloride.558mg, Potassium chloride.14.9mg, Magnesium chloride.10.16mg, Calcium chloride dihydrate.21.9mg, 20/6molar sodium lactate.1.34ml, Dextrose anhydrous.1.5gm | May,1973 | |
| Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection (Additional Strength) | Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection | For use as a surgical aid in anterior segments procedure including catract extraction & intra.ocular lens implantation. | 14.05.2008 |
| Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml) | Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml) | Same as Approved. | 25.08.2008 |
| Sodium Cromoglucolate | Sodium Cromoglucolate | Anti.asthmatic drug | November,1972 |
| Sodium Cromoglycate | Sodium Cromoglycate | May,1976 | |
| Sodium dichloro isocyanurate | Each tablet contains: Active ingredient.35mg,350mg, 1.75g, 3.5g | For chlorination of drinking water | 12.06.2000 |
| Sodium enoxaparin (LMWH) | Sodium enoxaparin injection low molecular weight heparin.20mg,40mg | As a prophylactic in the treatment of thromboembolic disorders during orthopaedic surgery, general surgery and haemodialysis. | 13.03.1992 |
| Sodium ferric gluconate complex in sucrose inj & bulk import | Each ml contains: sod,ferric gluconate complex with sucrose eq.to elemental iron.62.5mg (12.5mg/ml) | Treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy. | 05.09.2002 |
| Sodium Fluoride B.P. | Each enteric coated tablet contains: Sodium Fluoride B.P..20mg | ENT Specialists only | August,1975 |
| Sodium Fusidate | Each gm contains: Sodium Fusidate.20mg, application 3 times daily | Antibiotic. for the treatment of staphylococcal infections such as abscesses boils, carbuncles, varicose ulcer,eczema. | May,1974 |
| Sodium hyaluronate + chondroitin sulphate | Each ml of solution contains: sodium hyaluronate.30mg, sodium chondroitin sulphate.40mg | As a surgical aid in anterior & segment procedure including cataract extractran and inta ocular lens implantation. | 04.04.2000 |
| Sodium Hyaluronate 0.1% eye drops (Additonal Strength) | Sodium Hyaluronate 0.1% eye drops | Ophthalmic use. | 10.11.2005 |
| Sodium hyaluronate 2% Injection | Each ml of pre.filled syringe contains: sodium hyaluronate.20mg | To be used for facial tissue augmentation. | 14.01.2009 |
| Sodium Hyaluronate Cream 0.2% | Sodium Hyaluronate Cream 0.2% | For leg ulcer, diabetic ulcer etc. | 16.03.2006 |
| Sodium hyaluronate (0.1%) (Eye Drops) | Each ml contains: Sodium hyaluronate.0.1mg | For the treatment of sensation of ocular dryness and other minor complaints of no pathological significance such as burning and ocular fatigue induced for example by dust, smoke, dry atmosphere, air.conditioning, extended computer screen use or contact lens wear. | 16.01.2009 |
| Sodium hyaluronate (0.18 w/v) (Eye Drops) | Each ml contains: Sodium hyaluronate.1.8mg | For the treatment sensation of ocular dryness, and other minor complaints of no pathological significance viz., burning & ocular fatigue induced for example by dust, smoke, dry atmosphere, air conditioning, extended computer screen use or contact lens wear. | 21.06.2005 |
| Sodium Hyaluronate injectable gel (Each 0.6ml, 1ml pre filled syringe contains; sodium Hyaluronate 20mg/ml, 22.5mg/ml) | Each 0.6ml, 1ml pre filled syringe contains: sodium Hyaluronate 20mg/ml, 22.5mg/ml | For intradermal implantation and facial soft tissue augmentation. | 03.06.2008 |
| Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength) | Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml | Same as approved | 06.02.2010 |
| Sodium Hyaluronate Injection (1%) | Sodium Hyaluronate Injection (1%) | For OA. | 26.07.2006 |
| Sodium Hyaluronate Injection 8mg/vial (6ml Pre.filled syringe for Intra Articular use only) | Sodium Hyaluronate Injection 8mg/vial (6ml Pre.filled syringe for Intra Articular use only) | Indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesic. | 23.04.2012 |
| Sodium iron edetate | 55 mg | Iron chelate.EDTA | August,1961 |
| Sodium Nitroprusside | Each vial contains: Sodium Nitroprusside USP.50mg | To be supplied for use in hospitals /medical institutions/ clinics only | July,1979 |
| Sodium of Methylglucomine + 3,5.diacetamido.2,4,6.triodobenzoic acid | Sodium of Methylglucomine + 3,5.diacetamido.2,4,6.triodobenzoic acid | X.ray contrart media | May,1975 |
| Sodium phosphate | Each ml contains: monobasic sodium phosphate monohydrate.276mg, dibasic sodium phosphate heptahydrate.268mg. | By.RMP. patients on parenteral nutrition, increased excretion and decreased absorption of phosphorus, 'X' linked familial hypophosphalaemia decreased respiratory alkalosis, chronic alcoholism and patients of phosphate binding agents. | 31.08.2000 |
| Sodium picosulfate & liquid paraffin emulsion | Each 15 ml emulsion contains: sodium picosulfate.5mg, liquid paraffin.4.8ml | For constipation in adults. | 09.11.2001 |
| Sodium picosulphate | i).Each uncoated tab contains:sodium picosulphate.5mg,10mg ii).Each 5ml syrup contains: sodium picosulphate.5mg | Constipation bowel clearance before labour or surgery, radiological examination. | 11.02.1997 |
| Sodium polyhydroxy aluminium monocarbonate hexitol complex | 360 mg tabs | Antacid. | May,1963 |
| Sodium tolbutamide | Injection.diagnostic | Diagnostic | November,1962 |
| Sodium valporate | Sodium valporate | For additional indications: Manic episodes associated with bipolar disorders. | 17.07.2000 |
| Sodium valporate injection | Each vial contains: Sodium valporate freeze dried powder.400mg/ml | In treatment of generalised epilepsy as well as for partial epilepsy in patients for whom oral therapy is temporarily not possible. | 20.07.1999 |
| Sodium Valproate (750mg/1000mg) C.R. Tablet | Sodium Valproate (750mg/1000mg) C.R. Tablet | Addl.Strength | 26.08.2005 |
| Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate. 750mg CR tablet (Additional Strength) | Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate. 750mg CR tablet | Same as Approved. | 24.01.2008 |
| Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C.R. Tablet (Additional Strength) | Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C.R. Tablet | Same as Approved | 24.01.2008 |
| Sofalcone Capsule (100mg/50mg) | Each capsule contains: sofalcone.50mg, 100mg. | For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute exacerbation of chronic gastritis. | 02.06.2008 |
| Sofosbuvir Tablet 400mg | Each film coated tablet contains: sofosbuvir.400mg | In combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. | 13.01.2015 |
| Sofradex.F cream | Sofradex.F cream contains: framycetin sulphate.1%, dexamethasone.0.1%, clotrimazole.1% | In the treatment of dermatologic disorders caused or complicated by infection by bacteria and/or fungi along with inflammation. | 28.10.1993 |
| Solifenacin Succinate Tablet (5mg/10mg) | Solifenacin Succinate Tablet (5mg/10mg) | For overactive bladder with urge urinary incontinence urgency & urinary frequency. | 06.07.2006 |
| Solution for haemofiltration and haemodialysis | Each unit contains two compartments A & B. Before reconstitution; 1000ml of electrolyte solution in compartment A contains:calcium chloride.2H2O.5.145gm, magnesium chloride.2H2O.2.033gm, lactic acid.5.4gm, 1000ml of buffer solution in compartment B contains:sodium chloride.6.45gm, sodium bicarbonate.3.090gm | For treatment of acute kidney disease (renal failure), as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis. | 05.01.2011 |
| Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before reconstitution): • 1000ml of electrolyte solution in Compartment A contains: Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm Lactic Acid....5.4gm • 1000ml of buffer solution in Compartment B contains: Sodium Chloride....6.45gm Sodium Bicarbonate....3.090gm ) | Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before reconstitution): • 1000ml of electrolyte solution in Compartment A contains: Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm Lactic Acid....5.4gm • 1000ml of buffer solution in Compartment B contains: Sodium Chloride....6.45gm Sodium Bicarbonate....3.090gm ) | For treatment of acute kidney disease (renal failure), as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis. | 23.12.2010 |
| Somatostatin i.v infusion | Somatostatin i.v infusion | Severe acute haemorrhage from oesophegal varices/gastric or deodenal ulcers or acute erosive or haemorrhagic gastritis adjuvant treatment in pancreatic billiary and intestinal fistulae. Prophylaxis and treatment of postoperative complication following pancreatic surgery, adjuvant treat in diabetic keratoacidosis. | 24.04.1995 |
| Somatropin (r human growth hormone) (old molecule) | Each vial contains: rDNA developed human growth hormone.24IU (8mg) | By endorinologists. growth failure due to in adequate secretion of normal endogenous growth hormone. | 20.12.2000 |
| Somatropin (rDNA) injection | Vials.4 IU,16 IU, Cartridges.18 IU,36 IU,72 IU | For additional indication; i).for treatment of adult onset or childhood onset, adult growth hormone deficiency, ii).long term treatment of idiopathic short stature also called non growth hormone deficient short stature. Shelf life increase 24 months to 36 months when stored under 2Ċ.8Ċ. | 25.11.2004 |
| Somatropin (recombinant) inj. | Each cartridge for injection contains: somatropin (recombinant).36 IU (12mg powder) | Short stature due to inadequate or failed secretion of pituitary growth hormone. | 23.11.2001 |
| Somatropin injection (rDNA) | Each vial contains: 4 IU,16 IU, somatropin (rDNA), Each cartridge contains; 18 IU,36 IU, or 72 IU somatropin (rDNA) | Longterm treatment of children who have growth failure failure due to inadequate secretion of normal endogenous growth hormone and for treatment of short stature in children with Turner's syndrome confirmed by chromosomal analysis. | 04.02.1998 |
| Sorafenib (as Tosylate) (200mg) Tablet | Each tablet contains: sorafenib tosylate eq.to sorafenib.200mg | For the treatment of patients with advanced renal cell carcinoma. | 01.08.2007 |
| Sorafenib tablets 200mg (Additional Indication) | Sorafenib tablets 200mg | For hepatocellular Carcenoma. | 22.01.2008 |
| Sorafenib tosylate tablet 200mg (Additional indication) | Sorafenib tosylate tablet 200mg | For the treatment of patients with locally advanced or metastatic differentiated thyroid carcinoma refractory to radioactive iodine. | 25.09.2014 |
| Sorbide nitrate | 10 mg | Coronary vasodilator. | April,1962 |
| Sorbisteri capsules (Finish Formulation) | Each soft gelatin capsule contains: calcium loaded sulfonated polystyrene cation exchange resin 0.5gm (eq.to 1.8mEq Ca++), cross linked with 8% divinul benzene. | 13.09.1993 | |
| Sotalol | Sotalol | Beta.blocker. indicated in the treatment of angina pectoris, hypertension, cardiac arrythmias. | August,1978 |
| Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dlalpha.tocopherol 163.225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. | Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dlalpha.tocopherol 163.225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. | Total parenteral nutrition following major abdominal, major thoracic or major urological surgery. | 19.01.2010 |
| Sparfloxacin tablets | Each tab contains: sparfloxacin.100mg,200mg,400mg (100mg,400mg.Unichem 20.7.99) | Community acquired pneumonia, acute exacerbation of chronic bronchitis, other lower respiratory tract infection caused by susceptible bacteria, acute sinusitis genococcal and non genococcal urethritis in males uncomplicated UTI skin soft tissue infections, ENT infections. | 11.11.1996 |
| Spectinomycin hydrochloride | Spectinomycin hydrochloride | Anti gonorrheal agent. Indicated in the treatment of acute gonorrheal urethritis & proctitis in male and acute gonorrheal cervicitis & proctitis in females. | September,1985 |
| Spenglersan colloid G | Spenglersan colloid G | Immunomodulator | 02.06.1997 |
| Sphaeranthus indicus extract tablets | Each tablet contains: sphaeranthus indicus extract.700mg | For the management of psoriasis. | 08.01.2010 |
| Spiramycin inj. | Spiramycin inj. | November,1971 | |
| Spiranolactone | 100 mg, 4 times a day. | Promotes diuresis in patients with oedema or ascites, resistant or partly resistant to conventional diuretics. | March,1961 |
| Spironolactone 25mg + Furosemide 20mg tablets | Spironolactone 25mg + Furosemide 20mg tablets | For treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis. | 05.03.2010 |
| Spironolactone IP 25mg + Furosemide IP 40mg Tablet (Additional Strength) | Spironolactone IP 25mg + Furosemide IP 40mg Tablet | Additional strength | 05.01.2011 |
| Spironolactone tablets | Each tablet contains: Spironolactone.50mg | For the management of primary hyperaldosteronism and edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema, nephrotic syndrome, essential hypertension and hypokalemia. | 17.11.2005 |
| Stanozolol inj. | Stanozolol.50mg/ml | September,1987 | |
| Stavudine + lamivudine + neviramine tabs. | Each tab.contains: S tavudine.30mg,40mg, lamivudine.150mg, neviramine.200mg | HIV infections in adult patients. One patients have been stabilized on the maintenane regimen of neviramine 200mg B.D & have demonstrated adequate tolerability to neviramine. | 26.07.2001 |
| Stavudine 10mg + Lamivudine 40mg + Nevirapine 70mg dispersible tablet | Stavudine 10mg + Lamivudine 40mg + Nevirapine 70mg dispersible tablet | For HIV infection. | 11.11.2005 |
| Stavudine caps | Each cap contains; stavudine.15mg,20mg,30mg,40mg | Of adult patients with advanced HIV infection who are intoleratent of approved therapies. | 21.07.1997 to 12.07.1999 |
| Stavudine powder for suspension | Stavudine powder for suspension | For HIV.1 infusion. | 11.03.2005 |
| Stavudine SR 100mg tablet | Each SR tablet contains; stavudine.100mg | For the treatment of HIV infection in adults only. | 29.08.2006 |
| Sterile Solution for Peritoneal Dialysis | Each 1000 ml contains: Calcium chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + LAlanine 0.951 g/l + L. Arginine 1.071 g/l + L. Isoleucine 0.85 g/l + L. Histidine 0.714 g/l + L. Leucine 1.02 g/l + L. Lysine (as Hcl) 0.955 g/l + L.Methionine 0.85 g/l + LPhenylalanine 0.57 g/l + L.Proline 0.595 g/l + L. Serine 0.51 g/l + L. Threonine 0.646 g/l + L.Tryptophan 0.27 g/l + L.Tyrosine 0.3 g/l + L.Valine 1.393 g/l + Magnesium chloride hexahydrate 0.051 g/l + Sodium chloride 5.38 g/l + Sodium lactate 4.48 g/l | As Nutritional supplements for malnourished renal failure patients (Albumin concentration lower than 35 g/litre) being maintained on peritoneal dialysis. | 18.04.2012 |
| Sterillium rubin disinfectant for hands. | Sterillium rubin disinfectant for hands. | 20.05.1992 | |
| Streptococcus faecalis T.110 JPC 30 million + Clostridium butyricum TOA 2 million + Bacillus mesentericus TO.A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules | Streptococcus faecalis T.110 JPC 30 million + Clostridium butyricum TOA 2 million + Bacillus mesentericus TO.A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules | For restoration of intestinal microflora. | 15.03.2010 |
| Streptokinase.streptodornase | Anti.inflammatory. | April,1963 | |
| Stronger neo minophagen.c | Each 2ml contains: M onoammonium glycyrrhizinate.4mg (as glycyrrhizin), amino acetic acid.40mg, L.cystein hcl.2mg | Indicated for the management of subacute hepatic failure. | 14.12.1995 |
| Stronger neo minophagen.c injection | Same as above | For additional indication of cirrhosis with activity. | 05.05.1999 |
| Strontium Ranelate Granules (2gm/Sachet) | Each sachet contains; stronium ranelate (granule) anhydrus.2gm | For the treatment of osteoporosis in post.menopausal women. | 14.06.2005 |
| Sucralfate (7%) + Povidone Iodine (5%)Ointment | Each gm contains; sucralfate.70mg, povidone iodine.50mg | As topical anti infective in conditions like ulcer, wounds, cuts and skin infection. | 23.08.2005 |
| Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment | Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment | For infected wounds and ulcers. | 09.10.2007 |
| Sucralfate + Metronidazole + Lignocaine hcl cream | Each gm of topical cream contains: sucralfate.0.07gm, metronidazole.0.01gm, lignocaine.0.04gm | For RMP. for the treatment of bedsore, haemorrhoids, fistulae and anal fischers. | 23.08.2004 |
| Sucralfate + metronidazole cream | Each gm contains: Sucralfate.0.07g, metronidazole.0.01g | Bedsore, haemorrhoids, fistulae & fissures. | 29.04.2002 |
| Sucralfate tablets | Each tablet contains;: Sucralfate.1gm | Anti ulcer. Indicated in the treatment of gastric duodenal & benign ulcer. | November,1986 |
| Sucralose | Sucralose | for use as sweetner in drug formulations. | 09.05.2009 |
| Sucrolase USP (Bulk) | Sucrolase USP (Bulk) | 12.05.2009 | |
| Sufentanyl citrate i.v injection | Sufentanyl citrate i.v injection | 2004 | |
| Sulbactum sodium + ampicillin | Each vial contains: sulbactum sod.0.5gm, (6.5.92).250mg,1gm, ampicillin sod.1.0g, (6.5.92).500mg,2gm | September,1991 | |
| Sulbactum sodium + Cefoperazone sodium | Each vial of im/iv inj.contains: sulbactum sod. eq.to sulbactum.500mg, cefoperazone sod.eq.to cefoperazone.500mg | For treatment of i).RTI, ii).UTI(lower & upper), iii).Septicemia, iv).maningitis, v).skin & soft tissue infections, vi).endometritis, vii).other infections of genital tract, viii).intra abdominal infections, bone & joint infections. | 16.03.2000 |
| Sulbutiamine tabs | Each sugar coated tabs contains Sulbutiamine.200mg | Symptomatic treatment of functional asthenia. | 22.04.1996 |
| Sulfametopyrazine | Sulfametopyrazine | The drug sulphametopyrazine to be used only in manufacture of tablets containing this drug in combination with pyrimethamin for the treatment of cases of malaria which are resistant to chloroquin. | June,1978 |
| Sulfametopyrazine + Pyrimethamine | Each tablet contains: Sulfametopyrazine.500mg, Pyrimethamine.25mg | May,1978 | |
| Sulperazone sulbactum sodium + Cefoperazone sodium | Sulperazone sulbactum sodium + Cefoperazone sodium | 2000 | |
| Sulphachloropyrazine sodium 30% | Sulphachloropyrazine sodium 30% | 18.10.1993 | |
| Sulphadiazine + Trimethoprim tablets/suspension | Each tablet contains: sulphadiazine.400mg, trimethoprim.80mg, Each 5ml suspension contains; sulphadiazine.200mg, trimethoprim.40mg | January,1987 | |
| Sulpha.dimethoxy pyrimidine | Sulpha.dimethoxy pyrimidine | Chemotherapeutic, long acting. | April,1961 |
| Sulphadimethoxypyrimidine | Sulphadimethoxypyrimidine | October,1963 | |
| Sulpha.dimethyl oxazole (Sulfamoxole) | 1.2 g per day | Intermediate acting sulpha drug. | March,1962 |
| Sulphadoxine | Sulphadoxine | The drug sulphadoxine should be used only in the manufacture of tablets containing this drug in combination with pyrimethamine for the treatment of cases of malaria which are resistent to chloroquine. | April,1981 |
| Sulphamethoxy diazine | Sulphamethoxy diazine | Antibacterial | February,1965 |
| Sulphinpyrazone | Each tablet contains:100mg of Sulphinpyrazone, Each capsule contains; 200mg of Sulphinpyrazone | September,1977 | |
| Sulphinpyrazone USP | Sulphinpyrazone USP | September,1977 | |
| Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml) | Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml) | For diagnostic use in echocardiography doppler of macrovasculature an doppler of microvasculature. | 28.09.2007 |
| Sulpiride capsules | Each capsule contains: Sulpiride.50mg, 200mg(appr. On 14.3.2000) | In treatment of mild to moderate depression and neurotic depression. | 26.10.1999 |
| Sultamicillin tablets | Each film coated tablet contains: Sultamicillin (as tosylate).375mg (eq.to sulbactum 147mg and ampicillin 220mg) | In the treatment of intra abdominal infections, obstetrics and gynaecological infections, skin and soft tissue infections, bone and joint infections, upper and lower respiratory tract infections, ENT infections, urinary tract infections, gonorrhoea and surgical prophylaxis. | 06.05.1994 |
| Sulthiame | Sulthiame 200 mg tabs | Anti.convulsant, in the treatment of partial seizure especially psycho.motor or temporal epilepsy, rhininencepholic and diencephalic seizures also well controlled | June,1967 |
| Sumatriptan + Naproxen (50mg + 275mg) Tablets (Additional Lower Strength) | Sumatriptan + Naproxen (50mg + 275mg) Tablets | Additional Lower Strength. | 24.11.2008 |
| Sumatriptan 85 mg + Naproxen 500 mg Tablets | Sumatriptan 85 mg + Naproxen 500 mg Tablets | Additional Strength for the treatment of migraine. | 03.08.2009 |
| Sumatriptan nasal spray | Each actuation delivers: sumatriptan.5mg,20mg | Acute migraine attacks with or without aura only when there is a clear diagnosis. | 29.08.2001 |
| Sumatriptan tablets | i).Each film coated tab contains; sumatriptan (as succinate).100mg,50mg,25mg, ii).Sumatriptan injection contains; sumatriptan as succinate.6mg/0.5ml | Acute migraine attacks with or without aura, only where there is a clear diagnosis. | 06.02.1996 |
| Sunitinib malate Capsules 12.5mg/25mg (Additional Indication) | Sunitinib malate Capsules 12.5mg/25mg | Treatment of Unresectable or Metastatic Well.differentiated Pancreatic Neuroendocrine Tumours with Disease Progression in Adults. | 05.05.2011 |
| Sunitinib Maleate Capsules 12.5mg/25mg/50mg | Each hard gelatin capsule contains: sunatinib malate.12.5mg, 25mg, 50mg | For the treatment of G.I. Stromal tumor after disease progression on or intolerance to imatinib mesylate and advanced renal cell carcinoma. | 11.04.2007 |
| Super Oxidized Solution (containing Water 99.9% with salts like sodium hypochlorite, hypochlorous acid, hydrogen peroxide ozone, chlorine chloride, sodium hydroxide, sodium carbonate and sodium chloride) | Super Oxidized Solution (containing Water 99.9% with salts like sodium hypochlorite, hypochlorous acid, hydrogen peroxide ozone, chlorine chloride, sodium hydroxide, sodium carbonate and sodium chloride) | For use as cleaning and debriding agents in wounds management & care. | 12.06.2006 |
| Suramin | Suramin | September,1977 | |
| Synthetic ACTH bulk | Synthetic ACTH bulk | 15.11.2001 | |
| Synthetic Diosmin | Each tablet/capsule contains: Synthetic Diosmin.150mg | Haemorhoids. indicated in the treatment of haemorrhoids. | June,1979 |
| Tacalcitol ointment 4mcg | Each gram contains: Tacalcitol monohydrate.4.17mcg eq.to tacalcitol.4mcg | For the treatment of psoriasis vulgaris in adults only. | 26.09.2011 |
| Tacrine hydrochloride caps | Each capsule contains: Tacrine hcl.10mg,20mg,30mg,40mg | For the treatment of dementia in patients with Alzheimer's disease of mild to moderate severity. | 14.02.1996 |
| Tacrolimus Capsules 0.25mg | Tacrolimus Capsules 0.25mg | For the prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplant. | 03.12.2012 |
| Tacrolimus Capsules 0.5mg/1mg/5mg (Additional indication) | Tacrolimus Capsules 0.5mg/1mg/5mg | Lupus nephritis (in a case where the effect of steroids is insufficient or administration of steroids is difficult because of their adverse reactions). | 11.08.2011 |
| Tacrolimus Capsules 3mg (Additional Strength) | Tacrolimus Capsules 3mg | Same as Approved | 24.04.2010 |
| Tacrolimus Granules for oral suspension 0.2/1 mg per sachet | Tacrolimus Granules for oral suspension 0.2/1 mg per sachet | Prophylaxis of transplant rejection in kidney, liver or heart allograft recipient. | 26.11.2009 |
| Tacrolimus lipid suspension for injection | Each vial contains: Tacrolimus monohydrate eq.to tacrolimus.5mg | For prophylaxis of transplant rejection in liver, pancreas, lung, heart and kidney allograft recipients. And treatment of allograft rejection resistant to treatment with other immuno suppressive medicinal products. | 15.10.2008 |
| Tacrolimus ointment 0.03% & 0.1% (Not for children) | Each gm of ointment contains: Tacrolimus.0.3mg & 1mg | For dermatologists.For treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative convetional therapy is advisable. | 07.03.2003 |
| Tacrolimus oral capsules | Each capsule contains: tacrolimus 0.5mg,1mg,5mg | By nephrologists only. for the prophylaxis of organ rejection in patients receiving allogenic kidney transplant. | 21.05.2004 |
| Tacrolimus PR Caps 0.5/1/5 mg | Tacrolimus PR Caps 0.5/1/5 mg | For Prophylaxis of transplant rejection in adult kidney or liver allograft rejection. | 24.05.2010 |
| Tadalafil 10mg/20mg Tablets | Each film coated tablet contains: Tadalafil 10mg/20mg | For the treatment of erectile dysfunction in adult men. | 11.09.2003 |
| Tadalafil Orally Disintegrating Strip 10mg & 20mg (Additional Dosage Form) | Tadalafil Orally Disintegrating Strip 10mg & 20mg | For erectile dysfunction. | 30.07.2014 |
| Tadalafil Tablet 2.5mg/5mg | 2.5mg, 5mg | 1.For the treatment of erectile dysfunction. 2. For the treatment of erectile dysfunction with benign prostatic hyperplasia. | 27.02.2013 |
| Tadalafil tablet 20 mg (Additional Indication) | Tadalafil tablet 20 mg | For the treatment of pulmonary arterial hypertension. | 14.11.2009 |
| Tafluprost Eye Drops 0.0015% w/v | Each ml contains: Tafluprost.0.015mcg | For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. | 21.10.2011 |
| Tamsulosin + Finasteride | Each hard gelatin capsule contains: Finasteride, tamsulosin.0.04mg (as modified release pellets) | For the treatment of sign & symptoms of benign prostate hyperplasia. | 19.03.2004 |
| Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) Capsules (Additional Lower Strength) | Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) Capsules | Additional Lower Strength. | 17.11.2008 |
| Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet | Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet | For BPH. | 06.02.2006 |
| Tamsulosin hcl MR cap. | Each capsule contains: Tamsulosin hcl (as MR pellets).400mcg,200mcg | Signs & symptoms of benign prostatic hyperplasia. | 04.04.2002 |
| Tapentadol Extended release tablet 100/150/200mg (Additional Strength) | Tapentadol Extended release tablet 100/150/200mg | For use in in.patients under hospital setting for severe acute pain for a period not exceeding 5 days. | 09.12.2013 |
| Tapentadol Extended release Tablet 50mg (Additional Strength) | Tapentadol Extended release Tablet 50mg | For use in in.patients for dose titration under hospital settings for severe acute pain for a period not exceeding 5 days. | 12.11.2013 |
| Tapentadol Hydrochloride Tablets 50mg/75mg/100mg | Each film coated tablet contains: Tapentadol hydrochloride eq.to tapentadol.50mg, 75mg, 100mg | For relief of moderate to severe acute pain in adults 18 years of age or older. | 18.04.2011 |
| Taurolidine 2% or 0.5% | i).Each 100ml contains (2%); taurolidine.2g, povidone.5g, ii).Each 500ml contains (0.5%); taurolidine.2.5g, povidone.6.25g | 13.01.1994 | |
| Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (Additional Strength) | Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream | For Plaque psoriasis. | 24.05.2005 |
| Tazarotene (1mg) + Mometasone Furoate (1mg) per gram cream | Tazarotene (1mg) + Mometasone Furoate (1mg) per gram cream | For plaque psoriasis. | 01.04.2005 |
| Tegafur (100mg) + Uracil (224mg) capsule | Tegafur (100mg) + Uracil (224mg) capsule | For first line treatment of metastatic colorectal cancer in combination with calcium folinate. | 22.08.2007 |
| Tegaserod maleate tabs | Each uncoated tab contains: Tegaserod maleate eq.to tegaserod.6mg,2mg (appr.on 3.2.03) | For the treatment of constipation predominant irritable bowel syndrome (IBS) in adults. | 01.11.2002 |
| Teicoplanin for i.v/i.m infusion | Each vial contains: Teicoplanin.100mg.200mg,400mg | Glycopeptide antibiotic.use in serious gram +ve infection, staphylococcal infection in patients sensitive or unresponsive to penicillin and ciphalosporins CAPD related peritonitis, prophylaxis in ortho paedic surgery at risk of gram +ve infections. | 19.02.1997 |
| Telbivudine 600mg tablet | Each film coated tablet contains: Telbivudine 600mg | For the treatment of adult patients with chronic hepatitis B infection with evidence of viral replication and active liver inflammation. | 30.08.2006 |
| Telmisartan + hydrochlorthiazide tablets | Each uncoated tab contains: Telmisartan.40mg,80mg, hydrochlorthiazide.12.5mg | By RMP. for treatment of hypertension as 2nd line therapy. | 29.08.2003 |
| Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength) | Telmisartan + Ramipril (40mg + 2.5mg ) Tablets | For the treatment of essential hypertension. | 15.09.2008 |
| Telmisartan 20mg + Amlodipine Besylate Eq. to Amlodipine 2.5mg + Hydrochlorothizide 6.25mg Tablets (Additional Strength) | Telmisartan 20mg + Amlodipine Besylate Eq. to Amlodipine 2.5mg + Hydrochlorothizide 6.25mg Tablets | For the Treatment of Essential Hypertension. | 03.01.2013 |
| Telmisartan 40/80 mg + Indapamide SR 1.5/1.5 mg tablet | Telmisartan 40/80 mg + Indapamide SR 1.5/1.5 mg tablet | For the treatment essential hypertension. | 05.04.2010 |
| Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet | Each uncoated tablet contains: Telmisartan.40mg, amlodipine besylate BP eq.to amlodipine.5mg | For the treatment of essential hypertension in adults. | 30.08.2006 |
| Telmisartan 40mg + Atorvastatin (as calcium) 10mg Tablets | Telmisartan 40mg + Atorvastatin (as calcium) 10mg Tablets | For coexisting essential hypertension & hyperlipidemia. | 22.05.2008 |
| Telmisartan 80mg + Amlodipine 5mg tablet | Telmisartan 80mg + Amlodipine 5mg tablet | Additional higher strength. | 31.03.2009 |
| Telmisartan IP 80mg + Hydrochlorothiazide IP 25mg uncoated bilayered tablet (Additional Strength) | Telmisartan IP 80mg + Hydrochlorothiazide IP 25mg uncoated bilayered tablet | For the treatment of hypertension as second line therapy. | 14.05.2013 |
| Telmisartan tab | Each uncoated tab contains: Telmisartan.20mg,40mg,80mg | For mild to moderate hypertension. | 25.11.2002 |
| Telmisartan tablet 20/40/80 mg (Additional indication) | Telmisartan tablet 20/40/80 mg | For the prevention of cardiovascular morbidity and mortality in patient 55 years older at high risk of cardiovascular disease. | 14.05.2010 |
| Temoporfin 1mg/ml Injection (Additional Strength) | Temoporfin 1mg/ml Injection | Same as Approved. | 08.07.2008 |
| Temoporfin i.v injection | Each ml of i.v infusion contains: Temoporfin.2mg | Oncologist only. | May,2005 |
| Temoporfin solution for injection | Each ml contains: Temoporfin.4mg | For the palliative treatment of patients with advanced head & neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy surgery or systemic chemotherapy. | 14.06.2005 |
| Temozolamide capsules 140mg/180mg (Additional Strength) | Temozolamide capsules 140mg/180mg | Same as Approved. | 31.03.2008 |
| Temozolomide powder for solution for infusion | Each vial contains: Temozolomide.100mg | For the treatment of; i) Adult patients with newly.diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. ii) Children from the age of three years, adolescents and adult patients with malignant giloma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. | 28.05.2010 |
| Temsirolimus Concentrate for Infusion for Injection 25mg/ml | Each vial contains: Temsirolimus.25mg/ml | For the treatment of advanced renal cell carcinoma | 15.12.2010 |
| Teneligliptin Hydrobromide Hydrate 20mg | Each film coated tablet contains: Tenegliptin hydrochloride hydrate eq.to tenegliptin.20mg | "For the treatment of type 2 Diabetes Mellitus as a monotherapy adjunct to diet and Exercise." | 18.05.2015 |
| Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet | Each film.coated tablet contains: Emtricitabine.200mg, tenofovir disoproxil fumarate.300mg | For the treatment of HIV.1 infection in adults. | 07.08.2006 |
| Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet | Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet | For the treatment of adult patients with HIV infection. | 07.01.2008 |
| Tenofovir Disoproxil Fumarate Tablet (300mg) | Each film coated tablet contains: Tenofovir disoproxil fumarate.300mg | For the treatment of HIV.1 infection in combination with other anti.retroviral agents. | 17.08.2005 |
| Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet | Each film coated tablet contains: Efavirenz.600mg, emtricitabine.200mg, tenofovir disoproxil fumerate.300mg | For the treatment of HIV.1 infection in adults only. | 01.08.2006 |
| Tenofovir Disoproxil Fumerate 300mg | Tenofovir Disoproxil Fumerate 300mg | For the treatment of chronic Hepatitis B in adults. | 19.06.2009 |
| Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets | Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets | For the treatment of HIV infection in adults. | 23.07.2008 |
| Tenoxicam dispersible tabs | Each dispersible tab contains: Tenoxicam.20mg | 31.05.1995 | |
| Tenoxicam tablet | Each tablet contains: Tenoxicam.20mg | NSAID. rheumatoid arthritis, osteoarthritis, arthrosis, ankylosing spondylitis, gout, non.articular rheumatic conditions. | 29.04.1993 |
| Terazosin hcl tablet | Each tablet contains: Terazosin hcl eq.to 1mg,2mg,5mg of terazosin. | In the treatment of essential hypertension and BPH. | 27.01.1995 |
| Terbinafine tab/cream | Tablet.250mg, Cream.1% | Fungal infection of skin,hair nails. | 29.03.1995 |
| Terbutaline nebulising solution | Terbutaline sulphate **, aqueous solution.10mg/ml | For acute asthama. | March,1990 |
| Terbutaline sulphate with guaiphenesin syrup | Each 5ml contains: Terbutaline sulphate.1.5mg, guaiphenesin.66.5mg | October,1982 | |
| Terconazole vaginal ovule/vaginal cream | i).Each ovule contains; terconazole.80mg, ii).Terconazole vaginal cream contains; terconazole.0.8% | For the local treatment of vulvovaginal candidiasis (moniliasis) | 19.07.1994 |
| Terfenadine | Each tablet contains: Terfenadine.30mg,60mg,120mg, suspension.30mg/5ml | Anti histamine. Allergic rhinitis, allergic dermatological conditions and other histamine mediated disorders. | September,1990 |
| Terfinadine + Pseudoephedrine hcl E.R tabs (As Extended Release) | Each tablet contains: Terfinadine.60mg, pseudoephedrine hcl.120mg (as extended release) | 24.03.1995 | |
| Terizidone | Terizidone | Anti T.B. Drug. Indicated in the treatment of tuberculosis. | June,1981 |
| Terlipressin acetate injection i.v | Each vial contains: Terlipressin acetate.1mg | In the treatment of bleeding oesophagal varices. | 22.07.1995 |
| Tertatolol tablets | Each tablet contains: Tertatolol hcl.5mg | Anti hypertensive agent. Indicated in the treatment of hypertension. | June,1988 |
| Testolactone | Testolactone.10mg/mL | March,1975 | |
| Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injection | Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injection | For testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism. | 08.02.2007 |
| Testosterone decanoate & isocaproate | 100 & 250 mg of 1 ml | Androgenic | January,1964 |
| Testosterone Gel1%. | Testerone USP.1% w/w gel base. | For replacement therapy in male for conditions associated with deficiency or absence of endogenous testosterone viz. Primary hypogonadism & hypogonadotropic hypogonadism. | 12.07.2005 |
| Testosterone Transdermal Spray (12.5mg/spray) (Additional Lower Strength) | Testosterone Transdermal Spray (12.5mg/spray) | For replacement therapy in males with Testosterone deficiency. | 15.02.2006 |
| Testosterone transdermal Spray (25mg) | Each spray delivers: Testosterone.25mg | For replacement therapy in males for conditions with a deficiency or absence of endogenous testosterone. | 30.11.2005 |
| Testosterone Undecanoate 250mg/ml Injection | Each ml contains: Testosterone undecanoate.250mg | For Testosterone replacement therapy of male hypogonadism when testosterone dificiency has been confirmed by clinical features or biochemical tests. | 22.07.2008 |
| Testosterone undecanoate capsules | Each capsule contains: Testosterone undecanoate.40mg | Oral androgen. Indicated for replacement therapy in cases of hypergonadism and male climacteric in the treatment of gynaecomastia. | September,1985 |
| Tetanum & Diptheria Immunoglobin (Human) | Anti.tetanus activity.500IU, Anti.diptheria activity.1000IU | Anti.tetanium activity .500IU, Anti.Diptheria activity 1000IU | October,1977 |
| Tetrabenazine | Each tab contains: Tetrabenazine.25mg | In treatment of movement disorders associated with organic CNS conditions like Huntington's chorea, hemiballismus and senil chorea. | 10.03.1999 |
| Tetrachlorodecaoxide solution | Each 100ml contains: Tetrachlorodecaoxide.1.037mg. | Immuno modulator (tissue repair) of wounds with impaired healing such as infected wound, delayed post traumatic and post operative wound healing and delayed healing after operation. | 06.11.1992 |
| Tetracycline | Each capsule contains: Lymecycline eq. to 300mg of Tetracycline | October,1978 | |
| Tetracycline Hcl | Each Sustained release capsule contains: Tetracycline Hcl.250mg | August,1979 | |
| Tetracycline hcl + Broxyquinoline + Brobenzoxaldine | Tetracycline hcl.250+Broxyquinoline.200mg+Brobenzoxaldine.40mg | January,1969 | |
| Tetrahydro furfuryl salicylate + Ethyl nicotenate + n.Hexyl nicotinate | Tetrahydro furfuryl salicylate + Ethyl nicotenate + n.Hexyl nicotinate | Antirheumatic. | July,1963 |
| Tetramisole Hcl | Each 5mL contains: Tetramisole Hcl eq to 50mg og Tetramisole | December,1976 | |
| Tetramisole hydrochloride | Each tablet contains: Tetramisole hcl.50mg, 150mg | Anthelmintic | May,1970 |
| Tetramisole Hydrochloride | Tetramisole Hydrochloride.30% | July,1973 | |
| Tetranicotinoyl fructose | Each tablet contains: Tetranicotinoyl fructose.250 mg | December,1971 | |
| Thalidomide caps | Each cap contains: Thalidomide USP.50mg,100mg | For acute treatment of the cutaneous manifestation of moderate to severe erythema nodosum loprosum and for the treatment of multiple myeloma. | 12.08.2002 |
| Theonar | Theonar | January,1965 | |
| Theophylline 400mg SR + Montelukast 10mg Tablet | Theophylline 400mg SR + Montelukast 10mg Tablet | For the treatment of patients with bronchial asthma. | 31.03.2009 |
| Theophylline Anhydrous + Ephedrine Hcl + Diazepam + prednisalone | Each tablet contains: Theophylline Anhydrous.100mg, Ephedrine Hcl.10mg, Diazepam.1mg, prednisalone.1.5mg | March,1973 | |
| Theophylline Ethanoate of Piperazine | Each tablet contains: Theophylline Ethanoate of Piperazine . 0.25gm, Each mL contain Theophylline Ethanoate of Piperazine.0.125gm | November,1972 | |
| Thiabendazole | Thiabendazole | July,1968 | |
| Thiamine propyl disulphide | Thiamine propyl disulphide | July,1969 | |
| Thiethylperazine | 10 mg tabs., & 10mg/ml amp. | Antiemetic, antinausea and antivertigo action. | January,1968 |
| Thiethylperazine dimalate | Tablet.10.28mg of thiethylperazine dimalate, ampoule. Each ml contains; 10.86mg thiethylperazine dimalate | February,1969 | |
| Thiocholchicoside SR Tablet 16 mg | Thiocholchicoside SR Tablet 16 mg | As an adjuvant treatment in painful spasms associated with degenerative vertebral disorders and vertebral static problems, torticollis dorsal pain, low back pain, traumatological and neurological disorders. | 30.04.2010 |
| Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets | Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets | For the acute treatment of inflammatory musculoskeletal disorders associated with painful muscle spasm in adults. | 17.11.2008 |
| Thiocolchicoside 0.25% + Methyl salicylate IP 100mg + Menthol IP 50mg + Absolute alchol IP 50mg per gm gel | Thiocolchicoside 0.25% + Methyl salicylate IP 100mg + Menthol IP 50mg + Absolute alchol IP 50mg per gm gel | For the topical treatment of painful muscles spasms of skeletal musculature. | 11.10.2010 |
| Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets | Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets | For acute low back pain & other musculoskeletal painful and inflammatory condition in adults. | 11.06.2008 |
| Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets (Additional Strength) | Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets | Additional strength. | 25.04.2009 |
| Thiocolchicoside injection | Each 2ml ampoule contains: Thiocolchicoside.4mg | RMP. as an adjuvant treatment in painful spasm associated with degenerative vertebral disorders and vertebral static problem, torticollis dorsal pain, low back pain, traumatological and neurological disorders. | 25.03.2004 |
| Thiocolchicoside tablets | Each tab contains: Thiocolchicoside.4mg | As an adjuvant treatment in painful spasms associated with degenerative vertebral disorders and vertebral static problems, torticollis dorsal pain, low back pain, traumatological and neurological disorders. | 25.03.1996 |
| Thiophanate | Thiophanate | Anthelmentic | December,1973 |
| Thioproperazine | Tab.1mg, 5mg, 10mg, 25mg, amp.0.75% | Neuroleptic | June,1963 |
| Thiothixene | 10 mg tabs | Schizophrenic (anti.psychotic agent). | December,1967 |
| Thymogen intranasal formulation | Each vial contains: Thymogen.5mg/0.7ml | As an add on to convetional chemotherapy in breast cancer patients. | 12.02.2002 |
| Thymosin alfa.1 inj. | Each vial contains;: Thymosin alfa.1 1.6mg (lyophilized) | By gastroenterologist. in treatment of chronic hepatitis.B in patients 18 years of age or older with compensated liver diseases and hepatitis.B virus (HBV) replication. | 16.01.2001 |
| Tiagabine hcl tablets | Each film coated tablet contains: Tiagabine hcl USP.2mg,4mg,12mg,16mg. | By neurologists. as adjunctive therapy in treatment of partial seizure in adults and children 12 years and above. | 2004 |
| Tiamulin hydrogen fumarate solution for injection 162 mg/ml (Additional Dosage Form) | Tiamulin hydrogen fumarate solution for injection 162 mg/ml | For treatment and prevention of swine dysentery caused by Branchyspira hydodysenteriae. The product is not appropriate for use for the prevention of disease at the level of herd treatment but should only be used for prevention of swine dysentery in individual animals with a known history of exposure to diseased animals. | 17.04.2015 |
| Tiamulin soluble granules | Tiamulin hydrogen fumarate.45% | Indicated in the prevention & treatment of mycoplasma induced diseases of the respiratory tract including complications due to secondry infections only. | August,1986 |
| Tiapride Hydrochloride Tablets 25mg/50mg/100mg | Each uncoated tablet contains: Tiapride hydrochloride ph. Eur. Eq.to tiapride.25mg, 50mg, 100mg | For the treatments of agitation and aggressiveness in adult patients with cognitive impairment. | 23.06.2011 |
| Tiaprofenic acid tablets | Each tablet contains: Tiaprofenic acid.200mg,300mg | Anti inflammatory agent. Indicated in the treatment of post.operative period, sprains, fractures, various conditions. | December,1986 |
| Tiaprost trometamol injection (Iliren PGF2 alfa inj.) | Tiaprost trometamol.0.196mg eq.to 150mg of tiaprost | In inducing parturition in cows & buffalos. | 19.02.1997 |
| Tibolone tablets | Each tab contains: Tibolone.2.5mg | In the treatment of complaints resulting from the natural or surgical menopause. | 16.10.1996 |
| Ticagrelor Tablet 90mg | Ticagrelor Tablet 90mg | For the prevention of thrombiotic events (cardiovascular death, myocardial infarction and stroke) in patients with Acute coronary syndromes (ACS) unstable angina, non ST elevation Myocardial infarction (STEMI) including patients managed medically, and those who are managed with percutaneous those who are managed with percutaneous coronary intervention (PCI) or coronary artery by.pass grafting (CABG). | 03.05.2012 |
| Ticarcillin + Clavulanate acid inj. | Each vial contains: Ticarcillin.3gm, clavulanic acid.100mg | For the treatment of Bacterial infections caused by susceptible organisms in pediatric patients (age > 3 months) subject to all other conditions stipulated in initial permission of the drug remaining same. | 30.10.1996 |
| Ticlopidine | Ticlopidine | Addional indication prevention of subacute occlusion following coronary stent implantation. | 03.03.2000 |
| Ticlopidine hcl tablets | Each tablet contains: Ticlopidine hcl.250mg | Antiplatelet agent. for the prevention of cerebro and cardio vascular accidents in patients suffering from asterial insufficiency in the legs and cerebral vessels and correction of platelet disorders induced by extra corporeal circuits during surgery with extra corporeal circulation or haemodialysis (artificial kidney) | 11.02.1993 |
| Tigecycline powder For Inj. 50mg/vial | Tigecycline powder For Inj. 50mg/vial | For skin & skin structure infection & intra abdominal infection. | 28.08.2006 |
| Tilmicosin aqu.conc. Liquid | Each ml of aq.conc.liquid contains: Tilmicosin.250mg | In treatment of chronic respiratory diseases in poultry | 23.08.2002 |
| Timolol maleate + Pilocarpine hcl | Each ml of ophthalmic solution contains: Timolol maleate.5mg (as base), pilocarpine hcl.20mg | For reduction of intraocular pressure in patients with ocular hypertension or open angle glaucoma | 25.01.2000 |
| Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml | Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml | For the treatment of elevated intraocular pressure in patient with ocular hypertension or open angle glaucoma. | 14.05.2010 |
| Timolol maleate ophthalmic solution | i).Each 1 ml contains; timolol maleate eq.to 2.5mg of timolol, ii).Timolol maleate eq.to 5mg of timolol. | Indicated in the treatment of chronic open angle glaucoma, ocular hypertension, ophthalmic glaucoma, intraocular pressure. | July,1985 |
| Timolol Maleate SR Eye Drops 5.0mg/ml | Timolol Maleate SR Eye Drops 5.0mg/ml | For the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma. | 08.11.2008 |
| Timozolamide | Each capsule contains: Timozolamide.5mg,20mg,100mg,250mg | For the treatment of adult patients with recurrent malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma. | 17.01.2000 |
| Tinazoline bulk/nasal drops | Tinazoline hcl.0.08% solution | Nasal decongestant.Acute cold vasomotor rhinitis to facilitate rhinoscopy and to aid drainage of secretions in affectious of the paranasal sinuses. | August,1985 |
| Tinidazole | 150 mg t.i.d for 5days | Trichomonial agent. for the treatment of trichomoniasis & intestinal amoebiasis. | February,1974 |
| Tinidazole + Diloxanide furoate | Each tablet contains: Tinidazole.150mg, diloxanide furoate.250mg | September,1984 | |
| Tinidazole + Norfloxacin tabs | Each tab contains: Tinidazole.600mg, norfloxacin.400mg | 09.05.1995 | |
| Tinidazole CDDS tab | Each tab contains: Tinidazole.500mg | For amoebiasis & giardiasis in adult patients only. | 25.11.2002 |
| Tinidazole infusion | Tinidazole i.v infusion.2mg/ml in 400ml infusion bottle, 2mg/ml in 800ml infusion bottle. | In the treatment of anaerobic infections. | February,1990 |
| Tinidazole suspension | Each 5ml contains: Tinidazole.75mg | December,1983 | |
| Tioconazole Vaginal Gel 65mg per gm | Each gm contains: Tioconazole.65mg | For the local treatment of vulvo vaginal candidiasis in adult patients. | 22.03.2011 |
| Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules | Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules | As 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately. | 31.01.2008 |
| Tiotropium bromide rotacaps | Each cap contains: Tiotropium bromide.18mcg | For maintenance treatment of COPD | 16.04.2003 |
| Tirofiban (0.25mg/ml injection) (Additional Strength) | Tirofiban Hcl. (0.25mg/ml) in 25ml & 50ml pack sizes. | In combination with heparin for the treatment of acute coronary syndrome including patients undergoing PTCA or atherectomy. | 09.03.2005 |
| Tirofiban infusion | Each 1 ml inj.contains: Tirofiban (as hcl).0.05mg | By specialists only. in combination with heparin for the treatment of acute coronary syndrommes including patients undergoing PTCA or atherectomy. | 12.08.2003 |
| Tiropramide Hcl (100mg) tablet | Tiropramide Hcl (100mg) tablet | For abdominal spasmodic pain, colics of hepatobilliary track, abdominal colics. | 22.08.2006 |
| Tissel kit | 1 ml of reconstituted tisseol solution contains: clottable protein.75.115mg, thereof fibrinogen.70.110mg, plasmafibronectin (CIG).2.9mg, factor XIII 10.50 u2, plasminogen 40.120 mcg, aprotinin soln (bovine).3000 KIU/ml3 | For achieving hemostasis to seal or glue tissues and to support wound healing, by RMP | 30.05.2000 |
| Tizanidine hcl tablet | Each tablet contains: Tizanidine hcl.2mg,4mg | Painful muscle spasm, spasticity due to neurological disorders. | 22.12.1993 |
| Tobramycin + flurometholone ophthalmic suspension | Each ml contains: Tobramycin sulph. USP eq.to tobramycin.3mg, flurometholone USP.1mg | Steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated & where superficial ocular bacterial infection exists. | 12.09.2002 |
| Tobramycin Inhalation solution (300mg/5ml) | Tobramycin Inhalation solution (300mg/5ml) | For chronic pulmonary infection cystic fibrosis. | 22.03.2006 |
| Tobramycin injection | Each ml contains: Tobramycin.10mg,40mg | Antibiotic. Indicated in the treatment of serious bacterial infections such as septicaemia, lower respiratory tract infections, serious central nervous system infections, intra.abdominal infections, complicated & recurrent urinary tract infections, skin & bone infections. | September,1985 |
| Tobramycin ophthalmic solution | Tobramycin sulphate ophthalmic solution.0.03% per vial. | March,1987 | |
| Tofacitinib Tablets 5 mg | Each film coated tablet contains: Tofacitinib citrate eq.to tofacitinib.5mg | “For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to Methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease.modifying antirheumatic drugs (DMARDs)”. | 01.04.2016 |
| Tofisopam uncoated tablet JP... 50/100mg | Each uncoated tablet contains: Tofisopam JP.50mg, 100mg | For the treatment of anxiety and depression. | 16.04.2010 |
| Tolfenamic acid cap | Cap. 200mg | Additional indication of migraine | 07.01.2002 |
| Tolfenamic acid caps | Each acpsule contains: Tolfenamic acid.200mg | Rheumatoid arthritis, osteo arthritis, ankylosing spondylitis and releated conditions associated with pain. | 04.03.1998 |
| Tolnaftate | 1% sol. In bottle of 10 cc | Treatment of dermatomycosis. | January,1969 |
| Tolnaftate + Nystatin | Each gm contains: Tolnaftate.10mg, Nystatin.100,000 Units | February,1977 | |
| Tolperisone HCL 150mg + Paracetamol IP 500mg tablet | Tolperisone HCL 150mg + Paracetamol IP 500mg tablet | For the treatment of patients with acute painful musculoskeletal conditions. | 21.10.2010 |
| Tolperisone HCl 450mg + Diclofenac Sodium IP100mg SR tablets (Additional Strength) | Tolperisone HCl 450mg + Diclofenac Sodium IP100mg SR tablets | For the treament of Patients with acute muscle/musculo skeletal spasm in adul. | 12.04.2013 |
| Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets | Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets | For the treatment of Patients with acute muscle/musculoskeletal spasm in adult. | 07.12.2011 |
| Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Form) | Tolperisone HCl Mouth Dissolving tablet 50/100 mg | Same as Approved. | 04.11.2010 |
| Tolperisone Hcl SR 450mg Tablets | Tolperisone Hcl SR 450mg Tablets | For the relief of painful muscle spasms of the skeletal muscualture. | 30.03.2010 |
| Tolperisone HCl Tablet 50 / 100 / 150mg | Each film coated tablet contains: Tolperisone Hcl.50mg, 100mg, 150mg | For the relief of painful muscle spasms of the skeletal musculature. | 01.10.2008 |
| Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule | Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule | For BPH with overaction bladder in Adults only. | 15.06.2007 |
| Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet | Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet | For BPH with overactive bladder. | 15.06.2007 |
| Tolterodine Tartrate Extended release tablets 2mg/4mg (Additional Dosage Form) | Tolterodine Tartrate Extended release tablets 2mg/4mg | For the treatment of overactive bladder with symptoms of urge urinary incontinence, urinary incontinence, urgency and frequency. | 31.01.2014 |
| Tolterodine.L.tartrate | Each tab contains: Tolterodine.L.tartrate.2mg eq.to tolterodine.1.37mg | For treatment of patients wth symptoms of over active bladder including urinary frequency & urgency with or without urge inconsistence. | 13.09.2001 |
| Toltrazuril 2.5% solution | Each 100ml contains: Toltrazuril.2.5gm | For treatment of coccoidiasis in poultry. | 08.06.2001 |
| Toltrazuril solution | Each 100ml solution contains: Toltrazuril.2.5gm | 30.04.1998 | |
| Tolvaptan Tablets 15/30mg | Each uncoated contains: Tolvaptan.15mg, 30mg | For the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirhossis, and syndrome of inappropriate antidiuretic hormone (SIADH). | 06.09.2012 |
| Topiramate sprinkle capsule (Additional Strength) | Each capsule contains: Topiramate.15mg | Additional strength. | 24.12.2001 |
| Topiramate tablets & sprinkle capsules (For Additional Indication) | Topiramate tablets & sprinkle capsules | For additional indication. | October,2004 |
| Topiramate tablets (Finished Formulation) | Each tab contains: Topiramate.25mg,50mg,100mg,200mg,300mg,400mg, Each sprinkle cap.contains topiramate.25mg,50mg (appr on 12.2.2001) | In the treatment of partial and generalized tonic clonic seizures. | 23.08.1999 |
| Topotecan Hydrochloride capsules 0.25/1mg (New Dosage Form) | Topotecan Hydrochloride capsules 0.25/1mg | same as approved | 28.11.2011 |
| Topotecan injection concentrate | Each single dose vial contains: Topotecan hcl eq.to topotecan 4mg/vial | Metastatic ovarian cancer after failure of first line chemotherapy. | 15.06.1999 |
| Torasemide tab | Each tab contains: torasemide.5mg,10mg (20mg,100mg, 10mg/ml.appr on 7.8.2004 to cipla) | For treatment of oedema associated with CHF, renal or hepatic disorders and essential hypertension. | 09.06.2003 |
| Torsemide 10mg + Amiloride 5mg tablets | Each tablet contains: Torsemide.10mg, amiloride.5mg | For the treatment of oedema associated with congestive heart failure & hypertension. | 17.01.2007 |
| Trabectedin powder for Conc. solution for infusion (Additional Indication) | Trabectedin powder for Conc. solution for infusion | In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinumsensitive ovarian cancer. | 20.03.2010 |
| Trabectedin powder for concentrate for solution for infusion | Each vial contains: Srabectedin.0.25mg | For the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents. | 01.04.2009 |
| Trace metal additive infusion (TMA infusion) | Each ml contains: ZnSO4.0.660mg (heptahydrate eq.to elemental zinc 0.15mg), CuSO4.0.236mg (pentahydrate eq.to elemental copper 0.06mg), chronic chloride.1.83mg (anhydrous eq.to elemental chromium 0.6mg), MnSO4.0.047mg (monohydrate eq.to elemental magnaese 0.015mg), benzylalcho.1% (preservative) | 08.10.1994 | |
| Tramadol hcl + paracetamol tab | Each film coated tab contains: Tramadol hcl.37.5mg, paracetamol.325mg | For short term(five days or less) management of acute pain in adults. | 09.01.2003 |
| Tramadol HCL 200mg Controlled Release tablet (Additional Dosage Form) | Tramadol HCL 200mg Controlled Release tablet | For use in in.patients under hospital settings for severe acute pain for a period not exceeding 5 days. | 12.09.2013 |
| Tramadol hcl ER tab | Each ER tab contains: Tramadol hcl.300mg,400mg | Additional strength. management of moderate to severe pain. | 20.05.2003 |
| Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg Tablets | Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg Tablets | For the symptomatic treatment of moderate to severe pain in adult patients. | 21.11.2011 |
| Tramadol hydrochloride injection | Each capsule contains:Tramadol.50mg,100mg, Each 1ml ampoule contains: Tramadol hcl.50mg, Each 2ml ampoule contains:Tramadol hcl.100mg | Analgesic. Severe acute and chronic pain, diagnostic measures and surgical pain. | 27.01.1993 |
| Tramadol SR | Tramadol SR | Moderate to severe pain. | 27.01.1998 |
| Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg /240mg/180mg | Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg /240mg/180mg | Anti hypertensive. | 23.11.2006 |
| Trandolapril tablets (Bulk+ Formulation) | Each tablet contains: Trandolapril.1mg,2mg,4mg | RMP only. for the treatment of mild to moderate hypertension. | 03.10.2003 |
| Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet | Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet | For primary dysmenorrhoea and pain associated with menorrhagia in women. | 22.02.2005 |
| Tranexamic acid Mouth Wash (50mg/ml) | Tranexamic acid Mouth Wash (50mg/ml) | For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery. | 15.06.2007 |
| Tranexamic acid mouthwash (50mg/ml) | Each ml contains: Tranexamic acid.50mg | For the prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery. | 15.06.2007 |
| Tranexamic Acid Tab SR 750mg | Tranexamic Acid Tab SR 750mg | For the treatment of menorrhagia. | 20.02.2009 |
| Tranexamic acid tablets/inj. | Tranexamic acid tablets/inj. | Additional indication.abnormal bleeding in which local hyperfibrinolysis is considered to be involved (pulmonary, haemorrhage, epistaxis, renal bleeding abnormal bleeding during or after prostate surgery). | 06.06.2003 |
| Tranylcypromine sulphate | 10 mg tabs | Anti.depressant | 1962. December |
| Trapidil | Each capsule contains: trapidil.100mg,200mg, Each ml of inj.contains; trapidil.50mg | For prevention of restenosis after percutaneous transluminai coronary angioplasty (PTCA) in patients of athero sclerosis arterial disease. | 11.05.2000 |
| Trastuzumab powder concentrate infusion | Each vial contains: Trastuzumab.440mg | By cancer specialist.in metastatic breast cancer who have tumours that over express human epidermal growth factor receptor.2 (HER2) | 10.07.2000 |
| Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops | Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops | For decrease of intraocular pressure in patients with open angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta blockers or prostaglandin analogues. | 28.01.2008 |
| Travoprost (40mcg/ml) (Eye Drops) | Each ml contains;: Travoprost.40mcg | For the reduction of intraocular pressure in patients with open angle glaucoma & ocular hypertension. | 08.12.2005 |
| Trazadone tablets/capsules | Each tablet/capsule contains: Trazadone.25mg,50mg,100mg | Anti depressant. Indicated in the treatment of all types of depression. | July,1987 |
| Tretinoin | Airal vanishing cream.Each 20gm contains: Tretinoin.0.05%, Airal lotion. Each 50mL contains; Tritinoin. 0.05% | Topical acne therapy. For the treatment of Acne vulgaris. | July,1974 |
| Tretinoin + Cream tretinoin | Each Swab contains: Tretinoin.0.05%, Cream.Tretinoin 0.05% | July,1974 | |
| Tretinoin Microsphere Gel (0.1% W/V) | Tretinoin Microsphere Gel (0.1% W/V) | For topical treatment of acne vulgaris. | 26.08.2008 |
| Tretinoine Gel as Micro Sphere 0.04% % 0.1% | Tretinoine Gel as Micro Sphere 0.04% % 0.1% | For topical treatment of Acne vulgaris. | 14.10.2008 |
| Triamterene | Triamterene | Diurectic | February,1965 |
| Triamterene + Hydrochlorthiazide | Each tablet contains: Triamterene.50mg, Hydrochlorthiazide.25mg | September,1975 | |
| Trichlormethiazide USNF | Each tablet contains: Trichlormethiazide USNF.2mg | Diuretic. in the treatment of hepatic cirrohsis, edema, hypertension. | December,1978 |
| Triclabendazole bolus and suspension | Bolus.250mg,900mg, suspension.5%,10%w/v. | Broad spectrum flubicide. Indicated in the treatment of chronic fasciola gigantica, F.hepatica in sheep, goats, cattle and buffaloes. | September,1988 |
| Triclobendazole + Levamisol hcl suspension | Each 100ml of suspension contains: Triclabendazole 5gm,12.0gm, levamisole.3.75gm,7.5gm. | Indicated in the treatment and control of mature and developing immature infections of haemonchus, ostertagia, trichostrongylus, cooperia, nematodinus, bunostomum, oesophagastomum and dictyocaulus and all forms of liver fluke infection (early immature, immature and adult stage of fasciola hepatica and f.gigantica) in sheep/cattle. | 24.07.1992 |
| Triclofos | Triclofos | Hypnotic | December,1964 |
| Triethanalamine trinitrate bisphosphate | 8mg to 16mg daily | Treatment of Angina pectoris. It is a vasodilator like glyceryl trinitrate. | March,1961 |
| Trifluoperazine & Tranylcypromine | 1 & 10 mg | Antianxiety & depression. | August,1963 |
| Trifluoperazine dihydrochloride | Trifluoperazine dihydrochloride | Psychotic & psychoneurotics. | February,1967 |
| Trifluperidol Hcl | Oral liquid.Each 5mL contains:Trifluperidol Hcl.5mg, Injection.Each ml contains; trifluperidol hcl.1mg, Tablet.0.25mg, 0.5mg | Neuroleptic agent. | May,1973 |
| Trifluridine Eye Drops 1% w/v | Trifluridine Eye Drops 1% w/v | For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2. | 08.12.2011 |
| Triflusal | Each capsule contains: Triflusal.300mg | By RMP. for treatment & prevention of vascular thromboembolism. | 17.01.2001 |
| Trihexyphenidyl hcl. Sustaine release tab | Sustaine release tab | November,1962 | |
| Trimebutine Maleate | Each coated tablet contains: Trimbutine maleate eq.to trimebutin.100mg, 200mg | For the treatment of relief of symptoms associated with irritable bowel syndrome. | 10.10.2005 |
| Trimetazidine Dihydrochloride | Each tablet contains: Trimetazidine Dihydrochloride.3mg | Cardiac drug, indicated in the treatment of angina pectoris and intermittant Claudication | June,1980 |
| Trimetazidine modified release tablet | Each modified release film coated tablet contains: Trimetazidine Di Hcl.35mg | Ischaemic heart disease, angina pectoris, sequalaes of infarction. | 03.12.2001 |
| Trimethoprim + Sulfamoxole | Trimethoprim + Sulfamoxole | Indicated in the treatment of respiratory tract infection, urogenital infections, G.I. Tract infections etc. | September,1975 |
| Trimethoprim + sulmethoxazole | i).Each tablet contains:Trimethoprim.80mg, Sulphamethoxazole.400 mg, ii).Paediatric tablet.each tablet contains: Trimethoprim.20mg and Sulphamethoxazole.100 mg, iii).Suspension.each 5ml contains: Trimethoprim.40mg and Sulphamethoxazole.200 mg | Chemotherapeutic agent | July,1970 |
| Trimethoprim + Sulphadoxime | Trimethoprim . 4% w/v, Sulphadoxine . 20% w/v | July,1974 | |
| Trimethoprim + Sulphadoxine | Trimethoprim + Sulphadoxine | Bacterial infections in cattle. | September,1973 |
| Trimethoprim + Sulphamethoxazole | Each 5mL ampule contains: Trimethoprim.80mg, Sulphamethoxazole.400mg | For hospitals | October,1976 |
| Trimethoprim + Sulphamethoxozole | Each 3mL ampoule contains: Trimethoprim.160mg, Sulphamethoxozole.800mg | January,1979 | |
| Trimethoprim tablets | Each tablet contains: Trimethoprim.100mg | June,1983 | |
| Trimethoxazine | Trimethoxazine | Tranquiliser (minor) | April,1965 |
| Trimethoxysilyl Quaternary Ammonium Chloride 0.40% hand protectant and sanitizer | Trimethoxysilyl Quaternary Ammonium Chloride.0.40% | Hand Protectant and Sanitizer for external use. Effective upto 24 hours. | 11.06.2013 |
| Trimethoxysilyl Quaternary Ammonium Chloride solution for spray inanimate surfaces for disinfection 0.71%. | Trimethoxysilyl quaternary ammonium chloride.0.71% | Surface protectant and disinfectant for persistent disinfection of all inanimate surfaces. Effective upto 14 days. | 16.11.2012 |
| Trimethyl psoralen | Trimethyl psoralen | April,1965 | |
| Trinovum (triphasic oral contraceptive) | Each pill contains:0.5mg norethindrone + 35mcg ethinyloestradiol, Each pill contains; 0.75mg norethindrone + 35mcg ethinyloestradiol, Each pill contains; 1mg norethindrone + 35mcg ethinyloestradiol. | January,1988 | |
| Triphasic oral contraceptive tablets | Each tablet contains: Norgestimate, Ist day.180mcg. 2nd day.215mcg, 3rd day.250mcg, Ethinyloestradiol, 1st day.35mcg, 2nd day.35mcg, 3rd day.35mcg | 29.06.1993 | |
| Triple chamber bags for peritoneal dialysis soln.B.P | Compartment A.61ml; Each 1000ml contains: dextrose IP eq.to dextrose anhydrous.453.0gm NaCl IP.5.67gm, water for injection.q.s, Compartment B.104ml; Each 1000ml contains;dextroseIP eq.todextrose anhy.453.0g, NaCl IP.5.67g, WFI.q.s, Compartment C.1969ml; Each 1000ml contains;NaCl IP.5.67g, CaCl2 Ip.0.279g, MgCl2 IP.0.165g, Sod.lactate sol B.P eq.to sod.lactate .4.259g, WFI.q.s | For peritoneal dialysis. | 25.09.2001 |
| Tripotassium dicitrato bismuthate | Tripotassium dicitrato bismuthate | March,1989 | |
| Tripotassium dicitrato bismuthate chewable tablets/suspension | Chewable tablet.each contains:120mg of tripotassium dicitrato bismuthate calculated as bismuth, Suspension.each 5ml contains: 120mg as TDB calculated as bismuth. | Anti ulcer. Indicated in the treatment of gastric & duodenal ulcers. | January,1989 |
| Triptorelin controlled release injection (Finished Formulation Import) | Triptorelin controlled release injection | For the treatment of prostate cancer, ovarian cancer, breast cancer, precocious buperty, uterine fibroids, myomes, polycystic ovarian disease and pre.treatment in I.V.F | 05.07.1993 |
| Trithiopara methoxy phenyl propene | Trithiopara methoxy phenyl propene | Oral formulation | October,1962 |
| Trithioparamethoxy phenyl propene | Each tablet contains: Trithioparamethoxy phenyl propene.12.5mg | May,1969 | |
| Trithioparamethoxy phenyl propene + chlopheniramine maleate | Each tablet contains: Trithioparamethoxy phenyl propene.12.5mg, chlopheniramine maleate.3.0mg | May,1969 | |
| Trofodermin cream | Each 100gm contains: Clostebol.500mg, neomycin sulphate.500mg | June,1985 | |
| Trofosfamide | Each tablet contains: Trofosfamide.50mg | To cancer hospitals or institution and against prescription of cancer specialists | August,1976 |
| Trofosfamide | Trofosfamide | Indicated in the treatment of lymphogranulomatosis, lymphosarcoma, reticulosarcoma,ovarian carcinoma, carcinoma of breast. | November,1975 |
| Trolamine 0.67% (w/w) topical emulsion | 0.67% w/w | For change in warning; to be sold by dermatologist only. | 25.03.2004 |
| Trolamine cutaneous emilsion | Topical emulsion containg: Trolamine.0.67% w/w. | By dermatologists. for secondry erythema due to radiation therapies first, second degree burns and other non infected cutaneous wounds. | 25.03.2004 |
| Trolamine topical emulsion | Trolamine topical emulsion | For additional specialists.oncologists | 14.05.2004 |
| Tromantadine hcl ointment | Tramantadine hcl.1gm, gel base ad.100gm | Herpes simplex infection of the skin. | 23.02.1995 |
| Tropicamide sterile | Tropicamide USP.1% w/v and 0.5% w/v. | For mydriasis and cycloplegia in diagnostic procedures. | March,1990 |
| Trospium Chloride ER Capsules 60 mg | Trospium Chloride ER Capsules 60 mg | For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency. | 04.09.2009 |
| Trospium Chloride film coated tablet 20mg | Each film coated tablet contains: Trospium chloride BP. 20mg | For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frequency. | 01.06.2009 |
| Troxipide film coated Tablets 50mg /100mg | Each film coated tablet contains: Troxipide.50mg, 100mg | For the treatment of Gastric ulcers and for amelioration of gastric mucosal lesions (erosion, hemorrhage, redness and edema) in the diseases such as acute gastritis, acute exacerbation stage of chronic gastritis. | 20.05.2010 |
| Trypsin + chymotrypsin | Each mL contains: 10,000 Armour units of proteolytic activity of both Trypsin and chymotrypsin | July,1980 | |
| Trypsin.Kallikrein inactivator | 2.3 ampoule i.v, 4.6 amp daily | Inactivates trypsin & Kallikrein.indicated in pancreatitis. | February,1962 |
| Tulobuterol Transdermal Patch 0.5 mg/ 1.0 mg / 2.0 mg. | Each transdermal patch contains: Tulobuterol.0.5mg, 1.0mg, 2.0mg | For treatment of patients with Asthma and COPD without co.morbidity. | 24.04.2014 |
| Tylosin Tartrate | Tylosin Tartrate | Antimicrobial. Aid in the treatment of chronic respiratory disease in chicken and for maintaining weight gain and feed efficiency in Turkey. | May,1980 |
| Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary) | Each sachet contains: Tylvalosin (as tartrate).62.5% w/w. | For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment of diseases due to clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and treatment of ornithobacterium rhinotacheale (ORT). | 13.10.2008 |
| Udenafil Tablet 100mg/200mg | Each film coated tablet contains: Udenafil.100mg, 200mg | For the treatment of erectile dysfunction | 15.09.2011 |
| Ulinastatin for Injection 50000 IU / 100000 IU | Ulinastatin for Injection 50000 IU / 100000 IU | For the treatment of severe sepsis. | 03.04.2012 |
| Ulinastatin Injection 50,000 IU/1,00,000 IU | Each vial contains: Ulinastatin J.P.50,000 IU, 1,00,000 IU | For the treatment of mild to severe acute pancreatitis. | 19.09.2014 |
| Urea | Each mL contains: Urea (30%).300mg | Hospital supply | August,1975 |
| Urokinase for inj. | Urokinase for inj. | Thrombolytic agent. Indicated in the treatment of pulmonary embolism and thrombo embolic disorders involving deep veins. | May,1982 |
| Urosulfon | Urosulfon | Russian pharmacopoeia drugs | April,1965 |
| Urovison | Mixture of Sodium salt of and methyl glucanine salt of diatrizoate(40:18) | Contrast media. | December,1978 |
| Ursodeoxycholic acid | Each tablet contains:300mg | Earlier strength approved was 150 mg. | 12.04.2001 |
| Ursodeoxycholic Acid (600mg) S.R Tablet | UDCA (600mg) sustained release. | For treatment of i) primary billiary cirrhosis ii) gallstones | 20.07.2005 |
| Ursodeoxycholic Acid 300/600 SR Tablets (Additional Strength) | Ursodeoxycholic Acid 300/600 SR Tablets | For the dissolution of Radiolucent collestral goll stone, chronic cholestatic liver disease in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cyatic fibrosis. | 08.12.2008 |
| Ursodeoxycholic acid SR capsules | Each SR cap contains: Ursodeoxycholic acid.450mg | By RMP. for the dissolution of radiolucent cholesterol gallstone, chronic cholestatic liver diseases in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cystic fibrosis. | 01.12.2004 |
| Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml. | Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml. | For the treatment of patients with chronic cholestatic liver disease. | 11.02.2011 |
| Ursodeoxycholic acid tablets 600mg | Ursodeoxycholic acid tablets 600mg | For the treatment of patients with chronic cholestatic liver disease. | 30.01.2008 |
| Valacyclovir hcl tab & bulk | Each film coated tab contains: Valacyclovir hcl eq.to valacyclovir.500mg,1000mg | Herpes zoster infection & genital herpes (initial & recurrent) | 25.09.2002 |
| Valdecoxib | Each film coated tablet contains: Valdecoxib.10mg,20mg | RMP. For treatment of osteoarthritis rheumatoid arthritis & primary dysmenorrhoea in adults only. | 01.08.2002 |
| Valdecoxib + Paracetamol | Valdecoxib.20mg, paracetamol.500mg | RMP. for treatment of acute pain in adults only. | 20.09.2004 |
| Valdecoxib gel | Each gm of gel contains: Valdecoxib.10mg | RMP. for the treatment of local symptomatic relief of acute musculoskeletal disorders, post traumatic inflammatory pain. | 08.10.2003 |
| Valdecoxib tabs | Each tablet contains: Valdecoxib.40mg | Additional strength.for primary dysmenorrhoea in adult only. | September,2003 |
| Valethamate Bromide | Valethamate Bromide | November,1976 | |
| Valganciclovir Powder for Oral Solution 50mg/ml | Valganciclovir Powder for Oral Solution 50mg/ml | For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk. | 09.10.2009 |
| Valsartan + hydrochlorthiazide tab | Each tab contains: valsartan.80mg,160mg+hydrochlorthiazide.12.5mg, Valsartan 160mg+hydrochlorthiazide.25mg | For treatment of mild to moderate hypertension. | 18.03.2003 |
| Valsartan + S(.) amlodipine | Each hard gelatin capsule contains: Valsartan.80mg, s(.)amlodipine (as besylate).2.5mg | By RMP. for treatment of hypertension. | November,2003 |
| Valsartan bulk & cap. | Each capsule contains: Valsartan.80mg, 160mg | Mild to moderate hypertension | 10.12.2001 |
| Valsartan tablets | 40mg, 80mg, 160mg | Additional indication: Post myocardial infarction. | 25.02.2005 |
| Vancomycin hcl injection (Finished Formulation) | i).Each vial contains; vancomycin hcl eq.to vancomycin.500mg,1000mg ii).Each cap contains; vancomycin hcl eq.to vancomycin.125mg,250mg | 28.03.1994 | |
| Varenicline (As tartrate) 0.5mg/1mg tablets | Each film coated tablet contains: Varenicline tartrate eq.to varenicline.0.5mg, 1mg | As an aid to smoking cessation treatment in adults. | 30.05.2007 |
| Vasolastine | 2ml every other day | Enzyme complexes exerts a normalising influence on the deamination of amino acids and on lipid metabolism. | January,1961 |
| Vecuronium bromide injection | Vecuronium bromide injection | Muscle relaxant, neuromuscular blocking agent. Indicated for use in anaesthestic to relax muscle during surgical procedures and to facilitate contraction ventilation. | June,1986 |
Vemurafenib Tablet. 240mg | Each film coated tablet contains: Vemurafenib.240mg | For the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA.approved test. Vemurafenib is not recommended for use in patients with wild.type BRAF melanoma. | 19.10.2012 |
| Verapamil Hcl. | 5 ampl of 2.2 ml | Coronary vasodilation, coronary insufficiency heart, senile heart. | July,1967 |
| Vericella vaccine | Each dose (0.5ml) of the reconstituted vaccine contains: Not less than 103.3 plaque forming units of the attenuated varicella zoster virus. | For active immunization agaist varicella of healthy subjects from the age of 12 months onwards. | 19.06.1998 |
| Vernase | Vernase | Acid.stable digestive multienzyme. | November,1967 |
| Verteporfin powder for solution for infusion 15mg vials | Verteporfin powder for solution for infusion 15mg vials | For additional indication. "subfoveal choroidal neovascularization (CNV) secondry to other macular disease like pathologic myopia & ocular histoplasmosis syndromes" | 15.10.2003 |
| Verteporfin powder for solution for inj. | Each vial contains: Verteporfin.15mg | By opthalmologists only. indicated for the treatment of age related macular degenration in patients with predominantly subfoveal choroidal neovascularisation. | 20.03.2001 |
| Vilazodone HCl 20 mg 40 mg Tablet | Each film coated tablet contains: Vilazodone hydrochloride.20mg, 40mg | For the treatment of major depressive disorders in adults. | 19.08.2015 |
| Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg + 850mg + 1000mg tablets | Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg + 850mg + 1000mg tablets | For the treatment of type.II diabetes mellitus when single drug therapy along with diet, exercise do not result in adequate glycemic control. | 21.07.2008 |
| Vindesine sulphate injection | Each vial contains: Vindesine sulphate.1mg,5mg | Acute lymphocytic leukemia of childhood resistant to vincristine sulphate. Non hodgkins lymphomas, malignant melanoma, non.small cell carcinoma of the lung, blast crisis of chronic granulocytic leukemia and carcinoma of the breast. | 28.10.1998 |
| Vinorelbine tartrate | Each vial contains: Vinorelbine tartrate eq.to vinorelbine base.10mg/ml. | By oncologists. for advanced non.small cell lung cancer as a single agent or in combination and also in metastatic breast cancer patients who have failed the standard first line chemotherapy. | 29.01.2001 |
| Vinpocetin injection | Each 1ml inj contains: Vinpocetin.5mg | For the treatment of psychic & neurological symptoms of cerebral circulatory disturbances (i.e, impaired memory, locomotor disorders etc.) | 01.08.2003 |
| Vinpocetine tab | Each tab contains: Vinpocetine.5mg | Psychic or neurological symptoms of cerebral circulatory disturbances of various origin e.g, impaired memory, locomoter disorder. | 13.05.2002 |
| Virginiamycin | 2% premix contains; 40gm of Virginiamycin, 50% granules per kg | July,1975 | |
| Virginiamycin obtained from streptomyces virginiae | Virginiamycin obtained from streptomyces virginiae | Antibiotic. Indicated for growth propotion in poultry pigs and for prevention & treatment of swine dysentry. | February,1975 |
| Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule | Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule | For the treatment of vitamin deficiency states in adults. | 23.06.2010 |
| Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. | Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. | For vitamin C deficiency. | 12.07.2006 |
| Vitamin C slow release tabs | Each slow release tabs contains: Vitamin C.500mg | Vitamin C deficiency | 06.03.2002 |
| Vitamin D3 (Cholecalciferol) Orally disintegrating strips 2000 IU (Additional Dosage Form) | Vitamin D3 (Cholecalciferol) Orally disintegrating strips 2000 IU | For the treatment of Vitamin D3 deficiency. | 01.10.2015 |
| Voglibose (0.2mg/0.3mg) Tablet | Each uncoated tablet contains; voglibose.0.2mg, 0.3mg | For improvement of post pandrial hyperglycaemia in diabetic mellitus only when diet and/or excercise or oral hypoglycemic drugs or insulin preparations in addition to diet and /or excercise do not result adequate glycemic control. | 17.11.2005 |
| Voglibose 0.2 mg + Metformin 500mg Tablets | Voglibose 0.2 mg + Metformin 500mg Tablets | As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control. | 13.07.2009 |
| Voglibose 0.2mg/0.3mg tablet (Mouth Dissolving) | Voglibose 0.2mg/0.3mg tablet | For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic drug or insulin preparation in addition to diet and or exercise do not result in adequate glycemic control. | 28.12.2007 |
| Voglibose disp.tab.0.2mg/0.3mg | Voglibose disp.tab.0.2mg/0.3mg | As Approved | 20.11.2007 |
| Voglibose0.3 + Metformin (SR) 500mg (Additional Higher Strength) | Voglibose0.3 + Metformin (SR) 500mg | Additional higher strength | 06.08.2010 |
| Voriconazole Powder for oral soluion (40mg/ml) | Voriconazole Powder for oral soluion (40mg/ml) | Anti.fungal. | 21.02.2006 |
| Voriconazole tablets & injection | i).Each film coated tablet contains: voriconazole.50mg,200mg, ii).Each vial contains; voriconazole.200mg eq.to 10mg/ml following constitution. | Specialists only. for the treatment of invasive aspergillosis and serious fungal infection caused by seedosporium apiospermum and fusarium spp.including flusarium solani in patients intolerant of or refractory to other therapies. Also amended on 29.10.2004 to incorporate in indication; for the treatment of i).invasive aspergillosis ii).fluconazole resistant serious invasive candida infection (including c. krusci) iii).serious fungal infection, caused by seedosporium apiospermum and fusarium spp.including flusarium solani in patients intolerant of or refractory to other therapies. | 08.09.2004 |
| VSL # (Combination of lactic acid bacteria (VSL # 3) | VSL # (Combination of lactic acid bacteria (VSL # 3) | For the treatment of irritable bowel syndrome. | 31.01.2008 |
| VSL # 3 (Probiotic Blend) sachet | VSL # 3 (Probiotic Blend) sachet | For rotavirus diarrhoea in children. | 31.07.2007 |
| Xanthinol nicotinate | 1 ampl. 1 & 2 times daily | In treatment of peripheral and cerebral circulatory disturbances, thrombosis, embolism apoplexy and the consequences of apoplexy. | February,1967 |
| Xantinol nicotinate | Each sustained release tablet contains: Xantinol nicotinate . 500mg | February,1973 | |
| Xipamide | Each tablet contains: Xipamide.40mg | Diuretic, indicated in the treatment of oedema and hypertension only | July,1980 |
| Xylazine hcl | Each ml contains: Xylazine.20mg | Used as a sedative analgesic and muscle relaxant properties for use in horses, dogs and cattle's. | November,1990 |
| Xylometazoline | 0.05% and 0.11% solution, 2.3 drops in 3.4 hrs | Nasal decongestant. | March,1961 |
| Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray | Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray | For symptomatic treatment of nasal congestion with running nose (rhinorrhea). | 23.12.2009 |
| Yeast.Tannic acid + iodochloro hydroxy quinoline + benzal bronium chloride | Each tablet contains: Yeast.Tannic acid compound (Eldoform).250 mg, iodochloro hydroxy quinoline.150mg, benzal bronium chloride.10mg | Anti.diarrhoeal agent. | November,1971 |
| Yttrium.90 Microspheres Injection (Yttrium.90...3GBq (at the time of calibration) per vial) | Each vial contains: Yttrium 90.3GBq (at the time of calibration) | For the treatment of unresectable metastatic liver tumors from primary colorectal cancer with intra.hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). | 05.06.2009 |
| Zafirlukast tab & bulk | Each film coated tablet contains: Zafirlukast.10mg,20mg. | For prophylaxis & treatment of chronic asthma in adults & children over 5 year of age. | 03.12.2001 |
| Zalcitabine film coated tablets (Finished Formulation) | Each film coated tablet contains: Zalcitabine.0.375mg,0.750mg | For the treatment of AIDS | 26.07.1993 |
| Zaleplon cap & bulk | Each cap contains: Zaleplon.5mg,10mg | For short term treatment of insomnia | 17.01.2002 |
| Zaltoprofen film coated tablet …80mg JP | Each film tablet contains: Zaltoprofen JP.80mg | For anti inflammatory and analgesic activity in rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of shoulder, cervicobrachial syndrome, postoperative, post trauma, and post dental extraction. | 01.11.2010 |
| Zanamavir inhalation powder 5mg/blister | Zanamavir inhalation powder 5mg/blister | For influenzae. | 13.02.2006 |
| Zanamavir inhalation powder 5mg/blister (Additional Indication) | Zanamavir inhalation powder 5mg/blister | For prophylaxes and treatment of both influenza A & B in adults and children (greater than or equal to 5 years) | 22.01.2008 |
| Zanamivir inhalation powder in capsule | Each capsule contains: Zanamivir.5mg | For the treatment of both influenza A 7 B in adults and adolescent (≥ 12 years) who present with symptoms typical of influenza when influenza is circulating in the community. | 24.01.2007 |
| Zidovudine + Lamivudine | Zidovudine.600mg, lamivudine.300mg | For treatment of HIV. | 2004 |
| Zidovudine capsules & inj. | Zidovudine capsules & inj. | AIDS. Indicated in the treatment of short term management of serious manifestations of humam immuneno deficiency virus (HIV) infection in patients with AIDS. | April,1988 |
| Zidovudine 300mg tablets | 300mg film coated tablets | Additional strength for HIV. | 18.12.1998 |
| Zileuton uncoated bilayered extended release tablet ...600mg | Each uncoated bilayered extended release tablet contains: Zileuton.600mg | For the prophylaxis and chronic treatment of asthma in adults. | 30.09.2010 |
| Zinc (Gluconate) oral solution (20mg/5ml) | Each 5ml contains: Zinc gluconate USP eq.to elemental zinc.20mg | For the treatment of acute diarrhoea in children as an adjunct to oral rehydration. | 10.10.2005 |
| Zinc and vitamin.C chewable tablet | Each chewable tablet contains : zinc gluconate 87.1mg (eq.to elemental zinc 12.5mg), ascorbic acid.100mg, Sodium ascorbate.170mg (eq.to 150mg of ascorbic acid) | 12.12.1995 | |
| Zinc glucoheptonate | Zinc glucoheptonate | Mineral supplement. | February,1963 |
| Zinc gluconate | Each 5ml contains: Zinc gluconate USP eq.to elemental zinc.20mg | In treatment of acute diarrhoea in children as an adjunct to oral rehydration. | 04.09.2008 |
| Zinc Sulphate IP | Each capsule contains: Zinc Sulphate IP.200mg | September,1978 | |
| Ziprasidone caps | Each cap contains: Ziprasidone hcl monohydrate eq.to ziprasidone.20mg,40mg,60mg,80mg | Treatment of schizophrenia. | 15.03.2002 |
| Ziprasidone i.m injection | After reconstitution each ml of i.m inj.contains: ziprasidone mesylate eq.to ziprasidone.20mg | By psychiatrist only. for rapid control of agitation in psychotic patients. | 03.09.2004 |
| Zoalene + Ethoxyquin | Zoalene.25%, Ethoxyquin.0.125% | January,1975 | |
| Zoldronic acid injection | Zoldronic acid injection | Additional indication; 4mg/vial inj. "in prevention of skeletal related events, pathological fractures, spinal compression, radiation or surgery to bone or tumour induced hypocalcaemia in patients with advanced malignancies involving bones", in ref.to earlier permission no. MF 1517/04 dt. 25/06/04 (file 12.04/01.DC). | 29.11.2004 |
| Zoledronic acid 4mg/100ml ready to use (RTU) solution for i.v infusion (Additional Dosage Form) | Zoledronic acid 4mg/100ml ready to use (RTU) solution for i.v infusion | Treatment of: 1. Hypercalcemia of malignancy. 2. Patient with myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. | 27.12.11 |
| Zoledronic acid 5mg/100ml solution for infusion (Additional Indication) | Zoledronic acid 5mg/100ml solution for infusion | Post.menopausal osteoporosis. | 06.12.2007 |
| Zoledronic Acid Injection 5mg/100ml (Additional Indication) | Zoledronic Acid Injection 5mg/100ml | For the treatement of osteoporosis in post.menopausal women and in men who are at increased risk offracture,including those with a recent low.trauma hip fracture. | 07.01.2009 |
| Zoledronic acid powder in vial for infusion including solution | Each vial contains: Zoledronic acid anhydrous.4mg | Treatment of tumour induced hypercalcemia. | 05.11.2001 |
| Zoledronic Acid Solution for Infusion (Additional Indication) | Zoledronic Acid Solution for Infusion | Prevention of clinical fractures after hip fracture in men and women. | 01.08.2009 |
| Zolmitriptan Nasal spray | Zolmitriptan.5.0% w/v, benzalkonium chloride NF.0.01% w/v (as preservative). Each spray delivers: zolmitriptan.5mg | For the acute treatment of migraine with or without aura in adults. | 29.05.2009 |
| Zolpidem hemitartrate | Each film coated tablet contains: Zolpidem hemitartrate.5mg,10mg | Short term treatment of insominia. | 28.05.1999 |
| Zolpidem Tartarate Orally disintegrating Tablet 5mg/10mg (Additional Dosage Form) | Zolpidem Tartarate Orally disintegrating Tablet 5mg/10mg | For insomnia. | 12.10.2015 |
| Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). | Each coated.bi.layered tablet contains: Zolpidem tartrate.6.25mg, 12.5mg | For the treatment of insomnia, characterized by difficulties with sleep on set and/or sleep maintenance. | 10.07.2006 |
| Zonisamide (100mg) capsule | Zonisamide (100mg) | Anti.epileptic. | 21.12.2005 |
| Zonisamide capsule 25/50mg (Additional Strength) | Zonisamide capsule 25/50mg | Same as approved. | 25.05.2006 |
| Zopiclone | Each tab contains: zopiclone BP.7.5mg | Short term treatment of insomnia, transient, situational or chronic insomnia and insomnia secondry to psychiatric disorders where it is desilitating or severe. | 16.08.1996 |
| Zotepine tablet | Each film coated tablet contains: Zotepine.25mg, 50mg, 100mg | For the treatment of schizophrenia | 16.04.2010 |
| Zuclopenthixol (acetate/decanoate) injection | Each ml of inj.contains: uclopenthixol acetate.50mg & 200mg, Each film coated tab contains zuclopenthixol.25mg (Approved .31/3/2000) | By psychiatrist only. treatment of acute psychosis including mania & excerbation of chronic psychosis acute & chronic schizophrenia. | 29.07.1999 |
| β.pyridyl carbinol | New formulation but a new drug | Vasodilator delayed action tablets. | July,1964 |
| N.N.decamethylene.N.N.decamethylene.bis.amino quinaldine | 0.25mg.Loz, 0.4%. oint. | Anti.bacterial. | May,1962 |
| Centchroman tab 30mg | Each tablet contains: Centchroman.30mg | Used as a oral contraceptive. | November,1990 |
| Moxifloxacin intravenous infusion | Each 100ml infusion contains: Moxifloxacin Hcl eq.to moxifloxacin.400mg | Acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia & uncomplicated skin & skin structure infection in adults of age 18 years & above. | 13.02.2002 |
| Mesalazine SR | Mesalazine SR | Bowel disease (Inflammatory) | 04.04.2002 |
| Acotiamide Hydrochloride Bulk & Tablet 100mg | Each film coated tablet contains: Acotiamide hydrochloride hydrate.100mg | For the treatment of bloating afetr meals, epigastric bloating and early satiety in functional dyspepsia. | 06.07.2016 |
| Sacubutril + Valsartan 50mg/100 mg/200mg film caoted tablets | Each film coated caontains: Sacubutril + valsartan 50(24+26)mg, sacubutril + valsartan 100(49+51)mg, sacubutril + valsartan 200(97+103)mg. | To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II.IV) and reduced ejection fraction. | 14.07.2016 |
| Lurasidone Hydrochloride Bulk & Tablets 40mg/80mg | Each film coated tablet contains: Lurasidone hydrochloride.40mg, 80mg | For the treatment of Patients with Schizophrenia. | 18.07.2016 |
| Fenticonazole Nitrate bulk & vaginal capsules 600mg Fenticonazole Nitrate Vaginal Capsule 600 mg | Each soft gelatin vaginal capsule contains: fenticonazole nitrate Ph Eur.600mg, Excipients.q.s, Approved colours used used in capsule shell | For the treatment of vulvovaginal candidiasis. | 10.08.2016 |
| Palbociclib 75mg/100mg/125 mg Capsules | Each hard gelatin capsule contains: Palbociclib 75mg, 100mg and 125mg | Palbociclib is a kinase inhibitor indicated in combination with Letrozole for the treatment of postmenopausal women with estrogen receptor (ER).Positive, human epidermal growth factor receptor 2 (HER2).Negative advanced breast cancer as initial endocrine.based therapy for thie metastatic disease. | 11.08.2016 |
| Perindopril erbumine tablets | Each tablet contains: Perindopril tert.butyl amine/erbumine.8mg | For the treatment of arterial hypertension. | 15.07.2003 |
| Sirolimus tablets 2mg | Each tablet contains: sirolimus.2mg | For prophylaxis of organ rejection in patients receiving renal transplant along with the regimens of cyclosporins & corticosteroids. | 01.12.2003 |
| Nadroparin Calcium Injection 0.2ml, 0.3ml, 0.4ml, 0.6ml, 0.8ml and 1.0ml | 0.2ml. 5000 Axa ICU eg to 2050 Axa IU/ 0.3ml.7500 Axa ICU eg to 3075 Axa IU/ 0.4ml.1000 Axa ICU eg to 4100 Axa IU/ 0.6ml.15000 Axa eg to 6150 Axa IU/ 0.8ml.20000 Axa ICU eg to 8200 Axa IU/ 1.0ml.25000 Axa ICU eg to 10250 Axa IU | Used in the prophylactic treatment of venous thromboembolic disease, deep venous thrombosis. | 18.03.1996 |
| Nadroparin calcium inj. (Additional Indication) | Nadroparin calcium inj. | Additional indication of unstable angina and non.*wave myocardial infarction. | 10.01.2001 |
| Diphenoxylate Hcl..2.5mg + Atropine sulphate.0.025mg | Each tablet contains: Diphenoxylate Hcl..2.5mg + Atropine sulphate.0.025mg | June,1969 | |
| Chlordantoin | Chlordantoin | August,1970 | |
| Oxyfedrine | Oxyfedrine | Coronary vasodilator | April,1973 |
| Midodrine Hydrochloride 2.5 mg Tablet | Each film coated tablet contains: Midodrine hydrochloride eq.to midodrine 2.5mg | For the treatment of symptomatic orthostatic hypotension. | 02.09.2016 |
| Phospholipids Fraction from Bovine Lung (surfactant) 50 mg/vial | Each vial contains: Phospholipid fraction from bovine lung (surfactant).50mg/vial | Preventive use in premature neonates with a high risk of respiratory distress syndrome. | 12.09.2016 |
| Yeast Tannic Acid Compound | Yeast Tannic Acid Compound | Anti.diarrhoeal agent. | 01.10.1971 |
| Niflumic acid | Niflumic acid | Anti.inflammatory drug. indicate in the treatment of rheumatoid arthritis, osteoarthritis. | February,1975 |
| Flupenthixol | Flupenthixol | Neuroleptic agent. indicated in psychotic and schozophrenic cases where sedative and hypnotics effects are contra.indicated. | January,1977 |
| Loxitalmic Acid | Loxitalmic Acid | For cerebral angiography and urography (X.ray contrast media) | April,1977 |
| Clindamycin | Clindamycin | Antibiotic. indicated in the treatment of gram +ve organism pathogens, stephylococcus & streptococci pneumococci. | October,1981 |
| Metrizamide | Metrizamide | X.ray contrast medium. indicaed in lumber thoracic, cervical & total colummner myelography direct ventriculography etc. | October,1981 |
| Iohexol Sterile Sol. | Iohexol Sterile Sol. | X.ray contrast medium. Indicated in neuroradiology, angiography, urography, arthrography etc. | June,1986. |
| Etoposide capsule & injection | Each 5ml ampoule contains: Etoposide.100mg, etoposide capsules.50mg (4.11.92) | Anti cancer. Indicated in the treatment of small cell lung cancer, malignant lymphomas, acute leukaemia, testicular tumours etc. | March,1988 |
| Octreotide for injection | Each vial contains: Octreotide acetate eq.to octreotide base 10mg, 20mg, 30mg | Acromegaly, gastro.entero pancreatic endocrine tumours, carcinoid syndrome, VIPomas, glucagonomas, Zollinger.Ellison syndrome, insulinomas for pre.operative control of hypoglycaemia. | 18.05.2007 |
| Omalizumab Injection | Each vial contains: Omalizumab 75mg, 150mg (with adequate solvent solutions in ampoules) | For the treatment of adult patients with moderate to severe persistent allergic asthma whose symptoms are inadequately controlled with inhaled corticosteroids. | 26.10.2005 |
| Fusidic acid hemihydrate | Fusidic acid hemihydrate | Bacterial infection of the eye caused by susceptible organism in conjunctivitis, blepharitis, stykeratitis, dacryocystitis. It can be used for prophylaxis in ophthalmic surgery and in connection with removal of foreign bodies. | 1992.March |
| Combipack of Desogestrel and Ethinyl estradiol | Combipack of Desogestrel and Ethinyl estradiol | for oral contraceptive in women only. | 29.05.2000 |
| Fludarabine Phosphate for Injection | Each vial contains: Fludarabine phosphate 50mg eq.to 39.05mg of fludarbine | The treatment of patients with B.cell chronic lymphocytic leukaemia (CLL) who have not responded to at least one standard alkylating agent containing regimen. | 22.06.1999 |
| Dolutegravir Tablet 50mg & Bulk | Each film coated tablet contains: Dolutegravir sodium eq.to 50mg of dolutegravir | Indicated in combination with other antiretroviral agents for the treatment of HIV.1 infection in adults weighing more than 40kg. | 07.11.2016 |
| Alcaftadine eye drops 0.25% w/v & Bulk | Each ml contains: alcaftadine 2.5mg, benzalkonium chloride IP 0.005% w/v (as preservative), sterile aqueous vehicle q.s | For the prevention of itching associated with allergic conjunctivitis in patients between the age group 10 to 60 years. | 21.11.2016 |
| Perampanel 2mg/4mg/6mg/10mg/12mg Tablet | Each film coated tablet contains: Perampanel 2mg/4mg/6mg/8mg/10mg/12mg | The adjunctive treatment of partial.onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older. | 02.12.2016 |
| Lenvatinib hard gelatin capsule 4mg/10mg | Each capsule contains: i)lenvatinib mesylate 4.90mg eq.to lenvatinib 4mg, excipients q.s ii)lenvatinib mesylate 12.25mg eq.to lenvatinib 10mg, excipients q.s | For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine refractory differentiated thyroid cancer. | 02.12.2016 |
| Azilsartan 40mg/80mg Tablet | Each uncoated tablet contains: Azilsartan kamedoxil eq. To azilsartan medoxomil 40mg/80mg | Indicated for the treatment hypertension in adults patients, either alone or in combination with other antihypertensive agents. | 16.12.2016 |
| Lurasidone Hydrochloride Tablet 40mg/80mh & Bulk | Each film coated tablet contains: Lurasidone Hydrochloride 40mg, 80mh | For the treatment of patients with Schizophrenia. | 04.01.2017 |
| Hydrocortisone Aceponate 0.584mg/ml cutaneous spray solution | Each ml contains: Hydrocortisone Aceponate (HCA) 0.584mg/ml, Excipients.q.s | For symptomatic treatment of inflammatory and pruritic dermatosis in dogs. | 06.01.2017 |
| Dexlansoprazole delayed release capsule 30mg/60mg & Bulk | Each capsule contains: Dexlansoprazole 30mg (as modified release pellets), Each capsule contains; Dexlansoprazole 60mg (as modified release pellets) | For the treatment of i) Healing of all grades of erosive esophagitis (EE). Ii) Maintaining healing of EE and relief of heartburn. Iii) Treating heartburn associated with symptomatic non.erosive gastroesophageal reflux disease (GERD). | 16.01.2017 |
| Carfilzomib sterile lyophilized powder for injection 60mg/vial (50ml vial) | Each vial contains: Carfilzomib 60mg | Relapsed or refractory multiple myeloma i) Carfilzomib for injection is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. ii) Carfilzomib for injection is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. | 17.01.2017 |
| Dabrafenib capsule 50mg/75mg | Each hard gelatin capsule contains: Dabrafenib Mesylate eq. To 50mg Dabrafenib, Each hard gelatin capsule contains:Dabrafenib Mesylate eq. To 75mg Dabrafenib | As a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test. In combination with Trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test. | 18.01.2017 |
| Trametinib 0.5mg/2mg tablets | Each film coated tablet contains: Trametinib dimethyl sulfoxide eq. To 2mgTrametinib, Each film coated tablet contains: Trametinib dimethyl sulfoxide eq. To 0.5mg Trametinib | As a monotherapy and in combination with Dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test. | 18.01.2017 |
| Alectinib capsules 150mg | Each hard capsule contains: Alectinib 150mg eq. To Alectinib hydrochloride 161.3mg | For the treatment of patients with anaplastic lymphoma kinase (ALK).Positive, metastatic non.small cell lung cancer (NSCLC) who have progressed on or are intolerant to Crizotinib. | 23.01.2017 |
| Eliglustat capsules 84mg | Each capsule contains: Eliglustat 84mg (Eq. To 100mg of eliglustat tartrate or hemitartrate salt) | For the long term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (Ems), intermediate metabolizers (Ims), or poor metabolizers (PMs) as detected by an appropriate test. | 31.01.2017 |
| Tazarotene | Tazarotene | Anti acne. | 12.09.2003 |
| Risedronate Sodium | Risedronate Sodium | For osteoporosis. | 17.10.2003 |
| Valgancyclovir | Valgancyclovir | For CMV. | 20.11.2003 |
| Sufentanil Citrate | Sufentanil Citrate | Anesthetic agent. | 17.12.2003 |
| Cladribine | Cladribine | Anti cancer. | 09.09.2003 |
| Teriparatide | Teriparatide | For osteoporosis. | 04.09.2003 |
| Bendrofluazide | Bendrofluazide | Diuretic. | 24.07.2003 |
| Oxybutynine E.R. Tablets | Oxybutynine E.R. Tablets | For Neurogenic bladder disorder. | 05.05.2004 |
| Cefprozil 125mg/250mg Dispersible Tablet | Cefprozil 125mg/250mg Dispersible Tablet | Anti.biotic. | 22.06.2004 |
| Lithium Carbonate 450mg ER Tablet | Lithium Carbonate 450mg ER Tablet | Anti.Depression. | 28.06.2004 |
| Nebivolol 5mg + S(.) Amlodipine 2.5mg Tablet | Nebivolol 5mg + S(.) Amlodipine 2.5mg Tablet | Anti.hypertensive. | 14.09.2004 |
| Rabeprazole Sodium 20mg + Domperidone 30mg S.R Capsule | Rabeprazole Sodium 20mg + Domperidone 30mg S.R Capsule | For GERD. | 04.10.2004 |
| Epi.Growth Factor 1gm + Silversulphadiazine Cream | Epi.Growth Factor 1gm + Silversulphadiazine Cream | For Burns. | 19.10.2004 |
| Metoprolol Tartrate (Conventional) tablet | 25mg/50mg/100mg | For addl. Indications: i) myocardial infarction, ii) cardiac arrhythmia, iii) functional heart disorder with palpitation, iv) migraine prophylaxis | 30.06.2006 |
| Erlotinib Hcl tablets (25mg/100mg/150mg) | 25mg/100mg/150mg | Additional indication; Erlotinib Hcl tab in combination with gemcitabine is indicated for the first line treatment of patients with locally advance unresectable or metastatic pancreatic cancer. | 05.07.2006 |
| Leuprolide Acetate powder for Injection (7.5mg/vial 1 month depot injection) | Leuprolide Acetate powder for Injection (7.5mg/vial 1 month depot injection) | For children in central precocious puberty. | 10.08.2006 |
| Metoprolol tartrate solution for i.v injection | 1mg/ml | Additional indication: For the treatment of myocardial infarction. | 25.08.2006 |
| Bemiparin Sodium Solution for injection(2500/3500IU) (Additional Strength) | 2500IU & 3500IU | Additional strength. | 29.08.2006 |
| Ribavirin Caps (200mg) | 200mg | Additional indication: 24 week treatment regimen in the subgroup of hepatitis.C (genotype.1) low viral load, patients, who are HCV RNA negative of 4 weeks treatment. | 01.11.2006 |
| Ramipril (12.5mg/5mg/10mg/2.5mg) capsules | 12.5mg/5mg/10mg/2.5mg | Additional indication: i) Prevention of MI, CV death or stroke in high risk CV patients. ii) Prevention of MI CV death or stroke in high risk diabetes patients. | 02.11.2006 |
| Estradiol vaginal tablets | Each film coated tablet: Estradiol USP 25mcg | For treatment of atrophic vaginitis due to estrogen deficiencies. | 03.11.2006 |
| Minoxidil Topical Solution 5% | Each ml contains: Minoxidil 50mg | Indicated in treatment of alopecia (male pattern baldness) in men. | 16.05.2002 |
| Triptorelin for injection | Each twin pack contains: (i) Each single dose vial contains; Triptorelin pamoate (Lyophilized) eq. to 3.75mg/11.25mg Triptorelin, (ii) One ampoule of sterile water for injection 2ml | For the treatment of prostate cancer | 05.01.2012 |
| Indacaterol (as Maleate) capsules 150mcg/300mcg | Each capsule contains: Indacaterol 150mcg, 300mcg (as Indacaterol Maleate) | For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). | 28.02.2014 |
| Pasireotide long.acting release 20/40/60mg powder for suspension for injection (Additional Indication) | Pasireotide long.acting release 20/40/60mg powder for suspension for injection | For the treatment of patients with acromegaly who have had an inadequate response to surgery and/ or for whom surgery is not an option. | 14.02.2017 |
| Etonogestrel 68 mg implant | Etonogestrel 68 mg implant | for use by women to prevent pregnancy | 15.02.2017 |
| Bepotastine besilate 1.5 %w/v Ophthalmic solution | Bepotastine besilate 1.5 %w/v Ophthalmic solution | For the treatment of itching associated with allergic conjunctivitis | 22.02.2017 |
| Dienogest 2mg Tablets | Dienogest 2mg Tablets | For the management of Pelvic pain associated with Endometriosis | 09.03.2017 |
| Eprinomectin 0.5% for beef and dairy cattle | Eprinomectin 0.5% for beef and dairy cattle | It is indicated for the treatment and control of gastrointestinal roundworm (including inhibited Ostertagia ostertagi), lungworm, grubs, sucking and biting lice, chlorioptic and sarcoptic.mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. | 14.03.2017 |
| Bepotastine besilate 10 mg Tablets | Bepotastine besilate 10 mg Tablets | For the treatment of allergic rhinitis | 27.03.2017, 22.06.2017 |
| Prucalopride 1mg/2mg Tablet | Prucalopride 1mg/2mg Tablet | For the treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief | 13.04.2017 |
| Pomalidomide 1mg/2mg/4mg Capsules | Pomalidomide 1mg/2mg/4mg Capsules | In combination with dexamethasone, for patient with patient multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | 01.05.2017 |
| Sofosbuvir 400 mg +Velpatasvir 100 mg Tablet & Bulk | Sofosbuvir 400 mg +Velpatasvir 100 mg Tablet & Bulk | For the treatment of adult patients with .chronic Hepatitis C virus, Genotype 1,2,3,4,5 or 6 infection. .without cirrohis or with compensated cirrhosis .with decompensated with chronic for use in combination with Ribavirin | 04.05.2017, 25.05.2017 |
| Osimertinib 40 mg/80 mg Film coated Tablets | Osimertinib 40 mg/80 mg Film coated Tablets | For the treatment of patient with metastatic epidermal growth factor receptor (EGFR) T790 M mutation.positive non.small cell lung cancer (NSCLC), as detected by an appropriate test, whose disease has progressed on or after EGFR TKI therapy | 29.05.2017 |
| Argatroban Hydrate Injection 250 mg/2.5 ml | Argatroban Hydrate Injection 250 mg/2.5 ml | 1) For prophylaxis or treatment of thrombosis in adult patients with Heparin induced thrombocytopenia (HIT). 2) As an anticoagulant in adults patients with or at risk for heparin.induced thrombocytopenia undergoing percutaneous coronary intervention (PCI) | 30.05.2017 |
| Fluralaner chewable tablets 112.5 mg/250 mg/500mg/1000mg/1400 mg | Fluralaner chewable tablets 112.5 mg/250 mg/500mg/1000mg/1400 mg | 30.5.2017 | |
| Zidovudine 100mg/250mg Capsules | Each capsule contains: zidovudine 100mg/250mg | For the treatment of patients with advanced HIV disease, such as those with acquired immuno deficiency syndrome (AIDS) or AIDS related complex (ARC). | 23.03.1992 |
| Enoxaparin Sodium (Low Molecular Weight Heparin) Injection | Prefilled syringes as per the composition given below: 1. Enoxaprin sodium.100mg/1ml. Water for injection, 2.Enoxaprin sodium.80mg/0.8ml. Water for injection, 3.Enoxaprin sodium.60mg/0.6ml. Water for injection, 4.Enoxaprin sodium.40mg/0.4ml. Water for injection, 5.Enoxaprin sodium.20mg/0.2ml. Water for injection, | Indicated as a prophylactic in the treatment of thromboembolic disorders during orthopaedic surgery, general surgery and haemodialysis. | 21.11.1995 |
| Budesonide respirator solution 0.25mg/ml and 0.5mg/ml | Budecort 0.25mg/ml respules (Each 2ml contains; budesonide 0.5mg), Budecort 0.5mg/ml respules (Each 2ml contains; budesonide 1mg) | 01.03.1995 | |
| Fluticasone Furoate and Vilanterol Trifenatate 100 mcg and 25 mcg powder for inhalation | Fluticasone Furoate and Vilanterol Trifenatate 100 mcg and 25 mcg powder for inhalation | Indicated for the maintenance treatment of the airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/ or emphysema and to reduce exacerbation of COPD in patients with an exacerbation history. | 29.06.2017 |
| Mirabegron Prolonged Release Tablet 25 mg /50 mg | Mirabegron Prolonged Release Tablet 25 mg /50 mg | Symptomatic treatment of urgency, increased micturition frequency and / or urgency incontinence as may occur in patients with over active bladder (OAB) Syndrome | 12.07.2017 |
| Delamanid 50 mg tablet | Delamanid 50 mg tablet | For the use as part of an appropriate combination regimen for pulmonary multi.drug resistant tuberculosis (MDR.TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. | 02.08.2017 |
| Efonidipine Hydrochloride Ethanolate | Efonidipine Hydrochloride Ethanolate | Indicated for the management of Hypertension, Renal parenchymal hypertension and Angina. | 28.08.2017 |
| Brivaracetam Film Coated Tablets 50mg/75mg/100mg | Brivaracetam Film Coated Tablets 50mg/75mg/100mg | As adjunctive therapy in the treatment of partial .onset seizures in patients 16 years of age and older with epilepsy | 07.09.2017 |
| Treosulfan Bulk & injection 5g/vial | Treosulfan Bulk & injection 5g/vial | For the conditioning treatment prior to haematopoetic stem.cell transplantation | 26.09.2017 |
| Ribociclib 200 mg Film coated Tablets | Ribociclib 200 mg Film coated Tablets | In combination with an aromatase inhibitor as initial endocrine.based therapy for the treatment of post menopausal women with the hormone receptor (HR).Positive, human epidermal growth factor receptor 2 (HER2).Negative advanced or metastatic breast cancer | 27.09.2017 |
| Apremilast Bulk & film coated tablets 10 mg/20 mg/30 mg | Apremilast Bulk & film coated tablets 10 mg/20 mg/30 mg | Indicated for treatment of patients with moderate to severe plaque psoriasis who are candidate for phototherapy or systemic therapy | 13.10.2017 |
| Arbekacin Bulk & Injection 200mg/4ml | Arbekacin Bulk & Injection 200mg/4ml | Treatment of following infections caused by Methicillin resistant Staphylococcus aureus (MRSA)", sepsis pneumonia | 20.10.2017 |
| Benestermycin Intra mammary suspension (Vet) | Benestermycin Intra mammary suspension (Vet) | For the treatment of subclinical mastitis at drying off, and the prevention of new bacterial infections of the udder during the dry period in dairy cows, caused by bacteria susceptible to penicillin and framycetin. | 03.11.2017 |
| Midostaurin 25 mg capsules | Midostaurin 25 mg capsules | In combination with standard induction and consolidation chemotherapy followed by single agent in maintenance of therapy for adult patients with newly diagnosed with acute myeloid leukemia (AML) who are FLT.3 mutation positive. For the treatment of adult patients with advanced systemic mastocycosis (advanced SM) | 09.11.2017 |
| Tenofovir Alafenamide Fumarate Bulk & Tablets 25 mg Tablets | Tenofovir Alafenamide Fumarate Bulk & Tablets 25 mg Tablets | For the treatment of chronic Hepatitis B virus infection in adults with compensated liver disease | 10.11.2017 |
| Arteolane Maleate and Piperaquine phosphate Dispersible tablets (37.5 mg +187.5 mg) | Arteolane Maleate and Piperaquine phosphate Dispersible tablets (37.5 mg +187.5 mg) | Indicated in children aged 6 months to 12 years for the treatment of : acute uncomplicated Plasmodium falciparum malaria infection . acute uncomplicated Plasmodium Vivax malaria infection | 24.11.2017 |
| Macitentan Bulk and Tablets 10 mg | Macitentan Bulk and Tablets 10 mg | Macitentan is an endothelin receptor antagonist (ERA)l indicated for the treatment of Pulmonary arterial hypertension (PAH, WHO group I) to delay disease progression | 07.12.2017 |
| Budesonide 200mcg Aerosol inhalation | Each metered inhalation supplies Budesonide 200mcg | For bronchial asthma | 14.05.1992 |
| Budesonide 100mcg metered actuation inhalaer | Each metered inhalation supplies Budesonide 100mcg | 29.05.1992 | |
| Budesonide Respules 0.25mg/ml or 0.5mg/ml | Budesonide Respules (2ml single dose unit ampule) containing: 0.25mg/ml or 0.5mg/ml suspension in a suspension for nebulisation | 16.08.1995 | |
| Goserelin Acetate Depot Injection | Each pre.filled syringe contains: Goserelin acetate eq. to Goserelin 10.8mg in a long acting SR depot | For the treatment of prostate cancer suitable for hormonal manipulation. | 13.05.2004 |
| Ethynodiol diacetate + mestranol | Each tablet contains: Ethynodiol diacetate.1mg, mestranol.0.05mg | Oral contraceptive | January,1971 |
| Ethynodiol diacetate 1 mg, Ethinyloestradiol 0.05 mg | Ethynodiol diacetate 1 mg, Ethinyloestradiol 0.05 mg | Oral contraceptive | February,1970 |
| Etidronate disodium tabs | Each tablet contains: Etidronate disodium.200mg | Hypercalcemia induced by various malignant disorders. | 10.03.1995 |
| Etizolam 0.25 mg tablet (Additional Strength) | Etizolam 0.25 mg tablet | Same As Approved | 03.07.2010 |
| Etizolam CR Tablets 1.5 mg/3 mg (Modified Dosage Form) | Etizolam CR Tablets 1.5 mg/3 mg | Same as approved | 19.12.2011 |
| Etizolam Tablet (0.5mg/1mg) | Each film coated tablet contains: Etizolam.0.5mg, 1mg | For generalised anxiety disorder associated with depression. | 30.10.2007 |
| Etodolac 300/300mg +Thiocolchicoside 4/8mg | Etodolac 300/300mg +Thiocolchicoside 4/8mg | For the treatment of patients with acute painful musculoskeletal conditions. | 19.07.2010 |
| Etodolac 400mg + Paracetamol IP 500mg tablet (Additional higher Strength) | Etodolac 400mg + Paracetamol IP 500mg tablet | Additional higher strength | 01.10.2010 |
| Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet (Additional higher Strength) | Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet | Additional higher strength | 09.09.2010 |
| Etodolac caps/tabs | Each tab contains; etodolac BP.200mg,400mg, Each cap contains; etodolac.300mg | Inflammation and painful conditions in osteoarthritis, acute attacks of gout and pseudogout, pain following dental extraction, post operative and post episiotomy pain dysmenorrhoea acute musculoskeletal pain. | 10.04.1997 |
| Etodolac ER tablets 400mg/500mg | Each extended release tablet contains: Etodolate.400mg, 500mg | For the treatment of osteoarthritis & rheumatoid arthritis. | 08.05.2007 |
| Etodolac i.m injection 400mg/2ml (Additional Dosage form) | Etodolac i.m injection 400mg/2ml | For the treatment of post operative orthopaedic pain. | 14.12.2015 |
| Etodolac USP 400mg + Tolperisone HCL 150mg tablet | Etodolac USP 400mg + Tolperisone HCL 150mg tablet | For the treatment of acute inflammation conditions associated with spasm in adults only. | 11.10.2010 |
| Etofylline + salbutamol SR Caps. | Each SR cap.contains: Etofylline.300mg, salbutamol (as sulfate).4mg | 14..06.1993 | |
| Etomidate injection | Each ml contains: Etomidate.2mg | Anaesthetic agent. induction of general anaesthesia and for maintenance of short duration anaesthesia for surgical procedures. | August,1985 |
| Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) in smooth transparent ring | Each contraceptive(1.87g/unit) vaginal ring contains: Etonogestrel.11.7mg, ethinylestradiol.2.7mg | For Contraceptive in women only. | 15.02.2005 |
| Etoposide injection | Each 5ml ampoule contains: Etoposide.100mg, etoposide capsules.50mg(4.11.92) | Anti cancer. Indicated in the treatment of small cell lung cancer, malignant lymphomas, acute leukaemia, testicular tumours etc. | March,1988 |
| Etoricoxib + Paracetamol (60mg + 500mg) Tablets | Etoricoxib + Paracetamol (60mg + 500mg) Tablets | For the short term use in acute painful and inflammatory condition. | 30.09.2008 |
| Etoricoxib 1%+ Menthol 5% Spray | Etoricoxib 1%+ Menthol 5% Spray | For the topical treatment of acute musculoskeletal pain. | 16.03.2010 |
| Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel | Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel | For acute Musculoskeletal pain. | 14.12.2006 |
| Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream | Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream | Acute Musenlosleteal pain. | 21.03.2007 |
| Etoricoxib injection 90mg/ml | Etoricoxib injection 90mg/ml | For short term use in acute painful condition in adults only. | 28.03.2008 |
| Etoricoxib roll on Topical Solution 1% v/v | Etoricoxib roll on Topical Solution 1% v/v | For the treatment of pain, swelling & inflammatory conditions due to arthritis. | 16.09.2008 |
| Etoricoxib tablets | Etoricoxib tablets | March,2004 | |
| Etravirine Tablet 100mg | Etravirine Tablet 100mg | In combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV.1) infection in antiretroviral treatment.experienced adult patients who have evidence of viral replication and HIV.1 strains resistant to an NNRTI and other antiretroviral agents. It should be used only in situations where other treatments have failed or cannot be used because of side effects. | 26.04.2012 |
| Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35.70) :100mg tablet | Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35.70) :100mg tablet | For the treatment of haemorrhoid. | 29.02.2008 |
| Euphorbia Prostrata Dry Extract :100mg tablet (Additonal Indication) | Euphorbia Prostrata Dry Extract : 100mg tablet | For the treatment of 3° and 4° haemorrhoids (Addl. Indication) | 14.11.2009 |
| Euphorbia prostrata dry extract ethanolic 80% v/v [(35.70):1] cream 1% w/w | Each gram contains: Euphorbia prostrata dry extract ethanolic 80% v/v [(35.70):1]. 10mg | For the treatment of 1ᵒ and 2ᵒ internal haemorrhoids. | 17.11.2009 |
| Everolimus 2.5mg/5mg/10mg Tablets | Everolimus 2.5mg/5mg/10mg Tablets | 1. For the treatment of tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery. 2. For the treatment of postmenopausal women with hormone receptor positive advanced breast cancer in combination with an aromatase inhibitor. | 21.03.2013 |
| Everolimus 5/10mg Tablets (Additional Indication) | Everolimus 5/10mg Tablets | Treatment of advance renal cell carcinoma. | 16.05.2009 |
| Everolimus dispersible Tablet 0.1mg/0.25mg (Additional Indication) | Everolimus dispersible Tablet 0.1mg/0.25mg | For the prophylaxis of organ rejection in patients receiving a hepatic transplant. In liver transplantation, Everolimus should be used in combination with tacrolimus and corticosteriods. | 21.08.2015 |
| Everolimus Tablet 0.25 mg/0.5 mg/0.75 mg/1.0mg (Additional Indication) | Everolimus Tablet 0.25 mg/0.5 mg/0.75 mg/1.0mg | For the prophylaxis of organ rejection in patients receiving a hepatic transplant. In liver transplantation, Everolimus should be used in combination with tacrolimus and corticosteriods. | 21.08.2015 |
| Everolimus tablets | Each tablet contains: Everolimus 0.25mg,0.5mg,0.75mg,1.0gm, Each dispersible tablet contains: everolimus.0.1mg,0.25mg | By nephrologists only. for the prophylaxis of organ rejection in patients at low to moderate immunological risks receiving allogenic renal transplants in combination with cyclosporin & corticosteroids. | August,2004 |
| Exemestane 25mg Tablet (Additional Indication) | Exemestane 25mg Tablet | Indicated for adjuvant treatment of Post Menopausal Women with estrogen receptor positive early breast cancer who have received two.three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy. | 29.08.2009 |
| Exemestane tab | Each tab contains: Exemestane.25mg | For Treatment of advanced breast cancer in post menopausal women whose disease has progressed following Tamoxifen therapy. | 18.10.2001 |
| Exenatide 2 mg powder and solvent for prolonged release suspension for injection in a prefilled pen (s.c. Injection) (Additional Strength) | Exenatide 2 mg powder and solvent for prolonged release suspension for injection in a prefilled pen (s.c. Injection) | For treatment of type 2 diabetes mellitus in combination with Metformin, Sulphonylurea, Thiazolidinedione, Metformin and Sulphonylurea, Metformin and Thiazolidinedione In Adults who have not achieved adequate glycemic control on maximally tolerated doses of these oral therapies. | 09.09.2015 |
| Exenatide Inj. (Additional Indication) | Exenatide Inj. | Use in patients with type.2 diabetes mellitus who are using a thiazolidinedione alone or in combination with metformibn but have not achieved adequate glycemic control. | 24.05.2010 |
| Exenatide Injection (Additional Indication) | Exenatide Injection | Exenatide is a glucagon like peptide.1 (GLP.1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. | 09.10.2010 |
| Exenatide injection (Each 2ml vial contains; Exenatide 5mcg/10mcg per 0.2ml ) (Additional Strength) | Exenatide injection (Each 2ml vial contains: Exenatide 5mcg/10mcg per 0.2ml ) | For adjunctive therapy to improve glycemic control in patients with type.II diabetes mellitus, who have not achieved adequate glycemic control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas. | 30.01.2008 |
| Exenatide Injection .pre.filled pen (250mcg/ml) | Each pre.filled pen contains: Exenatide.250mcg/ml | For adjunctive therapy to improve glycemic control in patients with Type.II diabetes mellitus, who have not achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonylurea. | 09.07.2007 |
| Extract of Centella Asiatica | Extract of Centella Asiatica | Indicated in the treatment as ulcers, burns, skin grafts, keloids, bed sore etc. | February,1975 |
| Extraxt of mycobacterium vaccal | Each injection contains: Extract of mycobacterium vaccal eq.to 100mg/ml proteins | Indicated in the sterilization castration of male animals (dogs,cattle,buffalo, bulls). | August,1990 |
| Ezetimib tabs | Each tab contains: Ezetimib.10mg | By RMP only. for the treatment of primary hypercholesteromia homozygus familial hypercholesterolemia. | 17.12.2003 |
| Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets | Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets | For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function. | 01.09.2009 |
| Ezetimibe 10mg + Fenofibrate 160mg tablet | Ezetimibe 10mg + Fenofibrate 160mg tablet | For combined hypertipidemia | 04.04.2007 |
| Famciclovir tab & bulk | Each film coated tab contains: Famciclovir.125mg,250mg,500mg,750mg | Herpes zoster in immuno competents & immuno compromised patients. | 11.04.2002 |
| Famotidine injection | Each ml of famotidine injection contains: Famotidine.10mg | April,1990 | |
| Famotidine tablet/oral suspension | Tablet famotidine.20mg,40mg, 10mg(Intas.28.10.94), oral suspension.each 5ml contains: famotidine.40mg | Anti ulcer. Indicated in the treatment of duodenal & peptic ulcer, zollinger ellison syndrome. | May,1989 |
| Faropenam Sodium Extended Release Tablet 225/300/450 mg | Faropenam Sodium Extended Release Tablet 225/300/450 mg | For the Treatment of respiratory tract infections, urinary tract infection, skin and skin structure infections and gynaecological infections. | 08.03.2010 |
| Faropenem | Each film coated tablet contains: Faropenem sodium eq.to faropenem.200mg | For the treatment of upper and lower respiratory tract infection, urinary tract infection and skin & skin structure infection. | 16.04.2008 |
| Faropenem Sodium (150mg/200mg) Tablet | Each film coated tablet contains: Faropenem sodium eq.to faropenem.150mg, 200mg | For the treatment of respiratory tract infection, UTI, skin & skin structure infection & gynaecological infection. | 21.07.2005 |
| Flavonoids extracted from Rutacea (Aurantiaceae) containing a standard amount of diosmin | Flavonoids extracted from Rutacea (Aurantiaceae) containing a standard amount of diosmin | Haemorrhoids. Indicated in the treatment of haemorrhoids. | June,1978 |
| FDC of Aeterolane Malate (150mg) + Piperaquine Phosphate (750mg) Tablet | FDC of Aeterolane Malate (150mg) + Piperaquine Phosphate (750mg) Tablet | Treatment of acute uncomplicated malaria infection due to Plasmodium vivax in adults. | 11.10.2013 |
| FDC of Ambroxol + guaiphenesin | Each tab contains: Ambroxol hcl.30mg, guaiphenesin.200mg | For cough & congestion. | 10.09.2001 |
| FDC of Amlodipine (5mg) + Bisoprolol (2.5mg) | Each tablet contains: Amlodipine.5mg, bisoprolol fumerate.2.5mg | For the treatment of mild to moderate hypertension in adults. | 22.07.2005 |
| FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule | FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule | For Hypercholesterolemia. | 26.07.2005 |
| FDC of atorvastatin + fenofibrate | Each film coated tablet contains: Atorvastatin calcium eq.to atorvastatin.10mg, fenofibrate.160mg | For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function. | 01.08.2006 |
| FDC of beta.carotene + vitamins+minerals | Each cap contains: Beta.carotene (30% dispersion, eq.to vit.A 7500IU.15.0mg, vit.E acetate.25.0mg, vit.C.100.0mg, pyridoxine hcl (vit.B6).1.5mg, cyanocobalamine (vit.B12).5mcg, folic acid.400mcg, zinc (elemental) as ZnO.15mg, selenium (elemetal) as SeO2.100mcg, copper (elemental) as CuSo4.1mg | 10.10.2001 | |
| FDC of butaphosphan + methyl hydroxybenzoate + cyanocobolamine powder | Each one kg of the formulation contains: Butaphosphan.100gm, methyl hydroxybenzoate.1gm, cyanocobolamin.50gm | As vitamin and phosphorous supplement for livestock shrimp and fish. | 20.03.2009 |
| FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment | FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment | For psoriasis vulgaris. | 12.08.2005 |
| Ceftriaxone + Tazobactum Injection | Each vial contains: Ceftriaxone.1000mg, tazobactum sodium eq.to tazobactum.125mg | For the treatment of patients with community acquired pneumonia and lower respiratory infection. | 21.07.2005 |
| FDC of dipyridamole + acetylsalicylic acid | Each capsule contains: Pipyridamole BP.200mg(MR), acetylsalicylic acid.25mg | To reduce the risk of stroke in patients who had transient ischaemia of the brain or completed ischaemic stroke due to thrombosis. | 09.01.2007 |
| FDC of Drospirenone + Ethinylestradiol | Each tablet contains: Drospirenone.3.0mg, ethinylestradiol.0.03mg | For use as oral contraceptive for women. | 16.05.2005 |
| FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet | Each film coated tablet contains: Gabapentin.300mg, methylcobalamine.500mcg | For the treatment of neuropathic pain in adults. | 05.08.2005 |
| FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg) + Metformin (500mg E.R) Tablet | FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg) + Metformin (500mg E.R) Tablet | Anti.diabetic. | 12.08.2005 |
| FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule | FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule | Anti.histaminic & mucolytic. | 29.08.2005 |
| FDC of Loperamide + simethicone tab | Each chewable tab contain: Loperamide hcl.2mg, simethicone.125mg | For control of acute diarrhoea in adults only. | 16.10.2001 |
| FDC of Methylcobalamin (1500 mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet | Each tablet contains: Methylcobalamine(ER).1500mcg, pyridoxine Hcl(IR).20mg, Folic acid(IR).5mg | For the management of hyper.homocysteinemia. | 19.09.2005 |
| FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + Hydrochlorthiazide (12.5mg/12.5mg/25mg) | FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + Hydrochlorthiazide (12.5mg/12.5mg/25mg) | For essential hypertension. | 02.12.2005 |
| FDC of Papain + Urea Ointment | Each gm of ointment contains: Papain USP ≥ 521700 units, urea USP=100mg | For debriment of necrotic tissues and liquifaction of pus in acute & chronic lesions viz., decubitus vericose, diabetic ulcers, burns & postoperative wounds etc. | 15.07.2005 |
| FDC of rosiglitazone + metformin (Additional Strength) | Each tab contains: Rosiglitazone.4mg, metformin.500mg | Additional strength. | 21.02.2002 |
| FDC of S.amlodipine and valsartan | Each capsule contains: s.amlodipine besilate eq.to s.amlodipine.2.5mg, valsartan.80mg | For the treatment of mild to moderate hypertension in adult patients. | 12.01.2007 |
| FDC of S.Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ | Each tablet contains: S(.) metoprolol succinate eq.to s(.) metoprolol tartrate (ER).25mg, 50mg, Hydrochlorthiazide.12.5mg | For the treatment of mild to moderate hypertension in adults. | 11.11.2005 |
| Febuxostat 40mg (Additional Strength) | Febuxostat 40mg | Same As approved | 16.01.2010 |
| Febuxostat Tablets 80mg / 120mg | Each film coated tablet contains: Febuxostat.80mg, 120mg | For treatment of chronic hyperuricemia in conditions where urate depression has already occured (including a history, or presence of tophus and /or gouty arthritis). | 18.11.2009 |
| Felodipine | Each ER film coated Tablet contains: Felodipine.5mg,10mg. | Anti hypertensive. In the treatment of hypertension. | May,1991 |
| Fenbendazole | Fenbendazole | Anthelmetic. indicated to treat gastro.intestinal nematodes infections of live stocks. | January,1979 |
| Fenbendazole + oxyclozamide susp. & Bolus | i).1ml of suspension fenbendazole.2.5% w/w,1.5%w/v, oxyclonazide.7.5%w/v,4.5 w/v, ii).Each uncoated bolus contains; fenbendazole.175mg, oxyclozamide.625mg | In treatment of roundworms, lungworms, fluke in cattles & sheep only. | 04.10.1999 |
| Fenbendazole bulk drug | Fenbendazole bulk drug | January,1983 | |
| Fenfluramine Hcl | Each tablet contains: Fenfluramine Hcl .20mg | December,1972 | |
| Fenfluramine hcl SR caps. | Each SR capsule contains: Fenfluramine hcl.60mg | 09.07.1993 | |
| Fenfluramine hcl. | Each tablet contains: Fenfluramine hcl.20 mg | Anti.obesity drug. | April,1972 |
| Fenofibrate capsules | Each capsule contains: Fenofibrate.200mg (micronized) | For type IIa, IIb, III, IV & V hyper lipidaemias resistant to diet | 22.12.1999 |
| Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets | Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets | 18.07.2008 | |
| Fenoverine cap. (bulk+formulation) | Each capsule contains: Fenoverine.100mg | RMP. for the treatment of smooth muscle spasm of gastro intestinal tract & IBS. | 08.10.2003 |
| Fenpipramide Methobromide and p.Piperidinoethoxy o.carbomethoxy benzophenone Hydrochloride | Bulk drug | October,1980 | |
| Fentanyl citrate transmucosal tab | Each tab contains: Fentanyl citrate eq.to fentanyl.200mcg,400mcg,600mcg | New delivery system.management of break through cancer pain in patients with malignancies who are already receiving & who are tolerant to opoid therapy for this underlying persisten cancer pain. | 29.10.2002 |
| Fentanyl transdermal patch | Each 10,20,30,40 cm2 patch containing :2.5/5.0/7.5/10mg of fentanyl delivers 25/50/75/100 mcg of fentanyl per hour respectively. | For the management of chronic cancer pain and intractable pain requiring opioid analgesics. | 11.01.1999 |
| Feracrylum (1%) + Metronidazole (1%) | Each gm of gel contains: Feracrylum.1%, metronidazole.1% | An antiseptic gel for topical application. | 05.10.2005 |
| Feracrylum 1% mouth gargle 10mg/ml | Feracrylum 1% mouth gargle 10mg/ml | As haemostatic agent in dental surgery. | 28.19.2006 |
| Feracrylum 1% solution | Feracrylum 1% solution | Additional indication as antiseptic. | 05.10.2001 |
| Feracrylum 3% gel | Feracrylum 3% gel | For the management of post.operative wounds cuts, Abrasions as a Haemostatic Agent cum anti.septic. | 13.02.2002 |
| Feracrylum 3% solution | Feracrylum 3% solution | For the management of post.operative wounds cuts, Abrasions as a Haemostatic Agent cum anti.septic. | 13.02.2002 |
| Feracrylum gel & solution (3%) | i).Each gm contains; feracrylum 30mg soln, ii).Each gm contains; 30ml of feracrylum in gel. | Additional indication & strength.for management of post.operative wounds, cuts, abrasions, as an haemostatic agent cum antiseptic. | 13.02.2002 |
| Feracrylum gel & sterile cotton gauze | Each gm of gel contains: Feracrylum.10mg (1%), cotton gauze (30cm*30cm) contains feracrylum 1% solution. | By RMP. for the management of post operative wound,cuts,abrasion,as an haematinic agent. | 15.02.2001 |
| Feracrylum oral capsule | Each capsule contains: Feracrylum.100mg | Gastroenterologists.for the treatment of non ulcer dyspepsia associated with H.Pylori | September,2002 |
| Feracrylum solution 1% w/v | Each ampoule contains: Feracrylum solution 1% w/v. | External haemostatic agent. | 21.05.1992 |
| Feracrylum spray | Each spray contains: Feracrylum.1% & 3% | Management of post.operative wounds, cuts, abrasion as an haemostatic agent. | 24.07.2001 |
| Feracrylum tulle 3% w/w gauze dressing | Rayon dressing with water soluble base containg feracrylum.3% w/w. | By RMP. for the management of post operative wounds, cuts, abrasion as haemostatic agent. | 29.07.2004 |
| Ferric Carboxymaltose equivalent to elemental Iron…50mg/ml Injection | Ferric Carboxymaltose equivalent to elemental Iron…50mg/ml Injection | For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used. | 11.02.2011 |
| Ferric sodium citrate | Ferric sodium citrate | April,1972 | |
| Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. | Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. | For iron deficiency anemia. | 08.06.2006 |
| Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) | Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) | For the treatment of iron deficiency anaemia. | 18.08.2008 |
| Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form) | Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) | Same as Approved. | 27.08.2008 |
| Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega.3.fatty acid 200mg capsules combikit | Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega.3.fatty acid 200mg capsules combikit | For iron, folic acid & omega.3.fatty acid deficiency. | 08.01.2010 |
| Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. To Elemental Zinc 22.5mg Tablet | Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. To Elemental Zinc 22.5mg Tablet | For the treatment of iron deficiency anaemia. | 05.01.2011 |
| Ferrous Ascorbate eq. to elemental iron 100mg + Folic acid IP 1.1mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength) | Ferrous Ascorbate eq. to elemental iron 100mg + Folic acid IP 1.1mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. | For the treatment of Iron deficiency anaemia. | 19.10.2011 |
| Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule. | Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule. | For Vitamin and mineral deficiency | 13.10.2010 |
| Ferrous ethylene diamine tetra acetate trihydrate | 25.50 mg | Oral iron compound (chelate form). | March,1962 |
| Ferrous sulphate + Folic acid CR tablets | Each CR tablet contains: Ferrous sulphate CR.100mg (eq.to elemental iron), Folic acid.0.5mg. | For the prophylaxis of iron and folic acid deficiencies during pregnancy. | 03.11.1992 |
| Fexofenadine + pseudo ephedrine ER Tabs | Each film coated tab contains: Fexofenadine.120mg, pseudo ephedrine sulphide USP in ER form.180mg | Allergic & seasonal rhinitis only | 17.09.1999 |
| Fexofenadine 120mg + Montelukast 10mg | Fexofenadine 120mg + Montelukast 10mg | For treatment of allergic rhinitis in adults only. | 31.08.2010 |
| Fexofenadine 120mg + Montelukast 10mg Chewable tablet | Fexofenadine 120mg + Montelukast 10mg Chewable tablet | Additional dosage form | 07.07.2011 |
| Fexofenadine hcl | Each tablet contains: Fexofenadine hcl.60mg, 30mg | By RMP. 30mg for relief of seasonal allergic rhinitis in children (6.12yrs), 60mg tab for relief of chronic idiopathic urticaria in 12yrs age and older chldren. | 01.11.200 |
| Fexofenadine hcl suspension | Each 5ml contains: Fexofenadine hcl.60mg | For paediatric & geriatric patients. | 27.08.2001 |
| Fexofenadine hcl tablets | Each tablet contains: Fexofenadine hcl.120mg,180mg | In the treatment of relief of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria in adults only. | 16.09.1998 |
| Fexofenadine suspension (30mg/5ml) | Fexofenadine suspension (30mg/5ml) | Seasonal allergic rhinitis & chronic idiopathic urticaria. | 19.01.2007 |
| Fibrinolysin (human) | 50000.100000 Units | To promote the dissolution of intravenous thrombi. | April,1961 |
| Fibrinolysin and Desoxy ribonuclease combined (Bovine) | Fibrinolysin and Desoxy ribonuclease combined (Bovine) | Enzymes useful in removal of exudates and clots from wound and promote healing. | February,1962. |
| Filgrastism injection (Finished Formulation) | 1.6ml contains: filgrastin.48MU, 1ml contains; filgrastim.30MU | 30.09.1993 | |
| Finasteride | 1mg | Additional indication. in treatment of male pattern hair loss in men only. | 23.04.2001 |
| Finasteride tabs | Each film coated tablet contains: Finasteride.5mg | Benign prostatic hypertrophy only. | 09.10.1996 |
| First Aid Dressing | Each first aid dressing strip (length 72mm x width 19mm) contains: Absorbent wound pad with top layer containing polyethylene net with metalic silver coating. | As a first aid dressing for covering minor cuts, abrasion and lacerisation. | 31.01.2007 |
| Fish gut sutures | Fish gut sutures | 28.08.1996 | |
| Fitostimoline topical cream & vaginal pessary | 1) Each 100gm of cream contains; Aqueous extract of Triticum Vulgare (dry residue 200mg/100ml).15gm, 2.phenoxyethanol Eur. Ph.1gm. 2) Each 3.5gm of vaginal pessary contains; Aqueous extract of Triticum Vulgare (dry residue 200mg/100ml).0.60gm, 2.phenoxyethanol Eur. Ph.0.04gm. | Cream. for the treatment of ulcers and bed sores. Vaginal pessary. for the treatment of phlogistic and dystrophic disorders of the female genital tract. | 20.11.2009 |
| Flavophospholipol (Flavomycin) | Flavophospholipol (Flavomycin) | Antibiotic. Used as feed additive in farm animals and poultry farm, birds. | September,1989 |
| Flecainide acetate | Each tablet contains: flecainide acetate.100mg, Each ampoule contains; (15ml) inj. flecainide acetate.150mg/ml | Antiarrhythamic | 26.03.1993 |
| Fluconazole | Each 5ml contains: Fluconazole.50mg | For systemic candidiasis, mucosal candidiasis, cryptocosis, prevention of fungal infection in patients with malignancy. | 29.05.2000 |
| Fluconazole (2%) + Zinc Pyrethione (1%) suspension | Each ml of lotion contains: Fluconazole.20mg, zinc pyrithione.10mg | For the treatment of seborrhoic dermatitis. | 22.02.2005 |
| Fluconazole + Secnidazole + Azithromycin | Each combikit contains: i).Uncoated tablet of one Fluconazole.150mg, ii).one tablet of azithromycin dihydrate eq.to azithromycin.1gm, iii).two film coated tablet of secnidazole.1gm | 07.06.1999 | |
| Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion | Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion | For the treatment of seborrhoeic dermatitis. | 15.09.2008 |
| Fluconazole 400mg tablet (Additional Indication) | 400mg | Additional indication:pityriasis versicolor. | 03.03.2005 |
| Fluconazole capsules/injection | Each capsule contains: Fuconazole.50mg,100mg,200mg, fluconazole i.v injection 100ml, 200ml contains: fluconazole.2mg/ml | For the treatment of systemic candidiasis, mucosal candidiasis, cryptococosis, prevention of fungal infections in patients with malignancy. | 28.01.1993 |
| Fluconazole Dispersible tablets 50mg | Each uncoated tablet contains: Fluconazole USP.50mg | For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy. | 22.04.2008 |
| Fluconazole (Eye Drops) | Each ml contains: Fluconazole.0.3% w/v | For fungal corneal, ulcers/keratitis only. | 04.02.1998 |
| Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml) | Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml) | For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy. | 20.08.2010 |
| Fluconazole tab (Additional Strength) | Fluconazole.400mg | Additional strength | 2003 |
| Fluconazole tablet 300mg (Additional Strength) | Fluconazole tablet 300mg | same as approved | 28.11.2011 |
| Fluconazole tablets (Additional Strength) | 400mg | Additional strength | April,2004 |
| Fluconazole tabs/caps/inj. | Each cap/tab contains: Fluconazole.50mg,100mg,200mg,150mg, Fluconazole i.v injection contains: fluconazole.2mg/ml | 26.04.1993 | |
| Fluconazole topical gel (0.5%) | Each gm of gel contains: Fluconazole.5mg | By dermatologists.for the treatment of topical fungal infection due to tinea cruris and tinea corporis. | 13.08.2004 |
| Flucortolone & flucortolone caproate | Flucortolone & flucortolone caproate | Acute & chronic eczema, allergic dermatosis. | July,1968 |
| Fludarabine injection & tablet (100mg) | 100mg | For additional indication; for the treatment of V.cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow, first time treatment with fludarabine oral should only be initiated in patients with adv.disease rai stages III/IV (Binet stages.c) or rai stage I/II (Binet stag A/B) where the patients has disease related symptoms or evidence of progressive diseases. | April,2005 |
| Flumequine | Flumequine | Respiratory tract infections. | September,1987 |
| Flumethasone pivalate + iodochloro hydroxyquinoline | Flumethasone pivalate.0.02%, iodochloro hydroxyquinoline.1.00% | October,1972 | |
| Flumethrin 1% solution | Each 100ml contains: Flumethrin.1gm | Management of all tick species on the body of cattle. | 29.10.1997 |
| Flunarizine hcl. | Each capsule contains: Flunarizine.5mg,10mg(6.9.93), Each tablet contains; flunarizine.10mg | For migraine. As a maintenanace treatment for classical and common migraine (prphylaxis). | November,1990 |
| Flunisolide nasal spray | Flunisolide.0.025% w/v | For the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever. | 30.11.1993 |
| Fluocinolone acetonide | Fluocinolone acetonide | Corticosteroid | August,1962 |
| Fluocortolon Trimethyl acetate + Fluocortolone caproate + Clenizole undecyclate + Cinchocaine Hcl | Ointment.Each gm contains: Fluocortolon Trimethyl acetate.0.92mg, Fluocortolone caproate.0.95mg, Clemizole undecylate.10mg, Cinchocaine Hcl.5mg, Suppositories.Fluocortolon Trimethyl acetate.0.612mg, Fluocortolone caproate.0.630mg, Clemizole undecylate.5mg, Cinchocaine Hcl.1mg | October,1978 | |
| Fluocortolone + Fluocortolone Caproate + Neomycin Sulphate | Each gm contains: Fluocortolone.2.5gm, Fluocortolone Caproate.2.5mg, Neomycin Sulphate.5mg | November,1978 | |
| Fluocortolone caproate + Fluocortolon Trimethyl acetate | Each 100gm contains : Fluocortolone caproate.0.25gm, Fluocortolon Trimethyl acetate.0.25gm | June,1978. | |
| Fluorescein Sodium Solution for Injection (100mg/ml) | Fluorescein Sodium Solution for Injection (100mg/ml) | Ophthalmological diagnostic agent. | 02.03.2006 |
| Fluorometholone + gentamicin | Each ml contains: Fluorometholone USP.1mg, gentamicin.3mg (as sulphate) | By RMP. the infection of the anterior segment of the eye due to bacteria susceptible to gentamicin. | 28.07.2000 |
| Fluorometholone + Gentamicin eye drops | Each ml contains: Fluorometholone.1mg, gentamicin.3mg (as sulphate) | The infection of the anterior segment of the eye due to bacterial susceptible to gentamicin. | 28.04.1997 |
| Fluorometholone + Neomycin sulphate sterile ophthalmic suspension | Each ml contains: Fluorometholone.1mg, neomycin sulphate.3.5mg (as base), benzalkonium chloride.0.04mg | In the treatment of infected inflammatory ocular conditions. | 04.09.1996 |
| Fluorometholone 0.1% and fluorometholone forte liquifilm 0.25% ophthalmic suspension | Fluorometholone.ophthalmic suspension.0.1%, fluorometholone forte liquifilm suspension.0.25% | Of non infected/infected inflammatory ocular condition. | 26.07.1996 |
| Fluorouracil | Fluorouracil | Cytotoxic | December,1964 |
| Fluoxetine hydrochloride | Each capsule contains: Fluoxetine hcl.20mg (60mg cap.Intas), fluoxetine hcl syrup.20mg/5ml | For the treatment of depression. | March,1990 |
| Flupenthixol Decanoate | Each mL contains: Flupenthixol Decanoate.20mg | July,1977 | |
| Flupenthixol Hydrochloride | Each tablet contains: Flupenthixol Hydrochloride.0.5mg | Neuroleptic agent. indicated in psychotic and schozophrenic cases where sedative and hypnotics effects are contra.indicated. | February,1977 |
| Fluphenazene | 0.5mg | Anxiety & Tension only. | 1961. May |
| Fluphenazine enanthate | 25 mg (1 c.c) | Tranquilizer | December,1967 |
| Flupirtine Maleate Capsules 100mg | Each capsule contains: Flupirtine maleate.100mg | For treatment of acute and chronic pain, i.e, for painful increased muscle tone of the posture and motor muscles, primary headache, tumor pain, dysmenorrhea and pain after traumatologic / orthopaedic operations and injuries. | 15.06.2010 |
| Flupirtine Maleate Sustained Release Tablets 400mg | Flupirtine Maleate Sustained Release Tablets 400mg | For the treatment of acute and chronic pain, i.e. for painful increased muscle tone of the posture and motor muscle, Primary Headache, tumor pain, Dysmenorrhea and pain after Traumatology/Orthopedic Operations and injuries. | 18.10.2012 |
| Fluprednylidene acetate + Gentamicin | Fluprednylidene acetate.0.1%, Getamicin as sulphate.0.1% | February,1980 | |
| Fluprednylidene Acetate + Gentamicin Sulphate + 5.Chloro.8.hydroxyquinoline | Fluprednylidene Acetate.0.1%, Gentamicin Sulphate.0.1%, 5.Chloro.8.hydroxyquinoline.0.5% | October,1978 | |
| Flurazepam capsules | Each capsule contains Flurazepam as hcl.15mg,30mg. | Hypnotic.indicated in all types of insomnia. | August,1985 |
| Flurbiprofen | 50 & 100mg | Non steroid anti inflammatory. Indicated in the treatment of rheumaoid arthritis, Oesteoarthritis and allied disorders. | July,.1979 |
| Flurbiprofen (Eye Drops) | Flurbiprofen.0.03% | July,1989 | |
| Flurbiprofen plaster 20 mg (7cm X 10cm) | Flurbiprofen plaster 20 mg (7cm X 10cm) | for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder. | 11.12.2009 |
| Flurbiprofen Sodium 0.03% Ophthalmic solution USP | Flurbiprofen Sodium 0.03% Ophthalmic solution USP | For the reduction of post.operative inflammatory condition. | 14.11.2009 |
| Flurbiprofen SR cap. | Each SR cap. Contains: Flurbiprofen.200mg | Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis. | May,1990 |
| Flutamide | Each tablet contains: Flutamide.250mg | Oral anti cancer. Indicated for pallative treatment of advanced prostatic cancer only. | June,1986 |
| Fluticasone furoate nasal spray | Each spray delivers: Fluticasone furoate.27.5mcg | For the treatment of symptoms of allergic rhinitis. | 20.03.2009 |
| Fluticasone propionate (125mg/250mg) + Salmeterol (as xinafoate) (50mcg) metered dose inhaler | Fluticasone propionate.125mg, 250mg + Salmeterol (as xinafoate).50mcg | Additional indication; chronic obstructive pulmonary disease . | March,2005 |
| Fluticasone propionate + salmoterol accuhaler | Each blister contain: Powder for inhaled providing fluticasone propionate.500mcg,250mcg,100mcg, salmoterol (as the xinafoate).50mcg | For regular treatment of bronchial asthma where the use of a bronchodilator and an inhaled cortocosteroid are appropriate | 29.03.2000 |
| Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation | Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation | For the maintenance treatment of asthma and for the treatment of COPD associated with chronic bronchitis. | 25.05.2010 |
| Fluticasone propionate cream/ointment | Fluticasone propionate cream.0.05%, Fluticasone propionate ointment.0.005%, Fluticasone propionate nasal spray.0.05% (12.5.2000) | Inflammatory and pruritic manifestation of corticosteroid responsive eczema dermatitis. | 18.03.1996 |
| Fluticasone propionate nebuliser solution | Each 2ml respules contains: Fluticasone propionate B.P.0.5mg, 2.0mg | By RMP. for the prophylactic management of severe chronic bronchial asthma in patients requiring high dose inhaled or oral corticosteroid therapy. | 09.11.2000 |
| Fluvastatin sodium | Fluvastatin sodium | 25.11.2003 | |
| Fluvastatin sodium sustained release (80mg) tablet | Fluvastatin sodium SR tablet.80mg | For secondary prevention of major adverse cardiac events in patients with coronary heart disease after coronary transcatheter therapy. | 02.03.2005 |
| Fluvastatin Tablet (As calcium) 10mg/20mg/40mg (Additional Strength) | Fluvastatin Tablet (As calcium) 10mg/20mg/40mg | As approved | 29.01.2007 |
| Fluvestrant 250mg/5ml Injection (Additional Dosage Regime) | Fluvestrant 250mg/5ml Injection | (Same as approved) Posology : Adult females (Including the elderly). The recommended dose is 500mg at interval of one month, with an additional 500mg dose given two weeks after initial dose. | 20.04.2011 |
| Fluvoxamine maleate | Each film coated tab contains: Fluvoxamine maleate.50mg,100mg | In treatment of obsessive compulsive disorder and depression. | 21.02.2000 |
| Fluvoxamine Maleate100/150mg ER Tablets | Fluvoxamine Maleate100/150mg ER Tablets | For the treatment of obsessive compulsive disorder (OCD)and depression. | 19.08.2009 |
| Folic acid + Ferrous sulphate | Folic acid.0.5mg, Ferrous sulphate.150 mg | January,1969 | |
| Fomepizole Bulk &1.5gm/Ampoule | Each ampoule contains: Fomepizole hydrate 1.83ml eq.to fomepizole.1.5gm | As an antidote for Ethylene glycol or Methanol used poisoning or for use in suspected Ethylene glycol or Methanol ingestion, either alone or in combination with hemodialysis. | 14.03.2016 |
| Fondaparinax Sodium injection (Additional Indication) | Fondaparinax Sodium injection | Treatment of acute coronary syndrome (ACS) with and without ST.segment elevation. | 28.01.2008 |
| Fondaparinux sodium | Each pre filled syringe of subcutaneous injection contains: Fondaparinux sod..2.5mg/0.5ml | Specialist | 2003 |
| Formestane depot inj. (i.m) | Each vial contains: Formestane sterile.250mg | For the treatment of advance stage of breast cancer in women with natural or artificially induced post menopausal status. | 06.03.1995 |
| Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder Inhalation | Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder Inhalation | For the treatment of patients with bronchial asthma and COPD, where the use of combination is found appropriate. | 30.12.2009 |
| Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250 /500mcg) dry powder inhaler | Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250 /500mcg) dry powder inhaler | For Asthma & COPD. | 10.05.2006 |
| Formoterol fumarate + budesonide rotacaps (as dry powder inhaler) | Each cap.contains; formoterol fumerate.6mcg, budesonide B.P.100mcg,200mcg | Asthma where use of combination of inhaled regular corticosteroid & long acting beta agonist is appropriate. | 17.08.2001 |
| Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg /250mcg MDI | Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg /250mcg MDI | For Asthma & COPD | 14.10.2006 |
| Formoterol fumerate & budesonide inhaler | Each actuation delivers: Formoterol fumerate.6mcg, budesonide BP.400mcg | Asthma where use of combination of inhaled regular corticosteroid & long acting beta.agonist is apropriate. | 23.04.2002 |
| Formoterol fumerate + Budesonide inhaler | Each actuation delivers: Formoterol fumerate.6mcg, budesonide.100mcg,200mcg | Persistent asthma where use of a combination of inhaled corticosteroids therapy & long acting beta.agonist has been found to be appropriate. | 19.11.2001 |
| Formoterol fumerate + budesonide rotacaps (Additional Strength) | Each cap.contains: Formoterol fumerate.6mcg, budesonide.400mcg | Additional strength | 07.03.2002 |
| Forskolin (1%) (Eye Drop) | Forskolin Eye drop (1%) | For open angle glaucoma. | 27.07.2006 |
| Fortison liquid/powder, Pepti.2000 liquid/powder | Fortison liquid/powder, Pepti.2000 liquid/powder | 27.01.1995 | |
| Fosaprepitant (as Dimeglumine) for Injection 150mg. | Each vial contains: Fosaprepitant dimeglumine eq.to fosaprepitant.150mg | 1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. 2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. | 16.12.2011 |
| Fosfomycin trometamol sachets | Each sachet contains: Fosfomycin trometamol 5.631gm eq.to fosfomycin.3gm | For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcus faecalis. | 16.07.2010 |
| Fosfomycin Tromethamine Sachet 3gms | Each sachet contains: Fosfomycin tromethamine eq.to fosfomycin.3gm | For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcus faecalis. | 13.10.2008 |
| Fosinopril sod.tab & bulk | Each tab contains: Fosinopril sodium.10mg,20mg,40mg | Mild to moderate hypertension. | 10.01.2002 |
| Fosphenytoin sod. Inj. | Each 2ml & 10ml vial contains: Fosphenytoin sod. 75mg/ml eq.to phenytoin sod. 50mg/ml | Generalized convulsive status epilepticus, prevention & treatment of seizures occurring during neurosurgery & head injury when other means of phenytoin administration are unavailable, inappropriate or less advantageous. | 01.10.2022 |
| Fotemustine i.v injection | Each vial contains: Fotemustine powder.208mg (with solven) | In the treatment of disseminated malignant melanoma including cerebral localisation and primary malignant cerebral tumours. | 23.12.1996 |
| Framycetin + Hydrocortisone + Fluconazole topical cream | Framycetin sulphate.1%, hydrocortisone acetate.1%, fluconazole nitrate.2% | March,1987 | |
| Frusemide + KCl | Each tablet contains: Frusemide.20mg, potassium chloride.750mg | March,1989. | |
| Frusemide + potassium chloride CR tablet | Each CR tablet contains: Frusemide.40mg,20mg(23.9.93), pot.chloride.600mg,300mg(23.9.93) | 26.02.1993 | |
| Frusemide + Spironolactone | Each capsule/tablet contains: Frusemide.20mg, spironolactone.50mg,100mg | September,1984 | |
| Fulvestrant Inj. 250mg/5ml prefilled syringe | Fulvestrant Inj. 250mg/5ml prefilled syringe | Anti Cancer. | 30.08.2006 |
| Furazolidone + Metronidazole Benzoate + Pectin + Kaolin | Each 5mL contains: Furazolidone.30mg, Metronidazole Benzoate.100mg, Pectin, Kaolin. | March,1979 | |
| Furosemide | Furosemide | Oral diuretic | April,1965 |
| Fusidic acid eye drops | Each gm contains: Fusidic acid BP.10mg | Bacterial infection of the eye caused by susceptible organism in conjunctivitis, blepharitis, stykeratitis, dacryocystitis. It can be used for prophylaxis in ophthalmic surgery and in connection with removal of foreign bodies. | 03.03.1992 |
| Gabapentin | Gabapentin.600mg,800mg | Additional strength by RMP | 06.06.2003 |
| Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength) | Gabapentin 100mg + methylcobalamin 500mcg tablets | Same as Approved. | 24.01.2008 |
| Gabapentin caps | Each capsule contains: Gabapentin.300mg,400mg | Epilepsy. | 03.08.1995 |
| Gabapentin ER 450/600/900mg tablet | Each film coated E.R tablet contains: Gabapentin.450mg, 600mg, 900mg | For the treatment of neuropathic pain and as adjunctive therapy in the treatment of partial seizures with or without secondary generalisation in adults. | 15.12.2006 |
| Gabapentin SR 600mg tablets | Gabapentin SR 600mg tablets | As adjunctive therapy in the treatment of partial seizures of epilepsy. | 30.01.2008 |
| Gadobenate dimeglumine IV Injection (Gadobenate dimuglimine 529mg equivalent to Gadobenate acid 334mg + Meglumine 195 mg) (Additional Indication) | Gadobenate dimeglumine IV Injection (Gadobenate dimuglimine 529mg equivalent to Gadobenate acid 334mg + Meglumine 195 mg) | Contrast.enhanced MR.angiography where it improves the diagnostic accuracy for detecting clinically significant stenoocclusive vascular disease in patients with suspected or known vascular disease of the abdominal or peripheral arteries. | 11.08.2011 |
| Gadobenate dimuglimine i.v inj. | Each ml contains: Godabenate acid 334 mg as dimuglimine salt. | Contrast medium for MRI of liver & CNS. | 07.03.2003 |
| Gadobutrol 1.0mmol/ml solution for Injection | Each ml contains: Gadobutrol.604.720mg | "In adult, adolescence and children aged 2 years and older for: 1. contrast enhancement in cranial and spinal magnetic resonance imaging (MRI) 2. Contrast enhancement MRI of other body regions: liver kidneys 3. Contrast enhancement in Magnetic Resonance Angiograpy (CE.MRA) 4. For MRI of the breast to assess the presence and extent of Malignant breast disease". | 07.05.2015 |
| Gadodiamide i.v inj (Finished Formulation) | Each 1ml injection contains: Gadodiamide 287mg eq.to 0.5 m mol (in 10ml vial) | Contrast media | 21.01.1994 |
| Gadopentetate dimegluminate inj. | Each ml contains: 469.01mg gadopentetic acid, dimeglumine salt in aqueous solution. | Contrast media. Cranial and spinal magnetic resonance tomography. | 06.05.1992 |
| Gadopentetic acid dimeglumine salt injection 469mg/1ml (0.5mmol) (Additional Indication) | 1ml solution for injection or infusion contains: Gadopentetic acid, dimeglumine salt 469mg (0.5 mmol) | For use in MRI in adult patients to facilitate visualization of lesions with abnormal vascularity in the body (excluding heart). | 23.02.2015 |
| Gadoversetamide inj. | Each ml contains: Gadoversetamide.330.9mg (0.5mm) | For use in magnetic resonance imaging in patients with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues. | 04.06.2003 |
| Galanthamine Hydrobromide | Galanthamine Hydrobromide | Treatment of neuritis & poliomyelitis, infantile cerebral palsies. | December,1978 |
| Ganciclovir sodium | Each capsule contains:Ganciclovir.250mg, Each vial contains :Ganciclovir.500mg. | For the prevention & treatment of cytomegalo virus disease in immuno compromised individuals and for the prevention of CMV disease in transplant receipients. | 05.04.2000 |
| Ganirelix soln for inj. | Each 0.5ml of soln for inj.contains: Ganirelix.0.25mg | Prevention of premature leutinising hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction technique. | 08.10.2001 |
| Garenoxacin Mesylate tablets 200mg | Each film coated tablet contains: Garenoxacin mesylate eq.to garenoxacin.200mg | For the treatment of bacterial respiratory tract infection. | 07.06.2013 |
| Gatifloxacin (0.3%) + Prednisolone Acetate (1%) (Eye Drops) | Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops | For Ophthalmic use. | 02.06.2006 |
| Gatifloxacin (200mg) + Ornidazole (500mg) tablet | Gatifloxacin (200mg) + Ornidazole (500mg) tablet | For diarrhoea of mixed infection in adults. | 06.06.2005 |
| Gatifloxacin (as sequihydrate).3mg + Flurbiprofen sod..0.3mg/ml (Eye Drops) | Gatifloxacin (as sequihydrate).3mg + Flurbiprofen sod..0.3mg/ml eye drops | For reduction of post.operative inflammatory conditions of eye, when bacterial infection exists. | 29.11.2007 |
| Gatifloxacin + Ambroxol tablets | Each tablet (film coated bilayered) contains: Gatifloxacin sesquihydroate eq.to gatifloxacin.400mg, ambroxol hcl BP.75mg (SR form) | By RMP. for the treatment of respiratory tract infection by susceptible organisms in adults. | 24.12.2004 |
| Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% (Eye Drops) | Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop | For reduction of part operative inflammatory condition of eyes. | 24.07.2008 |
| Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspension | Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspension | For Post.Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists. | 19.05.2011 |
| Gatifloxacin Eye drop 5 mg/ml | Gatifloxacin Eye drop 5 mg/ml | For the treatment of bacterial conjunctivitis caused by susceptible strains. | 21.02.2011 |
| Gatifloxacin (Eye Drops) | Each ml contains: Gatofloxacin.3mg | For treatment of external bacterial infection of eyes. | 21.05.2003 |
| Gatifloxacin (0.3%) (Eye Ointment) | Each gm of ointment contains: Gatifloxacin.3mg | Ophthalmologists only. for the treatment of external bacterial infections of eyes. | 15.10.2004 |
| Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v (Eye Drops) | Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v | For the treatment in the patients with inflammatory occular conditions where bacterial infection or a risk of bacterial occular infection exists. | 24.10.2011 |
| Gatifloxacin tab & inj. | Each film coated tab contains: Gatifloxacin.200mg,400mg, Each single use vial of inj.contains gatifloxacin.10mg/ml | Acute bacterial exacubation of chronic bronchitis/acute sinusitis/community acquired pneumonia/uncomplicated UTI (cystitis)/uncomplicated urethral & cervical gonorrhoea & complicated UTI | 03.10.2001 |
| Gatifloxacin tabs/inj. | Gatifloxacin tabs/inj. | Additional indication. for skin & skin structure infection. | July,2004 |
| Gefitinib | Gefitinib | Anticancer | 17.02.2004 |
| Gefitinib tab 250mg (Additional Indication) | Gefitinib tab 250mg | Indicated for the first line treatment of patients with locally advanced or metastatic non small cell lung cancer (NSLC) who have activating mutationof the EGFRTK". | 18.12.2009 |
| Gemcitabine for (Additional Indication) | Gemcitabine for additional indication | Additional indication. gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelial ovarian cancer more than 6 months after latnum based first line therapies. | 26.07.2004 |
| Gemcitabine HCl injection 2gm/vial (Additional Strength) | Gemcitabine HCl injection 2gm/vial | Same As Approved | 03.07.2010 |
| Gemcitabine HCl injection ready to use infusion bags (Approved as infusion bags) | Gemcitabine HCL equivalent to Gemcitabine 10mg per mL (100,120,130,140,150,160,170,180,190 and 200mL) | Ovarian cancer.Gemcitabine injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has replaced at least 6 months after completion of platinum based therapy. Breast Cancer.Gemcitabine injection in combination with Paclitaxel is indicated for the first line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy, unless anthracyclinces were clinically contraindicated. Non.small cell lung concerGemcitabine injection is indicated in combination with cisplatin for the first line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) | 17.06.2014 |
| Gemcitabine Hydrochloride for injection 2g/vial (New Dosage Form) | Gemcitabine Hydrochloride for injection 2g/vial | In the management of non small cell lung cancer. | 27.10.2011 |
| Gemcitabine in combine with cisplatin | Gemcitabine in combine with cisplatin | For additional indication | 2003 |
| Gemcitabine Injection 38mg/ml | Gemcitabine Injection 38mg/ml | Ovarian cancer.Gemcitabine injection in combination with cisplatin is indicated for the treatment of patients with advanced ovarian cancer that has replaced at least 6 months after completion of platinum based therapy. Breast Cancer.Gemcitabine injection in combination with paclitaxel is indicated for the first line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. Non.small cell lung cancer Gemcitabine injection is indicated in combination with cisplatin for the first line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (stage IV) non.small cell lung cancer. Pancreatic cancer. Gemcitabine injection is indicated as first.line treatment for patient with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine injection is indicated for patients previously treated with 5.EU. | 05.12.2012 |
| Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Additional Indication) | Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg | For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata. | 05.04.2010 |
| Gemfibrozil capsules | Each capsule contains: Gemfibrozil.300mg, (900mg.19.8.97) | Lipid lowering agent. Indicated for the treatment of adult patients with very high triglyceryl levels (type IV.hyperlipidemia). | August,1988 |
| Gemifloxacin (as msylate) 320mg tablet | Gemifloxacin (as msylate) 320mg tablet | Antibiotic | 30.08.2006 |
| Gemifloxacin + Ambroxol (320mg + 75mg SR) FC Tablets | Gemifloxacin + Ambroxol (320mg + 75mg SR) FC Tablets | Indicated for the treatment of lower respiratory tract infections in adult patients. | 24.12.2008 |
| Gemigliptin 50 mg tablet | Each film coated tablet contains: Gemigliptin tartrate sesquihydrate (eq.to gemigliptin 50mg).68.9mg | As an adjunct to the diet & exercise to improve to improve glycemic control in adults with type.2 diabetes mellitus, as an monotherapy or in combination with metformin in patients with inadequate glycemic control on metformin alone. | 21.08.2015 |
| Gemtuzumab ozogamicin inj. | Each vial contains: Gemtuzumab ozogamicin (lyophilized powder).5mg | Treatment of acute myeloid leukemia | 12.09.2002 |
| Genatamicin sulphate | Each mL contains: Gentamicn sulphate eq to 2mg of Gentamicin base | 1978 | |
| Genotropin 4iu/12iu/16iu injection (Finished Formulation) | Genotropin 4iu/12iu/16iu injection | Short stature due to inadequate or failed incretion of pituitary growth hormone. | 05.09.1994 |
| Gentamicin sulphate | 0.8mg/kg, 0.4mg/kg | Urinary tract infection. | July,1968 |
| Gestodene + ethinyl estradiol | Each film coated tablet contains; Gestodene.60mcg, Ethinyl Estradiol.15mcg, 24 tablets + 4 dummy tablets per pack | By RMP. oral contraceptive for women | 17.07.2000 |
| Ginger extract caps.& bulk | Each cap.contains: Standardised ginger ext..200mg | Adjunct therapy in minimising drug induced emesis associated with cancer chemotherapy. | 29.08.2001 |
| Ginkgo biloba extract Tablet 120mg (Additional Strength) | Ginkgo biloba extract Tablet 120mg | For the treatment of dementia, vertigo and tinnitus in adult patients. | 09.12.2014 |
| Ginko biloba | Each film coated tablet contains: Dried extract of ginko biloba.40 mg (containing 9.6mg of ginko flavone gylycosides) | Herbal extract. In treatment of disorders in the functioning of the brain (reduced intellectual ability and alertness), giddiness buzzing in the ears, headache, poor memory, weakening of the voice resulting from anxiety. | 08.09.1992 |
| Glatiramer Acetate Injection (20mg/ ml) & Pre.filled syringe (20mg/ml) | i) Each 1ml vial contains: glatiramer acetate.20mg, ii) Each 1ml pre.filled syringe contains: glatiramer acetate.20mg | For the reduction of the frequency of relapses in patients with Relapsing.Remitting Multiple Sclerosis. | 03.06.2009 |
| Glatiramer Acetate injection (20mg/ml) | Glatiramer Acetate injection (20mg/ml) | Multiple sclerosis. | 21.02.2007 |
| Glibenclamide + Metformin SR tablets | Glibenclamide.2.5mg,5mg, metformin.500mg | 20.08.2004 | |
| Glibenclamide + Metformin tabs | Each film coated tablet contains: Glibenclamide.2.5mg, metformin.400mg | 30.11.1995 | |
| Glibenclamide 5mg + MetFormin SR 850mg tablet (Additional Strength) | Glibenclamide 5mg + MetFormin SR 850mg tablet | As approved | 15.02.2007 |
| Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets | Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets | As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control. | 23.02.2009 |
| Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg (Additional strength) | Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg | Additional strength | 19.07.2010 |
| Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet | Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet | Anti. diabetic. | 22.08.2006 |
| Gliclazide M.R. (30mg/60mg) + Metformin HCl (500mg) ER Tablet | Gliclazide M.R. (30mg/60mg) + Metformin HCl (500mg) ER Tablet | For type.II diabetes. | 27.04.2005 |
| Gliclazide modified release tablet | Each un.coated MR tablet contains: Gliclazide.30mg, 60mg | For the treatment of type.II diabetes mellitus. | 14.08.2007 |
| Gliclazide modified release tabs. | Each u.c, scored M.R tabs gliclazide.30mg | By RMP. in treatment of NIDDM (type.II) in association with dietary measures in adult only. | 09.11.2000 |
| Gliclazide tablets | Each tablet contains: Gliclazide.80mg | Anti diabetic. Indicated in the treatment of all types of maturity onset diabetes, diabetes without or with obesity in adults. | November,1988 |
| Glimenclamide + Metformin tabs | Each tab contains: Glibenclamide.2.5mg,5mg, metformin.400mg,500mg | Non insulin dependent diabetes mellitus patients poorly controlled with sulphonyl urea or biguanide alone. | 26.11.1996 |
| Glimepiride | Each tablet contains: Glimepiride 1mg/2mg/3mg/4mg | Adjunct to diet or exercise to lower the blood glucose in patients with non insulin dependent(type.II) diabetes mellitus whose hyperglycemia cannot be controlled by diet and single agent alone. | 24.01.1999 |
| Glimepiride + metformin SR tab | Each uncoated tab contains: Glimepiride.1mg,2mg, metformin hcl IP.500mg in SR form | For patients with type 2 diabetes mellitus when diet, exercise & the single agent do not result in adequate glycemic control. | 13.11.2002 |
| Glimepiride + pioglitazone tab (Additional Strength) | Each uncoated tab contains: Pioglitazone hcl eq.to pioglitazone.30mg, glimepiride.1mg,2mg | Additional strength | 13.03.2003 |
| Glimepiride + rosiglitazone | Glimepiride.1mg, rosiglitazone.4mg | For the treatment of type.II NIDDM. | 12.12.2003 |
| Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets | Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets | For the treatment of type II diabetes mellitus associated with dyslipidemia. | 17.12.2009 |
| Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (Additional Strength) | Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet | As approved | 08.06.2007 |
| Glipizide + Metformin tablets | Each tab contains: Glipizide.2.5mg,5mg, metformin.250mg,500mg | For non insulin dependent diabetes mellitus. | 20.03.1998 |
| Glipizide GITs tabs (gastro intestinal therapeutic system) | Each tab contains: Glipizide.5mg,10mg | Non insulin dependent diabetes mellitus (NIDDM type.II) | 21.08.1996 |
| Glucagon | Glucagon | Hypoglycemic agent. indicated in the treatment of severe hypoglycemic reaction in diabetic patients. | October,1978 |
| Glucomannan sachets (herbal medicine) | Each sachet containing: Glucomannan.0.75gm,1.0gm,1.3gm | For reduction of blood glucose level reduction serum lipid level. | 06.09.1993 |
| Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets | Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets | For the treatment of adult patients with osteoarthritis of knee and/or hip joints. | 03.11.2009 |
| Glucosamine sulphate SR Tablet | Each SR tablet contains: Glucosamine sulphate.750mg | For the treatment of osteoarthritis. | 05.04.2007 |
| Glutathione for Injection 600mg | Each vial contains: Glutathione.600mg | For the treatment of alcoholic liver diseases like alcoholic fatty liver, alcoholic liver fibrosis, alcoholic liver cirrhosis, and hepatitis | 14.09.2011 |
| Glycopyrrolate + neostigmine inj. | Each 5ml contains: Glycopyrrolate.500mcg, neostigmine methyl sulphate.2500mcg | Reversal of residual non.depolarising competitive neuromuscular block. | 11.04.2002 |
| Glycopyrronium bromide inhalation powder hard capsule with inhaler | Each capsule contains: 62.5 mcg Glycopyrronium bromide eq. to Glycopyrronium 50 mcg. | Indicated as a once daily maintenance bronchodilator treatment to relieve symptoms of patients with Chronic Obstructive Pulmonary Disease (COPD). | 01.04.2014 |
| Glydiazinamide | Glydiazinamide | Oral hypoglycemic acid. indicated in the treatment of diabetes. | February,1976 |
| Gonadorelin (6.D.Phe) 0.05mg/ml solution for injection (Veterinary) | Each ml contains: 0.05mg gonadorelin (6.D.Phe) eq.to 0.0524mg gonadorelin (6.D.Phe) acetae. | Control and induction prodecude in cattle and pig reproduction. Therapy of ovarian infertility disorders or dysfunctions of the reproductive organs in cattle and horses. | 15.06.2016 |
| Goserelin acetate injection | Goserelin acetate eq.to 3.6mg of gesoserlin | In the treatment of prostate cancer, breast cancer, endometriosis. | 24.04.1996 |
| Gramicidin | Gramicidin | Russian pharmacopoeia drugs | April,1965 |
| Granisetron tabs | Each film coated tablet contains: granisetron hcl eq.to granisetron.1mg,2mg, each ml of inj.contains: granisteron hcl eq.to granisetron.1mg. | By RMP. for nausea vomiting in cancer patients treated with cytotoxic drugs. | 05.07.200 |
| Guaiphenasin Syrup 133mg/5ml | Guaiphenasin Syrup 133mg/5ml | For the treatment of productive cough accompanied by phlegm. | 18.12.2009 |
| Guaiphenesin ER Tablet (600mg) | Each extended release tablet contains: Guaiphenesin IP.600mg | For the treatment of productive cough accompanied by phlegm. | 28.08.2008 |
| Guaiphenesin ER Tablet 1200mg | Guaiphenesin ER Tablet 1200mg | For the treatment of productive cough accompanied by Phlegm. | 16.05.2009 |
| Guanethidine (as sulphate) | 25mg to 50mg | Antihypertensive | April,1961 |
| Guanethidine sulphate | Each ml contains: Guanethidine sulphate.10mg | October,1969 | |
| Gugulipid | Gugulipid | Lipid lowering agent | June,1986 |
| Gugulipid tablets | Each tablet contains: Gugulipid eq.to guggulsterone.25mg | March,1987 | |
| Gynera tablets | Each tablet contains: Gestoden.75mcg, ethinyloestradiol.30mcg | July,1988 | |
| Haemmacel | 500 ml bottles | Blood plasma substitute | May,1965 |
| Haemocoagulase gel (topical) | Each gm of gel contains: Haemocoagulase isolated from Bothrops Atrox or Bothrops jararaca 1.0 CU, Chlorhexidine gluconate solution (0.1w/w) | For the topical treatment of localised capillary haemorrhage & wound healing. | 22.11.2004 |
| Haemodialysis Powder/Liquid Form containing citrate | Haemodialysis Powder/Liquid Form containing citrate | For use for patients being treated by hemodialysis. | 19.08.2008 |
| Haemophilus type.b conjugate vaccine (Finished Formulation) | Haemophilus type.b conjugate vaccine | For the indication in infants from 2 months for the prevention of invasive disease such as meningitis,septicemia epiglotitis. | 13.12.1994 |
| Halcinonide | Halcinonide | Topical cream. indicated in the treatment of various common dermatosis. | July,1976 |
| Halcinonide + Neomycin Sulphate | Each gm contains: Halcinonide 1mg, Neomycin Sulphate eq to 2.5mg of Neomycin base | July,1979 | |
| Halobetasol 0.05% + Clotrimazole 1.0% cream | Halobetasol 0.05% + Clotrimazole 1.0% cream | For the treatment of steroid responsive fungal infections including eczema and psoriasis. | 04.01.2008 |
| Halobetasol 0.05% + Salicylic acid 6% Ointment (Additional Strength) | Halobetasol 0.05% + Salicylic acid 6% Ointment | For the treatment of plaque psoriasis. | 14.05.2008 |
| Halobetasol 0.5mg + Miconazole 20mg per gram Cream | Halobetasol 0.5mg + Miconazole 20mg per gram Cream | For steroid responsive dermatoses associated with superficial fungal infection of skin. | 31.01.2008 |
| Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment | Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment | For plaque psoriasis. | 01.08.2007 |
| Halobetasol Scalp Approved 0.05% w/v | Halobetasol Scalp Approved 0.05% w/v | For the relief of inflammatory andpuritic manifestation of corticosteroidrespensive dermatosis. | 18.02.2009 |
| Halobetazol Propionate Cream (0.05%) | Halobetazol Propionate Cream (0.05%) | Corticosteroid responsive dermatomes. | 02.02.2007 |
| Halofuginone (Derivative of an alkaloid isolated from plant Dichora Febrifuga Lour) | Halofuginone (Derivative of an alkaloid isolated from plant Dichora Febrifuga Lour) | Poultry feed additive. for prvention & treatment of poultry Coccidiosis. | July,1980 |
| Halometasone (as monohydrate ) 0.05% Cream | Each gram contains: Halometasone monohydrate.0.5mg | For the relief of inflammatory and pruritic manifestation of non.infected corticosteroid responsive dermatoses like eczema. | 11.09.2008 |
| Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w cream | Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w cream | For the treatment of acute and chronic infected eczematous dermatitis. | 15.12.2009 |
| Haloperidol decanoate i.m injection | Haloperidol decanoate injection.50mg/ml,100mg/ml | In the management of chronic schizophrenia only | February,1990 |
| Haloperidol Tablet (0.5mg) (Additonal Lower Strength) | Haloperidol Tablet (0.5mg) | As approved earlier. | 30.03.2006 |
| Halquinol | Halquinol | Antiamoebic, antidysentric. | September,1965 |
| Hamycin | Hamycin | Anti.fungal, anti.biotic. | November,1961 |
| Hamycin glycerin | 300000 units/ml | January,1971 | |
| Hamycin hair cream | Each gm contains: Hamycin 0.1% (eq.to hamycin 20,000 units) | September,1992 | |
| Hand wash liquid soap/hand lotion | Hand wash liquid soap/hand lotion contains: Nonoxynol.9.2%w/v, chlorometaxylenol.0.5%w/v. | 26.Jul.1995 | |
| Heparin sod. & 0.9% sod.chloride inj. | Each ml contains: Heparin sod..2 USP heparin units, sod. Chloride.9mg | As an aid in the maintenance of catheter cannule potency. | 26.03.2002 |
| Heparin Sodium Topical Solution 1000 IU/ml (Additional Dosage Form) | Heparin Sodium Topical Solution 1000 IU/ml | For the management of post infusion superficial thrombophlebitis. | 16.01.2014 |
| Heparinoid & hyaluronidase | 3.5 cm of ointment applied 2.3 times a day | Thrombophlebitis, tendovaginitis, sprains etc. | December,1967 |
| Hepatitis A Vaccine | Each 0.5ml dose contains: Hepatitis A (GBM strain) virus.160 antigen unit. | For active immunization agaist infection caused by hepatitis A virus | 05.02.1998 |
| Hepatitis B vaccine (recombinant DNA) | Hepatitis B vaccine (recombinant DNA) | For treatment of Hepatitis B virus infection. | January,1987 |
| Heta starch in NaCl I.V inj | Each 100 ml contains: Hydroxyethyl starch (mol.wt. 450000Da).6gm, NaCl.0.9gm | For the treatment of hypovolemia. | 29.04.2002 |
| Hexadimethrine bromide | 1.33mg for 100USP units of Heparin | Heparin antagonist. | April,1962 |
| Horse anti human lymphocyte globulin | Horse anti human lymphocyte globulin | For aplastic anaemia. | May,1991 |
| Hydroxypropyl Methylcellulose USP… ................................................. %w/v Dextran70 ............................................. %w/v Glycerin ................................................ %w/v Sterile ophthalmic drops | Hydroxypropyl Methylcellulose USP… ................................................. %w/v Dextran70 ............................................. %w/v Glycerin ................................................ %w/v Sterile ophthalmic drops | For the temporary relief of burning and irritation due to dryness of the eye and for use as a protection against further irritation. For the temporary relief of discomfort due to minorirritations of the eyes or to exposure to wind or sun. | 06.07.2010 |
| HSA free recombinant human erythropoietin injection | Each vial contains: HSA free recombinant erythropoietin injection.1000 IU, 2000 IU, 3000 IU, 4000 IU, 10000 IU | 07.12.2001 | |
| Human follicle stimulating Hormone (FSH) and Human leutenising harmone (LH) | Human follicle stimulating Hormone (FSH) and Human leutenising harmone (LH) | Fertility drug. to be supplied to gynaecologists attached to hospitals where facilities exist for screening patients and to private consultations of academic & professional standing. | October,1978 |
| Human Insulin (r.DNA) Powder inhaler | Human Insulin (r.DNA) Powder inhaler | For type.I & Type.2 Diabetes. | 30.08.2006 |
| Human interferon alfa.2b (reombinant) inj. | Each vial contains: Human interferon alfa.2b (recombinant).3mIU,5mIU,10mIU | By cancer specialists.for multiple myeloma, kaposis sarcoma in patients with AIDS, malignant melanoma, hairy cell leukemia, chronic myelogenous leukemia, laryngeal papilimatosis, condylomate accuminata, superficial and nodulocerative basal cell carcinoma. | 02.01.2001 |
| Human placental Extract | Human placental Extract | September,1978 | |
| Human recombinant granulocyte colony stimulating factor (Hu r GCSF) inj. | Each ml contains;: Hu r GCSF.300mcg | For decreasing the severity of cytotoxic chemotherapy induced neutropenia, acceleration. | 28.06.2001 |
| Hyaluronic acid (cross linked) Pre.filled syringe 18mg/0.6ml and 24mg/0.8ml | Hyaluronic acid (cross linked) Pre.filled syringe 18mg/0.6ml and 24mg/0.8ml | For intradermal implantation and facial soft tissue augmentation. | 31.01.2009 |
| Hyaluronic acid injection | Each ml contains: Hyaluronic acid.20mg in PFS | For treatment of wrinkles & folds of face & lips enhancements. | 03.04.2003 |
| Hyaluronic Acid Pre. filled Syringe 30mg/2ml& 60mg/4ml (Additional Strength) | Hyaluronic Acid Pre. filled Syringe 30mg/2ml& 60mg/4ml | To Restore Visco.Elastic Properties of the Synovial Fluid, with Alleviation of Pain and improvement of Joint, Mobility in Patients Affected by Degenerative or Mechanical Arthopathy. | 05.05.2011 |
| Hyaluronic Acid Salt 25mg + Cross.Linked Hyaluronic acid 25mg per ml in prefilledsyringe | Hyaluronic Acid Salt 25mg + Cross.Linked Hyaluronic acid 25mg per ml in prefilledsyringe | For intradermal implantation and facial soft tissue augmentation. | 30.01.2008 |
| Hyaluronic Acid Sodium Salt | (i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad containsHyaluronic Acid Sodium Salt 50/100mg | For the treatment of wound of different etiology. | 31.03.2009 |
| Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream. | Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream. | For the treatment of wound of different etiology. | 31.03.2009 |
| Hyaluronic acid sodium salt injection | 1) Each vial contains; hyaluronic acid sodium salt.20mg/2ml, 2) Each 2ml pre.filled syringe contains; hyaluronic acid sodium salt.20mg | For relief of pain in patients with osteoarthritis of the joint who have failed to respond adequately to convetional therapy. | 01.10.2008 |
| Hydrcortisone 17.butyrate cream/oitment | Hydrocortisone 17.butyrate.0.1% | Topical corticosteroid. Indicated in the treatment of conditions responsive to topical corticosteroids e.g, eczema, dermatitis, psoriasis, lichen simplex. | August,1985 |
| Hydrocortisone (10%) enema form | 10% w/w | For adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients of ulcerative colitis & proctosigmoditis. | 09.08.1999 |
| Hydrocortisone acetate + Nitrofurazone | Hydrocortisone acetate.1%w/w, Nitrofurazone.0.2%w/w | June,1973 | |
| Hydroflumethiazide + rauwolfia | i) HFT.25 + R.50, ii) HFT.50 + R.50, iii) HFT.25 | March,1971 | |
| Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel | Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel | For short term intermittent treatment of moderate to severe melasma of the face in the presence of measures for sun avoidance including use of sun screen. | 31.01.2008 |
| Hydroquinone 2% + Tretinoin 0.05% + Hydrocortisone 1% Cream | Hydroquinone 2% + Tretinoin 0.05% + Hydrocortisone 1% Cream | For the treatment of patients with skin hyperpigmentation. | 23.02.2009 |
| Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream | Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream | For the treatment of melasma of face in adults. | 23.02.2009 |
| Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel | Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel | For treatment of hyper pigmentry disorders. | 31.01.2011 |
| Hydrotalcite | Each tablet/suspension 5ml contains: Hydrotalcite.500mg, simethicone (activated).125mg | Antacid. Indicated in the treatment of flatulance, hyperacidity, gastritis, heart burn, dyspepsia etc. | June,1986 |
| Hydroxy ethyl starch 10% Solution for infusion | Hydroxy ethyl starch 10% Solution for infusion | For the treatment of imminent or manifest hypovolemia and shock. | 18.07.2009 |
| Hydroxychloroquine 400mg tablets (Additional Strength) | Hydroxychloroquine 400mg tablets | Same as Approved | 31.01.2008 |
| Hydroxychloroquine Sulphate (Additional indication) | Hydroxychloroquine Sulphate | For the treatment of systemic lupus erythematosus. | 17.10.2008 |
| Hydroxychloroquine Sulphate Tablet 300mg (Additional Strength/Indication) | Hydroxychloroquine Sulphate Tablet 300mg | Indicated for the treatment of patietns with lower body weight i.e 45 to 60kg in Rhemuatoid arthritis, Systemic Lupus Erythematosus & Polymorphic Light Eruption. | 09.08.2014 |
| Hydroxychloroquine Sulphate USP 400 mg tablets (Additional Indication) | Hydroxychloroquine Sulphate USP 400 mg tablets | As an adjunct to diet and exercise to improve glycemic control of patients on metformine, sulfonylurea combination in patients with Type II Diabetes. | 28.07.2014 |
| Hydroxycobalamine | Hydroxycobalamine | Same as vitamin B12 quicker, higher & prolonged blood . | July,1961 |
| Hydroxyethyl starch (130/0.4) i.v infusion | Each 100ml contains: Hydroxyethyl starch (130/0.4).6gm | By specialists only. For the treatment & prophylaxis of hypovolaemia & shock due to surgery, trauma, burns, infections, therapeutic haemodilution, extracorporea circulation and leukapheresis. | February,2005 |
| Hydroxyethyl theophylline + Theophylline Monohydrate | Each sustained release tablet contains: Hydroxyethyl theophylline.231 mg, Theophylline Monohydrate.69mg | June,1981 | |
| Hydroxyurea tablets | 1000mg | April,2004 | |
| Hydroxyurea USP | 500mg | Anti neoplastic agent. | January,1971 |
| Hydroxyzine Hydrochloride SR Tablets 25/50/75mg | Hydroxyzine Hydrochloride SR Tablets 25/50/75mg | For management of pruritus due to allergic conditions such as chronic urticaria and atopic contact dermatoses, and in histamine .mediated pruritus. | 20.08.2010 |
| Hydroxyzine hydrochloride sustained release tablets | Each uncoated sustained reelase tablet contains: Hydroxyzine hydrochloride USP.25mg, 50mg, 75mg | For the management of pruritis due to allergic conditions such as chronic urticaria and atopic and contact dermatosis, and in histamine.mediated pruritis. | 26.08.2010 |
| Hylan GF 20 injection | Each ml contains: Hylans.8mg | Treatment of pain in osteoarthritis of knee in patients who have failed to respond adequately to conservative non.pharmacological therapy & to simple analgesics. | 20.12.2001 |
| Hylan GF 20 Injection (Synvisc) (Additional Indication) | Hylan GF 20 Injection (Synvisc) | For pain management in patients suffering with osteoarthritis of the knee, hip, shoulder and ankle. | 31.03.2008 |
| Hyoscine Butylbromide 20 mg tablet (Additional Strength) | Hyoscine Butylbromide 20 mg tablet | Same as Approved. | 04.11.2010 |
| Hyoscine.N.butyl bromide suppositories | Each suppositories contain: Hyoscine.N.butyl bromide.7.5mg,10mg | In treatment of gastrointestinal tract spasm, spasm & dyskinesia of the billiary system genito urinary tract spasm. | 23.08.1999 |
| Hyoscine.N.Butylbromide (10mg) + Paracetamol 500mg Tablet | Hyoscine.N.Butylbromide (10mg) + Paracetamol 500mg Tablet | For spasmodic pain. | 08.12.2005 |
| Hyper immune rabies serum | Potency 1.20 I.U/ml | March,1969 | |
| Ibandronic Acid Tablet (150mg) & Inj. (1mg/ml) (Addiotnal Strength) | Ibandronic Acid Tablet (150mg) & Inj. (1mg/ml) | Addition indication; Tablet. for the treatment of prevention of osteoporosis in post menopausal women. Infusion. for metastatic bone diseases due to breast cancer subj to other condition of previous permission No. 6519/06 dt 30.3.2006 same. | 29.05.2006 |
| Ibopamine hcl (bulk+formulation) (Eye Drops) | Each ml of eye drop contains: Ibopamine hcl eq.to ibopamine.2mg | Ophthalmologists. as mydriatic agents in diagnostic ophthalmology. | 03.10.2003 |
| Ibrutinib 140mg Hard gelatin Capsule | Each capsule contains: Ibrutinib.140mg | For the treatment of adult patients with:.mantle cell lymphoma (MCL) who have recieved at least one prior therapy..Chronic Lymphocytic leukemia (CLL) who have recieved at least one prior therapy.. Chronic lymphocytic leukemia with 17p deletion. | 07.10.2015 |
| Ibuprofen + Paracetamol tablets | Each tablet contains: Ibuprofen.400mg, paracetamol.325mg | October,1984 | |
| Ibuprofen 400mg + Chlorzoxazone 500mg Tablets | Ibuprofen 400mg + Chlorzoxazone 500mg Tablets | For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only. | 07.04.2010 |
| Ibuprofen controlled release | Each controlled release tablet contains: Ibuprofen 600mg, Each SR cap contain ibuprofen 200mg,300mg,400mg,800mg | For chronic arthritic disorders and painful musculoskeletal conditions. | March,1990 |
| Ibutilide fumarate injection 0.1mg/ml | Each ml contains: Ibutilide fumarate.0.1mg (eq.to ibutilide free base 0.087mg) | For the rapid converion of artirial fibrillation or artrial flutter of recent onset to sinus rhythm. Patients with artrial arrhythmias of longer duration are less likely to respond to Ibutilide fumarate injection. The effectivess of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration. | 10.06.2016 |
| Icodextrin 7.5% peritoneal dialysis solution | Icodextrin 7.5% peritoneal dialysis solution | For peritoneal dialysis. | 08.06.2006 |
| Idaravone Injection (1.5mg/ml) | Idaravone Injection (1.5mg/ml) | For improvement of neurologic symptoms, disorders of activitis of daily living and functional disorder associated with acute ischemic stroke. | 26.07.2007 |
| Idebenone tablets | Each sugar coated tab contains: Idebenone.30mg | In the treatment or improvement of decreased volition, emotional disturbance and speech disturbances associated with sequelae of cerebral infarction, sequelae of cerebral haemorrhage, cerebral asteriosclerosis. | 26.09.1997 to 26.09.1999 |
| Idoxuridine | 0.5% ophthalmic sol. | Simplex keratitis epithelial infection. | July,1967 |
| Ifosfamide & Mesna (Combipack) | Ifosfamide.1gm/vial, mesna.100mg/ml | NOC granted to the firm as it was earlier licenced by SLA (Maharashtra) | 30.07.1999 |
| Ilaprazole Tablets 5mg/10mg | Each enteric coated tablet contains: Ilaprazole.5mg, 10mg | For the treatment of duodenal ulcer in adults only. | 05.04.2011 |
| Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg | Each uncoated tablet contains: Iloperidone.1mg,2mg,4mg,6mg,8mg,10mg,12mg | For the acute treatment of adults with schizophrenia. | 18.02.2011 |
| Imatinib mesilate capsules | Each cap contains: Imatinib mesilate (eq.to free imatinib base).100mg | Oncologists only. for chronic myeloid leukemia (CML) in blast crisis accelerated phase or in chronic phase after failure of IFN.alfa therapy. | 04.12.2001 |
| Imatinib mesilate100/400mg tablets and 100 mg capsules (Additional indication) | Imatinib mesilate100/400mg tablets and 100 mg capsules | Treatment of Paediatric patients with newly diagnosed Philadelphia chromosome positive acute Lymphoblastic Leukaemia (Ph+ALL) integrated with chemotherapy. | 09.09.2014 |
| Imatinib mesylate (gamma crystalline) | Each film coated tablet contains: Imatinib mesylate eq.to (gamma crystal form) imatinib.100mg | By oncologists only. for treatment of CML in blast crisis, accelerated phase or in chronic phase after failure of interferon alpha therapy. | 26.02.2005 |
| Imatinib mesylate 100 mg/400mg Tablets (Additional Indication) | Imatinib mesylate 100 mg/400mg Tablets | 1. Adjuvant treatment of adult patients following resection of gastro. intestinal stromal tumours (GIST) 2. For the treatment of CML in blast crisis, accelerated phase or in chronic phase after failure of interferon alpha therapy. 3. Newly diagnosed Philadelphia positive chronic myeloid leukaemia (Ph+CML). | 15.11.2011 |
| Imatinib mesylate 100 mg/400mg Tablets and 100mg Capsules (Additional Indication) | Imatinib mesylate 100 mg/400mg Tablets and 100mg Capsules | 1. For the Treatment of Adult Patients with newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukaemia(Ph+ALL) integrated with chemotherapy 2. Treatment of Adult patients with relapsed or refractory Ph+ALL as monotherapy 3. Treatment of Adult patients with Myelodysplastic/Myeloproliferative diseases (MDS/MPD) associated with platelet .derived growth factor receptor (PDGFR) gene rearrangements. 4. Treatment of Adult Patients with Systemic Mascocytosis (SM) without the D816V c.Kit mutation or with cKit mutational status unknown 5. Treatment of Adult Patients with Hypereosinophillic Syndrome(HES) and/or Chronic Eosinophilic Leukaemia(CEL) 6. Treatment of Adult Patients with Unrespectable, Recurrent and/or Metastatic Dermatofibrosarcoma Protubrans (DFSP). | 11.08.2011 |
| Imatinib Mesylate 100/400mg Tablets (Additional Indication) | Imatinib Mesylate 100/400mg Tablets | Adjuvant treatment of adult patients following resection of gastrointestinal stromal tumours (GIST). | 05.04.2010 |
| Imedeen branded capsule of fish extract + ascorbic acid + zinc. | Imedeen branded capsule of fish extract + ascorbic acid + zinc. | 08.11.2005 | |
| Imedeen oral tablets | Imedeen oral tablets | October,2005 | |
| Imidacloprid + Moxidectin spot on solution | For dogs; each pipette containing 0.4ml, 1.0ml, 2.5ml, 4ml of 10% imidacloprid and 2.5% moxidectin, For cats; each pipette containing 0.4ml, 0.8ml of 10% imidacloprid and 1.0% moxidectin | For the treatment and prevention of flea infestation, treatment of ear mite infestation, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats. | 05.04.2011 |
| Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) | Each pippette contains: (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin | For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats. | 03.10.2009 |
| Imidacloprid cutaneous solution | Each tube contains: Imidacloprid 40mg,100mg,250mg | Prevention & treatment of flee infestation on dogs. | 23.03.2001 |
| Imidapril hcl tablets | Each tablet contains: Imidapril hcl.2.5mg,5mg,10mg | By RMP only. for the treatment of mild to moderate hypertension. | 23.02.2004 |
| Imipenem + cilastatin inj. | Each vial contains: Imipenem eq.to anhd.imipenem.250mg,500mg, Cilastatin sod.eq.to cilastatin.250mg,500mg | For the treatemnt of serious lower respiratory/urinary tract infection, intra abdominal, bone & joint infections, endocarditis & bacterial septicemia. | 25.07.2003 |
| Imipenem 50mg + Clistatin 50mg | Imipenem 50mg + Clistatin 50mg | Treatment of infection caused by susceptible bacteria for the following indication as in neonates and infants (below 3 months of age) 1. Lower respiratory tract infections 2. Urinary tract infections 3. Intraabdominal infections 4. Bacterial septicemia 5. bone and joint infections 6. Skin and Skin structure infections 7. Bacterial endocarditis | 14.07.2010 |
| Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 1 g Powder for Injection (Additional Strength) | Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 1 g Powder for Injection | For the treatment of serious lower respiratory tract infections, urinary tract infections, intra.abdominal, bone and joint infection, endocardities and bacterial septiceimia. | 28.06.2012 |
| Imiquimod topical cream (5%) w/w | Each 0.25gm contains: Imiquimod.12.5mg | By RMP. for the treatment of external genital/periannal warts in adults patients. | 29.12.2004 |
| Inactivated purified rabies vaccine (Pitman moore strain propagated on duck embryo) | Each vial contains: Inactivated purified rabies virus (Pitman moore strain propagated in duck embryo).≥ 2.5 IU | Active immunization against rabies. | 12.07.2002 |
| Inactivated Rabies Vaccine (Human diploid cell) | Inactivated Rabies Vaccine (Human diploid cell) | Antirabies. For the treatment of rabies. | April,1981 |
| Indacaterol (as Maleate) Inhalation Powder Hard Capsules....150/300mcg | Each capsule contains: Indacaterol maleate eq.to indacaterol.150mcg, 300mcg | For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). | 28.04.2010 |
| Indapamide (SR) 1.5mg/1.5mg + Nebivolol 2.5mg/5mg tablet | Indapamide (SR) 1.5mg/1.5mg + Nebivolol 2.5mg/5mg tablet | For the treatment of hypertension not controlled with monotherapy. | 12.05.10 |
| Indapamide Hemihydrate | Each tablet contains: Indapamide Hemihydrate.2.5mg | Antihypertensive. for mild to moderate hypertension. | November,1978 |
| Indapamide SR tab | Each SR coated tab contains: Indapamide.1.5mg | 12.06.1996 | |
| Indinavir sulphate | Each capsule contains: Indinavir (as sulphate).200mg, 400mg | By RMP. indicated in treatment of HIV infection in adults only in combination with anti.retroviral agents. | 02.02.2001 |
| Indomethacin | Indomethacin | Anti.rheumatic, anti.inflammatory. | August,1965 |
| Indomethacin Injection 1mg/vial (Additional Dosage Form) | Indomethacin Injection 1mg/vial | To close a hemodynamically significant patent ductus arteriosus (PDA) in premature infants weighing between 500g and 1750g when after 48 hrs. usual medical management (e.g. fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear.cut clinical evidence of hemodynamically significant patent ductus arteriosus should be present, such as respratory distress, a continous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest X.ray. | 30.04.2015 |
| Indomethacin suppositories | Each suppository contains: Indomethacin.50mg, 100mg | July,1970 | |
| Infectious bursal disease vaccine inactivated | Infectious bursal disease vaccine inactivated | Bursal disease vaccine. In the treatment of infectious bursal disease in poultry. | March,1986 |
| Infectious coryza vaccine (Inactivated) | Infectious coryza vaccine | March,1987 | |
| Infliximab i.v injection | Each 10ml vial contains: Infliximab.100mg | For treatment of moderate to severly active crohn's disease for the reduction of signs and symptoms in patients who have an inadequate response to conventional therapies. | 25.01.2000 |
| Infliximab inj. (Additional Indication) | Each vial contains: Infliximab 100mg in 10ml | Reduction of signs & symptoms of rheumatoid arthritis in patients who have an inadequate response to methotrexate (additional indication). | 04.10.2001 |
| Influenza vaccine inactivated (vaxigrip) | Influenza vaccine inactivated (vaxigrip) | Prophylaxis against influenza. | 13.08.1996 |
| Influenza vaccine inactivated for equine. | Influenza vaccine inactivated for equine. | For treatment of Influenza in equine. | November,1987 |
| Injection monocomponent insulin lispro (r DNA) | Each 10ml vial contains: Monocomponent insulin lispro.40 Iu/ml (rDNA origin) | 01.12.1997 | |
| Injection of iron sorbitol citric acid complex | Injection of iron sorbitol citric acid complex | November,1967 | |
| Injection of vitamin A, D, B | Injection of vitamin A, D, B | Vitamin preparation. | July,1969 |
| Insulin glargine inj. | Each vial/cartridge contains: Lantus insulin glargine soln for inj.100 IU/ml | Insulin dependent diabetes mellitus type.I & type.II cases. | 07.01.2003 |
| Insulin lispro mixtures (rDNA) inj. | Insulin lispro mixtures (rDNA) inj. | Already approved for different mixtures, diabetes mellitus. | 31.07.2000 |
| Interferon alfa.2b (Human serum albumin free solution) injection. | Each vial contains: Recombinant interferon alpha.2b 3mIU, 5mIU, 10mIU, 18mIU, 25mIU | For use in cancer.hospital/institution and against the prescription of specialistsonly. for multiple myeloma, AIDS related kaposis sarcoma, malignant melanoma, hairy cell leukemia, chronic myelogenous leukemia, laryngeal papillomathesis, condylomata, acuminata, superficial and nudulo ulcerative basal cell carcinoma chronic hepatitis.B and hepatitis.C. | 27.12.2000 |
| Interferon alpha 2b injection. | Interferon alpha 2b injection. | Anti cancer. Indicated in the treatment of multiple myeloma hairy cell leukaemia etc. | May,1988 |
| Intra uterine infusion | Each 100gm syringe contains: Oxytetracycline hcl.500mg, furazolidone.500mg, clioquinol.500mg | 05.07.1993 | |
| Itraconazole inj. | Each ml inj.contains: Itraconazole.10mg | Emperic therapy of febrile neutroprnic patients with suspected fungal infections. | 29.04.2002 |
| Intralipid (30%) intavenous fat emulsion | Each 100ml contains: Purified soyabean oil EP(30g), purified egg phospholipids EP(1.2g), glycerol BP.1.67g | For the patients with essential fatty acid deficiencies who can not maintain or restore normal essential fatty acids by oral intake. | 12.05.2005 |
| Intralipids intravenous fat emulsion | Intralipids intravenous fat emulsion | October,1981 | |
| Intravenous fat emulsion (10%w/v) | Each 100ml contains: Soyabean oil USP.10.0gm, egg lecithin.0.60gm, glycerol IP.2.5gm | By RMP. parenteral nutrition in critical care condition. | 28.08.2000 |
| Intravenous fat emulsion with medium chain triglycerides | Each 100ml contains: Soyabean oil USP.5g or 10g, med.chain triglycerides.5g or 10g, egg lecithin.1.20g or 1.20g, glycerol IP.2.50g or 2.50g, water for inj. Q.s or q.s, energy content.1058 kcal/lit or 1908 kcal/lit, osmolarity.345 Mos mol/lit or 380 Mos mol/lit. | For patients requiring parental nutrition in energy depletion as well as essential fatty acid deficiency states. | 11.07.2001 |
| Iobenzamic acid | Iobenzamic acid | Oral cholecystography | August,1965 |
| Iobitridol soln for inj. | Each ml contains: Iobitridol corresponding to 250mg, 300mg, 350mg of iodine. | For patients undergoing i.v urography, barin & whole body CT, digital substraction angiography of aorta & lower limbs & angio cardiography. | 17.10.2001 |
| Iobitridol Solution for Injection Each 100mg solution contain 65.81 g Iobitridol corressponding mass of Iodine 30gm | Iobitridol Solution for Injection Each 100mg solution contain 65.81 g Iobitridol corressponding mass of Iodine 30gm | By intracavity route for Arthrography and Hysterosalpingography. | 19.03.2013 |
| Iodamide | 300/350 | 300.intravenous urography, 350.angiocardiography. | October,1967 |
| Iomeprol inj. | Each ml contains: Iomeprol corresponding to 300mg,400mg iodine. | For use in hospitals, nursing home, institution only. For use in intravenous urography C/T (Brain & Body) | 05.10.2000 |
| Iopamidol sterile solution | Iopamidol sterile solution | X.ray contrast medium. Indicated in neuroradiology, angiography, urography, arthrography etc. | June,1986 |
| Iopromide | Each ml contains: Iopromide.0.499 g, 0.623 g, 0.769 g | Used as a contrast medium for angiography. | July,1990 |
| Iopromide injection (Equ. To 300 & 370mg of Iodine) (Additional Indication) | Iopromide injection (Equ. To 300 & 370mg of Iodine) | for intravascular use and use in body cavities for contrast enhancement in computerised tomography (CT), Arteriography and Venography, Intravenous /Intraarterial digital substraction angiography(DSA); Intravenous urography, use of ERCP, Arthrography and Examination of other body cavities. | 05.12.11 |
| Ioversol injection (Finished Formulation) | 160,240,300,320,350 | Contrast medium | 29.12.1993 |
| Ipratropium bromide inhaler | Each actuation delivers: Ipratropium bromide.20 mcg. | Anti chlonergic bronchodilator. Chronic obstructive bronchitis, emphysema, bronchospasm, during and after surgery and moderate to asthmatic attacks in chronic form of asthma. | 20.11.1992 |
| Ipratropium bromide respirator solution/nasal spray | Ipratropium bromide respirator solution.250mcg/ml, ipratropium bromide nasal spray each actuation delivers.20mcg. | 08.04.1993 | |
| Irbesartan | Each uncoated tablet contains : Irbesartan.75mg,150mg,300mg | By RMP. for the treatment of mild to moderate hypertension only. | 26.06.2000 |
| Irbesartan + hydrochlorthiazide | Each uncoated tablet contains: Irbesartan.150mg,300mg, Hydrochlorthiazide.12.5mg | By RMP. for mild to moderate hypertension. | 31.01.2001 |
| Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml) | Irinotecan HCl Trihydrate Injection 20 mg/ml | For the treatment of metastatic colorectal cancer. | 31.08.2010 |
| Irinotecan hcl trihydrate solution for i.v infusion | Each 2ml solution contains: Irinotecan hcl trihydrate.40mg, Each 5ml solution contains: irinotecan hcl trihydrate.100mg | Anticancer.For the treatment of colo.rectal cancer. | 23.05.1997 to 22.05.1999 |
| Iron (III) isomaltoside 1000 solution for injection/infusion 100mg per ml | Each ml contains: Iron (III) isomaltoside 1000.100mg | For the treatment of iron deficiency anaemia when oral iron preparations are ineffective or cannot be used and when there is a clinical need to deliver iron rapidly. | 20.08.2013 |
| Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg + Zinc Picolinate (26mg) eq. To elemental zinc 5.5mg syrup | Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg + Zinc Picolinate (26mg) eq. To elemental zinc 5.5mg syrup | For the treatment of Iron Deficiency Anaemia. | 22.12.2011 |
| Iron dextran glycoside | 5 & 10 ml ampl. | iron deficiency anaemia. | June,1967 |
| Iron polymaltose | 2ml=100mg Fe | Antianaemia.iron therapy. | April,1963 |
| Iron sorbitol citric acid complex | Each ml contains: eq.of 50mg of Iron as iron sorbitol citric acid complex. | July,1969 | |
| Iron sorbitol citric acid complex (Injection of colloidal iron) | Iron sorbitol citric acid complex | January,1969 | |
| Iron sucrose complex inj. i.v (Finished Formulation) | Iron sucrose complex inj. i.v | All cases of iron deficiency in which rapid and reliable substitution of iron is required. | 02.01.1999 |
| Iron sucrose injection | Eacg 5ml contains: Iron (as iron sucrose).100mg | Indicated in iron deficiency anemia in which rapid and reliable substitution of iron is required. | 25.03.2004 |
| Carbenicillin Disodium | Each vial contains: Carbenicillin Disodium.1gm | Antibiotic | August,1973 |
| Carbenoxolone sodium | Each tablet contains: Carbenoxolone sodium.50mg | 1974 | |
| Carbenoxolone Sodium | Carbenoxolone Sodium | Gastric ulcer | December,1973 |
| Carbocisteine | Carbocisteine | Mucolytic agent. Indicated as an adjunctive therapy in respiratory disorder. | August,1987 |
| Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrup | Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrup | For symptomatic treatment of cough. | 24.12.2008 |
| Carbonyl iron (MR) + folic acid + Vitamin B12 | Each film coated tablet contains: Elemental iron (as carbonyl modified release).45mg, folic acid.1.5mg, vitamin B12.15mcg | By RMP. for the treatment of nutritional iron deficiency anemia in adults only | 19.04.2004 |
| Carboplatin bulk/injection | Each vial contains; carboplatin.50mg,150mg, Mannitol IP.50mg,150mg. | Anti cancer. Advance stage of ovarian cancer, small cell carcinoma of lungs. | March,1989 |
| Dinoprost injection | Each ml contains: Dinoprost.5mg | May,1986 | |
| Carboquone tablet/injection | Each tablet contains: Carboquone.0.25mg,0.5mg, Each vial contains: Carboquone.1mg | Anti cancer. in the remission of subjectived objective symptoms of encephaloma gastro.intestinal cancer, lung cancer malignant lumphoma & chronic leukaemia. | August,1985 |
| Carboxy Methyl Cellulose Sodium Lubricant Eye Drops 0.5% w/v (Unit dose pack without preservative) | Carboxy Methyl Cellulose Sodium Lubricant Eye Drops 0.5% w/v (Unit dose pack without Preservative) | For temporary relief from burning irritation and discomfort due to dryness of the eye or due to exposure to wind or sun. May also be used as a protectant against further irritation. | 27.05.2013 |
| Carisoprodol | Carisoprodol | Muscle relaxant | March,1965 |
| Carmustine (polifeprosan 20 with carmustine Implant (Wafer) | Carmustine (polifeprosan 20 with carmustine Implant (Wafer) | 1) In newly diagnosed high.grade malignant glioma patients as an adjunct to surgery and radiation. 2) In recurrent glioblastoma multiforme patients as an adjunct to surgery. | 31.01.2008 |
| Carmustine for inj. 100 mg | Carmustine for inj. 100 mg | Indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: 1.Brain tumors—glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. 2.Multiple myeloma—in combination with prednisone. 3.Hodgkin’s Disease—as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4.Non.Hodgkin’s lymphomas—as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. | 10.06.2010 |
| Carnecaine injection | Carnecaine 2%.20mg articaine. | February,1987 | |
| Carnecaine with Adrenaline injection | Carnecaine 2% with adrenaline, carnecaine 4% with adrenaline | February,1987 | |
| Caroverine cap. 20mg & Inj. 40mg/2ml | i) Each capsule contains: Caroverine.20mg, ii)Each 2ml injection contains: Caroverine.40mg | For the treatment of abdominal pain & tinnitus in adults only. | 28.08.2006 |
| Caroverine hydrochloride & Caroverine base | Caroverine hydrochloride & Caroverine base | 24.10.2008 | |
| Carteolol hcl tabs and ophthalmic solution | i).Each film coated tab contains: Carteolol hcl.5mg, ii).sterile ophthalmic solution.2% w/v | In the management of hypertension and also in the prophylactic management of patients with angina pectoris. Ophthalmic silution is indicated in ocular hypertension, chronic open angle glaucoma and some secondry glaucomas. | 09.07.1996 |
| Carvedilol (already approved) new strength 3.125mg/6.25mg | 3.125mg, 6.25mg | In treatment of congestive hearth failure (CHF) | 10.03.1999 |
| Carvedilol Phosphate ER tablet 10/20/40/80mg | Carvedilol Phosphate ER tablet 10/20/40/80mg | 1. Mild to severe chronic heart failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension. | 11.12.2009 |
| Carvedilol tablets & bulk | Each tab contains: Carvedilol.12.5mg,25mg | Essential hypertension only. | 16.10.1998 |
| Carvedilol Tablets 3.125/6.25/12.5/25mg Additional indication) | Carvedilol Tablets 3.125/6.25/12.5/25mg | To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure). | 09.05.2009 |
| Caspofungin Acetate injection (50mg/70mg per vial) | Caspofungin Acetate injection (50mg/70mg per vial) | For invasive candidiasis fungal infection. | 23.12.2005 |
| Caspofungin acetate Injection (Addl. Indication) | Caspofungin acetate Injection | For use in following: (I) Empirical therapy for presumed fungal infections in febrile neutropenicpatients. (II) Treatment of Candidemia and the following Candida infections: Intra.abdominal abscesses, Peritonitis and Pleural space infections. (III) Treatment of esophagealCandidiasis. (IV) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). | 31.01.2009 |
| Catalin | Catalin | Anti.cataract Preparation. indicated in the treatment of cataract. | January,1976 |
| Cefaclor cap./bulk | Each capsule contains: cefaclor.250mg,500mg (as cefaclor monohydrate), Each 5ml suspension contains: 125mg(as cefaclor monohydrate), 250mg92.7.910, Cefaclor drops. Each ml contains: Cefaclor.100mg(as cefaclor monohydrate), Cefaclor suspension for paediatric use 187mg/5ml (19.4.93) | Antibiotic. In respiratory infections, ENT infection, UT infections, Skin and skin structure infections. | April,1991 |
| Cefaclor modified release tablet | Each MR tablet contains: Cefaclor.375mg,750mg. | 27.01.1995 | |
| Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet | Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet | For the treatment of adult patients with infections caused by susceptible microbes including S. Aureus viz. UTI, LRTI and gonococcal urethritis. | 30.08.2006 |
| Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup | Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup | For the treatment of adult patients with infections caused by susceptible microbes including S. Aureus viz. UTI, LRTI and gonococcal urethritis. | 30.08.2006 |
| Cefadroxil 500mg + Clavulanic acid 125mg tablet | Cefadroxil 500mg + Clavulanic acid 125mg tablet | For the treatment of adult patients with infections caused by susceptible microbes including S. Aureus viz. UTI, LRTI and gonococcal urethritis. | 30.08.2006 |
| Cefadroxil capsules/tablets/oral suspension/dispersible tablets | Tablets/capsules.500mg,1gm, Oral suspension.125mg/5ml,250mg/5ml, Dispersible tablet contains; cefadroxil eq.to cefadroxil anhydrous.250mg (TPL.11.8.94) | Antibiotic. Indicated in the treatment of UTI, skin & skin structure infections caused by S.cocci or streptococci, pharyngitis, tonsilitis, respiratory tract infections only. | February,1989 |
| Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup (Additional strength) | Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup | Same as Approved. | 25.07.2008 |
| Cefalonium 250 mg suspension | Each 3G syringe contains: Cefalonium dihydrate.250mg | For routine dry cow therapy to treat existing sub.clinical infections and to prevent new infections which occur during the dry period. | 08.04.2013 |
| Cefazoline sodium injection | Each vial contains: Cefazolin sodium.0.5gm,1gm,250mg | Cephalosporin antibiotic. Indicated in the treatment of serious infections due to susceptible organisms.respiratory tract infections, urinary tract infections, skin billiary tract infections, septicaemia. | September,1985 |
| Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml | Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml | For the treatment of community acquired pneumonia, acute exacerabation of chronic bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis. | 29.04.2008 |
| Cefdinir bulk,caps & oral suspension | Each caps contains: Cefdinir.300mg, Each 5ml of reconstituted oral suspension contains: cefdinir.125mg | Community acquired pneumonia acute exacerbation of chronic bronchitis, uncomplicated skin & skin structure infection, pharyngitis, tonsilitis. Acute maxillary sinusitis & acute bacterial otitis media.additional | 10.10.2001 |
| Cefdinir caps & oral suspension | Cefdinir caps & oral suspension | Additional indication of acute maxillary sinusitis & acute bacterial otitis media. | 22.11.2001 |
| Cefdinir dispersible tablets | 125mg | For additional indication. | |
| Cefditeron (as pivoxil) 200mg tablet | Cefditeron (as pivoxil) 200mg tablet | Anti.biotic | 03.03.2006 |
| Cefditoren pivoxil 400mg tablets (Additional Strength) | Cefditoren pivoxil 400mg tablets | Same as Approved. | 11.03.2008 |
| Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage Form for children) | Cefditorene pivoxil dispersible tablet (30mg/50mg | As approved | 08.06.2007 |
| Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj. | Each vial contains: Amikacin sulphate I.P eq.to amikacin.0.125gm, 0.250gm, Cefepime hydrochloride eq.to cefepime.0.5gm, 1.0gm | For the treatment of pneumonia, bacterial septicaemia, respiratory, abdominal, urinary & skin infection. | 11.08.2006 |
| Cefepime (250mg) + Tazobactam (31.25mg) Injection (Additional Strength) | Cefepime (250mg) + Tazobactam (31.25mg) Injection | As approved | 30.07.2007 |
| Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg | Each vial contains: Cefepime Hcl USP.500mg,1000mg, Tazobactum sodium eq.to tazobactum.62.5mg,125mg | For the treatment of uncomplicated and complicated urinary tract infections, uncomplicated skin and skin structure infections, and complicated intra abdominal infections. | 30.08.2006 |
| Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 1000/500/250mg per vial of injection | Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 1000/500/250mg per vial of injection | For serious CRTI, uncomplicated and complicated UTI, Uncomplicated skin & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection. | 24.01.2008 |
| Cefepime hcl for inj/bulk | Each vial contains: Cefepime (as hcl).500mg,1gm,2gm | Uncomplicated and complicated UTI, umcomplicated skin and skin structure infection, lower respiratory tract infection, acute bacterial exacerbation of chronic bronchitis and acute bronchitis intra abdominal infection. | 30.10.2002 |
| Cefepime injection | Each vial contains: Cefepime.250mg | For the treatment of LRTI & UTI, skin & skin structure infection. | September,2004 |
| Cefepime Injection (New Indication) | Cefepime Injection | For bacterial meningitis in children. | 14.06.2007 |
| Cefepime injection 500mg/1gm/2gm (ForAdditional Indication) | Cefepime injection 500mg/1gm/2gm | For bacterial meningitis in children. | 14.06.2007 |
| Cefetamet Pivoxil Hcl oral suspension 250mg/ml | Cefetamet Pivoxil Hcl oral suspension 250mg/ml | Anti.biotic. | 15.02.2006 |
| Cefetamet pivoxil oral suspension | Each (5ml) contains: Cefetamet pivoxil hcl.250mg | By RMP. for the treatment of infection caused by susceptible microorganism found in the otitis media, sinusitis, pharyngo tonsilitis, acute exacerbation of chronic bronchitis of bacterial origin, pneumonea, complicated/uncomplicated UTI and acute gonococcal urethritis. | August,2004 |
| Cefetamet pivoxil tab | Each film coated tab contains: Cefetamet pivoxil hydrochloride.500mg, 250mg (appr.on 28.3.03) | Infections caused by susceptible microorganism found in otitis media, sinusitis, pharyngotonsillitis, acute exacerbation of chronic bronchitis, tracheobronchitis of bacterial origin, pneumonia, complicated & uncomplicated UTI, acute gonococcal urethritis in men. | 14.11.2002 |
| Cefexime capsules | Each cap/tab contains: Cefixime.100mg, 200mg(Torrent), 400mg(18.8.93, cadila) | Oral cephalosporin. in the treatment of UTI, respiratory tract infections, billiary tract infections. | 24.02.1993 |
| Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet | Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet | Antibiotic. | 29.08.2006 |
| Cefixime (SR) 400mg + Moxifloxacin (SR) 400 mg Tablets | Cefixime (SR) 400mg + Moxifloxacin (SR) 400 mg Tablets | For the treatment of lower respiratory tract infections in adults only. | 08.08.2011 |
| Cefixime + Ornidazole tablets | Regretted to give permission for mfg/mrk | 05.12.2005 | |
| Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab. | Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab. | Antibiotic | 31.08.2006 |
| Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets | Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets | For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections. | 12.02.2010 |
| Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets | Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets | For the treatment of patients with typhoid fever and urinary tract infection in adults. | 26.04.2010 |
| Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets | Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets | For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections. | 22.09.2009 |
| Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (Additional strength) | Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. | Antibiotic | 14.11.2006 |
| Cefixime 200mg + Pot. Clavulanate (125mg) tablet | Cefixime 200mg + Pot. Clavulanate (125mg) tablet | Anti.biotic | 20.07.2006 |
| Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet | Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet | For the treatment of Urinary tract infections, respiratory tract infections, biliary tract infections in adult patients prone to antibiotic associated diarrhoea. | 07.01.2008 |
| Cefixime dispersible tablet 400mg (New Dosage Form) | Cefixime dispersible tablet 400mg | Antibiotic. | 22.11.2006 |
| Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet | Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet | Additional strength | 31.08.2010 |
| Cefixime Tablets 200mg & Cefixime Oral Suspension 100mg/5ml | Cefixime Tablets 200mg & Cefixime Oral Suspension 100mg/5ml | For the treatment of enteric (typhpoid) fever. | 22.02.2013 |
| Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form ) | Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet | Same as approved | 20.04.2011 |
| Cefoperazone + sulbactum | Each 1.5gm & 2gm vials contains cefoperazone sod.eq.to cefoperazone 1g, 2g sulbactum sod. Eq.to sulbactum 0.5g, 1g | For specific subset of patients immuno compromised febrile neutropenic cancer patients. | 12.06.2001 |
| Cefoperazone sodium inj. Im/iv | Each vial contains; cefoperazone sodium.1g,2g | 23.08.1993 | |
| Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for Additional indication) | Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection | For surgical prophylaxis (additional indication). | 18.05.2007 |
| Cefotaxime injection | Cefotaxime.0.25gm,0.5gm,1gm and 2gm | Antibiotic. Indicated in the treatment of patients with serious infections. | June,1987 |
| Cefotaxime sodium + sulbactam sod. Inj. | Each vial contains: sterile cefotaxime sodium USP eq.to cefotaxime.500mg,1000mg, sterile sulbactam sod.USP eq.to sulbactam.250mg,500mg | RMP & gynaecologists only. for the treatment of lower respiratory tract infection and genito urinary tract infection. | 26.12.2003 |
| Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) | Cefotaxime sodium + Sulbactam sodium for injection | For the treatment of lower respiratory tract infection in children. | 24.06.2008 |
| Cefovecin (as sodium) 80mg/ml Lyophilised powder for injection (Veterinary) | Each ml contains: Cefovecin sodium eq.to 80.0mg cefovecin | For the treatment of skin bacterial infections in dogs and cats. | 07.10.2009 |
| Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection. | Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection. | For the treatment of infection caused by sensitive organisms viz. lower RTI, complicated UTI, Septicemia, bacteremia. | 24.01.2008 |
| Cefpirome injection | Each vial contains: Cefpirome sulfate corresponding to cefpirome.0.25g, 0.5g, 1.0g, 2g | Infections caused by cefpirome sensitive organisms, lower respiratory tract infection, complicated upper and lower urinary tract infections bacteraemia/septicaemia. | 26.09.1997 to 26.09.1999 |
| Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet | Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet | For LRTI, URTI and UTI. | 30.07.2007 |
| Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg | Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg | For the treatment of lower RI, Skin and soft tissue, bone and joint infections and ENT infections in adult patients prone to antibiotic induced diarrhoea. | 06.08.2010 |
| Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength) | Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup | Same as Approved. | 31.01.2008 |
| Cefpodoxime IP 100mg/100mg/200mg/200mg + Ofloxacin IP 100mg/200mg/100mg/200mg Tablets | Cefpodoxime IP 100mg/100mg/200mg/200mg + Ofloxacin IP 100mg/200mg/100mg/200mg Tablets | For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only. | 16.04.2011 |
| Cefpodoxime proxetil tab/syrup | i).Each tab contains: cefpodoxime proxetil.100mg, ii).Each 5ml suspension contains: Cefpodoxime proxetil.40mg | Acute bronchitis, exacerbations of chronic bronchitis, bronchiolitis pneumonia, sinusitis, recurrent chronic tonsillitis, pharyngitis, acute otitis. | 19.09.1997 to 19.09.1999 |
| Cefpodoxime proxetil tabs/dry syrup | i).Each tab contains: cefpodoxime proxetil.100mg, ii).cefpodoxime proxetil dry syrup.40mg/5ml | 12.03.1996 | |
| Cefprozil 250mg/500mg+Clav. Acid.62.5mg /125mg. Tab | Cefprozil 250mg/500mg+Clav. Acid.62.5mg /125mg. Tab | For the treatment of adult patients with upper&lower RTI, Skin & Skin structure infection. | 12.11.2007 |
| Cefprozil Powder for oral suspension (125mg/5ml) | Cefprozil Powder for oral suspension (125mg/5ml) | Antibiotic. | 06.01.2006 |
| Cefprozil tab & suspension & bulk (locally) | Each film coated tab contains: cefprozil USP.250mg,500mg, Each 5ml of reconstituted syrup contains: Cefprozil USP.125mg | For treatment of patients with mild to moderate upper respiratory tract infection, lower respiratory tract infection, skin & skin structure infection. | 10.01.2003 |
| Cefprozil tablet & powder for oral suspension | i) Each film coated tablet contains: Cefprozil USP.250mg, 500mg, ii) Each 5ml of recons.syrup contains: Cefprozil.125mg | For the treatment of patients with mild to moderate upper respiratory tract infection, lower respiratory tract infection, skin & skin structure infection. | 29.08.2006 |
| Cefquinome sulphate | Cefquinome sulphate | 31.10.2008 | |
| Ceftaroline Fosamil Injection 600 mg/Vial | Ceftaroline fosamil powder for concentrate for solution for infusion.600mg/vial | "For the treatment of adult (≥ 18 years of age) patients with community.acquired pneumonia". | 09.05.2016 |
| Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection | Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection | 1. For LRTI infections, 2. for UTI . Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic infections including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis. | 24.12.2008 |
| Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) | Ceftazidime + Tobramycin injection (1gm + 120mg) | Same as Approved. | 05.08.2008 |
| Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection | Each vial contains: Ceftazidime.500mg,1000mg, tazobactum sodium eq.to tazobactum.62.5mg,125mg | For the treatment of hospital acquired infections like nosocomial pneumonia, uncomplicated skin and skin structure infections. | 30.08.2006 |
| Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) | Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) | For the treatment of lower respiratory tract infection caused by pseudomonas aeruginosa. | 08.01.2008 |
| Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection | Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection | Antibiotic | 08.06.2007 |
| Ceftazidime pentahydrate injection | Each vial contains: Ceftazidime.250mg,500mg,1gm,2gm | Antibiotic. Indicated for UTI, respiratory, skin soft tissue, G.I infections, meningitis etc. | June,1988 |
| Ceftazidine (2gm) + Sulbactam (1gm) Injection (Additional strength for additional indication) | Ceftazidine (2gm) + Sulbactam (1gm) Injection | For serious abdominal infection. | 06.09.2007 |
| Ceftibuten caps/suspension | i).Each cap contains: Ceftibuten.200mg,400mg, ii).Each 5ml suspension contains (on reconstitution); ceftibuten.90mg,180mg | Upper respiratory tract infection, lower respiratory tract infections, UTI and enteritis and gastroeneteritis. | 19.11.1996 |
| Ceftiofur Crystalline free acid Suspension equi to Ceftiofur .... 200 mg(veterinary) | Each ml suspension contains: Ceftiofur crystalline free acid eq.to ceftiofur.200mg | For treatment of bovine respiratory disease (BRD, Shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non.lactating dairy, and lactating dairy cattle. | 01.10.2008 |
| Ceftiofur hcl liquid sterile suspension | Each ml suspension contains: Ceftiofur hcl eq.to ceftiofur.50mg | For treatment & control of swine & bovine bacterial respiratory diseases. | 08.10.2002 |
| Ceftiofur HCl Suspension (as HCl salt) ....125mg (veterinary) | Each 10ml syringe contains: Ceftiofur eq.to (as the hydrochloride salt).125mg | For treatment of clinical mastitis in lactating dairy cattle asssociated with coagulase.negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. | 01.10.2008 |
| Ceftiofur HCl Suspension (as HCl salt) ....500mg (veterinary) | Each 10ml syringe contains: Ceftiofur eq.to (as the hydrochloride salt).500mg | For treatment of sub clinical mastitis in dairy cattle at the time of dry off asssociated with staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. | 01.10.2008 |
| Ceftiofur sod. Inj. | Each vial contains: ceftiofur sodium sterile powder for injecion.500mg | Additional lower strength. | 12.10.2004 |
| Ceftiofur sodium inj. | Each 1gm & 4gm vial contains: (on reconstitution with 20ml or 80ml sterile WFI); ceftiofur sod.eq.to ceftiofur.50mg/ml | For treatment of bovine respiratory diseases, acute bovine interdigital necrobacillosis, bacterial respiratory diseases in swine, sheeps & horses, cannine UTI & for control of mortality associated with E.coli in day old chickens & day old turkey poultry. | 08.10.2002 |
| Ceftizoxime sodium sterile | Each vial contains: 500mg,1000mg. | 1st generation cephalosporin. | May,1990 |
| Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection | Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection | For LRTI. | 3/22/1902 |
| Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection (Additional strength) | Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection | As approved. | 01.03.2007 |
| Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (Additional Strength) | Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection | Anti.biotic. | 06.07.2006 |
| Ceftriaxone + Sulbactam injection (Additional Indication) | Ceftriaxone + Sulbactam injection | for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis. | 18.08.2008 |
| Ceftriaxone 2gm + Tazobactum 250mg for injection | Ceftriaxone 2gm + Tazobactum 250mg for injection | As Approved | 21.11.2007 |
| Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/1000mg.injection | Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/1000mg.injection | Additional Indication . For the treatment of urinary tract infections and lower respiratory tract infections, various bacteria. | 21.09.2011 |
| Ceftriaxone sodium injection | Each vial contains: ceftriaxone sodium eq.to 250mg,500mg,1gm of ceftriaxone base. | Cephalosporin antibiotic. Indicated in the treatment of UTI, lower respiratory tract infections, bacteraemia, septicaemia, meningitis, abdominal infections and infections caused by pseudomonas species. | April,1988 |
| Cefuroxime axetil | Each tablet contains: Cefuroxime (as cefurexime axetil).125 mg,250mg,500mg | Antibiotic. Indicated for lower & upper respiratory tract infection,UTI, gynaecological infection, skin or soft tissue infection etc. | May,1990 |
| Cefuroxime axetil extended release tablets | Each ER tablet contains: Cefuroxime axetil eq.to cefuroxime.500mg,1000mg | October,2004 | |
| Cefuroxime injection | Each vial contains: cefuroxime.250mg,750mg,1.5gm | Antibiotic. Indicated in the treatment of respiratory tract infections, UTI, ENT soft tissue infections etc. | June,1988 |
| Cefuroxime Sodium 250mg intramammay infusion for Veterinary (PFS) (New dosage form) | Cefuroxime Sodium 250mg intramammay infusion for Veterinary (PFS) | For the treatment of Clinical mastitis in milking cows. | 13.12.2011 |
| Cefuroxime Sodium 750/1500mg + Sulbactam Sodium 375/750mg | Cefuroxime Sodium 750/1500mg + Sulbactam Sodium 375/750mg | For the treatment of mild to moderate lower respiratory tract infection. | 06.07.2010 |
| Cefuroxime.125/250/500mg + Clav.Acid.31.25/62.5/125mg | Cefuroxime.125/250/500mg + Clav.Acid.31.25/62.5/125mg | For adult patients with infection caused by susceptible microbs,including s.aureus. (e.g.UTI,Upper&lower RTI & gonococcal urethrities) | 05.10.2007 |
| Celecoxib | Each capsule contains: celecoxib.100mg,200mg | For treatment of R.A & O.A | 22.02.2000 |
| Celecoxib 100/200mg +Diacerein 50/50mg | Celecoxib 100/200mg +Diacerein 50/50mg | For the treatment of adult patients with osteoarthritis of knee and/or hip joints. | 19.07.10 |
| Celecoxib cap | Celecoxib cap | For additional indication of management of acute pain in adults & primary dysmenorrhea. | 15.02.2002 |
| Celecoxib Mouth Dissolving Tablet 50/100/200 mg | Celecoxib Mouth Dissolving Tablet 50/100/200 mg | For the Treatment of Osteoarthritis and Rheumatoid Arthritis. | 25.02.2010 |
| Celiprolol hydrochloride tablets and Bulk | Each film coated tablet contains: celiprolol hydrochloride.100mg, 200mg, 400mg. | Mild to moderate hypertension, angina pectoris. | 01.12.1994 |
| Each gm contains: Feracrylum ....................................... 3%w/w Centbucridine… ............................. 0.5%w/w Topical Gel | Each gm contains: Feracrylum ....................................... 3%w/w Centbucridine… ............................. 0.5%w/w Topical Gel | For the treatment of hemorrhoid & anal fissure associated with bleeding etc. | 11.01.2005 |
| Centbucridine Bulk/Injection | Centbucridine.0.5% | For the purpose of infiltartion or regional block anethesia and for dental surgery only. | August,1985 |
| Centbutindole bulk | Centbutindole bulk | Neuroleptic agent | December,1986 |
| Centbutindole tablets | Each tablet contains: Centbutindole.1.5mg | February,1987 | |
| Centella Asiatica | Each vial contains: Extract of Centella Asiatica.2%, Each tablet contains: Extract of Centella Asiatica.200mg, Ointment.Extract of Centella Asiatica.1%, Powder.Extract of Centella Asiatica.2% | May,1976 | |
| Centpropazine caps | Each cap contains: centpropazine.20mg | In the treatment of depression. | 16.08.1996 |
| Cephacetrile sodium intra mammary infusion | Each tube contains: cephacetrile sod.eq.to 235 mg of cephacetrile in 10gm of suspension. | Mastitis caused by streptococcus agalactial, str.dysgalactial, str. Uberis, str. Aureus (both penicillin.sensitive and resistant strain) gram negative bacterial including E.coli and klebsiella. | 13.05.1992 |
| Cephalexin | Cephalexin | Broad spectrum antibiotic. | October,1971 |
| Cephalexin + Bromhexine cap | Each capsule contains: cephalexin.250mg,500mg, Bromhexine (as hcl).4mg,8mg, Each 5ml of reconstituted suspension contains: cephalexin monohydrate eq.to cephalexin.125mg,250mg, bromhexine hcl eq.to bromhexine.2mg,4mg (appr 27.1.95) | RTI characterized by excessive or viscid mucous. | 16.09.1994 |
| Cephalexin + Carbocisteine caps. | Each capsule contains: Cephalexin monohydrate eq.to cephalexin.500mg,250mg, Carbocisteine.150mg, Oral suspension each 5ml contains: Cephalexin anhydrous.250mg, carbocisteine.150mg | 30.10.1994 | |
| Cephalexin ER tabs | Each ER film coated tablet contains: Cephalexin IP eq.to cephalexin anhydrous.375mg,750mg | 17.11.1998 | |
| Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension per 10 gm Intramammary Suspension | Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension per 10 gm Intramammary Suspension | For the treatment of clinical mastitis in lactating dairy cows for bacteria susceptible to the combination of cephalexin and kanamycin such as Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus uberis and Escheria coli. | 07.03.2012 |
| Cephalexin tablets | 1 gm cephalexin | October,1988 | |
| Cephalothin Sodium, Cefalotin sodium | Cephalothin Sodium, Cefalotin sodium | Cephalosporin antibiotic. in the treatment of infections of soft tissue, respiratory and urinary tract, meningitis other infections due to susceptible organisms and in the treatment of infections due to penicillin resistant strains of straphylococci. | December,1980 |
| Cephapirin benzathine intramammary infusion | Each 10ml disposable syringe contains: 300mg of cephapirin benzathine activity in a stable peanut.oil gel | For the treatment of mastitis in dairy cattle during the dry period. | 25.09.2012 |
| Cephradine | i).Each capsule contains: cephradine.250mg & 500mg, ii).Each vial contains: Cephradine .250mg, 500mg &1gm, iii).Each 5mL suspension contains: Cephradine.250mg | Antibiotic. indicated in the treatment of infection of G.I., genito.utrinary, respiratory tract and soft tissue. | March,1976 |
| Cerebrolysin solution for injection. | Each ml contains: Porcine brain derived peptide preparation (Cerebrolysine concentrate) 215.2mg | For amelioration of cranial injury, cerebrovascular pathological sequelae and aprosexia in dementia. | 25.07.2014 |
| Cerebroprotein Hydrolysate injection (Lyophilised) …..1050mg / 2100mg (approx) equivalent to nitrogen….30mg / 60mg respectively. | Each lyophilized vial contains: i) cerebroprotein hydrolysate 1050mg (approx) eq.to nitrogen.30mg, ii) cerebroprotein hydrolysate 2100mg (approx) eq.to nitrogen.60mg | For amelioration of cranial injury, cerebrovascular pathological sequelae and aprosexia in dementia. | 09.11.2010 |
| Ceritinib Hard gelatin Capsule150 mg | Each hard gelatin capsule contains: ceritinib.150mg | For the treatment of patients with anaplastic lymphoma kinase (ALK).positive metastatic non.small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. | 03.07.2015 |
| Cerivastatin tab | Each tablet contains; cerivastatin sodium.100mcg,200mcg,300mcg | By RMP. primary hypercholesterolemia type IIa, IIb resistant to diet. | 11.05.2000 |
| Certoparin sodium inj. (finished formulation) | 1 disposible syringe of 0.3ml solution contains: certoparin sodium.3000 IU | For thromboembolism prophylaxis only. Antifactor Xa. | October,1999 |
| Cetirizine HCl drops (10mg/ml) | Each 1ml of drop contains: cetirizine Hcl.10mg | For the treatment of seasonal/perennial allergic rhinitis & chronic idiopathic urticaria in infants & children. | 10.11.2005 |
| Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v (Concentrate Solution) | Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution | For cleansing of physically contaminated wounds and for preoperative disinfection. | 09.02.2009 |
| Cetrizine + Pseudoephedrine tabs | Each film coated tab contains: cetrizine dihydrochloride.5mg(immediate release), pseudoephedrine hcl.120mg (SR) | 09.11.1997 | |
| Cetrizine 10 mg + Ambroxol 75 mg SR Tablet | Cetrizine 10 mg + Ambroxol 75 mg SR Tablet | For symptomatic relief of productive cough associated with allergic rhinitis, when both antihistamine and mucolytic agents are desired. | 13.04.2009 |
| Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup | Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup | For the symptomatic relief of productive cough associated with allergic rhinitis, when both antihistamine and mucolytic agents are desired. | 23.02.2009 |
| Cetrizine dihydrochloride tablets | Each film coated tablet contains: cetrizine dihydrochloride.20mg (appr 02.8.1996), 10mg & 5mg(22.05.1996), Cetrizine DHC syrup.10mg/10ml & cetrizine DHC drops.10mg/ml (appr 30.6.1994, cipla) | Seasonal rhinitis and conjuctivitis, perannual allergic rhinitis, pruritis and urticaria. | 25.06.1993 |
| Cetrorelix acetate inj. | Each vial contains: 0.26.0.27mg cetrorelix acetate, 3.12.3.24mg cetrorelix acetate | By gynaecologists. prevention of premature ovulation in patients under going a controlled ovarian stimulation followed by oocyte picking and assisted reproductive techniques. | 22.03.2001 |
| Cetrorelix Acetate injection 0.25mg/0.5ml in 0.5 ml prefilled syringe. (Additional pack size) | Cetrorelix Acetate injection 0.25mg/0.5ml in 0.5 ml prefilled syringe. | Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick.up and assisted reproductive techniques. | 26.08.2015 |
| Chandonium iodide injection | Each 2ml ampoule contains: chandonium iodide.2mg/ml | Marketed as neuromuscular blocking agent | 01.03.1994 |
| Chelate amino acid based minerals (Finished Formulation) | Chelate amino acid based minerals | Trace mineral deficiencies. | 20.07.1993 |
| Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier | Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier | As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement. | 11.02.2010 |
| Chemically modified sodium hyaluronate and carboxymethylcellulose absorbable adhesion barrier | It is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose membrane (CMC) | As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of posoperative adhesions at the site of placement. | 12.02.2010 |
| Chenodeoxycholic acid capsules | Each capsule contains: Chenodeoxycholic acid.250mg | Dissolution of all bladder stone. | December,1987 |
| Chlophedianol hydrochloride Drops | 5% | Antitussive | April,1961 |
| Chloramphenicol | Each capsule contains: Chloramphenicol.500 mg | October,1972 | |
| Chloramphenicol palmitoyl glycolate | Chloramphenicol palmitoyl glycolate | For Pediatric use. | May,1961 |
| Chlordantoin + Benzylkonium chloride | Each 100gm contains: Chlordantoin.1%, Benzylkonium chloride.0.05% | Anti.fungal agent | August,1970 |
| Chlordiazepoxide + Clidinium bromide | Each tablet contains: Chlordiazepoxide.5mg, Clidinium bromide.2.5mg | .July,1973 | |
| Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v Solution | Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v Solution | Surgical hand scrub & healthcare personnel hand wash. | 29.12.2010 |
| Chlormezanone | Tabs.100 mg | Muscle relaxant & tranquiliser. | August,1962 |
| Chlorohexidine Gluconate Gel 0.2% | Chlorohexidine Gluconate Gel 0.2% | For the prevention of Plaque and treatment of gengivitis. | 30.12.2009 |
| Chlorohexidine Gluconate Mouth wash 0.1% | Chlorohexidine Gluconate Mouth wash 0.1% | For the prevention of Plaque and treatment of gengivitis. | 30.12.2009 |
| Chloroquine Phosphate eye drops (0.3mg/ml) | Chloroquine Phosphate eye drops (0.3mg/ml) | For dry eye syndrome. | 13.07.2005 |
| Chlorpheniramine maleate USP | Each sustained release tablet contians: Chlorpheniramne Maleate USP.8mg | April,1978 | |
| Chlorphenoxamine Embonate | Each 5mL syrup contains: Chlorphenoxamine Enbonate.17.5mg | March,1979 | |
| Chlorpromazine + Trifluoperazine + Trihexy phenidyl | Each tablet contains: Chlorpromazine.50mg, Trifluoperazine.5mg, Trihexy phenidyl.2mg | Schedule C | May,1979 |
| Chlorprothixene Tablets | Tab.50mg & vial.50mg | Anti.depressant. | September,1961 |
| Chlorthalidone Tablets | 100mg to 200mg | A long acting oral diuretic. | March,1961 |
| Chlorthalidone | Chlorthalidone | Diuretic | September,1963 |
| Chlorthalidone Tablet 6.25mg | Chlorthalidone Tablet 6.25mg | For the treatment of mild to moderate hypetension. | 03.10.2009 |
| Chlosal Butamide | Chlosal Butamide | Antifungal | October,1963 |
| Chlorzoxazone | 250 mg tabs | Muscle relaxant. | April,1963 |
| Cholestyramine Powder for oral suspension (4gm/sachet) | Cholestyramine Powder for oral suspension (4gm/sachet) | For hypercholesterolaemia. | 30.03.2006 |
| Choline Fenofibrate DR Capsule 45mg/135mg & DR Tablet 45mg/135mg. | Each hard gelatin capsule contains: choline fenofibrate eq.to fenofibric acid.45mg, 135mg | For treatment of mixed lipidemia in combination with statins, severe hypertriglyceridemia. | 01.11.2012 |
| Ciclesonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps | Ciclesonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps | For the treatment of patients with bronchial asthma where use of said combination is found appropriate. | 29.08.2006 |
| Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler (Additional strength) | Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler | As approved. | 27.02.2007 |
| Ciclesonide 160mcg/320mcg cap. for inhalation | Ciclesonide 160mcg/320mcg cap. for inhalation | Anti asthmatic. | 28.11.2006 |
| Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler | Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler | As third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately. | 31.01.2008 |
| Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI | Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI | Indicated as third line treatment of severe cases of COPD, whenmonotherapy and second line therapy with two drugs do not respond adequately. | 13.04.2009 |
| Ciclesonide 80mcg/160mcg + Formotorol 4.5mg inhaler | Ciclesonide 80mcg/160mcg + Formotorol 4.5mg inhaler | For the treatment of patients with bronchial asthma where use of said combination is found appropriate. | 29.08.2006 |
| Ciclesonide Inhaler 80/160mcg per actuation | Each actuation delivers: Ciclesonide.80mcg, 160mcg | For the treatment to control persistent asthma in adults (18 yeras & older). | 06.02.2006 |
| Ciclesonide Nasal Spray 50mcg/spray | Ciclesonide Nasal Spray 50mcg/spray | For seasonal & perennial allergic rhinitis in adults, adolescents aged ≥ 12 years. | 08.06.2007 |
| Ciclesonide rotacaps (200/400mcg) | Ciclesonide rotacaps (200/400mcg) | For Asthma. | 19.05.2006 |
| Ciclopirox olamine solution/cream/vagina cream | Solution.Each ml contains: 10mg of ciclopirox olamine, Cream.1gm contains: 10mg as ciclopirox olamine, Vaginal cream.1gm contains: 10mg of ciclopirox olamine | Anti fungal. Indicated in the treatment of fungal infections of the skin and vagina. | October,1985 |
| Cifixime 200mg + Erdosteine 300mg Capsules | Cifixime 200mg + Erdosteine 300mg Capsules | Acute Exacerbation of chronic bronchitis. | 21.03.2007 |
| Cilnidipine Tabs. 5mg, 10mg | Each tablet contains: Cilnidipine.5mg, 10mg | For the treatment of mild to moderate hypertension. | 21.06.2007 |
| Cilostazol tab & bulk | Each tab contains: Cilostazol.50mg, 100mg | For treatment of stable intermittent claudication, acting or cramping in legs that occure with walking. | 23.01.2003 |
| Cilostazole E.R Tablet (100mg/200mg) | Cilostazole E.R Tablet (100mg/200mg) | For management intermittent claudication. | 30.10.2007 |
| Cimetidine injection | Each ml contains: cimetidine hydrochloride eq.to 100mg of cimetidine | September,1985 | |
| Cimetropium Bromide tablet 50mg | Cimetropium Bromide tablet 50mg | For the treatment of irritable bowel syndrome. | 31.01.2008 |
| Cinacalet (as HCl) Tablet 30/60/90mg | Each film coated tablet contains: Cinacalcet hydrochloride.30mg, 60mg, 90mg | For the treatment of secondary hyperparathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma. | 16.01.2009 |
| Cinitapride (as hydrogen tartrate) 1mg tablet | Cinitapride (as hydrogen tartrate) 1mg tablet | For the treatment of gastroesophageal reflux disease and functional inconveniences of the gastrointestinal motility. | 04.01.2008 |
| Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules | Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules | For the treatment of gastirc ulcer,gastroesophageal reflux disease(GERD) & Dyspepsia not responding to omeprazole alone. | 12.05.2010 |
| Cinitapride Hydrogen Tartrate ER Tablet 3mg | Cinitapride Hydrogen Tartrate ER Tablet 3mg | For the treatment of gastroesophageal reflux disease (GERD) and functional inconveniences of the gastrointestinal motility. | 26.11.2009 |
| Cinnarizine + Domperidone tablets | Each tablet contains: Cinnarizine.20mg, Domperidone.15mg | Prevention of symptoms caused by vestibular disorders and vertigo/motion sickness, nausea, dizziness, headache, vomiting, sensation of fullness, when there is a delay in gastric emptying. | February,1992 |
| Cinnarizine 20mg + Dimenhydrinate 40mg tablets | For the treatment of vertigo | 03.02.2010 | |
| Cinnarizine SR tablets | Each tablet contains: cinnarizine.75mg | 02.09.2004 | |
| Cinnarizine tablets | Each tablet contains: cinnarizine.25mg,15mg and others | Anti histaminic. in the treatment of vestibular disturbances & vertigo only. | August,1985 |
| Ciprofibrate tab | Each tablet contains: ciprofibrate.100mg | Indicated in treatment of primary hyperlipidaemia resistant to appropriate dietary management including cholesterolaemia, hypertriglyceriaemia and hyperlipidaemia (Fredrickson types Iia, Iib, III and IV) | 01.05.1998 |
| Ciprofloxacin + Dexomethasone (Eye Drops) | Each 5ml contains: ciprofloxacin.0.3% w/v, dexomethasone.0.1% w/v | For post operative steroid responsive inflammatory ocular conditions when bacterial ocular infections or a risk of bacterial ocular infections exists. | 29.09.1999 |
| Ciprofloxacin + ornidazole tab | Each film coated tab contains: ciprofloxacin hcl eq.to ciprofloxacin.500mg, ornidazole.500mg | For treatment of diarrhoea of mixed infection in a adult patients only. | 03.02.2003 |
| Ciprofloxacin bulk | Ciprofloxacin bulk | May,1989 | |
| Ciprofloxacin ER Caps. | Each capsule contains: ciprofloxacin.500mg, 1000mg | By RMP. In treatment of respiratory tract infection, sinusitis, urinary tract infection, skin & soft tissue infection, gynaecological infection. | 16.08.2001 |
| Ciprofloxacin eye drops/eye oitment | Ciprofloxacin.0.3% w/v | Indicated in the treatment of external ocular infection of the eye. | February,1991 |
| Ciprofloxacin infusion | Each 50ml bottle contains: ciprofloxacin lactate eq.to 100mg ciprofloxacin , Each 100ml bottle contains: ciprofloxacin lactate eq.to 200mg ciprofloxacin | May,1989 | |
| Ciprofloxacin tablets | Each tablet contains: Ciprofloxacin hcl monohydrate eq.to 250mg,500mg,750 ciprofloxacin, | Antibacterial. Indicated in the treatment of respiratory tract infection, UTI, skin & soft tissue, severe systemic infections, surgical, gynae, G.I, bone & joint infections, STD. | May,1989 |
| Cisapride + MPS chewable tablets | Cisapride + MPS chewable tablets | Management of dyspepsia due to functional causes, peptic ulcer, oral oesophagitis, prevention and therapy of reflux oesophagitis, gastroporesis, due to diabetic neuropathy, anorexia.nervosa, vagotomy, post operative causes, radiation therapy, gastritis, intestinal pseudo obstruction uremia ulcerative and non ulcerative dyspepsia, restoration of intestinal motility in chronic constipation. | 03.05.1993 |
| Cisapride tablets | Each tablet contains: cisapride.5mg,10mg,20mg.(24.8.94), Each 1ml suspension contains: cisapride.1mg. | Gastro intestinal disorders. Oesophagitis and gasto oesophageal reflux disorders, chronic functional and non ulcer dyspepsia, gastroparesis intestinal pseudo obstruction and constipation. | 06.11.1992 |
| Cisatracurium Besylate Bulk & 2mg/ml injection | Each single dose vial of 5ml contains: cisatracurium besylate eq.to 2mg/ml, Each multi dose vial of 10ml contains: cisatracurium besylate eq.to.2mg/ml | As an adjunct to general anaesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery. | 14.03.2016 |
| Cisplatin injection/bulk | Each vial contains: cisplatin.10mg,50mg | Anticancer. Indicated in treatment of metastatic testicular & metastatic ovarian tumours. | April,1982 |
| Citalopram HBr. | Each film coated tablet containing: citalopram HBr eq.to citalopram base 10mg,20mg,40mg | Psychiatrists only. for treatment of depressive illness in the initial phase and as maintenance therapy against potential relapse/recurence panic disorder with or without agoraphobia. | 03.10.2001 |
| Citicholine 500mg + Piracetam 400mg Tablets | Citicholine 500mg + Piracetam 400mg Tablets | For the treatment of acute stroke. | 16.03.2010 |
| Citicholine Syrup 750mg/5ml | Citicholine Syrup 750mg/5ml | For the treatment of disturbance of consciousness resulting from head injuries, brain operation and acute stage of cerebral infarction in adults only. | 04.01.2008 |
| Citicholine tablets & injection | Each film coated tablet contains: citicholine sod.eq.to citicholine.500mg. Each ml of injection contains: citicholine sod.eq.to citicholine.250mg,500mg. | Neurologists & specialists. tablets: for treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerating damages and chronic cerebral vascular injuries in senile dementia. injections: for the treatment of disturbances of cnsciousness resulting from head injuries, brain operations and acute stage of cerebral infarction. | 23.08.2004 |
| Citicholine(as Sod.).200mg/500mg /750mg granules per sachet | Citicholine(as Sod.).200mg/500mg /750mg granules per sachet | As Approved | 26.11.2007 |
| Citicoline (750mg) tablet (Additional Strength), syrup 500mg/5ml (New Dosage Form) ,(not For children) | Citicoline (750mg) tablet,Syrup 500mg/5ml | As approved | 10.04.2007 |
| Citicoline 500mg + Piracetam 400mg per 5 ml syrup (Additional Dosage Form) | Citicoline 500mg + Piracetam 400mg per 5 ml syrup | Additional dosage form | 11.10.2010 |
| Citicoline Chewable tablet (500mg) | Citicoline Chewable tablet (500mg) | For the treatment of disturbance of consciousness as resulting from head injuries , brain operation and acute stage of cerebral infraction in adult only. | 18.08.2008 |
| Citicoline CR Tab 1000mg | Citicoline CR Tab 1000mg | For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia. | 16.09.2008 |
| Citicoline Oral Drops | Citicoline Oral Drops | For the treatment of disturbance of consciousness resulting from head injuries, brain operation & acute stage of cerebral infraction in adult. | 30.09.2008 |
| Citicoline tablet 200mg (Additional Strength) | Citicoline tablet 200mg | As approved | 25.05.2007 |
| Citicoline Troches 200/500mg | Citicoline Troches 200/500mg | For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerative damages and chronic cerebral vascular injuries in senile dementia. | 31.10.2008 |
| Clarithromycin 1% gel | Each tube contains: Clarithromycin.1% | Acne vulgaris | 12.06.2002 |
| Clarithromycin M.R tabs | Each modified release tab contains: Clarithromycin.500mg | Lower respiratory tract infection, upper respiratory tract infection & skin & soft tissue infections. | 16.10.2001 |
| Clarithromycin tablets | Each tablet contains: Clarithromycin.250mg,500mg, (Clarithromycin paediatric suspension). Each 5ml contans: Clarithromycin.125mg,250mg (4.9.95) | Of mild to moderately severe infections like acute exacerbation of chronic bronchitis community acquired pneumonia including infections due to chlamydia, mycoplasma spegiocella acute streptococcal pharyngitis and skin and soft tissue infections. | 22.03.1995 |
| Clavulanic acid | Clavulanic acid | Antibacterial agent. To be used in combination with amoxycillin only in the treatment of bacterial infection. | February,1987 |
| Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur. (2.) Syrup...0.1 mg / ml Ph. Eur. (3.) Injection...1 mg / 2mlPh. Eur. | i) Each uncoated tablet contains: clebopride malate ph. Eur. Eq.to clebopride base.0.5mg, ii) Each ml syrup contains:clebopride malate ph. Eur. Eq.to clebopride base.0.1mg, iii) Each 2ml injection contains:clebopride malate ph. Eur. Eq.to clebopride base.1mg | For the treatment of various disorders associated with altered gastrointestinal motility like non.ulcer dyspepsia (NUD) and / or chronic gastritis, gastroesophageal reflux disease (GERD), nausea and vomiting of organic or functional origin. | 04.11.2010 |
| Clemastine | Clemastine | Anti.histaminic. indicated in the treatment of all allergic rhinitis, urticaria, pruritus, itching, dermatoses. | April,1979 |
| Clemastine tablet/Elixir | Each tablet contains: clemustine (as the hydrogen fumerate).1mg, Each 5ml contains(Elixir): clemastine (as the hydrogen fumerate).0.5mg | September,1985 | |
| Clenbuterol Hydrochloride Solution for injection 30mcg/ml | Clenbuterol Hydrochloride Solution for injection 30mcg/ml | For the treatment of equine respiratory diseases in horses where airway obstruction due to bronchospasm and/or accumulation of mucus is contributing factor and improved muco.ciliary clearance is desirable. The product should be used alone or as an adjuvant therapy. The product is of particular value in cases of: Acute, sub.acute and chronic infections where the presence of mucus and/or micro.organisms may stimulate bronchospam e.g. Bronchitis, broncholitis and Bronchopneumonia . Acute, sub.acute and chronic respiratory allergies. . Chronic obstructive pulmonary disease (COPD) | 01.07.2012 |
| Clidinium bromide | 2.5mg to 10mg | Anti.cholinergic | May,1962 |
| Clidinium Bromide + Diazepam + Analgin | Each tablet contains: Clidinium Bromide.2.5mg, Diazepam.2.5mg, Analginv.500mg | September,1979 | |
| Clindamycin + Tretinoin topical gel | 10gm tube contains: clindamycin.1%, tretinoin.0.25% | Mild to moderate acne vulgaris only. | 18.11.1996 |
| Clindamycin 1% + Isotretinoin 0.05% gel | Clindamycin 1% + Isotretinoin 0.05% gel | For acne. | 08.03.2007 |
| Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml | Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml | Indicated for the Prophylaxis against alpha.hemolytic(viridans group) sreptococci before dental, oral and upper respiratory tract surgery. | 14.12.2010 |
| Clindamycin Phosphate eq. To Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel | Clindamycin Phosphate eq. To Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel | For topical treatment of inflammatory acne vulgaris (Additional lower strength). | 30.08.2011 |
| Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (Additional indication) | Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg | Prophylaxis of infection in neck and head surgery. | 02.05.2009 |
| Clindamycin phosphate topical gel | Each gm contains: Clindamycin phophate eq.to 1% of clindamycin. | Indicated in treatment of acne vulgaris. | October,1992 |
| Clobazam tablets | Each tab contains: Clobazam.5mg,10mg,20mg. | Acute and chronic anxiety states and as an adjunctive therapy in patients with refractory epilepsy. | 11.11.1997 |
| Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment | Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment | For plaque psoriasis. | 20.07.2006 |
| Clobetasol propionate + Ammonium lactate gel | Clobetasol propionate.0.05% w/w, ammonium lactate.12% w/w | Dry hyperkeratotoic steroid responsive dermatoses inflammatory manifestation of psoriasis (or eluding wide spread plague psoriasis). | 07.08.1996 |
| Clobetasol propionate bulk | Clobetasol propionate bulk | October,1987 | |
| Clobetasol propionate cream/ointment | Clobetasol propionate.0.05% | Topical corticosteroid. | October,1987 |
| Clobetasone 17.butyrate cream/ointment | Clobetasone 17.butyrate.0.05% | Topical corticosteroid. Indicated in the treatment of mild eczema, seborrhoic dermatitis and other steroid responsive disorders. | December,1986 |
| Clofazemine | 50 & 100 mg | Anti.leprosy drug. | September,1969 |
| Clofibrate | 250 mg capsules | Coronary heart disease. | July,1967 |
| Clomiphene Citrate B.P | 50mg (1 tablet) daily for 5.days on or about 5 day of the cycle. | Fertility drug. induction of ovulation in patients with persistant ovulatory dysfunction who desire pregnancy. | February,1974 |
| Clomipramine hcl tablet/capsule | Each tablet contains: Clomipramine hcl.10mg,25mg,50mg, Each Capsule contains: Clomipramine hcl.50mg. | Anti depressant. Obsessive compulsive disorders, phobic states and depression (when sedation is required). | February,1992 |
| Clomipramine SR tablet | Each SR tablet contains: Clomipramine hcl.75mg | 19.10.1994 | |
| Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg | Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg | For the treatment of patients with co.morbid depression and axiety. | 08.07.2010 |
| Clonazepam tablets | Each tablet contains: Clonazepam.0.5mg,1.0mg,2.0mg | In the treatment of petitmal and its variant, akinetic and myoclonic seizures. | 25.01.1995 |
| Clonidin Hcl | Each tablet/capsule contains: Clonidin Hcl.100mcg, | Antihypertensive agent. indicated in the treatment of hypertension. | July,1975 |
| Clonidine + Chlorthalidone | Each tablet contains: Clonidine hcl BNF.0.1mg, 0.2mg Chlorthalidone IP.15mg | December,1977 | |
| Clonidine Bulk | Clonidine Bulk | Antihypertensive | March,1981 |
| Clonidine Hcl + Hydrochlorthiazide | Clonidin Hcl.100mcg+ Hydrochlorthiazide.20mg | Antihypertensive agent. indicated in the treatment of hypertension. | July,1975 |
| Clopamide | 20mg | Diuretic. indicated in the treatment of oedema of cardiac hepatic or renal origin and hypertension only. | July,1979 |
| Clopidogrel 300mg Tablet (Additional Strength) | Clopidogrel 300mg Tablet | As approved. | 02.09.2008 |
| Clopidogrel bisulphate | Each film coated tab contains: Clopidogrel bisulphate eq.to clopidogrel.150mg | 14.01.2004 | |
| Clopidogrel bisulphate | Each film coated tablet contains: Clopidogrel bisulphate eq.to clopidogrel.75mg | By RMP. for treament of atherosclerosis events (myocardial infarction, stroke & vascular death) | 01.02.2001 |
| Clopidogrel for (Additional Indication) | Clopidogrel for additional indication | Additional indication. in acute coronary syndrome. | 10.03.2004 |
| Clopidol | Clopidol | Coccodiosis | January,1972 |
| Clorexolone | 10mg & 25mg tablets | Hypertensive, cardiac failure, oedema, diabetes insipedus. | October,1968 |
| Closantel 15% oral solution | Each 100ml contains; closantel.15.00gm | Mature and immature fasciola species, haemonchus species, strongyloides species, and also for external parasites like oestrus ovis boophilus microplus hyalomma a. Anatolicum in cattle and sheep. | 03.10.1994 |
| Closantel Injection100mg/ml (for verterinary use) | Each ml contains; closantel.100mg | For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals. | 06.02.2009 |
| Clostebol acetate | Clostebol acetate | Protein anabolizing agent. Preparation containing the drug with neomycin shall be indicated in the treatment of infected wounds and 1st and 2nd degree burns. | September,1986 |
| Clostimethate Sodium of 1,00,000IU Injection | Clostimethate Sodium of 1,00,000IU Injection | For the treatment of serious infection caused Gram.ve bacteria including LRTI, UTI, where commonly used anti bacterial agent may be infective because of bacterial resistance. | 31.01.2008 |
| Clostridium botulinum toxin type A haemagglutin complex | Dysport injection.500 units | NOC for shelf life extension of 12 months to 15 months under 2ᵒ to 8ᵒ. | February,2005 |
| Clostridium botulinum toxin type.A | Each vial contains: Clostridium botulinum toxin type.A.100 units | For the treatment of benign essential blepharospasm in patients 18 years of age and above. | 27.09.2007 |
| Clostridium Botulinum Toxin Type.A Injection 100Units/Vial (Additional Indication) | Clostridium Botulinum Toxin Type.A Injection 100Units/Vial | For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy. | 03.06.2011 |
| Clostridium Botulinum type.A toxin haemagglutinin complex (Additional Indication) | Clostridium Botulinum type.A toxin haemagglutinin complex | For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy. | 22.04.2008 |
| Clotrimazole (10mg) + Methylprednisolone aceponate 1mg/gm of cream | Clotrimazole (10mg) + Methylprednisolone aceponate 1mg/gm of cream | For fungal infection of skin associated with inflammation. | 12.07.2007 |
| Clotrimazole lozenges | Clotrimazole.10mg | For local treatment of oropharyngeal candidiasis in immuno compromised patients. | 13.03.2000 |
| Clotrimazole soft gel pessary | Each soft gelatin pessary contains: clotrimazole IP.100mg | Vaginal candidiasis. | 17.02.1998 |
| Cloxacillin | Cloxacillin | Oral synthetic penicillin. | August,1965 |
| Cloxacillin benzathine intramammary infusion | Each disposible plastic syringe contains: Cloxacillin benzathine eq.to 500mg of cloxacillin | October,1987 | |
| Cloxacillin sodium + Colistine sulphate intramammary infusion | Each (10ml) syringe contains: Cloxacillin sodium.200mg, colistine sulphate.50000 units | 04.03.1998 | |
| Clozapine Tablet200mg (Additional Strength) | Clozapine Tablet200mg | Indicated in the management of Schizophrenic patients. | 19.08.2009 |
| Clozapine tablets | Each uncoated tablet contains: Clozapine.25mg, 100mg. | Indicated in the management of schzophrenic patients. | 07.03.1995 |
| Cobalt glutamate copper succinate | 30mg=5mg Co, 2mg=0.5mg Cu | Antianemic | August,1961 |
| Codeine phosphate 10mg + triprolidine hcl 1.25mg | Codeine phosphate.10mg, triprolidine hcl.1.25mg per 5/ml syrup | For symptomatic treatment of dry cough | 18.02.2003 |
| Cohorton ointment | Cohorton ointment | May,1965 | |
| Colesevelam Hydrochloride Tablets 625mg & Sachets for oral suspension 3.75gm/1.875gm. | Each film coated tablet contains: Colesevelam hydrochloride.625mg Each sachet contains: Colesevelam hydrochloride.3.75gm, 1.875gm | Indicated as an adjunct to diet and exercise to reduce elevated low.density lipoprotein cholesterol (LDL.C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl.glutaryl.coenzyme A (HMG CoA) reductase inhibitor (statin). Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | 29.08.2012 |
| Colfosceril palmitate inj. | Each vial contains: Colfosceril palmitate.108mg | New born babies with birth weight of 700gm or greater, undergoing mechanical ventilation of respiratory distress syndrome, whose heart rate and arterial oxygenation are continuously monitored. | 01.12.1993 |
| Coligen (Escherichia coli bacterin vaccine) | Coligen (Escherichia coli bacterin vaccine) | For the prevention of calf & cows, due to infection with enteropathogenic, E.coli organism. | June,1990 |
| Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU | Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU | Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis. | 28.07.2009 |
| Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU (Additional Strength) | Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU | Same as approved. | 20.07.2009 |
| Colistin | 50000 U/kg/day.inj, | Anabolic. | June,1962 |
| Colistin sulphate + pectin + kaolin | 30ml suspension contains: Colistin sulphate.0.154g, pectin.0.196g, kaolin.2.625g | July,1969 | |
| Colistin sulphomethate + Dibucaine | Each vial contains: Sterile powder of colistin sulphomethate sodium eq to 10,000,00 Units, Dibucaine Hcl.2mg | February,1980 | |
| Collagen dressing soft sponge (gel fix) | Each 5X5cm sponge contains: 250mg eq.to collagen anhydrous 210mg, each 1X1cm sponge contains: 10mg eq.to collagen anhydrous 84mg | RMP. As adjuvant in post surgical characterization of various ulcers & dicubitus sores. | 23.04.2001 |
| Collagen fleece | Collagen fleece | For surgical procedure. | 03.02.2000 |
| Collagen with gentamicin implant | Collagen with gentamicin implant | Control of infection in surgical procedures, bone marrow, osteomyelitis, osteitis loosened prosthesis, osteosynthesis, spondylodiseitis, facial bone defect, soft tissue rectal amputation vascular graft surgery, colostomy surgery. | 06.05.1998 |
| Collagenase ointment | Each gm contains: collagenase.250 units | In the treatment for debriding chronic dermal and severely burn areas. | 05.05.1994 |
| Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg | Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg | For HIV infection | 02.04.2007 |
| Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) | Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) | Antibiotic | 20.04.2007 |
| Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium each | Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium each | For osteoporosis in postmenopausal women. | 01.05.2007 |
| Combi pack of interferon alpha.2b inj. Multidose pen & ribavirin cap | Each combi pack contains: ribavirin caps.200mg each (70 caps), interferon alpha.2b inj.multidose pen.18MIU in 1.2 ml | 28.08.2001 | |
| Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol.250IU. | Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol.250IU. | For the treatment of osteoporosis in post.menopausal women. | 23.01.2008 |
| Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Efavirenz (600mg) | Each tablet contains: 2 film coated tablets of lamivudine.150mg, zidovudine.300mg & 1 film coated tablet of Efavirenz.600mg | For the treatment of HIV infection in adults. | 26.10.2005 |
| Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) | Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) | For HIV infection in adults. | 07.06.2005 |
| Combikit of artesunate, sulphadoxine and pyrimethamine tablets | Each combikit contains one tablet of; artesunate.150mg,200mg, sulphadoxine IP.500mg,750mg, pyrimethamine IP.25mg,37.5mg | For the treatment of p.falsiparum resistant malaria patients (age 9.14 yrs and above). | 25.07.2006 |
| Combikit of lamivudine tabs, efavirenz tab & didanosine delayed release capsules | Combikit of tablets & capsules. 1xefavirenz.600mg, 1xlamivudine.300mg, 1xdidanosine (delayed release).250mg,400mg | By RMP only. for treatment of HIV infection. | 20.09.2004 |
| Combikit of oxymetazoline & NaCl soln. | Each combikit contains: oxymetazoline 0.05%.10ml, NaCl soln 2%.15ml | Symptomatic relief of nasal mucosal congestion & adjunctive therapy of middle ear infection associated with acute/chronic rhinitis, common cold, sinusitis. | 12.10.2001 |
| combikit of pioglitazone & metformin tab | Each combikit contains: one tab of pioglitazone hcl eq.to pioglitazone.15mg, two tab of metformin hcl.500mg | Patients with type.II diabetes mellitus when diet, exercise & the single agent do not result in adequate glycemic control. | 18.02.2002 |
| Combikit of stavudine + Lamivudine + Nevirapine tablets | Each kit contains: 2 tablets of (uncoated) stavudine.3mg,40mg, lamivudine.150mg, 1 tablet of nevirapine.200mg | By RMP only. for HIV infection in adults who have been stabilized on the maintenance regimen of nevirapine (200mg) B.D and have demostrated adequate tolerability to nevirapine. | 22.11.2004 |
| Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.) | Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.) | For BPH. | 19.01.2006 |
| Combination of Lactic Acid Bacteria (VSL#3) Sachet | Combination of Lactic Acid Bacteria (VSL#3) Sachet | For mild to moderately active ulcerative colitis as an adjunctive therapy subject to condition that it should not be used in patients who are on steroids or immunocompromised. | 08.04.2013 |
| Combination of Oxethazaine, aluminium hydroxide & magnesium hydroxide | Combination of Oxethazaine, aluminium hydroxide & magnesium hydroxide | Antacid, demulcent & mucosal anaesthetic. | June,1966 |
| Combination vaccine DPT + Hi.b | Composition: Each 0.5ml dose contains: haemophilus influenza.b oligo saccharide.10mcg, diptheria CRM 197.25mcg, diptheria toxoid (adsorbed). 12.5Lf, tetanus toxoid (adsorbed).5Lf, pertusis vaccine (adsorbed) NMT.160 PU, aluminium NMT.0.85mg, thiomersal.50mcg. | For active immunization of children two months.five year of age against diptheria, tetanus, pertusis and haemophilus influenza type.b disease when indication for immunization with DTP vacc & Hib conjugate vaccine coincide and is not to be used for treatment of actual infection. | 01.06.2000 |
| Combined hepatitis A & hepatitis B vaccine inj. (import of finished formulation) | Each ml contains: NLT 720 EU of in activated hepatitis A virus+ 20mcg of HBs Ag protein (rDNA), Each 0.5ml dose contains: NLT 360 EU of inactivated HA Virus+ 10mcg of rDNA HBs Ag protein. | By RMP. use in non.immune adults and adolescents 16 years of age and children from 1 year to 15 years of age who are at risk of both hepatitis A and hepatitis B vaccine. | 07.06.2001 |
| Combipack | i).Omeprazole.20mg cap + Clarithromycin.250mg tab + Tinidazole.500mg tab, ii).Omeprazole.20mg cap + Amoxycillin.750mg tab + Tinidazole.500mg tab | For eradication of H.pylori associated with peptic ulcer. | 09.09.1997 |
| Combipack of 12 Artesunate.50mg tablets & 6 Mefloquin.250mg tablets | Combipack of 12 Artesunate.50mg tablets & 6 Mefloquin.250mg tablets | For drug resistant P.falciparum malaria infection. | 12.06.2007 |
| Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Additional Strength) | Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. | As Approved | 01.08.2007 |
| Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each. | i) Each film coated tablet contains: quinine sulphate IP.600mg ii) Each hard gelatin capsule contains: doxycycline hydrochloride IP eq.to doxycycline.100mg | For the treatment of P. Falciparam malaria in adults. | 10.08.2006 |
| Combipack of 21 tablets of FDC of Ethinylestradiol IP 0.03 mg + Levonorgestrel IP 0.15 mg and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron) | As contraceptive pill for women | 13.10.2010 | |
| Combipack of aminoacid & glucose inj.with electrolytes and IV fat emulsion. | Two bottles in a kit, one bottle of (1000ml) contains aminoacid (7%w/v) glucose (10%) with electrolytes injectable filled up to 750ml. Second bottle is supplied with fat emulsion (20%w/v) in 250ml. | By RMP. short term parenteral nutrition via peripheral route, pre & post opertaive nutrition in cancer [patients, burns patients, short bowel syndrome, inflammatory bowel disease, transition period between i.v nutrition and normal food. | 28.08.2000 |
| Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine | A. combipack of 1 stip of 3 tablets ofartesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg + pyrimethamine 6.25mg B. combipack of 1 stip of 3 tablets ofartesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg + pyrimethamine 25mg C. combipack of 1 stip of 3 tablets ofartesunate 100 mg and 1 strip of 2 tablet of sulphadoxine 500mg + pyrimethamine 25mg D.combipack of 1 stip of 3 tablets ofartesunate 200 mg and 1 strip of 3 tablet of sulphadoxine 500mg + pyrimethamine 25mg | For the treatment of P. falciparum resistant malaria patients. | 15.07.2009 |
| Combipack of omeprazole + clarithromycin + amoxycillin | Each combipack contains: Omeprazole cap.20mg×2 clarithromycin tab.500mg×2 amoxycillin cap.500mg×4 | For eradication of H.pylori in patients with active chronic gastritis, gastric ulcer & duodenal ulcer. | 01.10.2002 |
| combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack) | combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack) | As Approved. | 10.10.2006 |
| Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) each | Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) each | For drug resistant malaria. | 10.10.2007 |
| Combipacks (triple chambered bag) of aminoacid+electrolytes' dextrose (15% & 30%) and IV fat emulsion(LCT/MCT 20% w/w) | Combipacks (triple chambered bag) of aminoacid+electrolytes' dextrose (15% & 30%) and IV fat emulsion(LCT/MCT 20% w/w) | By RMP | November,2003 |
| Combipro (probiotic product) | Each sachet containing; saccharomyces boulardii.5 billion, L. sporogenous.60 million, L. acidophilus.60 million, bifido bacterium.10 million, bacillus mesentricus.10 million | 24.10.2005 | |
| Complex 15 cream | Complex 15 cream | Phospholipid.for the treatment/immediate relief of mild to moderate to severe dry skin as is associated with xerosis, dry eczema, senile dry skin, itchthyosis neurodermatitis sputitic as adjuvant therapy in atopic eczema. | 10.01.1997 |
| Concentrated potassium chloride inj. | Each 100/ml contains: pot.chloride.746mg,1.49gm,2.24gm,2.98gm | For treatment of potassium deficiency states when oral replacement is not feasible. | 29.04.2002 |
| Conivaptan Hydrochloride Injection 20mg/4ml. | Each 4ml ampoule contains: conivaptan hydrochloride.20mg | For the treatment of euvolemic hyponatremia (e.g. the syndrome of inappropriate secretion of antidiuretic hormone , or in the setting of hypothyroidism, adrenal insufficiency, pulmonary disorders, etc.) in hospitalized patients. | 21.08.2012 |
| Conjugated estrogen + MPA tabs (finished formulation) | Each sugar coated tab contains conjugated estrogen.0.625mg, MPA.2.5mg,5mg | Indicated in women with an intact uterus to reduce the risk of endometrial and prevention and management of osteoperosis, and vasomotor symptoms associated with estrogen deficiency. | 13.09.1999 |
| Contractubex gel | Each gm of gel contains: extract cepae.1gm, heparin sodium.500 IU, allantoin.0.1gm | Hypertrophic keloidal scars, movement restricting and cosmetically disfiguring scars after operations, amputation, burns and accidents and traumatic tendon contractions, cicatricial strictures. | 15.03.2002 |
| Coseal Surgical Sealent 2/4/8ml (Additional Indication) | Coseal Surgical Sealent 2/4/8ml | (1) Enforcement of suture and staple lines in lung resection procedures. (2) Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation. (3) Patients undergoing laparotomy or laproscopic abdomino.pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post surgical adhesion formation. | 06.02.2010 |
| Cosumix plus | Each 100 gm cosumix plus powder contains: Alpha chloropyridazine sodium.10g, Methoprin.2gm | May,1990 | |
| Coumaphos + propxur + sulphanilamide powder | Composition: coumaphos.3%, propoxur.2%, sulphanilamide.5% | For use as larvicidal bacteriostatic wound dressing in cattle, sheep, pigs & horses. | 23.04.2002 |
| Coumarin tabs | |||
| Cranio plastic (resinous material) | Each kit consists of 2 sets of powder & sterile liquid component. The quantity of powder & liquid in each unit is 30g powder/17ml. (A).powder component (%w/w) methyl methacrylate polymer.79.6%, methyl methacrylate styrene copolymer.19.9%, benzoyl peroxide.0.5% (B).liquid componenet (%v/v) methyl methacrylate monomer.95.05, ethylene dimethacrylate monomer.4.28, N.N.Dimethyl.p.toluidine.0.67, hydroquinone.20+/.5ppm, 4.methoxyphenol.12ppm | For cranial defects repairing. | 17.11.2005 |
| Creatine phosphate injection | Each vial contains: creatine phosphate.500mg,1gm | Endogenous biochemical substance. Deficient striated muscle activity, coadjuvant in the treatment of myocardial disorders for addition to cardioplegic solution as a means of protection in heart surgery. | 20.01.1997 |
| Crizotinib hard gelatin Capsules 200mg/250mg | Each hard gelatin capsule contains; crizotinib.200mg, 250mg | For the treatment of patients with locally advanced or metastatic non.small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) – positive as detected by an FDA.approved test. | 16.12.2011 |
| Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre.filled syrings | Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre.filled syrings | For filling any medium sized depression of the skin via mid dermis injection as well as for lip definition. The presence of lidocaine is meant to reduce the patients pain during the treatment. | 28.05.2010 |
| Cumophos 50% | Cumophos 50% | 05.07.1993 | |
| Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg | Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg | For Mineral & Vitamins deficiency states in adult patients. | 06.07.2010 |
| Cyanocobalamine + Zinc Tannic acid complex | 500 mcg every 2 week | Same as vit. B12, but it has rapid onset of action and provides prolonged effect for a month or more. | January,1961 |
| Cyclobenzaprine 7.5mg tablets (Additional Strength) | Cyclobenzaprine 7.5mg tablets | Same as Approved. | 18.08.2008 |
| Cyclobenzaprine HCl ER Capsule 15/30mg | Cyclobenzaprine HCl ER Capsule 15/30mg | As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions. | 17.12.2008 |
| Cyclobenzaprine Hcl. Tablets 5mg/10mg | Each film coated tablet contains: Cyclobenzaprine Hcl.5mg, 10mg | As adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. | 22.04.2008 |
| Cyclopenthiazide | 1.2 Tablets daily | Non.mercurial oral diuretic & hypotensive. | February,1962 |
| Cyclopentolate hcl | Cyclopentolate hcl BP.0.5%,1%,2% | For mydriasis and cycloplegia. | March,1990 |
| Cyclosporin 0.05% eye drops | Each ml contains: Cyclosporin.0.5mg | For treatment of moderate to severe dry eye syndrome (keratoconjunctivitis sicca) | 10.03.2003 |
| Cyclosporin capsules | Each capsule contains: Cyclosporin 10mg. | As additional strength. | 27.06.2000 |
| Cyclosporin Eye drops (0.1%) (Additional Strength) | Cyclosporin Eye drops (0.1%) | For Ophthalmic use. | 02.06.2006 |
| Cyclosporin oral solution, concentrate for inj. & capsules | Cyclosporin oral solution, concentrate for inj. & capsules | Immuno suppressant. Indicated in immuno.suppression in organ transplants. | .June,1988 |
| Cypermethrin high cis | Each litre contains: Cypermethrin high cis.100gm | For the control of tick, flies, lice and mites on cattle, sheep, dogs and poultry. | 16.09.1996 |
| Cyproheptadine | Each tablet contains: Cyproheptadine Hcl.4mg | January,1973 | |
| Cyproheptadine Hcl. | 4.20 mg | Anti.histamic, anti.serotonin. | April,1962 |
| Cyproterone acetate + ethinyl estradiol tab | Each 28 days pack contains: Cyproterone acetate.2mg tab 28 no. Ethinyl Estradiol.0.035mg tab (7 nos) | Androgen dependent disease such as acne, alopecia & mild of hirsutism. | 20.02.2003 |
| Cytarabine | Cytarabine | Anticancer indicated in the treatment of acue myeloid leukaemia | June,1980 |
| Cytarabine Injection 100mg Additional Packsize (20ml) | Cytarabine Injection 100mg Additional Packsize (20ml) | In combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia. | 10.02.2010 |
| Dabigatran Etexilate (as Mesilate) hard gelatin Capsules 75mg/110mg/150mg | Each hard gelatin capsule contains: Dabigatran etexilate mesilate eq.to dabigatran etexilate.75mg, 110mg, 150mg | For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation. | 12.12.2011 |
| Dabigatran Etexilate Mesilate eq to Dabigatran Etexilate 75mg/110mg/150mg | Dabigatran Etexilate Mesilate eq to Dabigatran Etexilate 75mg/110mg/150mg | For the prevention of venous thromboembolic events in patients who have undergone orthopaedic surgery. | 11.02.2013 |
| Dabigatran Etexilate Mesilate hard gelatin capsule 75/110/150mg (Additional Indication) | Dabigatran Etexilate Mesilate hard gelatin capsule 75/110/150mg | 1. Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death. 2.Prevention of recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE) and related death. | 17.11.2014 |
| Daclatasvir Dihydrochloride 30mg/60mg Tablet &bulk | Each film coated tablet contains: Daclatasvir dihydrochloride eq.to daclatasvir.30mg, 60mg | For use with Sofosbuvir for the treatment of patient with chronic hepatitis C virus (HCV) genotype 3 infection. | 14.12.2015 |
| Daclizumab solution for infusion (finished formulation, import) | Each vial contains: Daclizumab.25mg/5ml | By hospital, nursing homes, institution only. For prophylaxis in acute organ rejection in patients receiving transplants. | 12.10.2000 |
| Dalteparin sodium injection | Dalteparin sodium injection | For additional indication; for prophylaxis of deep vein thrombosis in medical patients who are at risk of thromboembolic complication due to severely restricted mobility during acute illness subject to all other conditions, statements of initial approvals same. | 02.05.2005 |
| Dalteparin Sodium Injection (Additional Indication) | Dalteparin Sodium Injection | For the extended treatment of symptomatic venous thromboembolism (VTE) proximal deep thrombosis (DVT) and/or pulmonary embolism (PE), to reduce the recurrence of VTE in patients with cancer. | 30.01.2008 |
| Danazol bulk substances | Danazol bulk substances | January,1982 | |
| Danazol capsules | Danazol.100mg,200mg | Gonadotropic inhibitor. Indicated in the treatment of endometriosis, gynaecomastia, fibrocystic mastitis, prococious puberty and pubertal breast hypertrophy. | March,1982 |
| Danofloxacin mesylate injection | Each ml contains: Danofloxacin mesylate eq.to 25mg of danofloxacin. | Bovine respiratory disease in beef cattle; non lactating dairy cattle calves caused by pasteurella haemolytica, p. Multocida & enteric infection caused by E.coli/salmonella | 12.08.1995 |
| Dapagliflozin Tablet 5mg/10mg | Each film coated tablet contains: Dapagliflozin propanediol monohydrate eq.to dapagliflozin.5mg, 10mg | "In adult aged 18 years and older with Type.II diabetic mellitus to improve glycemic conrol. As mono.therapy when diet and excercise alone do not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate due to intolerance. As add.on combination therapy in combination therapy in combination with other glucose. lowering medicinal products including insulin, when these, together with diet and excercise, do not provide adequate glycemic control". | 25.02.2015 |
| Dapoxetine (as Hydrochloride) Tablets …30mg/60mg | Each film coated tablet contains: Dapoxetine hydrochloride eq.to dapoxetine.30mg, 60mg | For the treatment of premature ejaculation (PE) in men 18 to 64 years of age. | 15.11.2010 |
| Daptomycin powder for concentrate for solution for infusion (350mg/500mg per vial) | Daptomycin powder for concentrate for solution for infusion (350mg/500mg per vial) | For the treatment of complicated skin and skin structure infections and for staphylococus aureus bloodstream infections (bacteremia). | 28.01.2008 |
| Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets | Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets | For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. | 31.01.2008 |
| Darunavir (as ethanolate) Tablet 300mg | Each film coated tablet contains: Darunavir (as ethanolate).300mg | For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV.1 strains resistant to more than one protease inhibitor when co.administered with 100mg ritonavir, and with other antiretroviral agents. | 23.03.2009 |
| Dasatinib 20mg/50mg/70mg (Additional Indication) | Dasatinib 20mg/50mg/70mg | Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase. | 16.03.2011 |
| Dasatinib tablet 20mg/50mg/70mg tablet | Dasatinib tablet 20mg/50mg/70mg tablet | For the treatment of adults with chronic accelerated or myeloid or lymphoid blast phase chronic myeloid leukemai (CML). | 30.08.2006 |
| Dasatinib Tablets 100mg (Additional Strength) | Dasatinib Tablets 100mg | Same as approved. | 10.07.2009 |
| Daunorubicin | Daunorubicin | Anticancer | December,1972 |
| Day & night capsules | Combikit of 5 tablets each i).pseudoephedrine hcl ER.120mg + cetrizine hcl.5mg (orange tab) ii).pseudoephedrine hcl ER.120mg + Tripolidine.2.5mg (blue tabs) | By RMP. for the treatment of symptomatic relief of allergic rhinitis in adults only. | August,2004 |
| Decapeptide lotion (basic fibroplast growth factor) | Each glass bottle contains: basic fibroplast growth factor.2mg | Treatment of vitiligo/white patches in adults. | 22.10.2001 |
| Decitabine Injection 30mg/vial (Additional pack size) | Decitabine Injection 30mg/vial | For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French.American.British subtypes(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate.1, intermediate.2, and high.risk international Prognostic Scoring System groups. | 13.02.2015 |
| Decitabine lyophilised powder for injection 50mg/20ml vial (Additional indication) | Decitabine lyophilised powder for injection 50mg/20ml vial | For the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy. | 09.04.2014 |
| Decitabine Lyophilized powder for injection 50mg/20ml vial | Each 20ml vial contains: Decitabine.50mg | For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French.American.British subtypes(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate.1, intermediate.2, and high.risk international Prognostic Scoring System groups. | 28.04.2009 |
| Deferasirox 100mg dis.tablet (Additional strength) | Deferasirox 100mg dis.tablet | As Approved | 28.11.2007 |
| Deferasirox dispersible tablet (400mg) (Additional strength) | Deferasirox dispersible tablet (400mg) | As approved | 17.08.2007 |
| Deferasirox Dispersible tablet 100/400mg (Additional indication) | Deferasirox Dispersible tablet 100/400mg | Treatment of chronic iron overload in patients with non.transfusion dependent thalassemia (NTDT) syndromes aged 10 years and older. | 26.09.2014 |
| Deferasirox dispersible tablet 125/250/500mg. | Each disp.tablet contains: Deferasirox.125mg, 250mg, 500mg | For the treatment of chronic iron overload due to blood transfusion (transfusional haemosiderosis) in patients aged 2 years and above. | 12.07.2006 |
| Deferasirox dispersible tablet 125mg/250mg/500mg | Each uncoated dispersible tablet contains: Deferasirox.125mg, 250mg, 500mg | For the treatment of chronic iron overload due to blood transfusion (transfusional haemosiderosis) in patients aged 2years and above. | 20.08.2007 |
| Deferasirox Tablet for Oral Suspension (Additional Dosage Form) | Deferasirox Tablet for Oral Suspension | Same as approved | 14.12.2010 |
| Deflazacort Oral Suspension (6mg/5ml) (New dosage form) | Deflazacort Oral Suspension (6mg/5ml) | For asthma, rheumatoid arthritis when glucocorticosteriod therapy is warranted. | 15.06.2007 |
| Deflazacort Tablet 18mg (Additional Strength) | Deflazacort Tablet 18mg | Same as approved | 30.01.2010 |
| Deflazocort 24mg tablets (Additional strength) | Deflazocort 24mg tablets | Same as Approved. | 14.05.2008 |
| Deflazocort oral suspension (6mg/5ml) (New Dosage Form) | Deflazocort oral suspension (6mg/5ml) | As approved | 15.06.2007 |
| Deflazocort tablets | Each tablet contains: Deflazocort.1mg,6mg,30mg | By specialists only. for the treatment of asthma, rheumatoid arthritis when glucocorticosteroid therapy is warranted. | 02.11.2004 |
| Degarelix for Injection 80mg / 120mg per vial | Each pack contains: 1. One vial containing; degarelix (as acetate) 80mg, 120mg 2. One solvent vial of water for injection 6ml 3.One syringe 4. One reconstitution needle & one injection needle. | For the treatment of adult patients with advanced hormone dependent prostate cancer. | 19.01.2012 |
| Dehydro.emetine | Anti.emetine (synthetic). | April,1963 | |
| Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml Pour–On Solution | Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml Pour–On Solution | Ready to use pour.on for cattle, sheep and goats. 1. For use in Cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g. house flies, to kill lice and protection against blackflies. 2. For use in sheep and goats for controlling Karoo paralysis, bontlegged and red.legged ticks. | 29.10.2009 |
| Deltamethrin and Piperonyl butoxide pour.on solution | Each ml of solution contains: deltamethrin 0.50% m/v, piperonyl butoxide.2.0% m/v | Ready to use pour.on for cattle, sheep and goats. For use in cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g, house flies, to kill lice and protection against blackflies. For use in sheep and goats for controlling karoo paralysis, bont legged and red.legged ticks. | 04.11.2009 |
| Deltamethrine | Each litre contains: Delta methrine.12.5gm | May1990 | |
| Deoxyribonuclease | Vials of 250000 & 100000 units | An enzyme preparation obtained in a crystalline form from bovine pancreas indicated in the treatment of localised abscess in mammary infection. | January,1968 |
| Depo.provera inj. (Finished Formulation) | Depo.provera inj. | 18.11.1993 | |
| Dequalinium acetate | Dequalinium acetate | Bacteriostatic and fungistatic. | November,1961 |
| Desamino.oxytocin | Desamino.oxytocin | Indicated in the treatment of induction of labour for various reasons for adequate uterine action. | December,1974 |
| Desflurane liquid for inhalation (240mg/bottle) | Desflurane liquid for inhalation (240mg/bottle) | For induction & maintenance of anaesthesia. | 22.02.2006 |
| Desloratadine (2.5mg) + Ambroxol (30mg) + Guiphenasine (50mg) + Menthol 1mg/5ml Syrup | Desloratadine (2.5mg) + Ambroxol (30mg) + Guiphenasine (50mg) + Menthol 1mg/5ml Syrup | For productive cough. | 02.03.2005 |
| Desloratadine + Pseudoephedrine (SR) tablets | Each tablet contains: Desloratadine.2.5mg,5mg, Pseudoephedrine SR.120mg,180mg | 2004 | |
| Desloratadine bulk & tabs. | Each tab contains (film coated): Desloratadine.5mg | Seasonal allergic rhinitis in adults. | 30.10.2001 |
| Desloratadine tabs. | Each tablets 5mg desloratadine | For additional indication; chronic idiopathic urticaria | 14.01.2002 |
| Desmopressin Acetate tablet 0.1/0.2 mg | Desmopressin Acetate tablet 0.1/0.2 mg | For the treatment of cranial diabetes insipidus , primary noctumal enuresis in patients. | 12.12.2008 |
| Desmopressin intranasal solution/nasal solution/nasal spray/injection | Desmopressin intranasal solution/nasal solution/nasal spray/injection | Central or neurogenic diabetes insipidus, bleeding disorders nocturnal enuresis. | August,1989 |
| Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets | Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets | For diabetes insipidus and noctural emuresis. | 08.05.2008 |
| Desogestrel | Desogestrel | Oral contraceptive. To be used in combination with ethinyloestradiol for contraception indicated in the treatment of gastric & duodenal ulcers. | January,1989 |
| Desogestrel + ethinyl estradiol | Each pack of 22 tabs consists of 7 blue tabs of desogestrel.0.025mg, EE.0.04mg, 15 white tabs of desogestrel.0.125mg, EE.0.03mg | For oral contraceptive in women only | 29.05.2000 |
| Desogestrel + Ethinyloestradiol tablets | Each tablet contains; desogestrel.0.1mg, ethinyloestradiol.0.03mg | November,1983 | |
| Desogestrel tab | Each film coated tab contains: Ddesogestrel.0.075mg | Oral contraception in women only | 20.08.2002 |
| Desonide cream | Desonide cream.0.05% | For relief of the inflammatory and pruritic manifestation of corticosteroid responsive dermatosis. | 07.03.1997 |
| Desoximetasone 0.05% oitment | Desoximetasone.0.05% | July,1979 | |
| Desvenlafaxine (as Succinate) ER Tablets 50mg/100mg | Each uncoated ER tablet contains: Desvenlafaxine succinate eq.to desvenlafaxine.50mg, 100mg | For the treatment of major depressive disorder (MDD). | 20.07.2009 |
| Dexamethasone + indomethacin | Each capsule contains: Dexamethasone.0.125 mg, Indomethacin.25 mg | November,1971 | |
| Dexamethasone Intravitreal implant 0.7mg (Additional Indication) | Dexamethasone Intravitreal implant 0.7mg | For the treatment of visual impairment due to Diabetic Macular Edema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non.corticosteroid therapy. | 12.10.2015 |
| Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system) | Dexamethasone Intravitreal Implant 0.7mg | For the treatment of macular edema following branch retinal vein occlusion (CRVO). | 16.01.2010 |
| Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system) | Dexamethasone Intravitreal Implant 0.7mg | For the treatment of non.infectious uveitis affecting the posterior segment of the eye. However it should not be used when there is gap in posterior capsule. | 20.02.2013 |
| Dexamethasone sodium metasulphobenzoate | Corticosteroid, anti.inflammatory. | April,1962 | |
| Dexamethasone tablets | Each uncoated tablet contains: Dexamethasone IP.4mg,8mg | Oncologists only. for steroid responsive neoplastic disease like leukemias and lymphomas in adults only. | 02.11.2004 |
| Dexamethasone trimethyl acetate | Dexamethasone trimethyl acetate | New salt for topical formulation. | August,1961 |
| Dexchlorpheniramine maleate | Each tablet contains: Dexchlorpheniramine maleate.2mg | July,1976 | |
| Dexfenfluramine hcl. Capsules | Each capsule contains: Dexfenfluramine hcl 15mg. | Anti obesity drug. Indicated in association with diet in the treatment of uncomplicated obesity, complicated obesity in adults, of refractory obesity, and of obesity involving disorders of dietary behaviour (carbohydrate compulsion). | 22.06.1992 |
| Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet | Each tablet contains: Dexibuprofen.200mg, 300mg, Paracetamol.500mg | For the relief of pain and inflammation associated with RA, OA & ankolysing spondylosis. | 10.08.2006 |
| Dexibuprofen Suspension 50mg/5ml | Each 5ml contains: Dexibuprofen.50mg | For the treatment of mild to moderate pain, reduction of fever. | 19.08.2008 |
| Dexibuprofen Tablet (200mg/300mg/400mg) | Dexibuprofen Tablet (200mg/300mg/400mg) | For OA, RA & ankylosing spondylitis. | 06.02.2006 |
| Dexketoprofen (as Trometamol) tablets 12.5mg/25mg | Dexketoprofen (as Trometamol) tablets 12.5mg/25mg | For the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain. | 28.03.2008 |
| Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets | Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets | For the treatment of Acute musculoskeletal pain. | 18.05.2009 |
| Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection | Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection | For the treatment of acute colicky pain in adult patients. | 28.04.2011 |
| Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets | Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets | For the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult patients. | 20.05.2010 |
| Dexketoprofen Trometamol ER Tablet 50mg (Additional Strength) | Dexketoprofen Trometamol ER Tablet 50mg | Same as approved | 21.02.2011 |
| Dexketoprofen Trometamol Gel 12.5mg/gm | Dexketoprofen Trometamol Gel 12.5mg/gm | For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle. | 13.10.2009 |
| Dexketoprofen Trometamol Injection 50mg/2ml | Dexketoprofen Trometamol Injection 50mg/2ml | Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as postoperative pain, renal colic and low back pain. | 22.10.2009 |
| Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg) | Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg) | For the topical treatment of acute musculoskeletal pain. | 06.07.2010 |
| Dexmedetomidine (as HCl) 100mcg/ml Injection | Each ml contains; dexmedetomidine Hcl eq.to dexmedetomidine.100mcg | For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting. | 29.05.2009 |
| Dexmedetomidine HCl Injection (Additional Indication) | Dexmedetomidine HCl Injection | Sedation of non.intubated patients prior to and/or during surgical and other procedure. | 14.11.2009 |
| Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules | Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules | For the treatment of Gastroeasophageal Reflux Disease (GERD) in patients not responding to dexrabeprazole alone. | 09.06.2008 |
| Dexrabeprazole Sodium E. Coated tablet 5mg/10mg | Dexrabeprazole Sodium E. Coated tablet 5mg/10mg | For duodenal ulcer, gastric ulcer & GERD. | 13.06.2007 |
| Dexrabeprazole sodium Enteric Coated tablet 5mg/10mg | Each entric coated tablet contains: Dexrabeprazole sodium.5mg, 10mg | For the treatment of gastric ulcer, duodenal ulcer, & GERD. | 13.06.2007 |
| Dexrazoxane powder for inj (lyophilized) IV | Each vial contains: 589mg powder for inj.which corresponds to 500mg dexrazoxane base. | Prevention of cardiotoxicity of doxorubicin containing chemotherapy regimens. | 26.02.2002 |
| Dextranomer bulk | September,1985 | ||
| Dextranomer sachet | Each sachet contains: Dextranomer.4gm,60gm | Ulcer & burn. In cleansing secreting wounds like venous stasis ulcers, decubitus ulcers, infected traumatic ulcers & infected burns. | September,1985 |
| Dextranomer soluidine complex | Dextranomer soluidine complex beads | August,1986 | |
| Dextrochlorpheniramine maleate | tablet.2mg, syrup.each 5 ml=2mg | Februaryy,1969 | |
| Dextrometharpahan HBr.10mg + Chlorphenaramine maleate.2mg /5ml syrup | Dextrometharpahan HBr.10mg + Chlorphenaramine maleate.2mg /5ml syrup | For the temporary relief of cough due to throat irritation, sneezing & ruunning nose. | 12.11.2007 |
| Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml | Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml | For the Relief of Persistent Dry irritating cough in adult patients Only. | 17.01.2011 |
| Dextromethorphan Hydrobromide Extended Release suspension 30mg/5ml (Additional Dosage Form) | Dextromethorphan Hydrobromide Extended Release suspension 30mg/5ml | For the relief of persistent dry irritating cough in adults patients only. | 01.08.2013 |
| Dextromethorphan Orodispersible strip 5.5mg/11mg | Dextromethorphan Orodispersible strip 5.5mg/11mg | For the relief of persistent dry irritating cough in adult patients only. | 28.01.2008 |
| Diacerein Modified Release Capsule 100mg | Diacerein Modified Release Capsule 100mg | Symptomatic treatment of osteoarthritis of knee & hip. | 20.11.2009 |
| Diacerin | Diacerin | 19.05.2005 | |
| Diacerin 50mg + Aceclofenac 100mg tablets | Diacerin 50mg + Aceclofenac 100mg tablets | For the treatment of adult patients with osteoarthritis of knee and or hip joints. | 11.04.2008 |
| Diacerin 50mg + Glucosamine sulphate 500mg tablets | Diacerin 50mg + Glucosamine sulphate 500mg tablets | For the treatment of adult patients with osteoarthritis of knee and hip joints. | 21.04.2008 |
| Diacerin capsules | Each capsule contains: Diacerin.50mg | By RMP | |
| Diazepam | Diazepam | Tranquiliser | March,1966 |
| Diazepam | Each mL contains: Diazepam.5mg | December,1977 | |
| Diazepam + Paracetamol | Each tablet contains: Diazepam.5mg, Paracetamol.500mg | October,1977 | |
| Diazepam + Sorbide Nitrate | Each tablet contains: Diazepam.2.5mg, Sorbide Nitrate.10mg | December,1979 | |
| Diazepam rectal solution | Each ml contains: diazepam IP.2mg,4mg. | Emergency treatment of convulsions as well as chronic prophylaxis against febrile seizures. | 17.06.1999 |
| Diazinon (Neocidol) | Diazinon.20% w/w | Indicated in the treatment for the control of ectoparasites in live stock. | April,1990 |
| Diazinon flea drops spot on dogs 30.0 % w/w | Each ampoule pipette contains: Diazinon.30.0% w/w | For dogs infected with fleas. | 11.11.2011 |
| Diazoxide | Diazoxide | Antihyertensive agent. indicated for reduction of blood pressure in malignant hypertension. | August,1978 |
| Dibazole | Dibazole | Russian pharmacopoeia drugs | April,1965 |
| Dibenal+allantoin + boric acid+menthol | Dibenal.0.5% w/w, allantoin.0.2% w/w, boric acid.1% w/w, menthol.0.08% v/w | May,1973 | |
| Dichlorphenamide | 50mg tabs | Carbonic anhydrase inhibitor. | January,1964 |
| Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard Gelatin Capsules. (New Dosage Form) | Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard Gelatin Capsules. | For the treatment of Patients with acute musculoskeletal spasm associated with low back pain. | 06.01.2012 |
| Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule (Additional Strength) | Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule | Same as approved | 31.05.2011 |
| Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules | Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules | Additional Lower Strength. | 24.12.2008 |
| Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules | Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules | For the treatment of acute inflammation conditions associated with spasm in adults only. | 21.10.2008 |
| Diclofenac 50mg + Chlorzoxazone500mg Tablets | Diclofenac 50mg + Chlorzoxazone500mg Tablets | For the treatment of acute inflammation conditions associated with spasm in adults only. | 16.03.2010 |
| Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet | Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet | For the treatment of acute pain in adults. | 24.01.2008 |
| Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules | Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules | For the treatment of acute arthritis (including attacks of gout), chronic arthritis especially rheumatoid arthritis (chronic polyarthritis), ankylosing spondylitis (morbus bechterew) and other inflammatory, rheumatoid syndromes of vertrebral column. | 19.05.2011 |
| Diclofenac Colestyramine 145.6mg Capsule Corresponding to Diclofenac Sodium 75mg (Additional Indication) | Diclofenac Colestyramine 145.6mg Capsule Corresponding to Diclofenac Sodium 75mg | For the treatment of post.traumatic or post.operative swelling and inflammation. | 25.02.2013 |
| Diclofenac colestyramine capsules | Each hard gelatin capsule contains: 145.6mg diclofenac.colestyramine (=diclofenac resinate) corresponding to 75mg diclofenac sodium. | For the treatment of acute arthritis (including attacks of gout), chronic arthritis especially rheumatoid arthritis (chronic polyarthritis), ankylosing spondylitis (morbus bechterew) and other inflammatory, rheumatoid syndromes of vertrebral column. | 19.05.2011 |
| Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional Strength) | Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm | Same as approved | 04.12.2009 |
| Diclofenac diethyl ammonium plaster | Each plaster of 10cm x 15cm dimension contains: Diclofenac diethyl ammonium.174mg | 21.05.1997 | |
| Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium 2.00 % w/v + Methyl Salicylate IP 10.00% w/v + Menthol 5.00 % w/v + Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional Strength) | Diclofenac diethylamine BP: 2.32%w/v eq. To diclofenac sodium.2.00% w/v + Methyl salicylate IP.10.0%w/v + Menthol.5.0%w/v + Absoule alcohol IP. 10.00% v/v | For the Treatment of Acute Lower Back Pain. | 01.01.2013 |
| Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP 4.00 % + Absolute Alcohol IP 10.00 % v/v Topical Solution | Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP 4.00 % + Absolute Alcohol IP 10.00 % v/v Topical Solution | For the Treatment of Acute Lower Back Pain. | 21.12.2012 |
| Diclofenac diethylamine transdermal patch | Each 50 sq.cm and 75 sq.cm transdermal patch contains; diclofenac diethylamine.100mg | By RMP only. for the treatment of mild to moderate pain due to osteoarthritis or soft tissue injury. | August,2004 |
| Diclofenac dispersible tablets | Each dispersible tablet contains: 46.5mg of diclofenac free acid eq.to 50mg of diclofenac sodium. | 30.09.1993 | |
| Diclofenac gel | 100gm of diclofenac diethlammonium gel contains .1.116g of diclofenac diethylammonium eq.to 1gm of diclofenac sodium. | March,1991 | |
| Diclofenac potassium | 25mg, 50mg | For additional indication of migraine attack. | 27.03.2001 |
| Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength) | Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules | For the treatment of acute pain in adults. | 08.04.2008 |
| Diclofenac potassium sugar coated tabs | Each sugar coated tablet contains: Diclofenac potassium.50mg | 18.03.1994 | |
| Diclofenac sod.+ gentamicin SO4 | Each ml contains: Diclofenac sod..1mg, Gentamicin SO4.3mg | Inflammation of the anterior segment of the eye when there is a risk of bacterial ocular infection. | 26.03.1999 |
| Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. | Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. | For OA & RA. | 28.02.2006 |
| Diclofenac Sodium (75mg/ml) Injection (Additional Strength) | Diclofenac Sodium (75mg/ml) Injection | For management of painful conditions in post.operative cases, rheumatoid arthritis and osteoarthritis. | 30.07.2007 |
| Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules | Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules | For the treatment of patient with acute musculoskeletal spasm associated with low back pain. | 24.08.2011 |
| Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules | Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules | For treatment of painful inflammatory conditions associated with gastroduodenal ulcers. | 31.01.2008 |
| Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets | Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets | For the treatment of adult patients with signs & symptoms of acute painful conditions. | 02.06.2008 |
| Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection | Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection | ` | 28.01.2008 |
| Diclofenac Sodium 50mg + Paracetamol 500mg tablets | Diclofenac Sodium 50mg + Paracetamol 500mg tablets | For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. | 30.01.2008 |
| Diclofenac sodium inj. | Each ml contains: Diclofenac sodium.25mg | 14.07.1993 | |
| Diclofenac sodium injection | Each 3ml ampoule contains: Diclofenac sodium.75mg | June,1987 | |
| Diclofenac Sodium Injection 75mg/2ml | Diclofenac Sodium Injection 75mg/2ml | For acute painful conditions in postoperative pain, renal colic and acute exacerbation of gouty arthritis. | 04.12.2012 |
| Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage Form) | Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule | For the treatment of acute inflammation conditions associated with spasm in adults only. | 15.11.2011 |
| Diclofenac sodium ophthalmic solution | Sterile solution contains: Diclofenac sodium.0.1% (1mg/ml) | Indicated in post operative inflammation in patients who have undergone cataract operation. | 27.01.1995 |
| Diclofenac sodium SR Tablet 150 mg | Diclofenac sodium SR Tablet 150 mg | For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondilytis,gout,painful post perative pain following dental surgery etc. | 26.03.2010 |
| Diclofenac sodium suppositories | Each suppository contains: Diclofenac sodium.100mg (adults), 12.5mg (children) | 26.09.1997 | |
| Diclofenac Sodium Sustained Release Tablet (Two layered tablets) 150mg (Additional Dosage Form) | Each tablet contains: Diclofenac Sodium IP.125 mg Slow Release, Diclofenac Sodium IP.25 mg Immediate Release. | For symptomatic treatment of pain and inflammation in irritation in association with degenerative joint disease/osteoarthritis. | 20.12.2013 |
| Diclofenac sodium sustained release tablets | Each sustained release tablet contains: Diclofenac sodium.100mg, 75mg(15.1.93 systopic) | .January,1988 | |
| Diclofenac sodium tablets | Each tablet contains: diclofenac sodium USP.25mg,50mg | Anti inflammatory agent. Indicated in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, painful post operative, pain following dental surgery etc. | September,1985 |
| Diclofenac transdermal patch | Each 70 sq.cm patch contains: Diclofenac diethylamine.200mg | By RMP. for the treatment of mild to moderate pain due to OA & soft tissue injuries. | October,2004 |
| Dicloxacillin | Dicloxacillin | Antibiotic. infection of respiratory tract, skin and mucosa infection, bone infection. | July,1978 |
| Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension | Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension | For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc. | 05.03.2010 |
| Didanosine chewable tabs | Each tablet contains: Didanosine.25mg, 50mg, 100mg | By RMP. HIV infection when anti.retroviral therapy is wanted. | 15.11.2000 |
| Didanosine delayed release caps. | Each delayed release cap.contains: Didanosine (as enteric coated beadlets).125mg,200mg,250mg,400mg | For HIV infections when anti retroviral therapy is warranted. | 24.07.2001 |
| Didanosine Powder for oral solution (2gm/4gm per bottles) | Didanosine Powder for oral solution (2gm/4gm per bottles) | Anti.AIDS | 26.08.2005 |
| Diethylamine Salicylate | Diethylamine Salicylate.10% w/w | For external use only | March,1978 |
| Diethylamine Salicylate + Nopoxamine | Each 100gm contains: Diethylamine Salicylate.10gm, Nopoxamine.1gm | March,1980 | |
| Diflorasone Diacetate ointment (0.5mg/gm) | Each gm of topical ointment contains: Diflorasone diacetate.0.5mg | By dermatologists. For the treatment of inflammatory & pruritic manifestation of corticosteroid responsive dermatoses. | 08.02.2005 |
| Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v (Eye Drops) | Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v | For steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. | 22.09.2011 |
| Difluprednate Opthalmic Emulsion 0.05% w/v | Each ml contains: Difluprednate.0.5mg | For the treatment of inflammation and pain associated with ocular surgery. | 01.04.2010 |
| Dihydrotestesterone gel (Finished Formulation) | Dihydrotestesterone gel | 25.04.1994 | |
| Dihydroxyacetone + alcohol | Dihydroxyacetone.15% w/v, alcohol (95%).40% v/v. Purified water.q.s | On prescription of a skin specialist only. | October,1971 |
| Dilazep Dihydrochloride | 56 mg of Dilazep Dihydrochloride eq to 50mg of Dilazep | Cardiac drug. indicated in the treatment of coronary insufficiency, coronary sclerosis, angina pectoris as well as for prophylaxis and follow up treatment of myocardial infarction. | November,1979 |
| Diltiazam modified release tablets | Each MR tablet contains: Diltiazam hcl.30mg, 60mg | july,1989 | |
| Diltiazam sustained release tablets | Each SR tablet contains: Diltiazam hcl.90mg,120mg | july,1989 | |
| Diltiazam tablets | Each tablet contains: Diltiazam hcl eq.to 30mg,60mg of diltiazam. | Coronary vasodilator. Indicated in the treatment of andina pectoris and chronic stable angina only. | July,1987 |
| Diltiazem Hcl. 2% gel | Each gm of gel contains: Diltiazem HCl IP.20mg | For the treatment of anal fissure. | 08.02.2007 |
| Diltiazem inj. | Each ml contains: Diltiazem hcl.5mg | 16.05.1994 | |
| Dimethindene maleate | Dimethindene maleate | Anti.histaminic | January,1965 |
| Dimethothiazine | 20 mg tabs | Anti.histamic drug. | October,1969 |
| Dimethyl Fumarate delayed release 120 mg/240 mg | Each delayed release capsule contains: Dimethyl fumerate.120mg, 240mg | For "Relapsing remitting multiple sclerosis". | 27.08.2014 |
| Dimethyl polysiloxone + Enzyme Concentrate Apergillus oryzae + Protease + Cellulose + Hemicellulose + Amylase + Papaverine Hcl | Each capsule contains: Dimethyl polysiloxone.100mg, Enzyme Concentrate Apergillus oryzae.120mg, Protease.126willstatter units, Cellulose.185 Grassmann units, Hemicellulose.64 Grassman units, Amylase.1.3 willstaller units, Papaverine Hcl.25mg | August,1978 | |
| Dimethylpolysiloxane | Cream tubes of 75 g & jar of 40 g | Prevention of irritation of skin. | May,1969 |
| Dimetridazole | Dimetridazole | Growth promotant in poultry. | August,1975 |
| Dinoprostone (PGE2) | Each tablet contains: Dinoprostone (PGE2).0.5mg | For the induction of labours. | February,1990 |
| Dinoprostone vaginal pessary | Each vaginal pessary contains: 10mg dinoprostone in 236 mg hydrogel polymer. | For the initiation & or continuation of envical ripening in patients at or near term in whom there is a medical or obsterical indication for the induction of labour. | 01.07.2001 |
| Dioctyl Sodium Sulfosuccinate | Dioctyl Sodium Sulfosuccinate USP.5% | September,1979 | |
| Diodohydroxyquinoline + Berberine Hcl + Homatropine methyl bromide | Diodohydroxyquinoline.300mg+Berberine Hcl.40mg+ Homatropine methyl bromide.0.5mg | January,1970 | |
| Diphenhydramine (as methyl sulpho methylate/methyl sulphate) | Tablet.60 mg, Syrup.480mg/100ml | Antihistaminic. | September,1961 |
| Diphenylpyraline hydrochloride | Each capsule contains: 5mg of diphenyl pyraline hcl | Allergic reaction, rhinitis, urticaria, eczema (anti.histamine). | April,1969 |
| Dipiprolate | Dragee.40mg | Anti.tussive. | March,1964 |
| Dipivefrin hcl ophthalmic solution USP | Dipivefrin hcl USP.0.1% | For the control of intra.ocular pressure in chronic open angle glaucoma. | 16.05.1996 |
| Diptheria + tetanus toxoid + pertusis vaccine adsorbed & haemophilus bCRM197. conjugated vacc. | Diptheria + tetanus toxoid + pertusis vaccine adsorbed & haemophilus bCRM197. conjugated vacc. | For active immunization of children (2 months.5 years) against diptheria, tetanus, pertusis & haemophilus.B diseases. | 12.10.1999 |
| Dipyridamole | tab.12.5mg, amp.2ml of 10mg | Coronary vasodilator. | April,1964 |
| Disinfectant (D.125) solution | Each bottle contains: n.Alkyl dimethyl benzyl ammonium chloride.2.37% and n.Alkyl dimethyl ethyl benzyl ammonium chloride.2.37%, inert ingredients.95.26% | To disinfect hard , non.porous surfaces against micro.organisms like E.coli, Staphylococcus and Klebseilla. | 03.05.2007 |
| Disodium Cromoglycate | Disodium Cromoglycate.2% | September,1976 | |
| Disodium pamidronate injection | Disodium pamidronate injection | Tumour inducer hypercalcaemia. | 21.02.1995 |
| Disophenol | Each c.c contains: Disophenol.45mg | Treatment of hook worm in dogs and cats. | April,1970 |
| Disopyramide | Each capsule contains: Disopyramide.100mg | Anti.arrhythimic agent. indicated in the treatment of cardiac arrhythmias including atrial fibrillation, vent. tachycardia arrhythmia. | .June,1977 |
| Disopyramide injection | Each ampoule contains: disopyramide phosphate eq.to 100mg of disopyramide base in 5ml aqueous solution, disopyramide phosphate eq.to 150mg of disopyramide base in 7.5ml aqueous solution. | August,1983 | |
| Disprospan injection | Each vial contains: Betamethasone dipropionate.6.43mg, betamethasone sodium phosphate.2.63mg | July,1984 | |
| Divalproex Sodium Oral Solution 500mg/5ml (Additional Dosage Form) | Divalproex Sodium Oral Solution 500mg/5ml | For monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with types of seizures for adult patients only. | 23.12.2013 |
| Divalproex sodium sprinkle capsule | Each sprinkle capsule contains: Divalproex sodium eq.to valproic acid.125mg, 250mg | As monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizure. | 06.12.2007 |
| Divalproex sodium tab | Each enteric coated tab contains: Divalpoex sodium eq.to valproic acid.125mg,250mg,500mg | As monotherapy or adjunctive therapy in the treatment of patients with complex partial seizure and manic episodes associated with bipolar disorder. | 17.01.2002 |
| dl.norgestrel + Ethinyloestradiol | Each tablet contains: dl.norgestrel.300mcg, Ethinyloestradiol.30mcg | October,1976 | |
| d.Norgestrel + Ehinyloestradiol | Each tablet contains: d.Norgestrel.0.15mg, Ehinyloestradiol.0.03mg | August,1974 | |
| d.norgestrel + ethinyloestradiol | Each tablet contains: d.norgestrel 0.25mg, ethinyloestradiol.0.05mg | April,1971 | |
| Dobutamine hcl iin 5% dextrose inj. | Each 100ml of inj.contains: dobutamine hcl USP eq.to dobutamine.50mg,100mg,200mg,400mg in 5% dextrose solution | Short term treatment of adult with cardiac decompensation due to depressed contractility resulting either from organic heart disease on from cardiac surgical procedure. | 02.04.2002 |
| Dobutamine hcl in 5% dextrose inj. | Each 250ml contains: dobutamine hcl eq.to dobutamine.250mg, 500mg, 1000mg | RMP.Short treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. | 05.01.2001 |
| Dobutamine hcl inj. (infusion concentrate) | Each ml contains: dobutamine hcl eq.to dobutamine.50mg | Indicated when parentral therapy is necessary for inotropic support in the short term treatment of cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical pocedures. | 04.10.1993 |
| Docetaxel injection | 20mg/0.5ml anhydrous concentrate & solvent for i.v infusion. | Additional indication; for the treatment of patients with hormone refractory metastatic prostate cancer in combination with prednisolone or prednisolone. | 09.03.2005 |
| Docetaxel injection (80mg/2ml) | 80mg/2ml | For additional indication; docetaxel in combination with doxorubicin & cyclophophamide as adjuvant therapy in treatment of patients with operable node positive breast cancer. Subject to all conditions of 12.6/95 dt. 21.06.96. | 2004 |
| Docetaxel injection (Shelf life extension) | Docetaxel injection (shelf life extension) | 24 months from 18 months for 20mg/0.5ml, 36 months from 24 months for 80mg/2ml | 2005 |
| Docetaxel injection conc. | Docetaxel injection conc. | For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer". | 31.03.2008 |
| Docetaxel injection concentrate | Each single dose vial contains: docetaxel trihydrate eq.to anhydrous docetaxel.80mg (2ml/vial) and 20mg (0.5ml/vial) with docetaxel solvent 6ml & 1.5ml. | Indicated in the treatment of patients with locally advanced or metastatic breast cancer and small cell lung cancer. | 20.06.1996 |
| Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml (Additional Indication) | Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml | In combination with cisplatin and 5.fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. | 17.12.2008 |
| Dog collar band containing deltamethrin 4% w/w | Each band contains: Deltamethrin.4% w/w | For control of infestations with ticks for 6 months, anti.feeding effect on phlebotomine sand flies for 5 to 6 months, prevention of infestations by fleas for 4 months, anti.feeding effect on adult mosquitoes for 6 months. | 25.08.2011 |
| Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet | Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet | For dyspepsia, colic pain & GERD. | 22.11.2005 |
| Domperidone SR tab | Each uncoated SR tab contains: Domperidone BP.30mg | For the treatment of chronic dyspepsia, gastro paresis, nausea & vomiting. | 16.01.2003 |
| Domperidone tablets/suspension/oral drops/rectal suppositories | Tablets.10mg, suspension.1mg/ml, oral drops.10mg/ml, rectal suppositories.30mg | Anti emetic. Indicated in the treatment of gastric motality disorder etc. | November,1987 |
| Donepezil (for additional indication) | Donepezil | For symptomatic improvement of vascular dementia (with cardiovascular diseases). | 10.08.2005 |
| Donepezil hcl. | Each film coated tablet contains: Donepezil hcl.5mg, 10mg | Indicated in the treatment of mild to moderately severe Alzheimer's dementia | 22.03.2001 |
| Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg | Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg | For the treatment of mild to moderate severe Alzheimer's Dementia. | 15.10.2009 |
| Donepezil Sustained Release Tablet 23mg (Modified Dosage Form) | Donepezil Sustained Release Tablet 23mg | For the Treatment of Mild to Moderate Severe Alzheimer's Dementia. | 03.06.2011 |
| Dopamine hcl & 5% dextrose inj. | Each 100ml contains: Dopamine hcl.80mg,160mg,320mg, Dextrose hydrous.5gm | For the correction of hemodynamic imbalance present in the shock syndrome due to myocardial infarctions, trauma, endotoxic speticemia, open heart surgery, renal failure & chronic cardiac decompensation as in congestive failure. | 02.04.2002 |
| Dopamine Hydrochloride | Each 5mL contains: Dopamine.200mg | Sympathomemetic agent. Indicated for the correction of haemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma endotoxic septicenia, open heart surgery, renal failure. | January,1980 |
| Doramectin 1% injectable solution | 1% injectable solution | For control of GI round worm, eye worm, screw worms in sheep & swine. | 03.10.2000 |
| Doramectin 1% injectible solution | Each ml contains: Doramectin.10mg | Treatment and control of gastrointestinal round worms, lung worms, eye worm, screw worms in cattle. | 17.10.1997 |
| Doripenem (as monohydrate) Injection 250mg/500mg | Each vial contains: Doripenem monohydrate eq.to doripenem.250mg, 500mg | For the treatment of nosocomial pneumonia in adults. | 16.02.2009 |
| Doripenem 500 mg powder for injection (Additional Indication) | Doripenem 500 mg powder for injection | Complicated intra.abdominal infections and complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia. | 10.08.2010 |
| Dorzolamide (as hcl) 20mg opthalmic solution (bulk+formulation) | Each ml contains: Dorzolamide (as hcl).20mg | Ophthalmologists. for the treatment of elevated intraocular pressure in patients with ocular hypertension on open angle glaucoma. | 03.10.2003 |
| Dorzolamide + Timolol eye drops | Dorzolamide.2%, timolol.0.5% | 28.08.2004 | |
| Dosulepin Hcl Tablet 25mg/75mg (Additional Indication) | Dosulepin Hcl Tablet 25mg/75mg | For the treatment of chronic pain. | 08.04.2010 |
| Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets | Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets | For the treatment of neuropathic pain. | 08.12.2011 |
| Dothiepin hydrochloride | Dothiepin hydrochloride | Anti depressant. indicated in the treatment of psychotic depression, neurotic depression, anxiety, depression. | May,1977 |
| Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet | Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet | For hypertension. | 30.11.2005 |
| Doxazosin mesylate | Each uncoated tablet contains: Doxazocin mesylate eq,to doxazocin.1mg,2mg,4mg | Mild to moderate hypertension only | 11.03.1999 |
| Doxepin cream | Doxepin hcl IP.5% w/w (eq.to doxepin.4.4%) | 26.07.1997 to 26.07.1999 | |
| Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication) | Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule | For the treatment of secondary hyperparathyroidism in patients with stage 3 or stage 4 chronic kidney disease. | 05.08.2008 |
| Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules | Each soft gelatin capsule contains: Doxercalciferol. 0.5mcg, 2.5mcg. | For the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. | 29.05.2008 |
| Doxifluridine Capsules 100mg/200mg | Doxifluridine Capsules 100mg/200mg | For carcinoma of the stomach, colon, rectum, breast, uterine, cervix and bladder. | 31.01.2008 |
| Doxofylline 400 mg + Ambroxol 30 mg Tablets | Doxofylline 400 mg + Ambroxol 30 mg Tablets | For the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate. | 23.12.2009 |
| Doxofylline ER tablets 400mg/800mg (Additional Strength) | Doxofylline ER tablets 400mg/800mg | For the treatment of bronchial asthma & COPD in adults. | 12.03.2008 |
| Doxofylline MR Tablet 650 mg | Doxofylline MR Tablet 650 mg | For the treatment of Bronchial Asthma and COPD in Adults. | 11.03.2010 |
| Doxofylline Syrup (20mg/ml) | Doxofylline Syrup (20mg/ml) | For bronchial asthma & COPD. | 30.03.2006 |
| Doxofylline Tablet (400mg) | Doxofylline Tablet (400mg) | For bronchial asthma & COPD. | 08.02.2006 |
| Doxofylline tablets & Syrup | i) Each tablet contains:Doxofylline.200mg, 400mg ii) Each ml contains:Doxofylline.20mg | For the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD). | 31.08.2005 |
| Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets | Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets | For the treatment of bronchial asthma in adults. | 07.04.2010 |
| Doxophylline injection.10mg /ml | Doxophylline injection.10mg /ml | For bronchial asthama & COPD in adult patients, when oral therapy is in approriate. | 31.12.2007 |
| Doxophylline syrup | Each ml contains: Doxophylline.20mg | For the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD). | 13.12.2007 |
| Doxophylline.400mg + Salbutamol(as sulphate).2mg/4mg Tablets | For treatment of Bronchial asthma in adults. | 29.11.2007 | |
| Doxorubicin Hcl | Each vial contains: Doxorubicin Hcl.10mg | Cancer specialists | August,1976 |
| Doxorubicin Hcl liposomal injection | 2mg/ml | For additional indication; in the treatment of metastatic breast cancer, where there is an increased cardiac risk. | April,2005 |
| Doxorubicin hcl pegylated liposomal inj. | Each vial (fill volume of 25ml) contains 50mg doxorubicin hcl | Import of finished formulation in additional strength. | 03.05.2001 |
| Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional Indication) | Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) | In combination with bortezumab for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. | 23.08.2008 |
| Doxorubicin Hydrochloride | 10mg/vial | Anticancer drug. indicated in the treatment of various types of neoplasia, both acute & chronic leukaemia lymphomata, soft tissue sarcomata, breast and lung cancer. | April,1975 |
| Doxorubicin hydrochloride liposomal injection | Each ml of i.v liposomal encapsulated injectable contains: Doxorubicin Hcl.2mg (in 10ml, 20ml glass vial for single use only). | For the treatment of metastatic ovarian carcinoma in patients who are refractory to paclitaxel & platinum based chemotherapy and also in AIDS related kaposi's sarcoma. | 23.08.2006 |
| Doxorubicin injection | Each vial contains: Doxorubicin hydrochloride.10mg | July,1986 | |
| Doxycycline | 100mg and 10mg/ml | Broad spectrum antibiotic. | December,1967 |
| Doxycycline Hcl | Each capsule contains: Doxycycline Hcl eq.to Doxycycline base . 100mg | December,1972 | |
| Doxycycline.100mg + L.bacillus spores.5 billion | Doxycycline.100mg + L.bacillus spores.5 billion | For adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea. | 12.11.2007 |
| Doxyphylline 400 mg + Terbutaline 5mg tablets | Doxyphylline 400 mg + Terbutaline 5mg tablets | For the treatment of asthma and chronic obstructive pulmonary disease in adult patients only. | 23.02.2009 |
| D.Pencillamine | 300mg (1 to 4 tablets for daily) | Metalic poisoning. In the treatment of metalic poisoning and Wilson's disease. | July,1974 |
| DPT Acthi B Vaccine | January,1998 | ||
| Dried Aluminium Hydroxide Gel IP 600mg + Magnesium Hydroxide IP 300mg + Simethicone IP 25mg + Oxetacaine BP 10mg per 5ml syrup | Dried Aluminium Hydroxide Gel IP 600mg + Magnesium Hydroxide IP 300mg + Simethicone IP 25mg + Oxetacaine BP 10mg per 5ml syrup | For the treatment of symptoms of functional gastrointestinal disorders like irritable bowel syndrome, functional dyspepsia, peptic ulcer, gasteroesophagal reflux disease which include smooth muscle spasms, flatulence, abdominal distension, hyperacidity, gastric distress, bloting etc. | 05.10.2010 |
| Dried ferrous Sulphate + Ascorbic acid + Sodium Bicarbonate + Talcum | Each capsule contains: Dried ferrous Sulphate eq. To 50mg as Elemental Iron , Ascorbic acid.3mg, Sodium Bicarbonate.84mg, Talcum.12mg | December,1973 | |
| Dried Ivy Leaf Extract (0.7gm/100ml) cough syrup | Each 100ml solution contains: active agent dried ivy leaf extract.0.7gm | For the treatment of acute inflammation of respiratory tract accompanies by coughing & symptomatic treatment of chronic inflammatory bronchitis in adults. | 15.09.2005 |
| Dronedarone (as Hydrochloride) film coated tablet .... 400 mg. | Each film coated tablet contains: dronedarone hydrochloride eq.to dronedarone.400mg | To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted. | 09.04.2010 |
| Droperidol | Each ml contains: 2.5 mg droperidol | By RMP. to produce tranquilization and to reduce the incidence of nausea & vomiting in surgical & diagnostic procedures for premedication indication and as an adjunct in maintenance of general anaesthesia. | 29.03.2001 |
| Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) | Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) | Oral Contraceptive. | 11.05.2005 |
| Drosperinone + Ethinylestradiol tablets Same as approved | Drosperinone + Ethinylestradiol tablets Same as approved | For the treatment of moderate acne vulgaris in adult females, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. | 09.10.2010 |
| Drosperinone 3mg + Ethinyl Estradiol 0.02mg tablets | Drosperinone 3mg + Ethinyl Estradiol 0.02mg tablets | For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication). | 16.03.2010 |
| Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) | Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets | Oral contraceptive in women. | 28.03.2008 |
| Drotaverine + Aceclofenac (80mg + 100mg) Tablets | Drotaverine + Aceclofenac (80mg + 100mg) Tablets | For the treatment of adult patients with muscular pain associated with spasm. | 15.09.2008 |
| Drotrecogin alpha (activated) | Each vial contains: drotrecogin alpha (activated) lyophilized.5mg,20mg | For reduction of mortality in adult patients with severe sepsis. | 23.07.2002 |
| DTaP vaccine | Each 0.5ml contains: components of pertussis (pertussis toxoid:10mcg, filamentous hemagglutinin:5mcg, fimbrial (agglutinogens 243):5mcg, pertactin:3mcg (69KDa membrane protein), diptheria toxoid:15Lf, tetanus toxoid:5Lf | Primary immunization of infants at or above the age of 2 months and as a booster in children upto their 7th birthday against diptheria, tetanus & whooping cough. | 01.02.2002 |
| DTP + Hepatitis B.combined vaccine (finished formulation import) | Each 0.5ml dose of vaccine contains: min.30 IU (7.5 LF) of diptheria toxoid, min.60 IU (3.2 LF) of tetanus toxoid, min.4 IU (150U) of bordettella pertusis killed, r.H.Bs Ag protein.10mcg | In children from 6 weeks onwards, by RMP, for active immunization against DTP and Hepatitis.B | 25.05.2000 |
| D.trans Fentantyl Transdermal patches | D.trans Fentantyl Transdermal patches | For pain. | 05.04.2006 |
| D.Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) | D.Trans Fentanyl Metrix system (12mcg/hr.) | Same as Approved. | 07.01.2008 |
| Duloxetine HCl (60mg) tablet (Additional strength) | Duloxetine HCl (60mg) tablet | 28.02.2005 | |
| Duloxetine HCl capsules | Enteric coated pellets of duloxetine.20mg, 30mg, 40mg, 60mg | For additional indication; i) for the treatment of moderate to severe stress urinary incontinence in women. Ii) for the management of neuropathic pain associated with diabetic peripheral neuropathy. | 02.03.2005 |
| Duloxetine hcl enteric coated tablets | Each enteric coated tablet contains: Duloxetine hcl eq.to duloxetine.20mg,30mg,40mg, 40mg capsule should be used only for once daily dosing. | By psychiatrists. for the treatment of major depressive disorders in adults only. | 02.11.2004 |
| Dural graft implant | Primarily composed of type I bovine collagen | By specialists only. for use in procedures where the repair of substitution of the patients dura matter is intended. | 15.02.2005 |
| Dutasteride capsules | Each soft gelatin capsule contains: Dutasteride.0.5mg | By urologists only. for the treatment of symptomatic Benign Prostatic hyperplasia (BPH) in men with an enlarged prostate. | 13.02.2004 |
| Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega.3 acidtriglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha .tocopherol 0.20 gm +Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion. | Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega.3 acidtriglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha .tocopherol 0.20 gm +Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion. | For the supply of fats, including essential omega.6 fatty acids and omega.3 fatty acids, as part of a parenteral nutrition regimen in adults if oral or enteral nutrition is impossible, inadequte or contraindicated. | 14.05.2009 |
| Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules | Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules | For the treatment of chronic idiopathic constipation in adult patients only. | 16.05.2009 |
| Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm | Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm | For bowel cleansing prior to colonoscopy in adult patients only. | 11.02.2011 |
| Each Combikit contains Part A . One film coated tablet of Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B . One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg | Each Combikit contains Part A . One film coated tablet of Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B . One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg | For the treatment of HIV infection in adults. | 23.08.2011 |
| Each Combipack contains Part (A) One Strip of FDC of Ramipril + Amlodipine Tablets;.Each uncoated tablet contains Ramipril IP . 5mg, Amlodipine besylate IP eq to Amlodipine 5mg B) Each Film coated tablet contains ;. Atorvastatin Calcium IP eq to Atorvastatin 10mg/20mg | Each Combipack contains Part (A) One Strip of FDC of Ramipril + Amlodipine Tablets;.Each uncoated tablet contains Ramipril IP . 5mg, Amlodipine besylate IP eq to Amlodipine 5mg B) Each Film coated tablet contains ;. Atorvastatin Calcium IP eq to Atorvastatin 10mg/20mg | For the treatment of hypertension and as an adjunct to diet in patients to reduce elevated total cholesterol and triglyceride levels hypertension and dyslipidemia. The polypack should be used in patients for whom treatment with all of the three i.e Ramipril, Amlodipine and Atorvastatin is appropriate. | 28.11.2011 |
| Each Combipack contains: .A) One tablet of Risedronate Sodium .Each film coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi.Pentahydrate) . 35 mg B) Six Capsules of FDC of Calcitriol Calcium carbonate + Zinc Each soft gelatin capsule contains : .Calcitriol IP . 0.25mcg Calcium Carbonate IP . 500mg (eq. To elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mg | Each Combipack contains: .A) One tablet of Risedronate Sodium .Each film coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi.Pentahydrate) . 35 mg B) Six Capsules of FDC of Calcitriol Calcium carbonate + Zinc Each soft gelatin capsule contains : .Calcitriol IP . 0.25mcg Calcium Carbonate IP . 500mg (eq. To elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mg | For the treatment of Osteoporosis in post menopausal women. | 30.09.2011 |
| Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : .Ferrous Fumarate 75mg eq. to 24.375mg | Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : .Ferrous Fumarate 75mg eq. to 24.375mg | As contraceptive pill for women | 27.07.2011 |
| Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mg | Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mg | For the tretament of patients with mild to modrate essential hypertension. | 13.04.2009 |
| Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg | Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg | Addtional strength. | 25.04.2009 |
| Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel | Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel | For the topical treatment of inflammatory dermatitis withsecondry bacterial infection. | 16.05.2009 |
| Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion | Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion | For the tretament of pruritis and prickly heat. | 08.05.2009 |
| Each sustained release tablet contains: Thiocolchicoside IP 8/16mg + Lornoxicam 8/16mg (Additional Strength) | Each sustained release tablet contains: Thiocolchicoside IP 8/16mg + Lornoxicam 8/16mg (Additional Strength) | For the treatment of patients with acute painful musculoskeletal conditions. | 08.04.2013 |
| Ebastine tab & bulk | Each tab (film coated) contains; Ebastine.10mg | For Seasonal & prennial allergic rhinitis & chronic idiopathic urticaria. | 28.09.2001 |
| Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream | Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream | For the treatment of mild to moderate inflammed cutaneous mycoses. | 13.10.2010 |
| Eberconazole cream (1%) | Eberconazole cream (1%) | Dermatophyte infection of skin such As T.corporis, T.c, T.Pedis. | 22.03.2007 |
| Econazole Nitrate | Cream.Econazole Nitrate.1%, Vaginal tablet. Each tablet contains: Econazole Nitrate.150mg | Topical antifungal & antibacetrial agent, All fungal skin infections due to dermatophytes once vaginal candidiases | December,1980 |
| Econazole ophthalmic ointment | 1% | In the traetment of fungal infection of the eye. | September,1985 |
| Edaravone injection | Each ml contains: Edaravone.1.5mg | For the improvement of neurological symptoms, disorder of activities of daily living, and functional disorder associated with acute ischaemic stroke. | 27.07.2007 |
| Edrophonium chloride | 10 mg | Cholinergic & curare antagonist. | October,1961 |
| Efavirenz | Each capsule contains: Efavirenz 50mg,100mg,200mg | By RMP. in treatment of HIV.1 infection in combination with other antiretroviral agents. | 06.06.2001 |
| Efavirenz Oral Solution (30mg/ml) | Each ml contains: Efavirenz.30mg | For the treatment of HIV.1 infection in combination with other anti.retroviral agents in adults & adolescents and children 3 years of age and older who are unable to swallow the hard capsules. | 25.08.2005 |
| Efavirenz tab | Each film coated tab contains: Efavirenz.600mg | Higher strength | 30.04.2002 |
| Eflornithine HCl Cream (139mg/gm) | Eflornithine HCl Cream (139mg/gm) | For reduction of unwanted facial hair in women. | 22.03.2006 |
| Eicosapentaenoic acid + Docosahexaenoic acid capsules | Each capsule contains: Eicosapentaenoic acid.180mg, Docosahexaenoic acid.120mg | September,1989 | |
| Elemental Iron + Iron Polymaltose + Vitamin B5 + Vitamin B12 | Each tablet contains: 40mg of Elemental iron in a complex of iron polymaltose, Vitamin B6.2mg, Vitamin B12.40 mcg, Drops.Each mL contains: 50mg of elemental iron in a complex of iron polymaltose, Syrup.50mg of elemental iron in a complex of Iron polymaltose in aqueous solution, Vitamin B6.2mg, Vitamin B12.5mg | February,1977 | |
| Eletriptan Hydrobromide Tablets 20mg/40mg | Each uncoated tablet contains: Eletriptan hydrochloride eq.to eletriptan.20mg, 40mg | For the treatments of Migraine with or without aura in adults | 25.08.2011 |
| Eltrombopag (as Olamine) Tablets ...25mg / 50mg | Each film coated tablet contains: eltrombopag olamine eq.to eltrombopag as free acid.25mg, 50mg | For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). | 19.10.2010 |
| Eltrombopag olamine tablets 25mg/50mg (Additional Indication) | Each film coated tablet contains: Eltrombopag olamine eq.to eltrombopag olamine as free acid.25mg, 50mg | Indicated in patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia to: Enable the initiation of interferon based therapy, optimise interferon based therapy. | 07.04.2014 |
| Emollient cream | Composion: sod.pyrrolidone carboxylic acid.2.5%w/w, sod.lactate soln eq.to sod.lactate.2.5%w/w, vit.E IP.1%w/w, Olive oil BP.3%w/w | Dry scaly conditions associated with atopy, hyperkeratosic & other eczemas. | 15.04.2002 |
| Emphagliflozin Tablet 10/25 mg | Each film coated tablet contains: Empagliflozin.10mg, 25mg | As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes Mellitus. | 07.05.2015 |
| Empty Hydroxy Propyl Methyl Celulose Capsules | NA | 11.01.2011 | |
| Emtricitabine (200mg) capsule | Each capsule contains: Emtricitabine.200mg | For HIV infection in adults. | 09.06.2005 |
| Enalapril (2.5mg/5mg) + Hydrochlorthiazide (12.5mg) Tablet (Additional Strength) | Enalapril.2.5mg, 5.0mg, Hydrochlorthiazide.12.5mg in each uncoated tablets | For the treatment of patients with hypertension who are not adequately controlled on monotherapy. | 24.10.2005 |
| Enalapril maleate + Hydrochlorthiazide tablet | Each tablet contains: Enalapril maleate.10mg,20mg, hydrochlorthiazide.25mg,12.5mg. | Hypertension in patients for whom combination therapy is appropiate. | 08.10.1992 |
| Enalapril maleate bulk | Enalapril maleate bulk | September,1989 | |
| Enalapril maleate tablets | Each tablet contains: Enalapril maleate.2.5mg,5mg,10mg,20mg | All grades of hypertension. | August,1989 |
| Enoxaparin sodium inj. | Enoxaparin sodium inj. | For additional indication: prophylaxis of deep vain thrombosis. | 16.03.2000 |
| Enoxaparin Sodium Injection (Additional Indication) | Enoxaparin Sodium Injection | Treatment of acute ST.segment elevation myocardial infarction including patients to be managed medically or with subsequent percuaneous coronary intervention (PCI). | 19.08.2009 |
| Enrofloxacin 5% oral solution & 10% inj. | i).Each ml of inj.contains: Enrofloxacin.100mg,50mg, ii).Each ml of oral solution contains: Enrofloxacin.50mg,100mg | 10.01.1994 | |
| Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml) | Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml) | For chronic Hepatitis.B infection. | 05.12.2005 |
| Entocapone tablets | Each film coated tablet contains: Entocapone.200mg | By neurologists. adjunct to levodopa & dopa decarboxylase inhibitor in Parkinson's disease patients with end.of.use motor fluctuations, who can not be stabilized on these combinations. | 03.01.2005 |
| Enzalutamide 40 mg soft Capsule | Each soft capsule contains: Enzalutamide.40mg | "For the treatment of adults with metastatic castration resistant prostate cancer whose disease has progessed on or after Docetaxel therapy. | 18.12.2015 |
| Epalrestat 50mg + Methylcobalamin 500mcg Tablets | Epalrestat 50mg + Methylcobalamin 500mcg Tablets | For the treatment of Diabetic Neuropathy. | 16.11.2011 |
| Eperisone 50 mg + Paracetamol 500 mg Tablets | Eperisone 50 mg + Paracetamol 500 mg Tablets | For improvement of mytonic conditions caused by neck shoulder arm syndrome, scapulhumeral periarthritis and low back pain in adult patients only. | 10.11.2009 |
| Eperisone Hcl (50mg ) tablet | Eperisone Hcl (50mg ) tablet | For neck.shoulder ormsyndrome scapula hum oral per arthritis and low back pain. | 23.08.2006 |
| Eperisone Hydrochloride Sustained Release Capsule 75mg/150mg (Modified Dosage Form) | Eperisone Hydrochloride Sustained Release Capsule 75mg/150mg | For Improvement of Myotonic Conditions caused by Neck.Shoulder Arm Syndrome, Scapulohumeral Periarthritis and Low Back Pain. | 24.06.2011 |
| Ephedrine resonate | 50 mg | Same as ephedrine, longer duration of action. | January,1961 |
| Ephedrine sulphate | Each capsule contains: 75 mg ephedrine sulphide in sustained release. | May,1971 | |
| Epicillin (6.Aminopenicillanic acid) | Each capsule contains: Epicillin.250mg, 500mg | Antibiotic. For the treatment as respiratory tract, G.I. Tract and genitourinary tract infections. | May,1974 |
| Epicillin | Capsules.250mg & 500mg of Epicillin, Injection.250mg & 500mg of Epicillin, Oral suspension.Each 5mL contains: 125mg & 250mg | August,1979 | |
| Epinastine Hcl (0.05%) Opthlamic solution | Epinastine Hcl (0.05%) Opthlamic solution | For allergic conjunctivitis. | 22.09.2006 |
| Epirubicin injection | Epirubicin injection | Anti cancer drug. Indicated in the treatment of breast cancer, malignant lymphomas, soft tissue sarcoma, gastric lung and ovarian carcinomas. | July,1986 |
| Eplerenone Tablet (25mg/50mg) | Each film coated tablet contains: Eplerenone.25mg, 50mg | For the treatment of mild to moderate hypertension in adults. | 09.06.2005 |
| Eplerstat tablet 50mg | Eplerstat tablet 50mg | For abnormality of vibration sense and abnormal change in heart rate associated with diabetic peripheral neuropathy. | 25.05.2007 |
| Eprosartan Mesylate 400 mg / 600mg Tablets | Eprosartan Mesylate 400 mg / 600mg Tablets | For the treatment of essential hypertension. | 11.10.2008 |
| Eptifibatide i.v injection (finished formulation) | Each 10ml vial contains: Eptifibatide.2mg/ml, Each 100ml vial contains: Eptifibatide.0.75mg/ml | In treatment of patients with acute coronary syndrome & patients undergoing percutaneous coronary intervention. | 25.08.1999 |
| Equine influenza & equine rhino pneumonnitis vaccine | Equine influenza & equine rhino pneumonnitis vaccine | Vaccine against inflenza, respiratory diseases, caused by ENT virus, prevention of abortion due to ENT virus infection. | March,1989 |
| Erdosteine (150mg/300mg) Capsules | Each capsule contains: Erdosteine.150mg, 300mg | For chronic obstructive bronchitis. | 11.03.2005 |
| Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup | Each 5ml contains: Erdosteine.150mg, Guaifenesin IP.50mg, terbutaline sulphate IP.1.25mg | For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis. | 08.08.2006 |
| Erdosteine Powder for oral suspension 35mg/ml | Erdosteine Powder for oral suspension 35mg/ml | For chronic obstructive bronchitis. | 06.02.2006 |
| Ergometrine + Oxytocin injection i.m | Each 1ml ampoule contains: Ergometrine maleate.500 mcg, Oxytocin.5 units | 28.07.1995 | |
| Eribulin mesylate solution for injection 0.88mg / 2ml vial | Each 2ml vial contains: Eribulin (as mesylate) 0.88mg, Ethanol anhydrous 4.5% to 5.5% | For the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. | 27.01.2012 |
| Eribulin mesylate solution for injection 0.88mg in 2ml vial (Additional Indication) | Eribulin mesylate solution for injection 0.88mg in 2ml vial | For the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. | 18.02.2015 |
| Erlotinib HCl 25/100 mg Tablet (Additional Indication) | Erlotinib HCl 25/100 mg Tablet | As monotherapy for maintenance treatment in patients with locally advanced or metastatic non.small cell lung cancer with stable disease after 4 cycles of standard platinum based first line chemotherapy. | 03.07.2010 |
| Erlotinib HCl Tablet 150 mg (Additional Indication) | Erlotinib HCl Tablet 150 mg | Monotherapy for the Maintenance Treatment of Patients with locally advanced metastatic non.small lung cancer whose disease has not progressed after four cycles of Platinum based First Line Chemotherapy. | 04.01.2011 |
| Erlotinib Hydrochloride (25mg/100mg /150mg Tablet) | Each film coate tablet contains: Erlotinib Hcl eq.to erlotinib.25mg, 100mg, 150mg | For the treatment of patients with locally advanced or metastatic non.small cell lung cancer after failure of atleast one prior chemotherapy regimen. | 21.07.2005 |
| Ertapenem For injection (1gm/vial) | Each vial contains: Ertapenem sodium eq.to ertapenem.1gm | For the treatment of patient with moderate to severe bacterial infection viz: complicated intra.abdominal infections, skin and skin structure infection, community acquire pneumonia, complicated UTI, acute pelvic infections, post surgical gynecologic infections & bacterial septicemia. | 11.04.2007 |
| Ertapenem for injection 1gm/vial (Additional Indication) | Ertapenem for injection 1gm/vial (additional indication) | For the prophylaxis of surgical site infections following elective colorectal surgery. | 15.01.2008 |
| Erysimiine | Erysimiine | Russian pharmacopoeia drugs | April,1965 |
| Erythromycin | 300mg/6ml | For treatment of mastilis in lactating cows only. | 07.02.2000 |
| Erythromycin Propionate + Benzyl alcohol + Lidocane | Each mL contains: Erythromycin Propionate eq.to 50mg of Erythromycin base, Benzyl alcohol.0.02mL, Lidocane.0.02gm | March,1974 | |
| Escitalopram + Clonazepam | Each film coated tab contains: Escitalopram.10mg (as oxalate0, Clonazepam.0.5mg | Psychiatrist. for treatment of patients with comorbid depression & anxiety disorders. | 31.08.2004 |
| Escitalopram oxalate tab | Each film coated tab contains: Escitalopram oxalate eq.to escitalopram.5mg,10mg,20mg | For treatment of major depressive disorder & panic disorders with or without agoraphobia. | 24.01.2003 |
| Escitlopram (as oxalate)10mg + Clonazepam.0.5mg tablet (Additional Strength) | For comobid depression and anxiety disorder. | 12.12.2007 | |
| Eslicarbazepine Acetate Tablets 200mg/400mg/600mg/800mg | Each uncoated tablet contains: Eslicarbazepine acetate.200mg, 400mg, 600mg, 800mg | As an adjunctive therapy in adults with partial.onset seizures with or without secondary generalisation. | 07.03.2011 |
| Esmolol hcl inj. | Each 10ml ampoule contains: 2.5gm of esmolol hcl, Each 10ml vial contains: 100mg of esmolol hcl | Supraventricular tachycardia for rapid control of ventricular rates patients with atrial fibrillation or artrial flutter in perioperative, post.operative circumstances where short term control of ventricular rate is desirable. | 26.08.1994 |
| Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets | Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets | For the treatment of GERD, gastric and duodenal ulcer, Zollinger.Ellison syndrome. | 14.05.2008 |
| Esomeprazole + Domperidone SR capsules | Each capsule contains: Esomeprazole mag.eq.to esomeprazole.20mg,40mg (as enteric coated pellets), domperidone maleate BP eq.to domperidone.30mg sustained release. | By RMP. for the treatment of adult patients with gastroesophagal reflux disease (GERD) not responding to esomeprazole alone. | 2004 |
| Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules | Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules | For GERD. | 13.11.2006 |
| Esomeprazole Delayed Release Granules for Oral Suspension: Each 1g sachet contains: Esomeprazole Magnesium I.P(as trihydrate) equivalent to Esomeprazole 10 mg as enteric coated granules (Additional Dosage Form). | Esomeprazole Delayed Release Granules for Oral Suspension: Each 1g sachet contains: Esomeprazole Magnesium I.P(as trihydrate) equivalent to Esomeprazole 10 mg as enteric coated granules | 1) Treatment of Gastroesophageal Reflux Disease (GERD). 2) Risk Reduction of NSAID Associated Gastric Ulcer. 3) H.Pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence. 4) Pathological Hypersecretory Conditions Including Zollinger.Ellison Syndrome. | 13.05.2011 |
| Esomeprazole magnesium bulk & tab | Each enteric coated tablet contains: Esomeprazole magnesium eq.to esomeprazole.20mg,40mg | GERD, erosive reflux esophagitis, prevention of relapse of esophagitis & helps in eradication of H.Pylori associated peptic ulcer. | 04.12.2001 |
| Esomeprazole magnesium Delayed Release Tablets 20mg/40mg (Additional Indication) | Esomeprazole magnesium Delayed Release Tablets 20mg/40mg | 1. Pathological Hypersecretory Conditions Including Zollinger.Ellison Syndrome Ulcer. 2. Risk Reduction of NSAID Associated Gastric Ulcer. 3. Prolonged Treatment after IV Induced Prevention of Rebleeding of Peptic Ulcer. | 06.04.2011 |
| Esomeprazole Sodium For injection | Each vial contains: esomeprazole sodium eq.to esomeprazole.40mg | For GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral in take is not appropriate. | 05.04.2005 |
| Estraderm TTS 25/50/100 (finished formulation) | Estraderm transdermal TTS having estraderm.2mg,4mg,8mg estradiol. | 23.02.1994 | |
| Estradiol + dydrogesterone | Estradiol.2mg, dydrogesterone.10mg | For treatment of women with intact uterus for the symptoms of estrogen deficiency as consequence of the menopause or after overectomy and for the prevention of post menopausal osteoporosis. | 01.02.2000 |
| Estradiol topical emulsion 2.5mg/gm | Estradiol topical emulsion 2.5mg/gm | Vasomotor symptoms Associated with menopause. | 16.03.2007 |
| Estradiol transdermal spray | Each spray delivers: 17.beta.estradiol.2mg | Signs & symptoms of estrogen deficiency due to menopause whether natural or surgically induced. | 06.02.2002 |
| Estradiol valerate tab 1mg/2mg | 1mg, 2mg | 02.03.1998 | |
| Estramustine phosphate capsules | Estramustine phosphate capsules | Anti cancer drug. Indicated in the treatment of prostatic carcinoma. | July,1986 |
| Estriol Succinate | Each tablet contains: Estriol Succinate.2mg | Estrogen. indicated in the treatment of local and general complaints arising from diminished estrogen production after the menopause and after surgical removal of ovary. | March,1980 |
| Estrogen vaginal tablet 25mcg | Estrogen vaginal tablet 25mcg | For atropic viginitis. | 02.11.2006 |
| Eszopiclone tablet (1mg/2mg/3mg) | Eszopiclone tablet (1mg/2mg/3mg) | For insomnia | 07.02.2007 |
| Etanercept (recombinant) powder for inj.along with diluent & syringe | Each vial contains: Etanercept.25mg | Reduction of signs & symptoms of moderate to severe active rheumatoid arthritis in patients who have had an inadequate response to one or more disease modifying antirheumatic drugs | 07.12.2001 |
| Etanercept injection (25mg) | Etanercept injection (25mg) | For additional indication; for treatment of adult patients with chronic moderate to severe plaque psoriasis who are candiadates of systemic therapy or phototherapy. | 25.02.2005 |
| Ethacridine Lactate | Each mL contains: Ethacridine lactate.1mg | October,1977 | |
| Ethacridine Lactate | Ethacridine Lactate | Anti.diarrhoeal agent. | February,1973 |
| Ethacrynic acid USP | Each tablet contains: Ethacrynic acid USP.25mg & 50mg | Non.thiazide saluretic diuretic. | February,1973 |
| Ethambutal dihydrochloride | 100, 200 & 400 mg tablets | Mycobacterium tuberculosis. | March,1968 |
| Ethamivan | Ethamivan | June,1965 | |
| Ethamsylate + Tranexamic acid | Each film coated tablet contains: Tranexamic acid BP.250mg, Ethamsylate BP.250mg | By RMP. for the treatment of abnormal blood loss due to menorrhagia, local fibrinolysis and intra operative/post operative hemorrhage. | 29.12.2004 |
| Ethamsylate injection | Each two ml ampoule contains Ethamsylate.250mg | Indicated in the Ttreatment of small vessel haemorrhage, menorrhagia, prophylaxis of periventricular haemorrhage in neonates. | September,1991 |
| Ethamsylate tablets | Each tablet contains: Ethamsylate.250mg,500mg | Anti haemostatic. Indicated in the treatment of small vessel haemorrhage menorrhagia (including IUD users) prophylaxis of periventricular haemorrhage in neonates. | May,1988 |
| Ethionamide | 0.25.1 g | Anti.Tuberculosis drug, in cases resistant to other drugs. | February,1962 |
| Ethosuximide | TAB.250MG, Syrup.5ml=0.25g | Anticonvulsant for petitmal epilepsy | December,1961 |
| Ethyl esters of iodized fatty acids of poppy seed oil solution for injection 48%. | Each ampoule contains: Ethyl esters of iodized fatty acids of poppy seed oil qs Iodine content; 48%, i.e. 480mg per ml | In Diagnostic Radiology: Lymphography and Diagnosis of liver lesions. (Diagnosis of the spread of malignant lesions, whether hepatic or not, by selective hepatic arterial injection). In Interventional Radiology: Embolization with surgical glues. (In association with surgical glues during vascular embolizations). In Endocrinology: Prevention of iodine deficiency disorders. (This treatment should only be used when other methods of supplementation, particularly iodization of salt and/or drinking water, cannot be undertaken) | 22.08.2012 |
| Ethylestrenol | 2 mg tabs | Anabolic agent (oral). | June,1962 |
| Lobeglitazone Sulfate Tablet 0.5mg and Lobeglitazone Sulfate bulk | Lobeglitazone Sulfate Tablet 0.5mg and Lobeglitazone Sulfate bulk | Indicated for treatment of adult type 2 diabetes mellitus patients: o as monotherapy • who are inadequately controlled by diet & exercise for whom metformin is inappropriate because of contraindications or intolerance o as dual oral therapy in combination with • who are inadequately controlled by diet & exercise and taking metformin despite maximal tolerated dose of metformin monotherapy • who are inadequately controlled by diet & exercise and taking a sulphonylurea at maximal tolerated dose of sulphonylurea monotherapy in which metformin is inappropriate because of contraindications or intolerance | 16.09.2022 |
| Idelalisib 150 mg and 100 mg Tablets and Idelalisib bulk | Idelalisib 150 mg and 100 mg Tablets and Idelalisib bulk | Idelalisib is a kinase inhibitor indicated for the treatment of patients with: • Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. • Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies. • Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies. Limitation of use: Idelalisib is not indicated and is not recommended for first-line treatment of any patient. Idelalisib is not indicated and is not recommended in combination with bendamustine and/or rituximab for the treatment of FL. | 14.10.2022 |
| FDC of Bempedoic acid 180 mg+ Ezetimbe 10 mg tablet | FDC of Bempedoic acid 180 mg+ Ezetimbe 10 mg tablet | Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. | 07.11.2022 |
| Naftifine HCL USP cream 2% w/w and Naftifine HCL USP Bulk | Naftifine HCL USP cream 2% w/w and Naftifine HCL USP Bulk | Indicatede for the treatment of superficial fungal infection of the skin (tinea corporis and Tinea cruris) | 09.11.2022 |
| Entrectinib Capsules 100mg and 200mg | Entrectinib Capsules 100mg and 200mg | Adult patients with metastatic non small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Adult and padiatric patients 12 years of age and older with solid tumors that: 1 have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation. 2. are metastatic or where surgical resection is likely to result in sever morbidity and 3. have progressed following treatment or have no satisfactory alternative therapy. | 18.11.2022 |
| Sitagliptin Fentanil Phaohate Tablet 35 mg, 70 mg, 140 g | Sitagliptin Fentanil Phaohate Tablet 35 mg, 70 mg, 140 g | As an adjunct top diet and exercise to improve glycemic control In adults with Type-2 Diabetes Mellitus. | 29.11.2022 |
| Imeglimin Hydrochloride Tablet 500 mg /1000mg and bulk drug | Imeglimin Hydrochloride Tablet 500 mg /1000mg and bulk drug | Type 2 diabetes mellitus | 06.10.2022 |
| Imeglimin Hydrochloride Tablet 1000mg and bulk drug | Imeglimin Hydrochloride Tablet 1000mg and bulk drug | Type 2 diabetes mellitus | 18.11.2022 |
| Apalutamide 60 mg Tablet and bulk drug | Apalutamide 60 mg Tablet and bulk drug | For treatment of patients with metastatic castration-resistant prostate cancer (M-CRPC) and non metastatic, castration resistant prostrate cancer (NM-CRPC) | 18.11.2022 |
| Icatibant Acetate Injection, 30 mg/3ml(10mg/ml) and Icatibant Acetate Bulk drug | Icatibant Acetate Injection, 30 mg/3ml(10mg/ml) and Icatibant Acetate Bulk drug | Indicated for treatment of acute attacks of hereditary angioedema(HAE) in adults 18 years of age and older | 02.12.2022 |
| Lobeglitazone Sulfate Tablet 0.5mg and Metformin HCL extended release 500 mg Tablets and Lobeglitazone Sulfate Tablet 0.5mg and Metformin HCL extended release 1000 mg | Lobeglitazone Sulfate Tablet 0.5mg and Metformin HCL extended release 500 mg Tablets and Lobeglitazone Sulfate Tablet 0.5mg and Metformin HCL extended release 1000 mg | As an adjuant to diet and exercise – in patients who have inadequate glycemic control with maximum tolerated dose of metformin alone or in patients who are already receiving combination therapy of lobeglitazone and metformin | 30.12.2022 |
| Sodium Glycerophosphate 4.32g/20ml solution for infusion | Sodium Glycerophosphate 4.32g/20ml solution for infusion | For the treatment of patients, severly ,\malnourished hypophosphotamea due to refeeding syndrome. | 30.12.2022 |
| Gilteritinib 40 mg film coated tablet | Gilteritinib 40 mg film coated tablet | Indicated as monotherapy of adult patients who have replased or refractory acute myeloid leukaemia (AML) with as FLT3 mutation. | 30.12.2022 |
| Sofosbuvir 400 mg film coated Tablet | Sofosbuvir 400 mg film coated Tablet | In combination with other medicinal products for the treatment of Chronic Hepatitis C (CHC) in adults | 16.02.2017 |
| Hydralazine tablets BP 25 mg (AdditionalStrength) | Hydralazine tablets BP 25 mg | For moderate to severe hypertension (in conjunction with a β-adrenoceptor blocking agent or diuretic) and hypertensive crisis. | 23.02.2017 |
| Hydralazine tablets BP50 mg (Additional Strength) | Hydralazine tablets BP50 mg | For moderate to severe hypertension (in conjunctionwith a β-adrenoceptor blocking agent or diuretic) and hypertensive crisis. | 23.02.2017 |
| Bendamustinehydrochloride injection 90 mg/mL (Fill volume 0.5 mL in 2 ml capacity vial & 2 mL filled in 2 mL capacity vial) | Bendamustine hydrochloride injection 90 mg/mL (Fill volume 0.5 mL in 2 ml capacity vial & 2 mL filled in 2 mL capacity vial) | 1. For the treatment of patients with chronic lymphocytic leukemia 2. For the use in Indolent B-cell NonHodgkin’s Lymphoma (NHL) that has Progressed During or Within six months of treatment with Rituximab or a Rituximab containing Regimen. | 02.03.2017 |
| Eltrombopagolamine 25 mg/50 mg tablets (Additional Indication) | Eltrombopagolamine 25 mg/50 mg tablets | For the treatment of thrombocytopenia in paediatricpatients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. (It should be used only in patients with ITP whose degree of Thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). | 02.03.2017 |
| Azacitidine for injection 100 mg | Azacitidine for injection 100 mg | For the treatment of adult patients with all sub-types of Myelodysplastic Syndrome With the condition: to be sold by retail on the prescription of Oncologist only | 07.03.2017 |
| Methylcobalamin 1500 mcg orally disintegrating strips | Methylcobalamin 1500 mcg orally disintegrating strips | For the treatment of Diabetic Neuropathy and peripheral Neuropathy | 10.03.2017 |
| Cefditoren Pivoxil dry powder for suspension 100 mg/5 mL | Cefditoren Pivoxil dry powder for suspension 100 mg/5 mL | For the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the condition listed below: Acute Bacterial Exacerbation of Chronic Bronchitis Community-Acquired pneumonia Pharyngitis/Tonsillitis Acute sinusitis Uncomplicated skin and skin-structure infections | 30.03.2017 |
| Thiotepa Powder for concentrate for solution for infusion 100 mg (Additional Strength & Indication) | Thiotepa Powder for concentrate for solution for infusion 100 mg | 1. With or without total body irradiation(TBI), as conditioning treatment prior to allogenic or autologous hematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and pediatrics patients; 2. When high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumors in adult and pediatrics patients. With the condition: to be sold by retail on the prescription of Hematologist only | 06.04.2017 |
| Thiotepa Powder for concentrate for solution for infusion 15mg (Additional indication) | Thiotepa Powder for concentrate for solution for infusion 15mg | 1. With or without total body irradiation(TBI), as conditioning treatment prior to allogenic or autologous hematopoietic progenitor cell transplantation(HPCT) in haematological disease in adult and pediatrics patients; 2. When high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumors in adult and pediatrics patients. With the condition: to be sold by retail on the prescription of Hematologist only | 06.04.2017 |
| Bortezomib for Injection (i.v) 1 mg/vial (Additional Indication) | Bortezomib for Injection (i.v) 1 mg/vial | For the treatment of patients with mantle celllymphoma With the condition: to be sold by retail on the prescription of Oncologist only | 11.04.2017 |
| Bortezomib 3.5 mg/vial Powder for solution for injection (i.v/s.c) (Additional Indication) | Bortezomib 3.5 mg/vial Powder for solution for injection (i.v/s.c) | For the treatment of patients with mantle cell lymphoma With the condition: to be sold by retail on the prescription of Oncologist only | 11.04.2017 |
| Mesalamine Delayed Release Tablets 800 mg (Additional Dosage Form) | Mesalamine Delayed Release Tablets 800 mg | For the treatment of mild to moderate acute exacerbations of ulcerative colitis and for the maintenance of remission of ulcerative colitis. With the condition: to be sold by retail on the prescription of Specialist/Gastroenterologist only | 11.04.2017 |
| Teneligliptin Film coated Tablet 20 mg | Teneligliptin Film coated Tablet 20 mg | For the treatment of Type 2 Diabetes Mellitus as a monotherapy adjunct to diet and exercise. | 28.04.2017 |
| Ticagrelor 60 mg tablets (Additional Strength &Indication) | Ticagrelor 60 mg tablets | Indicated for the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing a thrombotic event. With the condition: to be sold by retail on the prescription of Cardiologist/Internal Medicine Speciality only | 02.05.2017 |
| Daclatasvir Tablet 30 mg | Daclatasvir Tablet 30 mg | “For use with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection”. With the condition: to be sold by retail on the prescription of Hepatologist only | 24.05.2017 |
| Daclatasvir Tablet 60 mg | Daclatasvir Tablet 60 mg | “For use with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection”. With the condition: to be sold by retail on the prescription of Hepatologist only | 24.05.2017 |
| Rosuvastatin Tablets 15 mg | Rosuvastatin Tablets 15 mg | a. Treatment of patients with primary hypercholesterolemia or mixed dyslipedemia, homozygous familial hyper cholesterolemia as an adjutant to diet,when response to diet and excercise is inadequate b. As an adjunctive therapy to diet for the treatment of adult patients with hypertriglycerdemia. c. As an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total C and LDL-C to target levels. d. Risk reduction of Myocardial Infarction stroke and arterial revascularization procedure in patients without clinically evident CHD but with multiple risk factors. e. As an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (type-III hyperlipoprotenemia). f. As adjunct to diet to reduce total-C,LDL-C and ApoB levels in adolescent boys and girls,who are atleast one year post-menarche,10-17 years of age with heterozygous familial hypercholesterolemia if after and adequate trial of diet therapy the following findings are present:LDL-C >190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more CVD risk factors. | 30.05.2017 |
| Rosuvastatin film coated Tablets 30 mg | Rosuvastatin film coated Tablets 30 mg | a. Treatment of patients with primary hyper cholesterolemia or mixed dyslipedemia, homozygous familial hyper cholesterolemia as an adjutant to diet,when response to diet and excercise is inadequate b. As an adjunctive therapy to diet for the treatment of adult patients with hypertriglycerdemia. c. As an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total C and LDL-C to target levels. d. Risk reduction of Myocardial Infarction stroke and arterial revascularization procedure in patients without clinically evident CHD but with multiple risk factors. e. As an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (type-III hyperlipoprotenemia). f. As adjunct to diet to reduce total-C, LDL-C and ApoB levels in adolescent boys and girls, who are atleast one year post-menarche,10-17 years of age with heterozygous familial hypercholesterolemia if after and adequate trial of diet therapy the following findings are present: LDL-C >190 mg/dL or > 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more CVD risk factors. | 30.05.2017 |
| Abiraterone Acetate Tablet 500 mg | Abiraterone Acetate Tablet 500 mg | 1. In combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer who have received prior chemotherapy containing docetaxel 2. For the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated with prednisone or prednisolone. With the condition: to be sold by retail on the prescription of Oncologist only | 12.07.2017 |
| Enzalutamide hard Gelatin Capsules 40 mg | Enzalutamide hard Gelatin Capsules 40 mg | For the treatment of adults with metastatic castration resistant prostate cancer whose disease has progressed on or after Docetaxel therapy. With the condition: to be sold by retail on the prescription of Oncologist only | 12.07.2017 |
| Rizatriptan Benzoate Orally Disintegrating Strips 5mg | Rizatriptan Benzoate Orally Disintegrating Strips 5mg | Anti-Migraine | 19.07.2017 |
| Rizatriptan Benzoate Orally Disintegrating Strips 10mg | Rizatriptan Benzoate Orally Disintegrating Strips 10mg | Anti-Migraine | 19.07.2017 |
| Vitamin D3 (Cholecalciferol) 60000 IU Orally disintegrating Strips | Vitamin D3 (Cholecalciferol) 60000 IU Orally disintegrating Strips | For the treatment of Vitamin D3 deficiency | 25.08.2017 |
| Empagliflozin 10mg, 25mg Tablet (Additional Indication) | Empagliflozin 10mg, 25mg Tablet | To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease. | 22.09.2017 |
| Ketamine Injection 50mg/ml (5ml & 10ml vial) Veterinary use only | Ketamine Injection 50mg/ml (5ml & 10ml vial) Veterinary use only | Ketamine Injection may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint. Warning:-to be sold by retail on the prescription of a “Veterinary Doctor” only | 03.10.2017 |
| Tacrolimus Prolonged Release Hard Gelatin Capsules 3 mg | Tacrolimus Prolonged Release Hard Gelatin Capsules 3 mg | 1. Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. 2. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. Warning:-to be sold on the prescription of physicians experienced in immunosuppressive therapy and management of organ transplant only | 13.10.2017 |
| Clonazepam IP Orally Disintegrating Strips 0.5 mg | Clonazepam IP Orally Disintegrating Strips 0.5 mg | In the treatment of petitmal, its variant, akinetic & myoclonic seizures. Warning:-to be sold by retail on the prescription of a “Neurologist & Psychiatrist” only | 23.10.2017 |
| Clonazepam IP Orally Disintegrating Strips 1mg. | Clonazepam IP Orally Disintegrating Strips 1mg. | In the treatment of petitmal, its variant, akinetic & myoclonic seizures. Warning:-to be sold by retail on the prescription of a “Neurologist & Psychiatrist” only | 23.10.2017 |
| Clonazepam IP Orally Disintegrating Strips 2mg. | Clonazepam IP Orally Disintegrating Strips 2mg. | In the treatment of petitmal, its variant, akinetic & myoclonic seizures. Warning:-to be sold by retail on the prescription of a “Neurologist & Psychiatrist” only | 23.10.2017 |
| Diclofenac Diethylamine Gel 2.32 % w/w | Diclofenac Diethylamine Gel 2.32 % w/w | For the local symptomatic treatment of post-traumatic inflammation of the tendons, ligaments, muscles and joints. Localized forms of rheumatism & soft-tissue rheumatism. | 23.10.2017 |
| Ibuprofen 100mg/ml Intravenous injection (8ml vial) | Ibuprofen 100mg/ml Intravenous injection (8ml vial) | Caldolor is an NSAID indicated in adults for the: 1. Management of mild to moderate pain. 2. Management of moderate to severe pain as an adjunct to opioid analgesics. 3. Reduction of fever. | 02.11.2017 |
| Crizotinib Hard Gelatin Capsules 200 mg (Additional Indication) | Crizotinib Hard Gelatin Capsules 200 mg | Crizotinib is a kinese inhibitor indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive. Warning:-to be sold by retail on the prescription of a “Oncologist” only. | 03.11.2017 |
| Crizotinib Hard Gelatin Capsules 250 mg (Additional Indication) | Crizotinib Hard Gelatin Capsules 250 mg | Crizotinib is a kinese inhibitor indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive. Warning:-to be sold by retail on the prescription of a “Oncologist” only | 03.11.2017 |
| Progesterone Sustained Release Tablet 200mg, 300mg, 400mg (Micronised) | Progesterone Sustained Release Tablet 200mg, 300mg, 400mg | For the treatment of secondary amenorrhea associated with normal estrogen level in women | 03.11.2017 |
| Sodium Hyaluronate Ophthalmic Solution 0.2% | Sodium Hyaluronate Ophthalmic Solution 0.2% | Symptomatic use in the treatment of dry eyes (Dry Eye Sundrome) including severe cases and after surgical interventions. With the condition: “To be sold by retail on the prescription of Ophthalmologist only." | 07.11.2017 |
| Raltegravir Tablet 400 mg (Additional Indication) | Raltegravir Tablet 400 mg | Raltegravir is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. | 17.11.2017 |
| Diosmin Tablet 900 mg | Diosmin Tablet 900 mg | For the treatments of Hemorrhoids | 24.11.2017 |
| Clostridium Botulinum Type-A toxin Haemagglutinin complex injection 300 units/vial | Clostridium Botulinum Type-A toxin Haemagglutinin complex injection 300 units/vial | Dysport® is Indicated in adults for symptomatic treatment of the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. With the condition: To be sold by retail on the prescription of specialist like Dermatologist, Plastic Surgeons, Anaesthesiologist, Ophthalmologist, Neurologist and ENT Surgeons. | 13.12.2017 |
| Nonoxynol-9 (1.0971g) vaginal Contraceptive Sponge | Nonoxynol-9 (1.0971g) vaginal Contraceptive Sponge | Contraception | 18.12.2017 |
| Ceritinib Capsules 150 mg | Ceritinib Capsules 150 mg | As monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK) – positive advanced non-small cell lung cancer (NSCLC). With the condition: to be sold by retail on the prescription of Oncologist only. | 28.12.2017 |
| Palbociclib Capsules 75mg/100mg/125mg (Additional Indication) | Palbociclib Capsules 75mg/100mg/125mg | “Palbociclib is a kinase inhibitor indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-Negative advanced or metastatic breast cancer in combination with: fulvestrant in women with disease progression following endocrine therapy”. With the condition: to be sold by retail on the prescription of Oncologist only | 30.12.2017 |
| Amprolium HCl IP 16.67% w/w Sulfaquinoxaline IP 16.67% w/w Powder (veterinary product) | Amprolium HCl IP 16.67% w/w Sulfaquinoxaline IP 16.67% w/w Powder (veterinary product) | For the treatment of Coccidiosis in poultry | 03.02.2017 |
| Each dispersible Tablet contains: Lamivudine IP 30mg Zidovudine IP 60mg (Additional Strength) | Each dispersible Tablet contains: Lamivudine IP 30mg Zidovudine IP 60mg | Indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in children. | 15.02.2017 |
| Each Combikit Contains: Part A: Two film coated tablets of Darunavir Ethanolate Each tablet contains: Darunavir Ethanolate eq. to Darunavir 600mg Part B: Two film coated tablets of Ritonavir Each film coated tablet contains: Ritonavir IP 100mg, tablets | Each Combikit Contains: Part A: Two film coated tablets of Darunavir Ethanolate Each tablet contains: Darunavir Ethanolate eq. to Darunavir 600mg Part B: Two film coated tablets of Ritonavir Each film coated tablet contains: Ritonavir IP 100mg, tablets | For the treatment of Human Immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor and with other antiretroviral agents. | 09.05.2017 |
| Each film coated tablet contains: Darunavir Ethanolate eq. to Darunavir 600mg Ritonavir IP 100mg, tablets | Each film coated tablet contains: Darunavir Ethanolate eq. to Darunavir 600mg Ritonavir IP 100mg, tablets | For the treatment of Human Immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor and with other antiretroviral agents. | 16.05.2017 |
| Each dose delivers: Budesonide 320 μg/inhalation Formoterol Fumarate Dihydrate 9μg/inhalation (Additional Strength) | Each dose delivers: Budesonide 320 μg/inhalation Formoterol Fumarate Dihydrate 9μg/inhalation | It is indicated in the regular treatment of asthma where use of combination of inhaled regular corticosteroid & long acting β-agonist is appropiate and patients with moderate to severe COPD with frequent symptoms and a history of exacerbations. | 13.06.2017 |
| Each capsule contains: Lopinavir 40mg Ritonavir 10mg oral pellets (capsules) (Additional Strength) | Each capsule contains: Lopinavir 40mg Ritonavir 10mg oral pellets (capsules) | Combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (14 days and older) | 12.06.2017 |
| Each Combikit contains: Part A: One film coated tablet of Dolutegravir: Composition: Each film coated tablet contains: Dolutegravir sodium eq. to Dolutegravir 50mg Part B: One bilayered film coated tablet of Lamivudine and Tenofovir DisoproxilFumarate IP Composition: Each bilayered film coated tablet contains: Lamivudine IP 300mg Tenofovir Disoproxil Fumarate IP 300mg | Each Combikit contains: Part A: One film coated tablet of Dolutegravir: Composition: Each film coated tablet contains: Dolutegravir sodium eq. to Dolutegravir 50mg Part B: One bilayered film coated tablet of Lamivudine and Tenofovir DisoproxilFumarate IP Composition: Each bilayered film coated tablet contains: Lamivudine IP 300mg Tenofovir Disoproxil Fumarate IP 300mg | For the management of Human Immunodeficiency Virus (HIV) infection in adults weighing more than 40kg. | 12.06.2017 |
| Each Combikit contains: Part A: One film coated Tablet of Dolutegravir. Composition: Each film coated tablet contains: Dolutegravir sodium eq. to Dolutegravir 50mg Part B: One film coated tablet of Abacavir and Lamivudine IP. Composition: Each film coated tablet contains: Abacavir sulphate IP eq. to Abacavir 600 mg Lamivudine IP 300mg | Each Combikit contains: Part A: One film coated Tablet of Dolutegravir. Composition: Each film coated tablet contains: Dolutegravir sodium eq. to Dolutegravir 50mg Part B: One film coated tablet of Abacavir and Lamivudine IP. Composition: Each film coated tablet contains: Abacavir sulphate IP eq. to Abacavir 600 mg Lamivudine IP 300mg | For the treatment of Human Immunodeficiency Virus (HIV) infection in adults weighing more than 40kg. | 12.06.2017 |
| Each Film coated tablet contains: Tenofovir Disoproxil Fumarate IP 300mg Lamivudine IP 300mg Efavirenz IP 400mg (Additional Strength) | Each Film coated tablet contains: Tenofovir Disoproxil Fumarate IP 300mg Lamivudine IP 300mg Efavirenz IP 400mg | For the treatment of Human Immunodeficiency virus-1 (HIV-1) infection in adults. | 09.06.2017 |
| Each film coated tablet contains: Abacavir Sulphate IP eq .to Abacavir 60mg Lamivudine IP 30mg (Additional Strength) | Each film coated tablet contains: Abacavir Sulphate IP eq .to Abacavir 60mg Lamivudine IP 30mg | In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in children | 09.06.2017 |
| Each Combipack of 28 Tablets contains : 24 tablets of Drospirenone IP 3mg and Ethinylestradiol IP 0.02 mg Each uncoated tablets contains: Drospirenone IP 3mg Ethinylestradiol IP 0.02mg with 4 inert tablets | Each Combipack of 28 Tablets contains : 24 tablets of Drospirenone IP 3mg and Ethinylestradiol IP 0.02 mg Each uncoated tablets contains: Drospirenone IP 3mg Ethinylestradiol IP 0.02mg with 4 inert tablets | For oral contraceptive in women only | 30.06.2017 |
| Paclitaxel Nanoparticle injection Each vial contains: Paclitaxel USP 100mg Human Albumin IP 900 mg | Paclitaxel Nanoparticle injection Each vial contains: Paclitaxel USP 100mg Human Albumin IP 900 mg | For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. | 20.02.2009 |
| Itraconazole 100 mg Capsule (Supra-bioavailable formulation) (Additional strength, Modified Dosage form) | Each Hard Gelatin Capsule Contains: Itraconazole…………………………………………100 mg | for the treatment of Systematic aspergillosis, candidiasis, cryptococcosis, sportrichosis, paracoccidioidomycossis, blastomycosis and other rarely occurring systemic or tropical mycosis The package insert should contain the following caution “This Itraconazole Capsules 100mg is not interchangeable or substitutable with other Itraconazole products due to the differences in dosing between Itraconazole capsule 100 (Supra bioavailable formulation) and other Itraconazole products”. Firm should present package insert mentioning the effect of Proton pump inhibitor, oral antacids, alcohol, other drugs interaction which may affect the bioavailability of the drug etc. before launch of the product in the market. The package insert should also include details of results of the BE study conducted in the country Firm should present package insert mentioning the effect of Proton pump inhibitor, oral antacids, alcohol, other drugs interaction which may affect the bioavailability of the drug etc. The package insert should also include details of results of the BE study conducted in the country "WARNING: To be sold by retail on the prescription of a Specialist only” | 28.09.2021 |
| Hydrogen Peroxide disinfectant liquid 4.28% w/w (Klercide sporicidal Enhanced Peroxide) | Each 100 ml contains: Hydrogen Peroxide (35%).…………………..4.28% w/w Water for injection …………….92.58% w/w | For disinfection of floors, walls and other hard surface against various pathogens like bacteria, virus etc including corona virus. | 17.04.2023 |
| Cholecalciferol Aqueous injection 6,00,000 IU/2ml | Each 2 ml contains: Cholecalciferol………………. 6,00,000 IU Excipients ……......................q.s | Indicated for the treatment of Vitamin D3 deficiency | 17.04.2023 |
| Chlorine-based disinfectant liquid 6.850 % w/w (Klercide sporicidal Active Chlorine) | Each 100 ml contains: Sodium hypochlorite (15%) …………6.85% w/w Water for injection …………….93.15% w/w | For disinfection of floors, walls and other hard surface, various pathogens like bacteria, virus etc including corona virus. | 17.04.2023 |
| Vardenafil oral jelly 20mg/5gm sachet | Each sachet (5g) contains: Vardenafil Hydrochloride Trihydrate equivalent to Vardenafil------------------------20mg | For the treatment of erectile Dysfunction WARNING: To be sold by retail on the prescription of an Urologist/Endocrinologists/Psychiatrist/Cardiologist only” and it shall be in box with red back ground. | 17.04.2023 |
| Delamanid Dispersible Tablets 25mg | Each dispersible tablet contains: Delamanid……………………….25mg | “Delamanid Dispersible Tablets 25 mg for the indication that “for use as part of an appropriate combination regimen for pulmonary multi-durg resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability” | 18.04.2023 |
| Dolutegravir Oral Film 5mg and 10mg | Each Oral Film contains: Dolutegravir Sodium equivalent to Dolutegravir…………5mg/10mg | Indicated combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficeincey Virus (HIV) infected adult, adolescents and children of at least 4 weeks of age or older and weighing at lease 3kg WARNING: To be sold by retail on the prescription of a Specialist only” and it shall be in box with red back ground. | 21.04.2023 |
| Saccharomyces Boulardii (Bulk) | 18.12..1997 | ||
| Fesoteroterodine Fumarate Extended Release Tablets 4mg and 8mg and Fesoteroterodine Fumarate Bulk | Extended Release Tablets 4mg and 8mg and Bulk | Indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. | 06.01.2023 |
| Imeglimin Hydrochloride Tablet 500mg/1000mg | 500mg/1000mg | Type 2 diabetes Mellitus. | 06.01.2023 |
| Trifarotene 50 microgram/g (0.005% w/w) Cream | (0.005% w/w) | Indicated for the cutaneous treatment of Acne Vulgaris of the face and /or trunk in patients 12 years of age and older. | 13.01.2023 |
| Crisaborole Ointment 2% | 0.02 | Indicated for topical treatment of mild to moderate atopic dermatitis in adult and paediatric patients 2 years of age and older. | 20.01.2023 |
| Prussian Blue Insoluble 340 mg and Magnesium Hydroxide 500 mg Capsule | 340mg and 500mg | As decorporation agent indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non radioactive thallium to increase their rates of elimination. | 20.01.2023 |
| Prussian Blue Insolube 340 mg and Prussian Blue Insolube Bulk Drug | 340mg and Bulk | As decorporation agent indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non radioactive thallium to increase their rates of elimination. | 27.01.2023 |
| Crisaborole Bulk Drug | Bulk | Indicated for topical treament of mild to moderate atopic dermatitis in adult and pediatric patients 2 years of age and older. | 10.02.2023 |
| Remifentanil Hydrochloride 1mg/2mg for Injection | 1mg/2mg | As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anestesia practitioner in a posto perative anesthesia care unit or intensive care setting. As an analgesic component of monitored anesthesia care in adult patients. | 15.02.2023 |
| . Cannabidiol Bulk Drug, Cannabidiol Oral Solution 100mg/ml | 100mg/ml | Indicated for the treatment of seizures associated with Lennox- Gastaut syndrome, Dravet Syndrome, or tuberous sclerosis complex in patients 1 year of age and older. | 06.04.2023 |
| 3-(trimethoxysilyl)propyl dimethyloctadecyl ammonum chloride,Benzalkonium chloride, & Didecyl Dimethyl ammonium chloride | _ | For surface Disinfectant and Hand Sanitizer. | 24.04.2023 |
| Ibuprofen Sodium Dihydrate Bulk Drug, Ibuprofen Sodium Dihydrate 256/512mg Tablet | 256/512mg | For the symptomatic relief of mild to moderate pain such as headache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, migrane, cold and flu symtoms, sore throat and fever. | 26.04.2023 |
| Niraparib Tablet 100mg | 100mg | Niraparib is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO stage-III and IV) highgrade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum -based chemotherapy. as monotherapy for the maintenance treatment of adult patients with platinumsensitive relapsed high grade serous epithelial ovarian, fallopian tube,or primary peritoneal cancer who are in response (complete or partia) to platinumbased chemotherapy. | 01.05.2023 |
| Polmacoxib Bulk Drug, Polmacoxib Capsule 2mg | 2mg and Bulk | Indicatged for treatment of Idiopathic (primary) osteoarthritis of Hip/Knec. | 01.05.2023 |
| Amines, N- C10-16-alkyl trimethylenedi-, reaction products with chloro acetic acid 1.0000% w/w | 1.0000% w/w | Surface celaning, aerial Misting, Hand Sanitization (Not for covid use). | 04.05.2023 |
| Squaric Acid 0.748 mg/ml & Squaric Acid 1.745 mg/ml Solution (Spray) | 0.748 mg/ml and 1.745 mg/ml | Disinfection of Inanimate surface like floor, toilet, garbage areas only. | 04.05.2023 |
| Dalbavancin Hydrochloride Bulk Drug, Dalbavancin Injection 500mg | 500mg and Bulk | Dalbavancin for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused bysusceptible isolates of the following Gram-positive microorganisms staphylococcus aureus (including methicillin susceptible and methicillin resistant strains), streptococcus pyogenes, streptococcus agalactiae, streptococcus dysgalactiae, streptococcus anginosus group (including S.anginosus, S. intermedius,S. constellatus) and Enterococcus faecalis (vancomycin susceptible strains). | 23.05.2023 |
| Lobeglitazone Sulfate 0.5mg+Glimepiride 1mg Tablets | 0.5mg +1mg | Indicated an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulphorylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulphonylurea alone. | 23.05.2023 |
| Sovateltide Bulk Drug & Sovateltide Injection 30 µg | 30 µg and Bulk | Cerebral ischemic Stroke. | 31.05.2023 |
| Lifitegrast Bulk drug & Lifitegrast Ophthalmic Solution 5%w/v | 5%w/v and Bulk | Indicated for the treatment of signs and symptoms of dry eye disease (DED) | 05.06.2023 |
| Plecanatide Bulk Drug & Plecanatide Tablets 3mg | 3mg and Bulk | 1.) Chronic idiopathic constipation (CIC) 2.) Irritable bowel syndrome with constipation (IBS-C) | 08.06.2023 |
| Linagliptin 5mg + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Film Coated Tablets | Linagliptin 5mg + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Film Coated Tablets | In patients with type 2 Diabetes Mellitus inadequately controlled on Metformin | 03.07.2023 |
| Metoprolol succinate IP 47.50 eq. to Metoprolol Tartrate (as extended release) 50mg + Telmisartan IP 40mg + Amlodipine Besilate IP eq. to Amlodipine 5mg film coated bilayered tablet | Metoprolol succinate IP 47.50 eq. to Metoprolol Tartrate (as extended release) 50mg + Telmisartan IP 40mg + Amlodipine Besilate IP eq. to Amlodipine 5mg film coated bilayered tablet | For the treatment of uncontrolled essential hypertension with stable coronary artery disease (CAD) | 03.07.2023 |
| Metoprolol succinate IP 47.50 eq. to Metoprolol Tartrate (as extended release) + Amlodipine Besilate IP eq. to Amlodipine + Chlorthalidone IP (50mg +5mg +6.25mg & 50mg + 5mg + 12.5mg) film coated bilayered tablets | Metoprolol succinate IP 47.50 eq. to Metoprolol Tartrate (as extended release) + Amlodipine Besilate IP eq. to Amlodipine + Chlorthalidone IP (50mg +5mg +6.25mg & 50mg + 5mg + 12.5mg) film coated bilayered tablets | For patients with uncontrolled essential hypertension | 03.07.2023 |
| Brimonidine Tartrate IP 2.0mg + Brinzolamide IP 10.0mg + Timolol Maleate IP eq. to Timolol 5mg + Benzalkonium Chloride Solution IP 0.2mg (as preservative) + Water for injection IP q.s. per ml ophthalmic suspension | Brimonidine Tartrate IP 2.0mg + Brinzolamide IP 10.0mg + Timolol Maleate IP eq. to Timolol 5mg + Benzalkonium Chloride Solution IP 0.2mg (as preservative) + Water for injection IP q.s. per ml ophthalmic suspension | For the treatment of patients with open angle glaucoma/ocular hypertension | 13.07.2023 |
| 1. Treprostinil Bulk Drug 2.Treprostinil Solution for infusion 1mg/ml & 10mg/ml | 1. Treprostinil Bulk Drug 2.Treprostinil Solution for infusion 1mg/ml & 10mg/ml | For the treatment of idiopathic or heritable pulmonary arterial hypertension (PAH) to improve exercise tolerance and symptoms of disease in patients classified as New York Heart Association (NYHA) functional class III. | 27.07.2023 |
| Linagliptin + Metformin Hydrochloride IP (as an extended release) (2.5mg + 1000mg, 5mg + 500mg & 5mg + 1000mg) film coated bilayered tablets | Linagliptin + Metformin Hydrochloride IP (as an extended release) (2.5mg + 1000mg, 5mg + 500mg & 5mg + 1000mg) film coated bilayered tablets | As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with Linagliptin and Metformin is appropriate. | 28.07.2023 |
| Metformin Hydrochloride IP (As SR form) + Vildagliptin (as SR form) (500mg + 50mg, 1000mg + 50mg, 500mg + 100mg & 1000mg + 100mg) film coated bilayered tablets | Metformin Hydrochloride IP (As SR form) + Vildagliptin (as SR form) (500mg + 50mg, 1000mg + 50mg, 500mg + 100mg & 1000mg + 100mg) film coated bilayered tablets | For the treatment of Type-II diabetes mellitus inadequately controlled on Metformin Monotherapy | 04.08.2023 |
| Combikit of: Each film coated tablet contains: Part A: Atazanavir Sulphate IP eq. to Atazanavir 300mg + Ritonavir IP 100mg Part B: Emtricitabine IP 200mg + Tenofovir Alafenamide Fumarate eq. to Tenofovir Alafenamide 10mg | Combikit of: Each film coated tablet contains: Part A: Atazanavir Sulphate IP eq. to Atazanavir 300mg + Ritonavir IP 100mg Part B: Emtricitabine IP 200mg + Tenofovir Alafenamide Fumarate eq. to Tenofovir Alafenamide 10mg | For the treatment of adult patients with HIV infection | 04.08.2023 |
| Montelukast IP eq. to Montelukast 4mg + Fexofenadine Hydrochloride IP 60mg suspension (In additional Strength) | Montelukast IP eq. to Montelukast 4mg + Fexofenadine Hydrochloride IP 60mg suspension (In additional Strength) | For the treatment of allergic rhinitis | 04.08.2023 |
| Icaridin API and Icaridin 20% w/v Spray | Icaridin API and Icaridin 20% w/v Spray | Indicated for mosquito and insect repellent | 19.09.2023 |
| Inclisiran solution for injection in prefilled syringe 284 mg/1.5 ml | Inclisiran solution for injection in prefilled syringe 284 mg/1.5 ml | Inclisiran is indicated in adults with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goal with the maximum tolrated dose of a statin, or - alone or in combination with other lipid lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated | 22.09.2023 |
| Relugolix Bulk Drug and Relugolix Tablet 120mg | Relugolix Bulk Drug and Relugolix Tablet 120mg | For the treatment of adult patients with advance prostate cancer | 16.10.2023 |
| Zolmitriptan Orally disintegrating strips 2.5mg & 5mg (Additional Dosage form) | Zolmitriptan Orally disintegrating strips 2.5mg & 5mg (Additional Dosage form) | For the prevention of acute and delayed nausea and vomiting associated with highly emetogenic Cisplatin-based cancer chemotherapy - For the prevention of acute and delayed nausea and vomiting associated with moderate emetogenic cancer chemotherapy in adult | 20.02.2018 |
| Zolmitriptan Orally disintegrating strips 2.5mg & 5mg (Additional Dosage form) | Each Orally disintegrating strips contains: Zolmitriptan 2.5mg & 5mg | For Acute treatment of migraine with or without aura in adults. | 10.08.2018 |
| Saroglitazar Tablets 4mg (Additional Indication) | Each uncoated tablet contains: Saroglitazar 4 mg | Noncirrhoic Non-Alcohol Steatohepatitis | 03.02.2020 |
| Bedaquiline Tablet 100 mg | Each uncoated tablet contains: Bedaquiline fumarate equivalent to……100 mg of Bedaquiline | In adult (>18 years) and pediatric patients (12 years to less than 18 years of age and weighing at least 30 kg) as part of combination therapy of pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis. | 16.07.2020 |
| Olaparib 100/150 mg (Additional Indication) | Each film-coated tablets contains: Olaparib……100mg/150 mg | Olaparib is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent. Warning “To be sold by retail on the Prescription of an Oncologist only” | 17.08.2020 |
| Olaparib 100/150 mg (Additional Indication) | Each film-coated tablets contains: Olaparib……100mg/1 50 mg | Olaparib in combination with bevacizumab is indicated for the Maintenance treatment of adult patients with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (Complete response or partial response) to first-line platinum-based chemotherapy with bevacizumab. Warning “To be sold by retail on the Prescription of an Oncologist only” | 21.08.2020 |
| Saroglitazar Tablets 4mg (Additional Indication) | Each uncoated tablet contains: Saroglitazar 4 mg. | Non-Alcoholic Fatty Liver Disease (NAFLD) with comorbidities (Either Obesity, Type 2 Diabetes Mellitus, Dyslipidemia Or Metabolic Syndrome) | 28.12.2020 |
| Ibrutinib Capsules 140 mg (Additional Indication) | Each Hard Gelatin Capsules Contains: Ibrutinib…….140 mg | For the treatment of patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20 based therapy "WARNING: To be sold by retail on the prescription of Oncologist only” | 21.01.2022 |
| Ibrutinib Capsules 140 mg (Additional Indication) | Each Hard Gelatin Capsules Contains: Ibrutinib…….140 mg | For the treatment of patients with chronic Graft Versus Host Disease (cGVHD) who have received at least one line of systemic therapy. "WARNING: To be sold by retail on the prescription of Oncologist only” | 21.01.2022 |
| Dabrafenib Capsules 50mg and 75mg (Additional Indication) | Each hard gelatin capsule contains: Dabrafenib Mesylate equivalent to Dabrafenib …… 50mg/75mg | Dabrafenib in combination with trametinib for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an appropriate test, and involvement of lymph node(s), following complete resection “WARNING: To be sold by retail on the prescription of Oncologist only” | 17.03.2022 |
| Dabrafenib Capsules 50mg and 75mg (Additional Indication) | Each hard gelatin capsule contains: Dabrafenib Mesylate equivalent to Dabrafenib ……50mg/75mg | Dabrafenib in combination with trametinib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAFV600E mutation and with no satisfactory locoregional treatment options. “WARNING: To be sold by retail on the prescription of Oncologist only” | 17.03.2022 |
| Perampanel Tablet 2mg/4mg/6mg/8mg/10mg/12mg (Additional Indication) | Each film coated tablet Contains: Perampanel………….2mg/4mg/6mg/8mg/10mg/12mg | Perampanel is indicated for the treatment of partialonset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older The firm should submit cognitive effects of the drug products in Indian Population (specially School going Children) within one year of the issuance of marketing approval of the applied drug product for proposed additional indication “WARNING: To be sold by retail on the prescription of Neurologist only” | 08.09.2022 |
| Perampanel Tablet 2mg/4mg/6mg/8mg/10mg/12mg (Additional Indication) | Each film coated tablet Contains: Perampanel………….2mg/4mg/6mg/8mg/10mg/12mg | Perampanel is indicated for the treatment of partialonset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older The firm should submit cognitive effects of the drug products in Indian Population (specially School going Children) within one year of the issuance of marketing approval of the applied drug product for proposed additional indication “WARNING: To be sold by retail on the prescription of Neurologist only” | 14.09.2022 |
| Isoprenaline sulphate | Isoprenaline sulphate | Cardiac drug | April,1970 |
| Isoprenaline sulphate | Each ml contains: Isoprenaline sulpahte.2mg | January,1970 | |
| Lafutidine Tablets.5mg/10mg. | Each tablet contains: lafutidine.5mg, 10mg | For the treatment of: i) gastric ulcers, duodenal ulcers and stromal ulcers. ii)gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis. | 16.11.2009 |
| Lafutidine Tablets.5mg/10mg. | Each tablet contains: lafutidine.5mg, 10mg | For the treatment of: i) gastric ulcers, duodenal ulcers and stromal ulcers. ii)gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis. | 19.01.2010 |
| Letrozole 2.5mg tablet (Additional Indication) | Letrozole 2.5mg tablet | Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy. | 28.12.2004 |
| Letrozole 2.5mg tablet (Additional Indication) | Letrozole 2.5mg tablet | For induction of ovulation in anovulatory infertility (additional indication). | 10.04.2007 |
| Lincomycin Hcl. | 500 mg tablets | Antibiotic infections caused by gram +ve organism which are sensitive to its actio. | August,1968 |
| Lincomycin hcl. | Lincomycin hcl eq.to lincomycin base.2% w/w | For acne vulgaris | 11.05.2000 |
| Lithium carbonate | In manic depression. | August,1969 | |
| Lithium carbonate | Each capsule contains: lithium carbonate.300mg | June,1970 | |
| Lithium carbonate | Each capsule contains: Lithium Carbonate.250mg | November,1972 | |
| Lorazepam | Each tablet contains: Lorazepam.1mg, 2mg | Psychiatric drug | December,1973 |
| Lornoxicam 8mg /2ml inj | Each 2ml injection contains: lornoxicam.8mg | For Short.term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery) | 10.04.2008 |
| Lynestrenol + Ethinyloestradiol | Each tablet contains: Lynestrenol.1mg, Ethinyloestradiol.50mcg | Oral contraceptive. | September,1973 |
| Lynestrenol + Ethinyloestradiol | 22 active tablets, each contains: Lynestrenol.1mg, Ethinyloestradiol.50mg, 6 Placebo tablets contain Ferrus Fumerate.60mg | June,1980 | |
| Mebeverine hcl | Each tablet contains: mebeverine hcl.100 mg | Musculo tropic spasmolytic | October,1971 |
| Mebeverine hcl | 50mg (1.2 tablets 3.4 times daily) | Musculo tropic spasmolytic | March,1971 |
| Mebrophen hydramine | Mebrophen hydramine | Anti.histamine | June,1965 |
| Mebrophen hydramine | Mebrophen hydramine.25mg | December,1969 | |
| Mesterolone | 10mg | Oral androgen. In the treatment of potency disturbances, infertility and hypogonadism only. | July,1974 |
| Mesterolone | Each tablet contains: Mesterolone.25mg | March,1981 | |
| Methandienone | Tabs 1mg & 5 mg | Anabolic agent. | February,1964 |
| Methandienone | Each ml contains: methandienone.22.5mg to 27.5mg | September,1969 | |
| Metronidazole | 250mg.oral, 500mg.vaginal | Treatment of trichomonal infestations. | March,1961 |
| Metronidazole | Each mL contains: Metronidazole IP.2mg | November,1978 | |
| Metronidazole Benzoate | Each 5mL suspension contains: Metronidazole Benzoate eq to 125mg of Metronidazole | April,1976 | |
| Metronidazole Benzoate | Each 5mL suspension contains: Metronidazole Benzoate eq. to 200mg of Metronidazole | August,1976 | |
| Miconazole Nitrate | Each gm of powder contains: Miconazole Nitrate.20mg | August,1975 | |
| Miconazole Nitrate | Each vaginal pessary contains: Miconazole Nitrate.100mg | June,1978 | |
| 2.Pyrrolidone acetamide | Each capsule contains: 2.Pyrrolidone acetamide.400mg, Each mL contains: 2.Pyrrolidone acetamide.200mg Inj. | To be used by physicians and in hospitals only | 1978 |
| 2.thymyloxy methyl Glyoxalidine Hcl | 0.05% | Vasoconstrictor. | November,1961 |
| 2.thymyloxy methyl Glyoxalidine Hcl | Each 100 ml contains: 2.thymyl.oxy.methyl glyoxalidine hydrochloride.0.05, buffered aq. Sol. Vehicle q.s | January,1971 | |
| 5.Fluorouracil | Each capsule contains: 5.Fluorourail.250mg | November,1977 | |
| 5.Fluorouracil | 5.Fluorouracil.250mg | December,1977 | |
| 5.Fluorouracil | Each 5ml vial contains: 5.Fluorouracil.250mg | Caution | January,1979 |
| Alphachymotrypsin | Natural endopeptidase (fungal antibiotics). | November,1967 | |
| Alphachymotrypsin | Each vial contains: Alphachymotrypsin...........5mg | for use of eye specialists only | August,1973 |
| Alphachymotrypsin | Each tablet contains: Alphachymotrypsin. 25chg units | July,1975 | |
| Amifostine injection | Amifostine.500mg/vial. On reconstitution, amifostine.50mg/ml (same as approved on 26.3.96) | Shelf life extended 24 months to 36 months. | 01.09.2004 |
| Amifostine injection | Sterile lyoplillized powder for injection | Shelf life extended 24 months to 36 months. | |
| Amifostine sterile lyophillized powder for inj. | Additional strength of 375 mg/vial on reconstitution each ml contain 50mg amifostine. | For import of finished formulation | 03.05.2001 |
| Amifostine sterile lyophillized powder for inj. | Each vial contains: Amifostine sterie lyophilised powder for inj. 300mg (on reconstitution each ml will contain 50mg of amifostine) | Additional strength. | 23.07.2001 |
| Amoxycillin | Each capsule contains: 250& 500mg, Syrup.Each 5mL contains 125mg & 250mg of amoxycillin, Paediatric suspension.Each 1.25mL contains 125mg of amoxycillin | 1979.January | |
| Amoxycillin | Each vial contains: Amoxycillin sodium eq to 250mg, 500mg & 1gm of Amoxycillin | 1979.June | |
| Aprotinin | Aprotinin | Acute Pancreatites. | November,1973 |
| Aprotinin | i)Each 5mL ampoule contains; Aprotinin.100,000 KIU, ii)Each 10mL ampoule contains; Aprotinin.200,000 KIU | 1974 | |
| Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet | Each film coated tablet contains: Arterolane maleate eq.to arterolone.150mg, Piperaquine phophate.750mg | Treatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults. | 19.10.2011 |
| Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet | Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet | Treatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults. | 19.10.2011 |
| Azelastine nasal spray | Each vial (10ml) contains: Azelastine hcl.0.01gm/10ml | Allergic rhinitis and perennial rhinitis. | 15.07.1997 to 15.07.1999 |
| Azelastine nasal spray | Azelastine nasal spray | Additional indication. for children in the age group of 6.12 years. | 08.01.2002 |
| Beclomethasone Dipropionate | Beclomethasone Dipropionate.0.025%, Beclomethasone Dipropionate.0.025%+ Neomycin Sulphate.0.5%, Beclomethasone Dipropionate.0.025%+ Chinoform.3% | April,1974 | |
| Beclomethasone Dipropionate | Each metered dose contains: Beclomethasone Dipropionate.50mcg | December,1975 | |
| Bedaquiline Tablet 100 mg | Each uncoated tablet contains: Bedaquiline fumarate eq.to.100mg bedaquiline | In adults (≥ 18 years), as part of combination therapy of pulmonary tuberculosis due to multi.drug resistant Mycobacterium tuberculosis when an effective treatment regimen cannot otherwise be provided. | 14.01.2015 |
| Bethanidine sulphate | 10 & 50 mg tablets | Hypertensive drug. | June,1968 |
| Bethanidine sulphate | 10 & 50 mg tablets | March,1969 | |
| Bleomycin | Bleomycin | Anticancer | December,1973 |
| Bleomycin | Bleomycin.5mg | Cancer specialists | October,1978 |
| Botulinum toxin type.A | Botulinum toxin type.A | Additional indication of cerebral palsey & cervical dystonia. | 08.07.2002 |
| Botulinum toxin type.A | Botulinum toxin type.A | Additional indication. adult spasticity. | |
| Bupivacaine Hydrochloride | Bupivacaine Hydrochloride | Anaesthetic | September,1972 |
| Bupivacaine Hydrochloride | Each mL contains: Bupivacaine hydrochloride.10mg | December,1974 | |
| Pentoxifylline | Each dragee contains: Pentoxifylline.100mg, Each 5mL ampoule contains; pentofylline.100mg | Vasodialator. indicated in the treatment of arterial and arteriovenous circulatory disorders. | November,1975. |
| Pericyazine | Pericyazine | Severe anxiety, tension, schizophrenia, manic depression. | February,1968 |
| Pericyazine | Pericyazine.2.5mg & 10mg | Specialists/hospital. | October,1969 |
| Pimozide | Each tablet contains: Pimozide.1mg, Pimozide. 4mg (forte tablet) | December,1974 | |
| Pimozide | Pimozide | Neuroleptic and anti psychotic agent. In the treatment of chronic Schizophrenia. | August,1974 |
| Praziquantel tablets | Each tablet contains; praziquantel.600mg | Neurocysticercosis. in the treatment of infections brought about by the larvae of pork tapeworm in the CNS. | August,1985 |
| Praziquantel tablets | Praziquantel tablets | Neurocysticercosis. In the treatment of infections brought about the larvas of the pork tapeworm in the central nervous system. | 1986.February |
| Prednisolone stearoylglycolate | Prednisolone stearoylglycolate | Corticosteroid | November,1970 |
| Prednisolone stearoylglycolate | Each tablet contains: Prednisolone stearoylglucolate.6.65mg, ophthalmic ointment. 1.9g, cream & ointment. 1.9 g | February,1971 | |
| Propanidiol | Each 10ml contains: 0.5gm propanidiol | July,1970 | |
| Propanidiol | 5% solution | Local anaesthetic | May,1970 |
| Propranalol Hcl. | 10 & 40 mg tablets & 5mg/5ml, 1mg/ml amp. | Cardiac drug indicated in angina pectoris, cardiac arrhythmia, pheochromacytoma and hypertrophic obstructive cardiac myopathy. | August,1967 |
| Propranalol Hcl. | Each tablet contains: Proppranolol hcl.10mg, Each ml contains; propranolol hcl.1ml | November,1971 | |
| Propranalol Hcl. | Each tablet contains: Propranolol hcl.10mg, 40mg, Each ml.1mg/ml | October,1972 | |
| Purified chick embryo cell (PCEC) tissue culture rabies vaccine | Purified chick embryo cell (PCEC) tissue culture rabies vaccine | Vaccine. Indicated for treatment after exposure to rabies and for pre.exposure prophylaxis. | November,1985 |
| Purified chick embryo cell (PCEC) tissue culture rabies vaccine | Purified chick embryo cell (PCEC) tissue culture rabies vaccine | Indicated for treatment after exposure to rabbies for pre.exposure prophylaxis. | December,1989 |
| 3.Methyl Pyrantel tartrate | 100ml of the oral solution contains: 4gm of pyrantel tartrate (4%). | May,1970 | |
| Reserpine + clopamide + dihydroergocristine | Reserpine + clopamide + dihydroergocristine | Diuretic | October,1971 |
| Reserpine + clopamide + dihydroergocristine | Each tablet contains: Reserpine.0.1mg, clopamide.5mg, dihydroergocristine.0.5mg | January,1972 | |
| Rifampicin | Each capsule contains: Rifampicin.150 mg & 300 mg | September,1971 | |
| Rifampicin | 450mg | Anti T.B drug | June,1971 |
| Rofecoxib | Each uncoated tablet contains: Rofecoxib.12.5mg,25mg | By RMP.for osteoarthritis, acute pain, dysmenorrhoea only. | 26.06.2000 |
| Rofecoxib | Each tablet contains: Rofecoxib.50mg | By RMP. same indication as approved earlier. | 30.03.2001 |
| Rosiglitazone + metformin (SR) tab | Each uncoated tab contains: Rosiglitazone maleate eq.to rosiglitazone.2mg,4mg, metformin hcl IP (in SR form).500mg | Treatment of patients with type.II diabetes where diet, exercise and the single agent do not result in adequate glycemic control. | 11.09.2002 |
| Rosiglitazone + metformin (SR) tab | Rosiglitazone.2mg,4mg, metformin Sr.1000mg | RMP. For the treatment of patients with type.2 diabetes mellitus when diet exercise and the single agent do not result in adequate glycemic control. | 20.05.2003 |
| S(.) amlodipine + atenolol tab | Each tab contains: S(.) amlodipine.2.5mg, atenolol.25mg,50mg | Essential hypertension & angina pectoris. | 17.10.2002 |
| S(.) amlodipine + atenolol tab | Each tab contains: atenolol.50mg, S(.) amlodipine.2.5mg | For treatment of essential hypertension & angina pectoris. | 25.03.2003 |
| Salbutamol Sulphate | Each 5mL contains: Salbutamol Sulphate.2mg | October,1974 | |
| Salbutamol Sulphate | Each 5 mL conatains;: Salbutamol Sulphate eq to 50mg of Salbutamol | January,1979 | |
| Salbutamol Sulphate | Each Sustained release tablet contains: Salbutamol Sulphate B.P Eq to 8mg of Salbutamol | March,1980 | |
| Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v | Each gram of powder/lotion contains: Sertaconazole nitrate.20mg | For the topical treatment of the superficial fungal infections of the skin. | 05.05.2009 |
| Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v | Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v | For the topical treatment of the superficial fungal infections of the skin. | 02.05.2009 |
| Sodium hyaluronate solution | 10mg/ml | * Intra ocular surgery. | June,1989 |
| Sodium hyaluronate solution | Sodium hyaluronate 5000 . 23mg/ml in disposable syringes. | By RMP. surgery in the anterior segment of the eye. | 07.03.2001 |
| Sodium Iothalamate | Sodium Iothalamate | Angiography | August,1965 |
| Sodium Iothalamate | Sodium Iothalamate oral solution.60% w/v (eq.to 360mg of iodine per ml) | June,1969 | |
| Sodium valproate | Sodium valproate | Antiepileptic drug | October,1981 |
| Sparfloxacin | Each 5ml contains: Sparfloxacin.0.3% w/v | Bacterial conjunctivitis, bacterial corneal infections like keratitis, kerato.conjunctivitis and corneal ulcer caused by suscepible micro organism. | July,2001 |
| Sparfloxacin | Each 5ml contains: sparfloxacin.0.3% w/v | Bacterial conjunctivitis, bacterial corneal infections like keratitis, kerato.conjunctivitis and corneal ulcer caused by suscepible micro organism. | 09.08.2001 |
| Stanozolol | Stanozolol | Anabolic | June,1965 |
| Stanozolol | Each tablet contains: Stanozolol.2mg | March,1973 | |
| Sulprostone injection | Sulprostone injection | Abortificient. For second trimester abortion only. | January,1986 |
| Sulprostone injection | Each ampoule contains: sulprostone.500mcg | To be made available to MTP centres approved by the states not below district level. | February,1987 |
| Surgical sealant | Consists of following components in individual pouches: i) One pouch for the premixed polyethylene glycol powder in syringe. ii) One pouch for the pre.assembled liquid (solution) syringe containing dilute hydrogen chloride solution and a phosphate/sodium carbonate solution. iii) One pouch(s) for the applicator (s) | To be indicated for use in sealing suture lines along arterial and venous reconstructions. | 31.03.2009 |
| Surgical Sealant | Surgical Sealant | To be indicated for use in sealing suture lines along arterial and venous reconstructions. | 26.03.2009 |
| Tamoxifen citrate | Tamoxifen citrate | Breast cancer in pre & post menopausal women. | June,1980 |
| Tamoxifen citrate | Each capsule contains: Tamoxifen citrate eq to 10mg of tamoxifen citrate | April,1981 | |
| Terbutaline Sulphate | Tablet.Terbutaline Sulphate.2.5 & 5mg, Syrup.Each mL contains; Terbutaline Sulphate.0.3mg | Anti.asthmatic drug. indicated in the treatment of asthma. | November,1979 |
| Terbutaline sulphate | Each mL contains: Terbualine Sulphate.0.5mg | July,1980 | |
| Testolactone | Testolactone | November,1971 | |
| Testolactone | Each tablet contains: Testolactone.50 mg | March,1972 | |
| Tranexamic acid tablets/i.v inj. | Each tab contains/cap: Tranexamic acid BP.250mg, 500mg | Haemorrhage or risk oh haemorrhage in increased fibrinolysis of hereditatory angioneurotic oedema. | 06.03.2002 |
| Tranexamic acid tablets/i.v inj. | Tranexamic acid tablets/i.v inj. | Change of indication to "treatment of excessive bleeding in patients with hemophilia during & following tooth extraction". | 05.07.2002 |
| Trimipramine | 10mg & 25mg tabs, 2ml injection.12.5mg/ml | Depressive illness, severe potentially suicidal depression, neurotic and reactive depression. | September,1968 |
| Trimipramine | Trimipramine maleate.10mg, 25mg | January,1969 | |
| Venlafaxine hcl | Each uncoated tablet contains: Venlafaxine hcl eq.to venlafaxine.25mg,37.5mg,75mg. | By psychiatrist only, for major depression only. | 18.09.2000 |
| Venlafaxine hcl | Each capsule contains: Venlafexine hcl eq.to venlafaxine.37.5mg,75mg,150mg as extended release pellets. | Major depression | 06.10.2000 |
| Vildagliptin Tablets 50mg/100mg | Each tablet contains: Vildagliptin.50mg, 100mg | As an adjunct to diet and exercise to improve glycemic control in patients with type.II diabetes mellitus. | 25.07.2008 |
| 3.Methyl pyrantel tartrate | 3.Methyl pyrantel tartrate | Anthelmintic | April,1970 |
| Furaltadone | Furaltadone | June,1973 | |
| Lorazepam | Lorazepam | Psychiatric drug. | September,1973 |
| Clonidine Hcl | Clonidine Hcl | Antihypertensive agent. indicated in the treatment of hypertension. | February,1975 |
| Clotrimazole | Clotrimazole | Antifungal & local anti trichomonial agent. Indicated against certain bacteria, protozoa and against certain organism which are sensitive to metronidazole. | May,1975 |
| Desoximetasone | Desoximetasone | Topical corticosteroid. Indicated in the management of various acute and chronic dermatoses viz eczema, nummular eczema, infantile eczema, atopical dermatitis. | July,1975 |
| Pentoxifylline | Pentoxifylline | Vasodialator. indicated in the treatment of arterial and arteriovenous circulatory disorders. | September,1975 |
| 2.Pyrrolidone acetamide | 2.Pyrrolidone acetamide | Indicated in treatment for behavior and psychotic problems in old age and mental retardation in children | December,1977 |
| Imipramine Pamoate | Each capsule contains: i).Imipramine Pamoate 112.50mg eq to 75 mg of Imipramine hcl, ii).Imipramine Pamoate 224.5mg eq to 150 mg of Imipramine hcl. | Antidepressant indicated in the treatment of allform of depression | January,1979 |
| Sodium valproate | Sodium valproate | Anti.epileptic drug. indicated in the treatment of all forms of epilepsis. | October,1981 |
| Carboprost tromethamine | Carboprost tromethamine | Syncrhronisation of oestrus and partium in animals and for the treatment of resistant cystic corpus luteum, help in the involution of uterus, in prolonged labour and for the removal of dead foetus in cattle, mares and sheep. | May,1986 |
| Vildagliptin Tablets 50mg/100mg | Vildagliptin Tablets 50mg/100mg | As an adjunct to diet and exercise to improve glycemic control in patients with type.II diabetes mellitus. | 18.01.2008 |
| Lornoxicam 8mg /2ml inj | Lornoxicam 8mg /2ml inj | For Short.term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery) | 12.11.2007 |
| Everolimus Tablet 5 mg/10 mg (Additional Indication) | Everolimus Tablet 5 mg/10 mg | Indication for the treatment of progressive neuroendocrine tumours of pancreatic origin (PNET) in patient with unrespectable, locally advanced or metastatic disease. | 21.12.2011 |
| Everolimus Tablet 5 mg/10 mg (Additional Indication) | Everolimus Tablet 5 mg/10 mg | Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis. | 27.12.2011 |
| Ferrous sulphate | 150 mg sustained release | January,1971 | |
| Ferrous sulphate | Each show release tablet contains: Ferrous sulphate. 160mg | November,1972 | |
| Flavoxate Hydrochloride | 100mg | Antispasmodic. indications for relief of dysuria, urgency, Nocturia, supropubic pain, frequency, incontinence prostatitis, urethritis,urethrocystitis,uretheotrigentis, vesico urethral spasms. | November,1980 |
| Flavoxate Hydrochloride | Each tablet contains: Flavoxate Hydrochloride.100mg | 1981 | |
| Fluphenazine Decanoate | Fluphenazine Decanoate | Anti.psychotic | September,1972 |
| Fluphenazine Decanoate | Each mL contains: Fluphenazine Decanoate.2mg | September,1973 | |
| Fluprednylidene.21.Acetate | Fluprednylidene.21.Acetate | Topical corticosteroid. Indicated in the treatment of allergic inflammmatory dermatoses. | December,1977 |
| Fluprednylidene.21.Acetate | Each 100gm contains: Fluprednylidene.21.Acetate.0.1gm | 1978 | |
| Formoterol fumarate | i).Each cap contains; formoterol fumerate.12mcg, ii).Each actuation delivers formoterol fumerate.12mcg (29.6.2001) | For bronchial asthma. | 16.02.2000 |
| Formoterol fumarate | Each actuation delivers: Formoterol fumerate.12 mcg | Bronchoconstriction in patients with reversible obstructive airway disease requiring long term bronchodilator therapy. | 29.06.2001 |
| Furaltadone | Furaltadone.20%w/w | Poultry disease only | August,1973 |
| Fusafungine | Each Aerosol cartridge contains: Fusafungine Hcl.25mg | March,1977 | |
| Fusafungine | 4 times a day for 5.10day | Fungal antibiotic. indicated in the treatment of sinusitis, pharyngitis, sore throat, laryngitis bronchitis, prevention of respitratory complication. | January,1977 |
| Fusafungine | Fusafungine | Old drug with new pump system | 26.03.1996 |
| Gemcitabine injection | Gemcitabine hcl eq.to gemcitabine.200mg,1000mg | In the management of non small cell lung cancer. | 24.01.1996 |
| Gemcitabine injection | Gemcitabine injection | Additional pack size 1.4gm/vial for pancreatic cancer. | 02.09.2004 |
| Gemcitabine injection | Gemcitabine injection | For label extension; gemcitabine alone or in combination for treatment of locally advanced or metastatic NSCLC & transition cell carcinoma of bladder. | October,2004 |
| Glybenclamide | Glybenclamide | Oral anti.diabetic | April,1970 |
| Glybenclamide | Each tablet contains: Glybenclamide.5 mg | August,1970 | |
| Glybenclamide | Each tablet contains: Glybenclamide.5 mg | September,1971 | |
| Glycopyrrolate | Each mL contains: Glycopyrrolate.0.2mg | Anaesthetic agent. for use as a pre operative antimuscarine to reduce salivary, tracheobronchial & phyrigeal secretions, arrhythmias & brodycardia associated with reversal o muscle relaxant. | December,1979 |
| Glycopyrrolate | ampole 1mL contain 0.2mg of Glycopyrrolate | September,1979 | |
| Haloperidol | Haloperidol | March,1969 | |
| Haloperidol | Each tablet contains: 0.25mg of haloperidol | May,1969 | |
| Hepatitis.B Vaccine (recombinant) | Each vial contains: Hepatitis B surface antigen (HBsAg).20mcg/ml, 100mcg/100ml, 10mcg/0.5ml | For active immunization against Hepatitis.B | 31.10.2000 |
| Hepatitis.B Vaccine (recombinant) | 20mcg/ml | 02.03.2000 | |
| Hyaluronic acid pre.filled syringe | 1) Each 0.6ml preifilled syringe contains; hyaluronic acid sodium salt.11mg, 2) Each 1ml pre.filled syringe contains; hyaluronic acid sodium salt.20mg | For cutaneous rejuvenation and for providing medium lasting correction of cutaneous contour deficiencies. | 13.10.2008 |
| Hyaluronic acid pre.filled syringe | Each 1ml pre.filled syringe contains: Auto across linked hyaluronic acid.20mg | For a medium lasting corrective action on minor soft tissue defects such as facial fine lines. | 13.10.2008 |
| Ibandronic acid injection | Each 6ml vial contains: Ibandronic acid mono sodium salt monohydrate eq.to ibandronic acid.1mg/ml | Oncologists.for treatment of tumour induced hypercalcaemia with or without metastasis. | 01.06.2004 |
| Ibandronic acid injection | Each 1ml/2ml ampoule contains: Ibandronic acid monosodium salt monohydrate eq.to 1mg/ml ibandronic acid. | By oncologists. for the treatment of tumour induced hypercalceamia with or without metastasis. | May,2004. |
| Ibuprofen | Each tablet contains: Ibuprofen.200 mg. | September,1971 | |
| Ibuprofen | 200mg | Anti rheumatic. | March,1971 |
| Ibuprofen | Each 5mL contains: Ibuprofen.100mg | April,1979 | |
| Ibuprofen | Ibuprofen.5% w/w, 10% w/w.cream, 10%.gel | In painful conditions. | July,1990 |
| Ifosfamide | Ifosfamide | Anticancer. indicated in the treatment of ovarian, breast, testicular carcinoma, hyper nephrone, pancreatic carcinoma and malignant lymphoma. | September,1978 |
| Ifosfamide | Each vial contains: Ifosfamide.200mg, 500mg & 1gm | To be supplied only against demand from hospitals/ cancer institutions for their use and against prescription of cancer specialists | March,1979 |
| Imipramine Pamoate | Each capsule contains: i).Imipramine Pamoate eq to 75 mg of Imipramine, ii).Imipramine Pamoate eq to 150 mg of Imipramine | May,1979 | |
| Infliximab injection | Infliximab injection | For additional indication. in maintenance therapy of Crohn's disease & fistulising Crohn's disease. | 15.07.2004 |
| Infliximab injection | Infliximab injection | For additional indication of. maintenance therapy in crohn's disease, fistulising crohn's diase and maintenance therapy in fistulizing crohn's disease. | 01.09.2004 |
| Ipratropium bromide + salbutamol sulphate | Each actuation delivers: Salbutamol sulphate eq.to salbutamol.100mg, Ipratropium bromide BP.20mcg | In treatment of chronic obstructive pulmonary disease. | 06.03.2000 |
| Ipratropium bromide + salbutamol sulphate | Each 2.5ml contains: Ipratropium bromide.500mcg, salbutamol sulphate eq.to salbutamol.2.5mg | By RMP. for bronchospasm in patients suffering from chronic pulmonary disorders. | 03.04.2001 |
| Carboprost Tromethamine | Each mL sterile solution contains: Carboprost Tromethamine eq. to 250mcg of carboprost | Abortificient. for the treatment of second trimester abortions only. | March,1979 |
| Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet | Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet | For adult patients with infection caused susceptible microorganisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis. | 27.09.2007 |
| Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet | Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet | For UTI, URTI and LRTI and gonococcal urethritis. | 05.10.2007 |
| Celecoxib injection | Celecoxib injection | October,2004 | |
| Celecoxib injection | Each ml of injection contains: Celecoxib.100mg | By specialists only. for short term treatment of acute post operative pain in adults only, with a spl.condition; in patients with cardiovascular disorders celecoxib inj.should be administered with precaustion under the supervision of cardiologists/specialists only. | 27.10.2004 |
| Chlorphenoxamine hcl | Each tablet contains: chlorphenoxamine hcl.12mg. | March,1971 | |
| Chlorphenoxamine hcl | Each tablet contains: Chlorphenoxamine Hcl.12mg, caffeine IP.30mg | July,1972 | |
| Choline salicylate | Sol. | Analgesic | April,1965 |
| Choline Salicylate | Choline Salicylate.8.7% | November,1978 | |
| Cimetidine | Each tablet/capsule contains: Cimetidine 200mg, Syrup .Each 5mL contain cimetidine.200mg | June,1980 | |
| Cimetidine | tablet.200mg, injection 100mg/mL and syrup.200mg/5mL | Anti.ulcer, indicated for treatment of benign gastric , duodenal, recurrent and stomal ulceration, reflex oesophagitis only | May,1980 |
| Clonazepam tabs. | Each tab.contains: Clonazepam.0.25mg | Additional indication; petitmal, its variant, akinetic & myoclonic seizures. | 05.07.2001 |
| Clonazepam tabs. | Clonazepam tabs. | Additional indication of panic disorder. | 17.10.2001 |
| Clonidine Hcl | Each tablet contains: Clonidine Hcl.0.15mg | .July,1975 | |
| Clonidine Hcl | Each ml contains: Clonidine Hcl.150mcg | June,1976 | |
| Clotrimazole | Each vaginal tablet contains: Clotrimazole.0.1gm | Antifungal & local anti trichomonial agent. Indicated against certain bacteria, protozoa and against certain organism which are sensitive to metronidazole. | June,1975 |
| Clotrimazole | Each 100gm contains/100mL contains Clotrimazole.1gm | June,1975 | |
| Cyclandelate | Vasodilating agent | October,1972 | |
| Cyclandelate | Each tablet contains; cyclandelate .200mg | February,1973 | |
| Cyclandelate | Each capsule contains; Cyclandelate.200mg | July,1977 | |
| Desoximetasone | Each 1 gm contains: Desoximetasone.2.5mg | Topical corticosteroid. Indicated in the management of various acute and chronic dermatoses viz eczema, nummular eczema, infantile eczema, atopical dermatitis. | September,1975 |
| Dicloxocillin Sodium | Dicloxocillin Sodium eq to 125mg & 250mg of Dicloxocillin | August,1979 | |
| Dicloxocillin Sodium | Dicloxocillin Sodium eq to 62.5 mg of Dicloxocillin | September,1979 | |
| Diphenoxylate Hcl. | Diphenoxylate Hcl. | May,1969 | |
| Diphenoxylate Hcl. | Diphenoxylate Hcl. | July,1969 | |
| Divalproex sodium tablets | Divalproex sodium tablets | For additional prescription condition to be sold under Neurologist & Psychiatrist only. | 21.04.2004 |
| Divalproex sodium tablets | Each extended release tablet contains: Divalproex sodium.750mg, 1000mg. | Additional indication. prophylaxis of migraine headache. | 25.06.2004 |
| Divalproex sodium tablets | Extended release tablets: 250mg,500mg,125mg | For additional indication.prphylaxis of migraine headache in adults with warning .not for women who are pregnant or planning for pregnancy. | August,2004 |
| dl.norgestrel + Ethinyl oestradiol | Each tablet contains: dl.naorgestrel.0.5mg, Ethinyl oestradiol.0.03mg | Oral contraceptive | April,1975 |
| dl.norgestrel + ethinyl oestradiol | Each tablet contains: dl.norgestrel.0.25mg, ethinyl oestradiol.0.05mg | Oral contraceptive | October,1971 |
| d.Norgestrel | Each coated tablet contains: d.Norgestrel.0.03mg | Oral contraceptive | April,1974 |
| d.Norgestrel | Each tablet contains: d.Norgestrel.0.03mg | August,1974 | |
| Doxapram Hcl | Doxapram Hcl | Respiratory stimulant. for the treatmnetof post.operative respiratory depression and respiratory depression due to poisoning. | September,1977 |
| Doxapram Hcl | Each vial contains: Doxapram Hcl.20mg | November,1978 | |
| Doxepin hydrochloride | Each tablet/dragee/capsule contains: Doxepine hydrochloride.10mg, 25mg & 50mg | September,1972 | |
| Doxepin Hydrochloride | Doxepin Hydrochloride | Psychotic drug | July,1972 |
| Epsilon Amino caproic acid | Epsilon Amino caproic acid | Anti.hemorrhage | November,1967 |
| Epsilon amino caproic acid | Each ml contains: Epsilon caproic acid.250 mg/ml | March,1971 | |
| Pretomanid tablets 200mg | Each tablets contains: Pretomanid ……………………200mg | Indicated as part of a combination regimen with Bedaquiline and Linezolid, in adults for the treatment of pulmonary extensively drug resistant (XDR), or treatment intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). For use in national TB Elimination Programme (NETP). The drug to be used only as conditional access under national TB Elimination programme (NETP) subject to condition that phase IV CT should be conducted under the programme. WARNING: For the use in National TB Elimination Programme (NTEP) “ which shall be in box with red background. | 23.03.2023 |
| Pretomanid tablets 200mg | Each tablets contains: Pretomanid ……………………200mg | Pretomanid is indicated, as part of a combination regimen with bedaquiline and linezolid, for treatment of MDR-TB or RR-TB in patients≥14 years of age who have no previous exposure (defined as >1 month) to bedaquiline, pretomanide, or linezolid, with moxifloxacin in the absence of baseline resistance to fluoroquinolones or without moxifloxacin if resistance to fluoroquinolones is presents (pre-XDR-TB). For use in national TB Elimination Programme (NETP). The drug to be used only as conditional access under national TB Elimination programme (NETP) subject to condition that phase IV CT should be conducted under the programme. WARNING: For the use in National TB Elimination Programme (NTEP) “ which shall be in box with red background. | 18.04.2023 |
| Each uncoated tablet contains: Miglitol 25 mg + Metformin Hydrochloride IP (as sustained release) 500mg tablets | Each uncoated tablet contains: Miglitol 25 mg + Metformin Hydrochloride IP (as sustained release) 500mg tablets | For adult with Type-II diabetes mellitus where simple drug therapy, diet and exercise do not result in adequate glycemic control. | 16.03.2010 |
| Brinzolamide USP… ................ % w/v Timolol Maleate IP… .................. %w/v eq. to Timolol ............................ %w/v Benzalkonium Chloride IP (As preservative) .............................. % w/v Ophthalmic Suspension | Brinzolamide USP… ................ % w/v Timolol Maleate IP… .................. %w/v eq. to Timolol ............................ %w/v Benzalkonium Chloride IP (As preservative) .............................. % w/v Ophthalmic Suspension | It is indicated for:- Decrease of intraocular pressure (IOP) in adults patients with open angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. | 18.02.2016 |
| Each Film Coated Tablet contains: Zidovudine. ................. 300mg Lamivudine ....................... 150mg Nevirapine. ......................... 200mg | Each Film Coated Tablet contains: Zidovudine. ............. 300mg Lamivudine ....................... 150mg Nevirapine. ......................... 200mg | It is indicated in the treatment of HIV infection in adult patients once the patients is stabilized on maintenance regimen Nevirapine 200mg B.D. | 13.11.2001 |
| Metoprolol succinate USP ER eq. to Metoprolol Tartrate 25/50 mg + Telmisartan IP 40/40mg bilayered film coated tablet | Metoprolol succinate USP ER eq. to Metoprolol Tartrate 25/50 mg + Telmisartan IP 40/40mg bilayered film coated tablet | For the treatment of essential hypertension | 20.12.2011 |
Icaridin API and Icaridin 20% w/v Spray | Icaridin API and Icaridin 20% w/v Spray | Indicated for mosquito and insect repellent | 19..09.2023 |
| Inclisiran solution for injection in prefilled syringe 284 mg/1.5 ml | Inclisiran solution for injection in prefilled syringe 284 mg/1.5 ml | Inclisiran is indicated in adults with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goal with the maximum tolrated dose of a statin, or - alone or in combination with other lipid lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated | 22.09.2023 |
| Relugolix Bulk Drug and Relugolix Tablet 120mg | Relugolix Bulk Drug and Relugolix Tablet 120mg | For the treatment of adult patients with advance prostate cancer | 16.10.2023 |
| Asciminib film-coated 20mg and 40 mg tablets | Asciminib film-coated 20mg and 40 mg tablets | Asciminib is indicated for the treatment of adult patients with: - Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) -Ph+CML in CP with the T315I mutation | 20.10.2023 |
| Lasmiditan Hemisuccinate Bulk Drug & Lasmiditan Tablet 50mg/100mg | Lasmiditan Hemisuccinate Bulk Drug & Lasmiditan Tablet 50mg/100mg | Indicated for the acute treatment of migraine with or without aura in adult | 29.11.2023 |
| Abrocitinib Tablets 50mg, 100mg & 200mg | Abrocitinib Tablets 50mg, 100mg & 200mg | Indicated for the acute treatment of migraine with or without aura in adult | 29.11.2023 |
| Cyclophosphamide Capsules 25mg/50mg | Cyclophosphamide Capsules 25mg/50mg | Cyclophosphamide is indicated for treatment of: Malignant Diseases: • Malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma, • Multiple myeloma, • Leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) • Mycosis fungoides (advanced disease) • Neuroblastoma (disseminated disease) • Adenocarcinoma of the ovary • Retinoblastoma • Carcinoma of the breast | 04.05.2023 |
| Esomeprazole Dual-Release GastroResistant Tablets 80mg ( Additional Dosage Form) | Esomeprazole Dual-Release GastroResistant Tablets 80mg (Additional Dosage Form) | Indicated for the treatment of moderate to severe refractory gastro-esophageal reflux disease (GERD) for 4 weeks only. | 17.05.2023 |
| Cefixime Oral Suspension IP 200mg/5ml ( Additional strength) | Cefixime Oral Suspension IP 200mg/5ml ( Additional strength) | For the treatment of enteric (typhoid) fever | 30.05.2023 |
| Perampanel Oral Suspension 0.5mg/ml ( Additional Dosage Form) | Perampanel Oral Suspension 0.5mg/ml ( Additional Dosage Form) | It is indicated adjunctive therapy for the treatment of :- • Partial-onset Seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. • Primary Generalized Tonic-Clonic Seizures in patients with epilepsy 12 years of age and older. | 30.05.2023 |
| Icosapent Ethyl Capsules 500mg and 1000mg ( Additional strength) | Icosapent Ethyl Capsules 500mg and 1000mg ( Additional strength) | Used as an adjunct therapy for severe hypertriglyceridemia a ( TG levels > 500mg/dl) and to reduce the risk of cardiovascular events in certain patients with elevated triglycerides. | 06.06.2023 |
| Amisulpride Injection 5mg/2ml ( Additional Dosage Form) | Amisulpride Injection 5mg/2ml ( Additional Dosage Form) | • Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. • Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis. | 06.06.2023 |
| Testosterone Topical gel 1.62% w/w (Metered-Pump Packed, containing 1.62% w/w Testosterone) (Also expressed as 16.2mg/gm of Testosterone) (Additional Dosage Form) | Testosterone Topical gel 1.62% w/w (Metered-Pump Packed, containing 1.62% w/w Testosterone) (Also expressed as 16.2mg/gm of Testosterone) (Additional Dosage Form) | Indicated in adults as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by the clinical features and biochemical tests. | 12.06.2023 |
| Tofacitinib Ointment 2% w/w ( Additional Dosage Form) | Tofacitinib Ointment 2% w/w ( Additional Dosage Form) | For the treatment of mild to moderate atopic dermatitis (AD) in patients 18 years & above having flare up of disease. | 16.06.2023 |
| Brivaracetam Sustained Release Tablets 50mg/100mg/150mg ( Additional srength ) | Brivaracetam Sustained Release Tablets 50mg/100mg/150mg ( Additional srength ) | As adjunctive therapy in the treatment of partialonset seizures in patients 16 years of age and older with epilepsy. | 26.06.2023 |
| Gabapentin Extended Release Tablets 300mg and 600mg (Additional Indication) | Gabapentin Extended Release Tablets 300mg and 600mg (Additional Indication) | For the treatment of neuropathic pain. | 28.07.2023 |
| Benzydamine Hydrochloride Mouthwash 0.15% w/v ( Additional Dosage Form) | Benzydamine Hydrochloride Mouthwash 0.15% w/v ( Additional Dosage Form) | Benzydamine Mouthwash is a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the mouth and throat including: • Traumatic Conditions: Pharyngitis following tonsillectomy or the use of a naso-gastric tube; • Inflammatory Conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy; • Dentistry: For use after dental operations. | 28.07.2023 |
| Darolutamide 300mg Film Coated Tablets (Additional Indication) | Darolutamide 300mg Film Coated Tablets (Additional Indication) | Darolutamide is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel. | 28.07.2023 |
| Tofacitinib Oral Solution 1 mg/ml ( Additional Dosage Form) | Tofacitinib Oral Solution 1 mg/ml ( Additional Dosage Form) | Additional Dosage Form) For the treatment of juvenile idiopathic arthritis (PcJIA) in patients 2 years of age and older. | 25.08.2023 |
| Icosapent Ethyl Capsule 1g ( Additional Indication) | Icosapent Ethyl Capsule 1g ( Additional Indication) | As ab adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150mg/dL) • Established cardiovascular disease or • Diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. • As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Limitations of Use: The effect of Icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. | 14.09.2023 |
| Dydrogesterone Extended Release Tablets 20mg ( Additional Dosage Form) | Dydrogesterone Extended Release Tablets 20mg ( Additional Dosage Form) | Indicated in cases where progesterone supplement is needed. | 03.11.2023 |
| Tacrolimus Lipid Suspension for enema 4 mg/vial and Diluent for Tacrolimus lipid suspension for enema (Additional Dosage Form) | Tacrolimus Lipid Suspension for enema 4 mg/vial and Diluent for Tacrolimus lipid suspension for enema (Additional Dosage Form) | For achieving remission in adult patients with mild to moderately active left-sided/distal ulcerative colitis including proctosigmoiditis/proctitis refractory to mesalamine treatment. | 02.11.2023 |
| Solifenacin succinate Oral solution 1mg/ml (Additional Dosage Form) | Solifenacin succinate Oral solution 1mg/ml (Additional Dosage Form) | For Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. | 03.11.2023 |
| Olaparib film coated tablets 100mg / 150mg (Additional Indication) | Olaparib film coated tablets 100mg / 150mg (Additional Indication) | In combination with Abiraterone and Prednisone or Prednisolone is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer. | 17.11.2023 |
| Methadone Hydrochloride oral Solution IP 1mg/ml (Additional Dosage Form) | Methadone Hydrochloride oral Solution IP 1mg/ml (Additional Dosage Form) | 1. For the management of chronic refractory moderate to severe pain. 2. For the treatment of opioid dependence and for maintenance treatment for opioid dependence. | 30.11.2023 |
| Lenalidomide Capsules 10mg (Additional Indication ) | Lenalidomide Capsules 10mg (Additional Indication ) | “Lenalidomide as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation “ | 01.12.2023 |
| Enzalutamide Oral solution 32mg/ml (Additional Dosage Form) | Enzalutamide Oral solution 32mg/ml (Additional Dosage Form) | 1. In the treatment of adult men with metastatic castration resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. 2. For the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) whose disease has progressed on or after Docetaxel therapy. | 04.12.2023 |
| Zolpidem Sublingual Spray 3.85% w/v ( Additional Dosage Form) | Zolpidem Sublingual Spray 3.85% w/v ( Additional Dosage Form) | For the short-term treatment of insomnia. | 12.01.2024 |
| Dydrogesterone Extended Release Tablets 30mg | Dydrogesterone Extended Release Tablets 30mg | Indicated “For the treatment of Endometriosis”. | 12.01.2024 |
| Imeglimin Hydrochloride Sustained Release Tablets 500mg/1000mg (Additional Dosage Form) | Imeglimin Hydrochloride Sustained Release Tablets 500mg/1000mg (Additional Dosage Form) | Indicated for the treatment of type 2 diabetes mellitus inadequately controlled with diet and exercise alone. | 18.01.2024 |
| Empagliflozin Tablets 10mg /25 mg (Additional Indication) | Empagliflozin Tablets 10mg /25 mg (Additional Indication) | To reduce the risk of sustained decline in eGFR (only for patients with eGFR 30-90 ml/mim/1.73m2), end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. | 18.01.2024 |
| Pegaspargase Injection 1500 IU/2ml vial | Pegaspargase Injection 1500 IU/2ml vial | Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to asparaginase. Pegaspargase Injection as First-Line chemotherapeutic agent for treatment of patients with acute lymphoblastic leukemia (ALL) | 06.02.2024 |
| Ferric Carboxymaltose Injection (50mg iron/ml) ( Additional Indication ) | Ferric Carboxymaltose Injection (50mg iron/ml) ( Additional Indication ) | For the treatment of iron deficiency in children and adolescents aged > 1 years when oral iron preparations are ineffective or cannot be used | 15.02.2024 |
| Tadalafil Oral Jelly 20 mg (Orange Flavour) (Additional Dosage Form) | Tadalafil Oral Jelly 20 mg (Orange Flavour) (Additional Dosage Form) | It is indicated for the treatment of erectile dysfunction in adult men. | 16.02.2024 |
| Bisoprolol Fumarate Tablets USP 3.75 mg/7.5mg (Additional Strength) | Bisoprolol Fumarate Tablets USP 3.75 mg/7.5mg (Additional Strength) | Treatment of stable chronic heart failure with reduced systolic left ventricular function in additional to ACE inhibitors, and diuretics, and optionally cardiac glycosides | 16.02.2024 |
| Sterile dehydrated Human Amnion Chorion Membrane (12x6cm2) | Sterile dehydrated Human Amnion Chorion Membrane (12x6cm2) | Indicated for the treatment of acute and chronic non-healing wounds. | 28.02.2024 |
| Hydroxyurea Oral Suspension 100 mg/ml ( Additional Dosage Form) | Hydroxyurea Oral Suspension 100 mg/ml ( Additional Dosage Form) | It is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age . | 07.03.2024 |
| Tacrolimus Lipid Tablets 3 mg ( Additional strength) | Tacrolimus Lipid Tablets 3 mg ( Additional strength) | For treatment of active rheumatoid arthritis in adult patients for whom disease modifying anti-rheumatic drug (DMARD) therapy is ineffective or inappropriate. | 21.03.2024 |
| Nicoumalone Tablets IP 1.5mg/2.5mg/3.5mg (Additional Strength) | Nicoumalone Tablets IP 1.5mg/2.5mg/3.5mg (Additional Strength) | For the prevention and treatment of thromboembolic diseases such as venous thrombosis, atrial fibrillation with embolization, pulmonary embolism and as an adjunct in the treatment of coronary occlusion. | 22.03.2024 |
| Esmolol Hydrochloride Topical Gel 14% w/w | Esmolol Hydrochloride Topical Gel 14% w/w | For the treatment of Diabetic foot ulcer. | 24.04.2024 |
| Alfuzosin Prolonged Release Tablets IP 10mg | Alfuzosin Prolonged Release Tablets IP 10mg | For the treatment of sign & symptoms of Benign Prostatic Hyperplasia (BPH). | 30.4.2024 |
| Tirzepatide 2.5mg /0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5 ml,12.5mg/0.5 ml,15mg/0.5 ml solution for injection in a prefilled pen | Tirzepatide 2.5mg /0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5 ml,12.5mg/0.5 ml,15mg/0.5 ml solution for injection in a prefilled pen | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | 19.01.2024 |
| Plazomicin injection 500mg/10ml (50mg/ml) | Plazomicin injection 500mg/10ml (50mg/ml) | Indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganism(s) Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae | 02.02.2024 |
| Etifoxine Hydrochloride Bulk drug & Etifoxine Hydrochloride capsules 50 mg | Etifoxine Hydrochloride Bulk drug & Etifoxine Hydrochloride capsules 50 mg | Indicated for psychosomatic manifestations of anxiety | 21.03.2024 |
| Vonoprazan fumarate Bulk drug & Vonoprazan tablets 10mg/20 mg | Vonoprazan fumarate Bulk drug & Vonoprazan tablets 10mg/20 mg | Treatment of reflux esophagitis(RE) Treatment of gastric ulcer (GU) Treatment of duodenal ulcer(DU) Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration. Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration. Adjunct to Helicobacter pylori eradication associated with: Gastric ulcer, Duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early-stage cancer, or Helicobacter pylori gastritis. | 08.05.2024 |
| Rifapentine Dispersible Tablets 150mg (Additional Dosage Form) | Rifapentine Dispersible Tablets 150mg (Additional Dosage Form) | For the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV – infected patients, or those with pulmonary fibrosis on radiograph). Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. Rifapentine Tablets 150mg must always be used in combination with isoniazid as a 12 week once weekly regimen for the treatment of latent tuberculosis infection. | 16.05.2024 |
| Acalabrutinib maleate 100mg tablets (Additional Dosage Form) | Acalabrutinib maleate 100mg tablets (Additional Dosage Form) | Acalabrutinib is indicated: 1. for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 2. for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). | 17.05.2024 |
| rdESAT-6 and rCFP-10 (Cy-Tb) injection (Additional indication) | rdESAT-6 and rCFP-10 (Cy-Tb) injection (Additional indication) | For Detection of Latent-TB for population of age group 1 year and above. For detection of Latent-TB for population below 1 year in implementation research mode under National program only. | 16.05.2024 |
| Selpercatinib Capsules 40 mg & 80 mg | Selpercatinib Capsules 40 mg & 80 mg | Adult patients with metastatic RET fusion-positive non-small cell lung cancer(NSCLC) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET mutant medullary thyroid cancer (MTC) who require systemic therapy. Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioative iodine is appropriate) | 16.05.2024 |
| Nelarabine bulk drug & Nelarabine Injection | (250mg/50ml(5mg/ml)) | For the treatment of patients with Tcell Lymphoblastic leukemia and Tcell Lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens | 31.05.2024 |
| Enmetazobactam bulk drug & Cefipime 2gm and Enmetazobactam 500mg Dry powder for injection | Enmetazobactam bulk drug & Cefipime 2gm and Enmetazobactam 500mg Dry powder for injection | Indicated for the treatment of patients 18 years of age and older for: Complicated urinary tract infection(CUTI) including acute pyelonephritis Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) Bacteremia with complicated urinary tract infection or hospital-acquired pneumonia | 31.05.2024 |
| Vildagliptin (as Sustained Release) + Metformin Hydrochloride IP (as Sustained Release) (100mg + 500mg & 100mg + 1000mg) film coated bilayered tablets | Vildagliptin (as Sustained Release) + Metformin Hydrochloride IP (as Sustained Release) (100mg + 500mg & 100mg + 1000mg) film coated bilayered tablets | For the treatment of Type II diabetes mellitus inadequately controlled on Metformin monotherapy. | 06.01.2023 |
| Cilnidipine 20mg + Telmisartan IP 40mg film coated tablets (In additional Strength) | Cilnidipine 20mg + Telmisartan IP 40mg film coated tablets (In additional Strength) | It is indicated for the treatment of essential hypertension. | 06.01.2023 |
| Combipack of 26 hormone-containing film coated tablets in the following: (i) 2 dark yellow each containing 3mg Estradiol Valerate EP (ii) 5 Medium red tablets each containing 2mg Estradiol Velerate EP and 2mg Dienogest IP (iii) 17 light yellow tablets each containing 2mg Estradiol Velerate EP and 3mg Dienogest IP (iv) 2 dark red tablets each containing 1mg Estradiol Valerate EP 2 hormone-free white film coated tablets-regarding. | Combipack of 26 hormone-containing film coated tablets in the following: (i) 2 dark yellow each containing 3mg Estradiol Valerate EP (ii) 5 Medium red tablets each containing 2mg Estradiol Velerate EP and 2mg Dienogest IP (iii) 17 light yellow tablets each containing 2mg Estradiol Velerate EP and 3mg Dienogest IP (iv) 2 dark red tablets each containing 1mg Estradiol Valerate EP 2 hormone-free white film coated tablets-regarding. | For the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception. | 06.01.2023 |
| Trifluridine IP + Tipiracil Hydrochloride (20mg + 8.190mg & 15mg + 6.140mg) film coated tablets | Trifluridine IP + Tipiracil Hydrochloride (20mg + 8.190mg & 15mg + 6.140mg) film coated tablets | Indicated for the treatment of: 1. Adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy 2. Adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/ neu-targeted therapy. | 30.01.2023 |
| Dapagliflozin Propanedilol Monohydrate eq. to Dapagliflozin + Vildagliptin IP (as sustained release) + Metformin Hydrchloride IP (as sustained release) uncoated bilayered tablets (5mg + 100mg + 500mg & 5mg + 100mg + 1000mg) | Dapagliflozin Propanedilol Monohydrate eq. to Dapagliflozin + Vildagliptin IP (as sustained release) + Metformin Hydrchloride IP (as sustained release) uncoated bilayered tablets (5mg + 100mg + 500mg & 5mg + 100mg + 1000mg) | For the treatment of patients with type 2 Diabetes mellitus. | 06.02.2023 |
| Ezetimibe IP 10mg + Rosuvastatin Calcium IP eq. to Rosuvastatin 40mg film coated tablets (In additional Strength) | Ezetimibe IP 10mg + Rosuvastatin Calcium IP eq. to Rosuvastatin 40mg film coated tablets (In additional Strength) | For the treatment of patients with primary hypercholesterolemia. | 06.02.2023 |
| Vildagliptin 50mg + Dapagliflozin 5mg film coated tablets (In additional Strength) | Vildagliptin 50mg + Dapagliflozin 5mg film coated tablets (In additional Strength) | Management of Type II diabetes mellitus (T2DM) | 08.02.2023 |
| Sitagliptin Phosphate IP eq. to Sitagliptin + Pioglitazone Hydrochloride IP eq. to Pioglitazone IP + Metformin Hydrochloride IP (as sustained release form) IP (100mg + 15mg + 500mg & 100mg + 15mg + 1000mg) uncoated bilayered tablets | Sitagliptin Phosphate IP eq. to Sitagliptin + Pioglitazone Hydrochloride IP eq. to Pioglitazone IP + Metformin Hydrochloride IP (as sustained release form) IP (100mg + 15mg + 500mg & 100mg + 15mg + 1000mg) uncoated bilayered tablets | It is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus | 08.02.2023 |
| Azelnidipine IP 16mg + Telmisartan IP 40mg uncoated bilayered tablets | Azelnidipine IP 16mg + Telmisartan IP 40mg uncoated bilayered tablets | For treatment of Stage-II Hypertension | 08.02.2023 |
| Combikit of Clarithromycin IP 500mg + Esomeprazole Magnesium IP eq. to Esomeprazole 40mg + Amoxicillin Trihydrate IP eq. to Amoxicillin 1000mg (In additional Strength) | Combikit of Clarithromycin IP 500mg + Esomeprazole Magnesium IP eq. to Esomeprazole 40mg + Amoxicillin Trihydrate IP eq. to Amoxicillin 1000mg (In additional Strength) | For healing of duodenal ulcer associated with Helicobacter pylori and eradication of Helicobacter pylori in patients with active or healed peptic ulcer | 15.02.2023 |
| Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP (5mg + 50mg + 500mg & 5mg + 50mg + 1000mg) film coated tablets | Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP (5mg + 50mg + 500mg & 5mg + 50mg + 1000mg) film coated tablets | It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | 13.03.2023 |
| Kabiven (3 Chamber Bag of Amino Acids and electrolytes + Fat emulsion 20% + Glucose 19%) emulsion for infusion | Kabiven (3 Chamber Bag of Amino Acids and electrolytes + Fat emulsion 20% + Glucose 19%) emulsion for infusion | Parenteral Nutrition for patients and children above 2 years of age when oral or eternal nutrition is impossible, insufficient or contraindicated | 17.03.2023 |
| Kabiven Peripheral (3 Chamber Bag of Amino Acids and electrolytes + Fat emulsion 20% + Glucose 11%) emulsion for infusion | Kabiven Peripheral (3 Chamber Bag of Amino Acids and electrolytes + Fat emulsion 20% + Glucose 11%) emulsion for infusion | Parenteral Nutrition for patients and children above 2 years of age when oral or eternal nutrition is impossible, insufficient or contraindicated | 17.03.2023 |
| Indacaterol (as acetate) eq. to Indacaterol 150mcg + Glycopyrrolate IP eq. to Glycopyrronium 50mcg + Mometasone Furoate IP 160mcg dry powder for inhalation (In additional Strength) | Indacaterol (as acetate) eq. to Indacaterol 150mcg + Glycopyrrolate IP eq. to Glycopyrronium 50mcg + Mometasone Furoate IP 160mcg dry powder for inhalation (In additional Strength) | Indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of long acting beta 2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in a previous year. | 24.04.2023 |
| Tenofovir Alafenamide Fumarate IP 25mg + Emtricitabine IP 200mg + Bictegravir Sodium 50mg film coated tablets | Tenofovir Alafenamide Fumarate IP 25mg + Emtricitabine IP 200mg + Bictegravir Sodium 50mg film coated tablets | For the treatment of human immunodeficiency virus type 1 (HIV-I) infection in adults who no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-2 RNA) less than 50 copies per ml) on a stable antiretroviral regimen for at least 3 month with no history of treatment failure and no known substitutions associated with resistance to Bictegravir, Emtricitabine and Tenofovir Alafenamide. | 24.04.2023 |
| Vildagliptin 50mg + Pioglitazone Hydrochloride IP eq. to Pioglitazone 15mg uncoated tablet | Vildagliptin 50mg + Pioglitazone Hydrochloride IP eq. to Pioglitazone 15mg uncoated tablet | For the treatment of Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy | 16.05.2023 |
| Alfuzosin Hydrochloride IP (as Extended Release) + Tadalafil IP .(10 mg +2.5mg & 10mg + 5mg) film coated tablets | Alfuzosin Hydrochloride IP (as Extended Release) + Tadalafil IP .(10 mg +2.5mg & 10mg + 5mg) film coated tablets | For the treatment of patients with Lower urinary Tract Symptoms (LUTS) associated with benign Prostatic Hyperplasia (BPH) | 07.06.2023 |
| Alkyl Dimethyl Benzyl Ammonium Chloride 0.260%w/w + Pyridine-2-Thiol 1-oxide, sodium salt 0.0250%w/w Surface Disinfectant Solution | Alkyl Dimethyl Benzyl Ammonium Chloride 0.260%w/w + Pyridine-2-Thiol 1-oxide, sodium salt 0.0250%w/w Surface Disinfectant Solution | Cleaning and Disinfectant | 07.06.2023 |
| Linagliptin 5mg + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Film Coated Tablets | Linagliptin 5mg + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Film Coated Tablets | In patients with type 2 Diabetes Mellitus inadequately controlled on Metformin | 03.07.2023 |
| Metoprolol succinate IP 47.50 eq. to Metoprolol Tartrate (as extended release) 50mg + Telmisartan IP 40mg + Amlodipine Besilate IP eq. to Amlodipine 5mg film coated bilayered tablet | Metoprolol succinate IP 47.50 eq. to Metoprolol Tartrate (as extended release) 50mg + Telmisartan IP 40mg + Amlodipine Besilate IP eq. to Amlodipine 5mg film coated bilayered tablet | For the treatment of uncontrolled essential hypertension with stable coronary artery disease (CAD) | 03.07.2023 |
| Metoprolol succinate IP 47.50 eq. to Metoprolol Tartrate (as extended release) + Amlodipine Besilate IP eq. to Amlodipine + Chlorthalidone IP (50mg +5mg +6.25mg & 50mg + 5mg + 12.5mg) film coated bilayered tablets | Metoprolol succinate IP 47.50 eq. to Metoprolol Tartrate (as extended release) + Amlodipine Besilate IP eq. to Amlodipine + Chlorthalidone IP (50mg +5mg +6.25mg & 50mg + 5mg + 12.5mg) film coated bilayered tablets | For patients with uncontrolled essential hypertension | 03.07.2023 |
| Brimonidine Tartrate IP 2.0mg + Brinzolamide IP 10.0mg + Timolol Maleate IP eq. to Timolol 5mg + Benzalkonium Chloride Solution IP 0.2mg (as preservative) + Water for injection IP q.s. per ml ophthalmic suspension | Brimonidine Tartrate IP 2.0mg + Brinzolamide IP 10.0mg + Timolol Maleate IP eq. to Timolol 5mg + Benzalkonium Chloride Solution IP 0.2mg (as preservative) + Water for injection IP q.s. per ml ophthalmic suspension | For the treatment of patients with open angle glaucoma/ocular hypertension | 13.07.2023 |
| Dapagliflozin propanediol Monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP (As ER) (5mg + 50mg + 500mg & 5mg + 50mg + 1000mg) film coated tablet | Dapagliflozin propanediol Monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP (As ER) (5mg + 50mg + 500mg & 5mg + 50mg + 1000mg) film coated tablet | It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | 13.07.2023 |
| Linagliptin + Metformin Hydrochloride IP (as an extended release) (2.5mg + 1000mg, 5mg + 500mg & 5mg + 1000mg) film coated bilayered tablets | Linagliptin + Metformin Hydrochloride IP (as an extended release) (2.5mg + 1000mg, 5mg + 500mg & 5mg + 1000mg) film coated bilayered tablets | As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with Linagliptin and Metformin is appropriate. | 28.07.2023 |
| Metformin Hydrochloride IP (As SR form) + Vildagliptin (as SR form) (500mg + 50mg, 1000mg + 50mg, 500mg + 100mg & 1000mg + 100mg) film coated bilayered tablets | Metformin Hydrochloride IP (As SR form) + Vildagliptin (as SR form) (500mg + 50mg, 1000mg + 50mg, 500mg + 100mg & 1000mg + 100mg) film coated bilayered tablets | For the treatment of Type-II diabetes mellitus inadequately controlled on Metformin Monotherapy | 04.08.2023 |
| Combikit of: Each film coated tablet contains: Part A: Atazanavir Sulphate IP eq. to Atazanavir 300mg + Ritonavir IP 100mg Part B: Emtricitabine IP 200mg + Tenofovir Alafenamide Fumarate eq. to Tenofovir Alafenamide 10mg | Combikit of: Each film coated tablet contains: Part A: Atazanavir Sulphate IP eq. to Atazanavir 300mg + Ritonavir IP 100mg Part B: Emtricitabine IP 200mg + Tenofovir Alafenamide Fumarate eq. to Tenofovir Alafenamide 10mg | For the treatment of adult patients with HIV infection | 04.08.2023 |
| Montelukast IP eq. to Montelukast 4mg + Fexofenadine Hydrochloride IP 60mg suspension (In additional Strength) | Montelukast IP eq. to Montelukast 4mg + Fexofenadine Hydrochloride IP 60mg suspension (In additional Strength) | For the treatment of allergic rhinitis | 04.08.2023 |
| Metformin Hydrochloride IP (As sustained release) 500mg + Myo-Inositol IP 600mg film coated bilayered tablet | Metformin Hydrochloride IP (As sustained release) 500mg + Myo-Inositol IP 600mg film coated bilayered tablet | For Poly cystic Ovary Syndrome management | 11.08.2023 |
| Budesonide IP 200mcg + Glycopyrronium (as Glycopyrrolate IP) 12.5mcg + Formoterol Fumarate Dihydrate IP 6mcg inhaler | Budesonide IP 200mcg + Glycopyrronium (as Glycopyrrolate IP) 12.5mcg + Formoterol Fumarate Dihydrate IP 6mcg inhaler | It is indicated as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). | 25.08.2023 |
| Dapagliflozin propanediol monohydrate eq. to Dapagliflozin + Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin IP + Metformin Hydrochloride (SR) IP + (10mg + 20mg + 500mg & 10mg + 20mg + 1000mg) film coated bilayered tablet | Dapagliflozin propanediol monohydrate eq. to Dapagliflozin + Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin IP + Metformin Hydrochloride (SR) IP + (10mg + 20mg + 500mg & 10mg + 20mg + 1000mg) film coated bilayered tablet | For the treatment of patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. | 12.09.2023 |
| Indacaterol Maleate eq. to Indacaterol + Budesonide IP (75mcg+200mcg & 150mcg +400mcg) dry powder for inhalation in capsule (Additional Indication) | Indacaterol Maleate eq. to Indacaterol + Budesonide IP (75mcg+200mcg & 150mcg +400mcg) dry powder for inhalation in capsule (Additional Indication) | Indacaterol and Budesonide powder for inhalation is indicated for treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is appropriate. | 22.09.2023 |
| Fluticasone Furoate 100mcg + Glycopyrronium Bromide Ph. Eur eq. to Glycopyrronium 50mcg + Vilanterol Trifenatate eq. to Vilanterol 25mcg Inhalation Powder in capsules | Fluticasone Furoate 100mcg + Glycopyrronium Bromide Ph. Eur eq. to Glycopyrronium 50mcg + Vilanterol Trifenatate eq. to Vilanterol 25mcg Inhalation Powder in capsules | Maintenance treatment of patients with moderate to severe COPD. | 26.09.2023 |
| Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP + Glimepiride IP (50mg + 1000mg + 1mg & 50mg + 1000mg + 2mg) tablets | Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin Hydrochloride IP + Glimepiride IP (50mg + 1000mg + 1mg & 50mg + 1000mg + 2mg) tablets | As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | 26.09.2023 |
| Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin Hydrochloride IP (as extended release) (10mg + 1mg + 1000mg & 10mg + 2mg + 1000mg) film coated tablets | Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin Hydrochloride IP (as extended release) (10mg + 1mg + 1000mg & 10mg + 2mg + 1000mg) film coated tablets | Indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. | 10.10.2023 |
| Calcium Asparate 1120mg + Magnesium Hydroxide IP 180mg + Vitamin D3 IP 1000IU tablets | Calcium Asparate 1120mg + Magnesium Hydroxide IP 180mg + Vitamin D3 IP 1000IU tablets | For Calcium and Vitamin D Deficiency | 25.10.2023 |
| Silodosin + Mirabegron (As extended release) (8mg + 25mg & 8mg + 50mg) film coated bilayered tablets | Silodosin + Mirabegron (As extended release) (8mg + 25mg & 8mg + 50mg) film coated bilayered tablets | In adult patients diagnosed with Benign Prostatic Hyperplasia complicated by overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency. | 02.11.2023 |
| Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin Hydrochloride (As extended release) (10mg + 1mg + 500mg & 10mg + 2mg + 500mg) film coated tablets (Additional strength) | Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin Hydrochloride (As extended release) (10mg + 1mg + 500mg & 10mg + 2mg + 500mg) film coated tablets (Additional strength) | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | 02.11.2023 |
| Vilanterol Trifenatate eq. to Vilanterol 12.5mcg + Glycopyrrolate IP eq. to Glycopyrronium 25mcg + Fluticasone Furoate Ph. Eur 50mcg inhaler (metered dose inhalation) | Vilanterol Trifenatate eq. to Vilanterol 12.5mcg + Glycopyrrolate IP eq. to Glycopyrronium 25mcg + Fluticasone Furoate Ph. Eur 50mcg inhaler (metered dose inhalation) | It is indicated for treatment of patients with moderate to severe COPD. | 02.11.2023 |
| Glycopyrronium Bromide eq. to 50mcg of Glycopyrronium 63mcg + Vilanterol Trifenatate eq. to 25mcg Vilanterol 40mcg Inhalation Powder in capsule | Glycopyrronium Bromide eq. to 50mcg of Glycopyrronium 63mcg + Vilanterol Trifenatate eq. to 25mcg Vilanterol 40mcg Inhalation Powder in capsule | Indicated as maintenance treatment for patients with Chronic Obstructive Pulmonary disease (COPD). | 15.11.2023 |
| Dapagliflozin 5mg + Vildagliptin 50mg + Metformin Hydrochloride IP 500mg film coated tablets (Additional strength) | Dapagliflozin 5mg + Vildagliptin 50mg + Metformin Hydrochloride IP 500mg film coated tablets (Additional strength) | Management of Type 2 Diabetes Mellitus (T2DM) | 15.11.2023 |
| Budesonide Ph. Eur. 160mcg + Glucopyrronium Ph. Eur 7.2mcg + Formoterol Fumarate Dihydrate Ph. Eur 5mcg inhalation preparations | Budesonide Ph. Eur. 160mcg + Glucopyrronium Ph. Eur 7.2mcg + Formoterol Fumarate Dihydrate Ph. Eur 5mcg inhalation preparations | Maintenance treatment of relieve symptoms and prevent exacerbations in adult patients with chronic obstructive pulmonary disease (COPD). | 29.11.2023 |
| Tramadol Hydrochloride IP 37.5mg + Acetaminophen IP 325mg effervescent tablets | Tramadol Hydrochloride IP 37.5mg + Acetaminophen IP 325mg effervescent tablets | For short term (five days or less) management of acute pain in adults | 29.11.2023 |
| Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin Hydrochloride (5mg + 1mg + 500mg, 5mg + 2mg + 500mg, 5mg + 1mg + 1000mg & 5mg + 2mg + 1000mg) film coated tablets (Additional strength) | Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin Hydrochloride (5mg + 1mg + 500mg, 5mg + 2mg + 500mg, 5mg + 1mg + 1000mg & 5mg + 2mg + 1000mg) film coated tablets (Additional strength) | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. | 29.11.2023 |
| Gliclazide IP (As sustained release) + Dapagliflozin (30mg + 10mg & 60mg + 10mg) film coated bilayered tablets | Gliclazide IP (As sustained release) + Dapagliflozin (30mg + 10mg & 60mg + 10mg) film coated bilayered tablets | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. | 29.11.2023 |
| Progesterone IP 100mg + Estradiol USP (as hemihydrates eq. to Anhydrous Estradiol) 1mg soft gelatin capsules | Progesterone IP 100mg + Estradiol USP (as hemihydrates eq. to Anhydrous Estradiol) 1mg soft gelatin capsules | It is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. | 29.11.2023 |
| Alcohol IP 36.8%v/w + Ketoprofen IP 2.5%w/w gel | Alcohol IP 36.8%v/w + Ketoprofen IP 2.5%w/w gel | Symptomatic relief of acute painful musculoskeletal conditions caused by trauma, such as soft tissue injuries, including sports injuries, sprains, strains, contusions and musculo-tendonitis swelling, backache, and rheumatic pain. Pain of non-serious arthritis. | 29.11.2023 |
| Calcium Orotate 1120mg + Magnesium Hydroxide IP 180mg + Vitamin D3 IP 1000IU) film coated tablets | Calcium Orotate 1120mg + Magnesium Hydroxide IP 180mg + Vitamin D3 IP 1000IU) film coated tablets | For calcium and vitamin D Deficiency | 05.12.2023 |
| Gliclazide IP (As sustained release) + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin (30mg + 100mg & 60mg + 100mg) film coated bilayered tablets | Gliclazide IP (As sustained release) + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin (30mg + 100mg & 60mg + 100mg) film coated bilayered tablets | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. | 07.12.2023 |
| Pioglitazone Hydrochloride IP 15mg + Vildagliptin (as sustained release form) 100mg film coated bilayered tablet | Pioglitazone Hydrochloride IP 15mg + Vildagliptin (as sustained release form) 100mg film coated bilayered tablet | For the treatment of patients with type II diabetes mellitus. | 07.12.2023 |
| Bilastine 3.3mg + Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride 5mg per 5ml syrup for oral administration | Bilastine 3.3mg + Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride 5mg per 5ml syrup for oral administration | For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. | 07.12.2023 |
| Vilanterol Trifenatate eq. to Vilanterol 12.5mcg + Glycopyrrolate IP eq. to Glycopyrronium 25mcg metered dose inhalation | Vilanterol Trifenatate eq. to Vilanterol 12.5mcg + Glycopyrrolate IP eq. to Glycopyrronium 25mcg metered dose inhalation | Indicated as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). | 07.12.2023 |
| Doxylamine Succinate USP 20mg + Pyridoxine Hydrochloride IP 20mg film coated extended release tablet | Doxylamine Succinate USP 20mg + Pyridoxine Hydrochloride IP 20mg film coated extended release tablet | It is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. | 07.12.2023 |
| Levonorgestrel IP 0.15mg + Ethinyloestradiol IP 0.03mg uncoated tablets | Levonorgestrel IP 0.15mg + Ethinyloestradiol IP 0.03mg uncoated tablets | Treatment of primary dysmenorrhea, treatment of abnormal uterine bleeding, treatment of endometriosis. | 18.12.2023 |
| Ascorbic Acid IP 50mg + Cholecalciferol (Vitamin D3) IP 200IU + D-Panthenol IP 2.5mg + Nicotinamide IP 15mg + Pyridoxine Hydrochloride IP 1mg + Riboflavin Sodium Phosphate IP eq. to Riboflavin 1mg + Thiamine Hydrochloride IP 2mg + Vitamin A (as palmitate) IP 2500IU + Cyanocobalamin IP 1mcg + Citrus Bioflavonoid Compound 5mg/5ml syrup | Ascorbic Acid IP 50mg + Cholecalciferol (Vitamin D3) IP 200IU + D-Panthenol IP 2.5mg + Nicotinamide IP 15mg + Pyridoxine Hydrochloride IP 1mg + Riboflavin Sodium Phosphate IP eq. to Riboflavin 1mg + Thiamine Hydrochloride IP 2mg + Vitamin A (as palmitate) IP 2500IU + Cyanocobalamin IP 1mcg + Citrus Bioflavonoid Compound 5mg/5ml syrup | For the treatment of vitamin deficiency state | 11.01.2024 |
| Hydrous Benzoyl Peroxide IP eq. to Anhydrous Benzoyl Peroxide 3.75% w/w + Clindamycin Phosphate IP 1.2% w/w eq. to Clindamycin 1% w/w topical gel (Additional strength) | Hydrous Benzoyl Peroxide IP eq. to Anhydrous Benzoyl Peroxide 3.75% w/w + Clindamycin Phosphate IP 1.2% w/w eq. to Clindamycin 1% w/w topical gel (Additional strength) | For the topical treatment of acne vilgaris in patients 12 years age and older | 11.01.2024 |
| Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg + Linagliptin 5mg tablet (Additional strength) | Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg + Linagliptin 5mg tablet (Additional strength) | In the treatment of type 2 diabetes mellitus inadequately controlled on Metformin therapy | 11.01.2024 |
| Azelnidipine IP + Metoprolol Succinate IP eq. to Metoprolol Tartrate (SR) (8mg+25mg, 8mg+50mg,16mg+25mg & 16mg+50mg) film coated bilayered tablets | Azelnidipine IP + Metoprolol Succinate IP eq. to Metoprolol Tartrate (SR) (8mg+25mg, 8mg+50mg,16mg+25mg & 16mg+50mg) film coated bilayered tablets | For the treatment in stage 2 hypertension | 11.01.2024 |
| Levosulpiride (as uncoated sustained release tablet) 75mg + Rabeprazole Sodium IP (as enteric coated tablet) 40mg hard gelatin capsules (Additional strength) | Levosulpiride (as uncoated sustained release tablet) 75mg + Rabeprazole Sodium IP (as enteric coated tablet) 40mg hard gelatin capsules (Additional strength) | For the treatment of Gastroesophageal Reflux Disease (GERD) | 29.01.2024 |
| Methylcobalamin IP 1500mcg + Alpha Lipoic Acid USP 100mg + Vitamin D3 IP 8000IU + Calcium Carbonate IP eq. to elemental Calcium 225mg Vitamin K2-7 50mcg + Zinc Sulphate USP eq. to elemental Zinc USP 7.5mg + Magnesium Oxide IP eq. to elemental Magnesium IP 50mg hard gelatin capsules | Methylcobalamin IP 1500mcg + Alpha Lipoic Acid USP 100mg + Vitamin D3 IP 8000IU + Calcium Carbonate IP eq. to elemental Calcium 225mg Vitamin K2-7 50mcg + Zinc Sulphate USP eq. to elemental Zinc USP 7.5mg + Magnesium Oxide IP eq. to elemental Magnesium IP 50mg hard gelatin capsules | For the treatment of Vitamins and Minerals deficiency in adult patients | 28.02.2024 |
| Glimepiride IP + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin (1mg + 100mg & 2mg + 100mg) film coated tablets | Glimepiride IP + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin (1mg + 100mg & 2mg + 100mg) film coated tablets | For the treatment of patients with type 2 diabetes mellitus, inadequately controlled on Metformin Monotherapy. | 08.03.2024 |
| Dapagliflozin propanediol Monohydrate eq. to Dapagliflozin + Linagliptin + Metformin Hydrochloride IP (as sustained release) (10mg + 5mg + 500mg & 10mg + 5mg + 1000mg) film coated bilayered tablets | Dapagliflozin propanediol Monohydrate eq. to Dapagliflozin + Linagliptin + Metformin Hydrochloride IP (as sustained release) (10mg + 5mg + 500mg & 10mg + 5mg + 1000mg) film coated bilayered tablets | Indicated in patients with type 2 diabetes mellitus inadequately controlled on Metformin alone | 08.03.2024 |
Disclaimer:
- Vaayath has only compiled and organized the data of new drugs available on CDSCO portal in a user friendly and easily searchable format. In case of any discrepancy, please refer and verify the same at www.cdsco.gov.in
- The list is dynamic in nature and we will keep on updating whenever new products are approved and in case of any discrepancy observed by ourselves or highlighted by our readers.
