| Name of Drug |
Indications |
Date of Approval |
| 5-Aminosalicyclic Acid |
Ulcerative Colitis |
Jun-89
|
| Abciximab |
Adjunct to PTCA |
02.05.1997
|
| Aclarubicin Injection |
Anti-Cancer |
Mar-88 |
| Adenosine |
Anti-Epileptic |
Jul-97
|
| Alendronate Sodium |
For post menopausal Osteoporosis |
Sep-97
|
| Alprazolam |
Anxiolytic agent |
Jun-88 |
| Altretamine |
Anti-Cancer |
Mar-95
|
| Ambroxol HCL |
"Acute and chronic disease of the respiratory tract associated with abnormal bronchial secretions in particular acute attacks of chronic bronchitis, asthamatic bronchitis,bronchial asthma." |
01.12.1995
|
| Amifostine |
Chemoprotective agent against the serious toxicities associated with intensive regimes of platinum and alkylating agent chemotherapy. |
21.03.1996
|
| Amineptine |
Anti-depressant |
Jan-88
|
| Amiodarone HCL |
Cardiac |
Apr-90
|
| Amitraz |
Veterinary |
Aug-96
|
| Amlodipine |
Antihypertensive |
May-93
|
| Amrinone Lactate |
Inotropic Agent |
May-98
|
| Amsacrine Inj. |
Anti-Cancer |
Feb-92
|
| Anti-Rabies Vaccine (Killed) Vet. |
Vaccine |
Mar-89
|
| Arteether |
Anti-Malarial |
14.01.1997
|
| Artemether Injection (Finishedd formulation) |
Promoted for use in severe malaria including cerebral malaria a second line in chloroquine resistant malaria cases only. |
02.08.1996
|
| Artesunate |
Malaria |
02.08.1996
|
| Astemizole |
Anti-allergic |
Feb-88
|
| Atorvastatin |
Anti Hyperlipidaemia |
17.09.1999
|
| Atorvastatin |
Anti-Lipid |
10.09.1999
|
| Azelastine Hydrochloride |
Anti-allergic rhinitis |
Jul-97
|
| Azithromycin |
Antibacterial |
May-94
|
| Babies Vaccine Inactivated (Vero-Cell) |
Vaccine |
Nov-88
|
| Bacillocid special |
Disinfectant (surface) |
May-92
|
| Baclofen |
"Voluntary muscle spasticity due to cerebrovascular accidents cerebral palsy, meningitis multiple sclerosis, spinal lesions." |
29.09.1995
|
| Bambuterol |
Bronchodilator |
13.12.1999
|
| Basiliximab Injection |
Immuno Suppressant |
28.05.1999
|
| Benazepril Hcl |
Anti-hypertensive and Congestive heart failure. |
22.04.1996
|
| Benidipine Hcl |
Hypertension Angina Pectoris |
12.08.1996
|
| Benoxinate Hcl |
Opthalmic |
Nov-92
|
| Benzydamine |
Topical analgesic |
Apr-88
|
| Betaxolol Hcl |
Opthalmic |
May-92
|
| Bezafibrate |
Lipid Lowering Agent |
Jan-88
|
| Bifonazole |
Anti-fungal |
Nov-97
|
| Biphenyl-acetic acid |
NSAID |
27.04.1998
|
| Bisoprolol fumarate |
Anti-hypertensive |
Feb-92
|
| Botulinum Toxin Type A.I.M.Injection |
Neurotoxin acting |
Jan-94
|
| Brimonidine Tartrate |
Opthalmic |
18.05.1999
|
| Budesonide |
Anti-asthmatic |
Feb-88
|
| Bulaquine Compound |
Antimalaria |
21.12.1999
|
| Buspirone |
Anxiolytic |
Oct-90
|
| Butafosfane + Cyanocobalmin Inj. |
Veterinary |
04.03.1998
|
| Butalex |
Vet.Drug |
Apr-91
|
| Calcitriol Injection |
Vit.D3 Biologically Active |
Mar-94
|
| Calcitriol Soft Gelatin Capsule |
Metabolic Bone Disease |
Aug-93
|
| Calcium Dobesilate |
for Chronic Venous |
Sep-97
|
| Carboplatin Inj. |
Anti-Cancer |
Mar-89
|
| Carteolol Hcl |
In management of Hypertension opth.20% is in ocular hypertension chronic open angle glaucoma and some secondary Glaucoma. |
09.07.1996
|
| Carvedilol |
Antihypertensive agent |
16.10.1998
|
| Cefaclor |
Antibiotic |
Apr-91
|
| Cefadroxyl |
Antibiotic |
Feb-89
|
| Cefixime |
Antibiotic |
Mar-93
|
| Cefoperazone Sodium Inj.IM/IV |
|
Aug-93
|
| Cefpirome |
Anti - infective |
Sep-97
|
| Cefpodoxime Proxetil |
For bronchitis |
Sep-97
|
| Cefpodoxime Proxetil |
"Antibacterial for use in adult and children with mild to moderate infections involving URT & LRT, skin & soft tissue, Uti, Sexually Transmitted infections." |
14.03.1996
|
| Certazidime pentahydrate |
Antibiotic |
Jun-88
|
| Ceftibuten (Finished formulation) |
"URTI, LRTI, UTI" |
19.11.1996
|
| Ceftizoxime Sod.Sterile |
Cephalosporin |
May-90
|
| Ceftriaxone Sodium |
Antibiotic |
Apr-88
|
| Cefuroxime Axetil |
Antibiotic |
May-90
|
| Cefuroxime |
Antibiotic |
Jun-88
|
| Celecoxib |
NSAID |
22.02.2000
|
| Centchroman |
Oral Contraceptive |
Nov-90
|
| Centropazine |
Antidepressant in the treatment of depression only |
16.08.1996
|
| Cephacetril Sodium |
Veterinary Drug |
May-92
|
| Cerivastatin |
Lipid Lowering Agent |
11.05.2000
|
| Cetirizine |
Seasonal rhinitis perennial allergic rhinitis pruritus |
Jun-93
|
| Chando Chelated |
Anti-bacterial |
May-89
|
| Ciprofloxacin Hydrochloride |
Anti-bacterial |
May-89
|
| Cisapride |
Gastro-Intestinal disorders |
Nov-92
|
| Clarithromycin |
Antibiotic |
Mar-95
|
| Clobazam |
Anti-Epileptic |
11.11.1997
|
| Clomipramine Hcl |
Anti-depressant |
Feb-92
|
| Clonazepam |
Anti-Epileptic |
Jan-95
|
| Closantel (Vet) |
Veterinary Drug |
Oct-94
|
| Clozapine |
Schizophrenia |
Mar-95
|
| Colfosceric Palmitate |
Respiratory Distress Syndrome |
Dec-93
|
| Coligen (vet) |
Veterinary Drug |
Jun-90
|
| Collagen with Gentamycin implant |
Anti-infective |
06.05.1998
|
| Collagenase |
|
May-94
|
| Complex 15 cream |
Phospholipid |
10.01.1997
|
| Creatine Phosphate |
Coadjuvant for Cardiac Muscles |
20.01.1997
|
| Cumophos (Vet.) |
Veterinary Drug |
Jul-93
|
| Cyclosporin oral soln. |
Immuno-suppressant |
Jun-88
|
| Cypermethrin high cis (Vet) |
"for control of ticks, flies, lice and mites in cattle, sheep, dogs, poultry." |
18.09.1996
|
| Danofloxacin mesylate (Vet. Inj) |
Bovine respiratory disease in beef cattle non lactating dairy cattle calves caused by P.haemolytica caused by E coli / salmonella sp. |
28.07.1995
|
| Desmopressine Intra nasal solution / nasal spray /inj. |
"Central or neurogenic Diabetes Insipidus,bleeding disorders,Nocturnal enuresis" |
Aug-89
|
| Desogestrel (to be combined with Ethinyl oestradiol) |
Oral Contraceptive |
Jan-89
|
| Desonide |
Cortico Steroid |
07.03.1997
|
| Diazinon (Vet.) |
Veterinary |
Apr-90
|
| Dinoprostone (PGE2) |
For induction of labour |
Feb-90
|
| Dipivefrin Hcl |
For the control of intra ocular pressure in chronic open angle glaucoma |
16.05.1996
|
| Disodium Pamidronate Inj. |
Anti-Cancer |
Feb-95
|
| Dobutamine |
Inotropic Agent |
Oct-97
|
| Docetaxel (inj.) |
In treatement of patients with locally advanced or metastatic breast cancer and small cell lungs cancer. |
20.06.1996
|
| Dovamectin (Vet) |
Vet Drug |
Oct-97
|
| Doxazosin Mesylate |
Anti-hypertensive |
11.03.1999
|
| DPT-ACT HiB Vaccine |
Vaccine |
Jan-98
|
| Eerioplast (Fitrin adhesive glue) |
"Tissue adhesion,Suture support Haemostasis wound care,sealing of body cavities & subarachnoid space only." |
19.06.1996
|
| Enalapril Meleate |
All grades of hypertension |
Aug-89
|
| Enrofloxacin |
Vet-Drug |
Jan-94
|
| Eptifibatide IV Injection |
Acute Coronary Syndrome |
25.08.1999
|
| Eptifibatide |
Coronary Heart Ailments |
30.06.1999
|
| Equino Inflyenza & equine Rhinopneumonitis Vaccine(Vet.) |
Vaccine |
Mar-89
|
| Erythropoietin (rDNA) |
Anaemia due to chronic renal failure |
Jan-93
|
| Esmolol Hydrochloride |
Cardio selective beta blocker |
Aug-94
|
| "Estradiol TTS 25,50,100 mcg/day" |
Estrogen |
Feb-94
|
| Ethamsylate |
Anti-haemostatic |
May-88
|
| Etidronate Disodium |
Anti-cancer |
Mar-95
|
| Etodolac |
NSAID |
10.04.1997
|
| Etoposide capsules & injection |
Anti-Cancer |
Jan-88
|
| Famotidine |
Anti-ulcer |
May-89
|
| Farvovirus Vaccine |
Vaccine |
Mar-89
|
| Felodipine |
Anti-hypertensive |
May-91
|
| Fenofibrate |
Anti Hyperlipidaemia |
22.12.1999
|
| Fexofenadine HCl |
Antihistamine agent |
16.09.1998
|
| Filgrastim injection |
Anti-Cancer |
Sep-93
|
| Finasteride |
Benign prostatic hypertrophy |
09.10.1996
|
| Firarubicin HCl Inj. |
Anti-Cancer |
May-91
|
| Flavophospholipol (Flavomycin) |
Antibiotic (vet.) |
Sep-89
|
| Flecainide Acetate |
Aniarrhythmic |
Mar-93
|
| Fluconazole |
Systemic Antifungal |
Jan-93
|
| Fludarabine Phosphate |
Anti-Cancer |
26.06.1999
|
| Flumethrin (Vet.) |
Vet Drug |
Oct-97
|
| Flunarizine Hcl |
Antimigraine |
Nov-90
|
| Flunisolide |
Allergic Rhinitis |
Nov-93
|
| Fluorometholone with Neomycin |
in non inflammatory ocular condition |
20.07.1996
|
| Fluoxetine Hcl |
Anti-depressant |
Mar-90
|
| Fluticasone propiopnate |
Inflammatory & Pruritic manifestation of cortisteroid responsive eczema dermatitis. |
18.03.1996
|
| Fluvoxamine Meleate |
Anti-depressant |
21.02.2000
|
| Formestane Depot Inj. |
Anti-Cancer |
Mar-95
|
| Fortison Liquid/Powder Pepti-2000 Liquid Powder |
Nutritional preparation |
Jan-95
|
| Fotemustine IV injection (finished formulation) |
In the treatment of disseminated malignant melanoma including cerebral localization and primary malignant cerebral tumours. |
23.12.1996
|
| Fucidic acid hemihydrate |
Opthalmic |
Mar-92
|
| Gabapentin (Finished formulation) |
as adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in adults with epilepsy |
03.08.1995
|
| Gadodiamide I.V.Injection |
Contrast Media |
Jan-94
|
| Gadopentetic acid Dimeglumine salt |
Contrast Media |
May-92
|
| Ganciclovir |
AntiViral |
05.04.2000
|
| Gemcitabine Inj. |
in management of non smallcell lung cancer. |
24.01.1996
|
| Gemfibrozil |
Lipid Lowering Agent |
Aug-88
|
| Genotropin Injection |
Growth Harmone |
Sep-94
|
| Ginkgo biloba extract |
Herbal extract |
Sep-92
|
| Gliclazide |
Anti-diabetic |
Nov-88
|
| Glimpiride |
Anti-diabetic |
22.01.1999
|
| Glucomannan |
Anti-Diabetic (herbal) |
Sep-93
|
| Goserelin Acetate |
"For the treatment of prostate cancer, endometriosis." |
24.04.1996
|
| Heamophilus type b Congugate Vaccine |
Influenzae Vaccine |
Dec-94
|
| Haloperidol |
Chronic Schizophrenia |
Feb-90
|
| Haltrexone |
In the treatment of narcotic dependence and alcohol dependence |
11.10.1996
|
| Hepatitis - A |
Vaccine |
05.02.1998
|
| Horse Antihuman Lymphocyte Globulin |
For Aplastic anaemia |
May-91
|
| Idarubicin Hydrochloride |
Anti Cancer Drug |
May-91
|
| Idebenone |
For cerebral arteriosclerosis |
Sep-97
|
| Immucyst (Bacillus Calmette & Guerin Vaccine) |
Anti-Cancer |
Jun-92
|
| Influenza Vaccine inactivated (finished formulation) |
Prophylaxis against influenza |
30.08.1996
|
| Interferon Alpha Inj. (Recombinant) |
Anti-Cancer |
May-88
|
| Iopromide (Ultravist) |
Contrast Media |
Jul-90
|
| Ioversol injection |
Contrast Media |
Dec-93
|
| Ipratropium bromide |
Anti-cholinergic bronchodilator |
Nov-92
|
| Irbesartan |
Anti Hypertensive |
26.06.2000
|
| Irinotecan Hcl Trihydrate |
Anti-Cancer |
23.05.1997 to 22.05. |
| Isepamicin |
Antibiotic |
Dec-97
|
| Isoflurane |
Anaesthesia |
Jul-90
|
| Itraconazole |
Antifungal |
Jul-93
|
| Itrolan (Isovist) |
Contrast Media |
Oct-92
|
| Ketorolac tromethamine |
Non-steroidal analgesic antiinflammatory |
Apr-92
|
| Ketotifen |
Anti Asthmatic drug |
May-91
|
| Korsolex Concentrate |
Instrument disinfectant |
May-92
|
| Lacidipine |
Anti Hypertensive |
06.05.1997 to 05.05. |
| Lamivudine |
Anti-Aids |
27.03.1998
|
| Lamotrigine |
Anti-Epileptic |
14.05.1998
|
| Lansoprazole |
Anti ulcer |
Dec-94
|
| Latonoprost |
Opthalmic |
12.05.1998
|
| L-Carnitine |
Vitamin Deficiency |
Jun-90
|
| Letrozole |
Anti-Cancer |
12.03.1998
|
| Levobunolol Hcl. |
For control of Intra occular pressure in chronic open angle glaucoma and occular hypertension. |
16.05.1996
|
| Levofloxacin |
Antibacterial |
26.07.1999
|
| Levovist |
Contrast Media |
Nov-97
|
| Levprolide Acetate Dept. Inj. |
Anti-Cancer |
Dec-97
|
| Lisinopril |
Anti-hypertensive |
Nov-91
|
| Lofepramine Decanoate |
Anti Depressant |
Jan-90
|
| Lomefloxacin |
Antibacterial |
May-94
|
| Loratadine |
Long acting anti-histamine |
Jun-92
|
| Losartan Potassium |
Anti-hypertensive |
16.06.1998
|
| Lovastatin |
Reduction of total L.D.L. Cholesterol in patients of primary hypercholesterolemia (type IIa and IIb hyperlipoprolcinemeia) |
05.10.1995
|
| Loxapine |
Antidepressant |
Sep-90
|
| Madramicin Concentrate |
Veterinary |
Jul-93
|
| Mefloquine Hcl |
Anti Malarial |
03.03.1997
|
| Melagenina Lotion |
Leukoderma |
May-88
|
| Melatonin |
Hormone |
12.03.1998
|
| Melitracen Hcl |
Antidepressant agent |
28.10.1998
|
| Meloxicam |
NSAID |
16.02.1999
|
| Mepartricin |
Benign prostatic hyperplasia |
May-93
|
| Midazolam |
Anasthetic General |
15.04.1997
|
| Milrinone Lactate |
Congestive Heart Failure |
17.05.1999
|
| Minocycline |
Antibiotic |
May-88
|
| Minoxidil |
Male-pattern baldness |
Apr-88
|
| Mitoxantrone HCL |
Anti-cancer |
Mar-89
|
| Mometasone Furoate |
Topical Corticosteroid |
Oct-90
|
| Monocomponent Insulin Lispra (rDNA) injection |
Anti-diabetic |
Dec-97
|
| Moxidectin (1%) 1M |
Veterinary |
16.01.1997
|
| Mupirocin |
Anti-Bacterial skin infection |
Sep-91
|
| Mycophenolate Mofetil |
immuno supressive agent |
07.02.1999
|
| Nabumetone |
NSAID |
18.05.1999
|
| Nafarelin Acetate |
GnRH Antagonist |
17.03.1999
|
| Naloxone Hydrochloride |
Barocotic antagonist |
Jul-92
|
| N-butyl-2-cyano Crylate |
For treatment of smooth and fresh skin wounds and surgical incisions. |
06.06.1996
|
| Nefopam |
Analgesic |
Apr-91
|
| Nevirapine |
Anti HIV |
06.03.2000
|
| Nicardipine Hcl |
Anti-hypertensive |
Oct-93
|
| Nicorandil |
Anti Anginal |
10.01.1997
|
| Nicotine Transdermal therapeutic System |
Anti-smoking |
May-95
|
| Nilutamide |
Anti-cancer |
Oct-91
|
| Nimesulide |
NSAID |
Jan-95
|
| Nimodipine |
Cerebral Protective agent |
Aug-92
|
| Nitrendipine |
Anti-hypertensive |
May-91
|
| Nitroscanate (Vet.) |
For control/eradication of hook worms/Round worms/Tape worms in puppies and adult dogs |
19.02.1996
|
| Ofloxacin |
Antibacterial |
Feb-90
|
| Olanzapine |
Anti Psychotic |
27.01.2000
|
| Omeprazole |
Anti-ulcer |
Apr-91
|
| Ondansetron Hcl. Dihydrate |
Antiemetic |
Feb-94
|
| Oral Polio Vaccine |
Polio Vaccine Oral (Verocell) |
May-92
|
| Ornidazole |
Anti Protozoal |
13.01.1997
|
| Orthoclone Sterile (OKT3) |
immuno suppressant |
Oct-90
|
| Oxaliplatin inj |
Anticancer agent |
26.10.1998
|
| Oxiconazole |
Antifungal |
17.01.2000
|
| Oxybutynin chloride |
Antimuscarinic agent |
03.09.1998
|
| Paclitaxel Injection |
Anti Cancer |
Aug-94
|
| Pantoprazole tabs |
Antiulcer agent |
09.12.1998
|
| Paspat Injection |
Bronchial Asthma Allergic |
May-93
|
| PCEC Vaccine (Rabies HEP Flurystrain) |
Vaccine |
Nov-88
|
| Pefloxacin Mesylate |
Anti-bacterial |
May-91
|
| Penflundol |
Neuroleptic agent |
Mar-88
|
| Perindoprill |
Anti-hypertensive |
Sep-91
|
| Permethrin |
Anthlice/Antiscabies |
Mar-95
|
| Pipecuronium Bromide |
Non-depolarising muscle relaxing agent |
Nov-92
|
| Piperacillin sodium |
Antibiotic |
Aug-89
|
| Piperacillin+Tazobactum IV Inj. |
Antibiotic |
13.08.1999
|
| Peperacillment Tazabactum |
Respiratory Tract Infections |
09.08.1999
|
| Piribedil |
Idopathic Parkinsons Disease |
Sep-93
|
| Piroxicam Beta-cyclodextrin |
"Rhematoid Arthritis,Osteoarthritis,ankylosing spondylitis,acute muscio skeletal disorders, acute gout." |
25.03.1996
|
| Podophyllotoxin |
Anogenital.Nonfacial warts |
May-95
|
| Polysacharide pneumococcal Vaccine (Finished formulation) |
for prevention and pnesonoccocal pneumonia |
09.07.1996
|
| Polyvinyl Alcohol with Povidone and chlorbutanol eye drops |
for relief from burning irritation and discomfort due to dryness of the eye. |
11.01.1996
|
| Prazosin |
Anti-hypertensive |
Jun-90
|
| Prednicarbate |
Anti-skin diseases |
Aug-97
|
| Prenoxdiazine Hcl (Libexin) |
Anti-Tissue agent |
Jul-90
|
| Promegestone |
"gynaecological conditions characterised by luteal insufficiency, menstrual irregularities and dysmenorrhea." |
23.09.1996
|
| Propfol Inj. |
Anaesthetic agent |
05.05.1998
|
| Propoxur + Flumethrin |
Veterinary |
03.05.1997
|
| Purified chick Embryo Tissue Culture Rabies Vaccine |
Vaccine (Human use) |
Dec-89
|
| Purified Vicapsular Polysaccharid of Salmonella Typhi |
Typhoid Vaccine |
Feb-93
|
| Rabbit Anti-human Thymocyte Immunoglobin I.V. |
For Aplastic anaemia |
May-91
|
| Ramipril |
ACE inhibitor |
Aug-91
|
| Recombinant Human Tissue type plasminogen activator Inj.(Actilyse) |
Fibrinolytic therapy |
Jul-89
|
| Repaglinide |
Anti Diabetic |
23.03.2000
|
| Retrodrine Hcl |
Toxaemia of pregnancy |
Feb-95
|
| Ribavirin (Virozole) |
Antiviral agent |
Nov-90
|
| Rilmenidine Dihydrogen Phosphate |
Anti Hypertensive |
Feb-95
|
| Riluzole Tablets |
For motor neurone disease |
Oct-97
|
| Risperidone |
Anti Psychotic |
03.04.1997
|
| Ritonavir Capsules |
Anti-HIV |
Sep-97
|
| Rivastigmine Caps |
Acetylcholine esterase inhibitor agent |
31.07.1998
|
| Rocuromiem Bromide Inj. |
As an adjuvant to general anaesthesia to facilitate endotracheal intubation to provide skeletal muscle relaxation during surgery. |
18.06.1996
|
| Rofecoxib |
NSAID |
26.06.2000
|
| Rosiglitazone Maleate |
Anti Diabetic |
28.06.2000
|
| Rowachol |
For hepato-billary disorders |
Sep-91
|
| Roxatidine Acetate Hcl |
Anti-ulcer |
May-91
|
| Roxithromycin |
Anti-bacterial |
Mar-92
|
| Sacharomyces boulardi |
Irritable bowel syndrome |
18.12.1997
|
| Sacchoromyces Boulardi |
Yeast |
Dec-97
|
| Salinomycin (Vet.) |
Veterinary drug |
Dec-88
|
| Salmetrol Xinofate |
Bronchodilator |
Dec-93
|
| Salmon Calcalcitonin Inj. (finished formulation) Osteoporosis |
"Hypercalceamia pain associated with advanced metastic bone cancer,Pagets disease,post menopausal" |
03.08.1995
|
| Saquinavir Capsules |
Anti - HIV |
Aug-97
|
| Secnidazole |
"Amoebiasis giardiasis bacterial and trichemonal, Vaginitis" |
May-93
|
| Selegiline Hcl |
Anti-Parkinsonism |
Aug-91
|
| Semduramycin Sod. |
Veterinary |
04.03.1998
|
| Sevoflurene inhalation (Finished formulation) |
For induction and maintenance of general anesthesia in all types of procedures and patients. |
09.07.1996
|
| Serenda Repcus |
For B P H |
Sep-97
|
| Sertraline Hcl |
Anti-depressant |
09.06.1998
|
| Sexfenfluramine Hcl |
Anti-Obesity |
Jun-92
|
| Sibutramine Hcl |
Anti-Obesity |
23.12.1999
|
| Silymarin |
Heptoprotective |
Jun-95
|
| Simuvastatin |
Anti hyperchlokesterolemia |
Sep-97
|
| Sodium Enoxaparin |
Thromoembolic |
Mar-92
|
| Sodium Hyaluronate solution |
Aid Intraocular Surgery |
Jun-89
|
| Sodium Picosulphate |
Laxatives |
11.02.1997
|
| Somatostatin I.V. Infusion |
Antihaemorrage |
Apr-95
|
| Somatropine (rDNA) Inj. |
Growth hormone |
04.02.1998
|
| Sorbister Capsules |
Nephrological |
Sep-93
|
| Sparfloxacin |
"Community, Acquired Pneumonea acute exacerbation of chronic bronchitis, other lower gonococcal and non gonococcal Burethritis is complicated U.T.I." |
11.11.1996
|
| Spenglersan |
Immuno-Modulator |
02.06.1997
|
| Stavudine |
Anti - HIV |
Jul-97
|
| Sterillium rubin disinfectant |
Disinfectant for hands |
May-92
|
| Stronger Neo minophagen-C (Finished Formulation) |
Indicated for the management of sub-acute hepatic failure |
14.12.1995
|
| Sulbutiamine |
Symptomatic treatment of functional asthenia. |
22.04.1996
|
| Sulpha Chloropyrazine Sodium |
Veterinary |
Nov-93
|
| Sulpiride |
Anti Depressant |
25.10.1999
|
| Sultamicilline |
Antimicrobial agent |
May-94
|
| Sumatriptan Tabs/Injection |
Acute Migrane attacks with or without aura only when there is a clear diagnosis. |
06.02.1996
|
| Tacrine HCL. |
For the treatment of dementia in patients with alzheimers disease of mild to moderate severity. |
14.02.1996
|
| Taurolidine 2% or 0.5% |
Antimicrobial |
Jan-94
|
| Telcoplanin for IV/IM |
Antibiotic |
19.02.1997
|
| Temozolamide |
Anti Cancer |
17.01.2000
|
| Tenoxicam |
NSAID |
Apr-93
|
| Teratolol Hydrochloride |
Anti-hypertensive agent |
Jun-88
|
| Terazosin/HCL |
Anti Hypertensive |
Jan-95
|
| Terconazole |
Anti fungal |
Jul-94
|
| Terfenadine |
Anti histamine |
Sep-90
|
| Terlipressin Acetate inj. I.V. (finished formulation) |
For the treatment of bleeding Oesophagal varices. |
22.07.1995
|
| Tetra Chlorodecaxide |
Immunomodulator |
Nov-92
|
| Tetrabenazine |
Presynaptic monoamine Depleting agent |
10.03.1999
|
| Thiocolchicoside |
"As an adjuvant treatment in painful spasm associated with degenerative vertebral disorders & vertebral static problems, Torticollis dorsal pain, low back pain, Traumatological and neurological disorders." |
25.03.1996
|
| Tiaprost Trometamol Inj. |
Veterinary |
19.02.1997
|
| Ticlopidine |
Antiplatilet aggregation |
Feb-93
|
| Tiobolone |
In treatment of Complaints resulting from natural or surgical menopause |
16.10.1996
|
| Tizenidine HCL |
Muscle - Relaxant |
Dec-93
|
| Tolfenamic Acid |
NSAID |
04.03.1998
|
| Toltrazuril |
Veterinary |
30.04.1998
|
| Topairamate Tablet |
Epilepsy |
23.08.1999
|
| Topiramale |
Antiepileptic |
23.08.1999
|
| Topotecan Hcl |
Anti-cancer (Ovarian) |
15.06.1999
|
| Tramadol |
Analgesic |
Jan-93
|
| Trapidil |
Adjuvant in angioplasty |
11.05.2000
|
| Triclabendazole (Vet.) |
Broad spectrum flukicide |
Sep-88
|
| Tripotassium Dicitrato Bismuthate |
Anti - ulcer |
Jan-89
|
| Triptorelin (Inj.) |
Anti-Cancer |
Jul-93
|
| Tromantadine Hydrochloride |
Anti-viral |
Feb-95
|
| Vancomycin HCL. Inj. |
Antibacterial |
Mar-94
|
| Vindesine Sulphate Injection |
Anticancer agent |
28.10.1998
|
| Xylazine Hcl |
Vet. Drug |
Nov-90
|
| Zalcitabine |
Anti-Aids |
Jul-93
|
| Zidovudine Caps. |
Treatment of HIV infections |
Apr-88
|
| Zolpidem |
Insomnia |
28.05.1999
|
| Zopiclone |
Short-term treatment insomnia |
16.08.1996
|
| Zuclopenthioxol Acetate |
Schizophrenia |
20.08.1999
|
| Zuclopenthixole Acetate |
Anti Maniac and Anti-Schizophrenia |
29.07.1999
|
| Butenafine HCL Cream 1% |
Anti Fungal |
14.02.2001
|
| Bupropion SR Tab. 150 mg |
Smoking cessation |
10.04.2001
|
| Clopidogrel |
Anti Platlet Aggregation Inhibitor |
02.02.2001
|
| Doneprazal HCL |
For Alzheirmer's Disease |
20.03.2001
|
| Efavirenz 50/100/200 mg* |
Anti HIV |
06.06.2001
|
| Indinavir Sulphate * |
Anti Aids |
01.02.2001
|
| Misoprostol |
Anti Ulcer |
21.06.2001
|
| Mitrzapine |
Anti depression |
14.02.2001
|
| Mosapride |
Prokinetic Agent |
13.03.2001
|
| Moxifloxacin |
Anti Bacterial |
26.06.2001
|
| Nelfinavir * |
Anti HIV |
29.06.2001
|
| Reloxifen |
Menopausal Osteoporosis |
04.05.2001
|
| Sildenafil Citrate |
Men Erectile Dysfunction |
08.01.2001
|
| Thymosin Alfa 1 Inj. * |
Anti-Hepa - B |
17.01.2001
|
| Triflusalcaps 30mg ** |
Prevention of Thromboembolism |
17.01.2001
|
| Vinorelbin Tartrate Inj. * |
Anti Cancer |
17.01.2001
|
| Cefdinir |
Anti Bacterial |
10.10.2001
|
| Citalopram HBr |
Anti Depressant |
03.10.2001
|
| Decapeptide |
For Vitrigo |
22.10.2001
|
| Desloratidine |
Anti-Allergic |
30.10.2001
|
| Ebastine |
Anti-Allergic |
28.09.2001
|
| Esomeprazole Mag. |
Anti-Ulcer |
04.12.2001
|
| Etanercept-Recomb. |
Anti-Rheumatic |
07.12.2001
|
| Exemestane |
Anti-Cancer |
18.10.2001
|
| Gatifloxacin |
Anti-Bacterial |
03.10.2001
|
| Genirelix |
Fertility Drug |
08.10.2001
|
| Imatinib Mesylate |
Anti-Cancer |
09.12.2001
|
| Lobitridol |
Contrast Medium |
17.10.2001
|
| Leflunomide |
Anti-Rheumatoid |
01.10.2001
|
| Linezolid |
Anti-Bacterial |
04.10.2001
|
| Nelfenavir Mesylate |
Anti-HIV |
02.07.2001
|
| Oxcarbazepine |
Anti-Epileptic |
30.10.2001
|
| Rabeprazole |
Anti-Ulcer |
27.12.2001
|
| Racecadotril |
Anti-Diarrhoeal |
10.10.2001
|
| Ropinrole |
For Parkinson's Disease |
03.12.2001
|
| Zolendronic Acid |
For Hypercalcaemia |
05.11.2001
|
| Meropenem Injection |
Beta - Lactum Antibiotic |
8/1/02
|
| Bimatoprost (ophthalmic Solution) |
Anti-Glaucoma |
8/1/02
|
| Fosinopril sodium Tabs |
Anti- hypertensive |
10/1/02
|
| Montelucast sodium Tabs |
Anti- asthama |
NA
|
| Thymogen Injection |
Anti - cancer |
10/2/02
|
| Mifepristone Tablets |
Progesterone antagonist |
13-02-2002
|
| Dexarazoxane Powder |
Cardio-protective agent |
26-02-2002
|
| Tranexamic acid |
Anti-fibrinolytic |
06.03.2002
|
| Bicalutamide tablets |
Anti-cancer |
07.03.2002
|
| Apraclonidine opthalmic solution |
a-2 Adrenergic agonist (ophth) |
15.03.2002
|
| Mizolastine tablets |
Anti-allergic |
15.03.2002
|
| Miltefosine tablets |
for Kalazar |
15.03.2002
|
| Loteprednol Etabonate ophthalmic solution |
Steriodal anti-inflammatory (ophth) |
15.03.2002
|
| Ziprasidone Hcl |
for Schizophrenia |
Not Available
|
| Nadifloxacin cream |
Anti-bacterial |
28.03.2002
|
| Tamsulosin HCL tablets |
a-Adrenoceptar antagonist |
04.04.2002
|
| Famiciclovir tablets |
Guanine analogue |
11.04.2002
|
| Nateglinide tablets |
Anti-hypertensive |
01.05.2002
|
| Lercanidine HCL tablets |
Anti-hypertensive |
07.05.2002
|
| Itopiride capsules |
Gastro prokinetic agent |
09.05.2002
|
| Alpostadil injection |
for erectile dysfunction |
09.05.2002 |
| Quetiapine fumerate |
Anti-psychotic |
31.05.2002
|
| Isotretinoin soft gel caps. |
for Aene vulgaris |
21.06.2002
|
| Abacavir |
Anti - HIV |
22.03.2002 |
| Vimpocetine |
Vasodilator |
13.05.2002 |
| Acamprosate Calcium |
For Alcohol Dependency |
30.10.2002 |
| S(-) Amlodipine Besylate |
Anti - Hypertensive |
16.08.02 |
| Aztrenam |
Anti - Bacterial |
01.11.02 |
| Balsalazide Disodium |
For Ulcerative Colitis |
12.11.02 |
| Butorphanol Tartrate |
Opoid Analgesic |
11.09.02 |
| Cabergoline |
For Hyperprolactinemia |
05.09.02 |
| Cefepime Hcl |
Anti-Biotic |
30.10.02 |
| Cefetamet Pivoxil |
Anti - Bacterial |
11.11.02 |
| Ceftiofur Sodium & Ceftiofur Hcl |
Anti-Biotic (For Veterinary Use) |
08.10.02 |
| Drotrecogin Alpha (Activated) |
For severe Sepsis |
23.07.02 |
| Fosphenytoin Sodium |
Anti - Epileptic |
01.10.2002 |
| Gemtuzumab Ozogamicin |
For Mycloid Leukemia |
12.09.2002 |
| Levocetrizine |
Anti - Histamic |
12.12.2002 |
| Metaxolone |
Muscle Relaxant |
08.10.2002 |
| Nebivolol Tab |
Anti - Hypertensive |
12.07.2002 |
| Parecoxib |
NSAID |
01.11.2002 |
| Pygenum Africanum |
For Benign Prostatic Hypertrophy |
30.07.2002 |
| Quinapril |
Anti - Hypertensive |
19.09.2002 |
| Sirolimus |
Immunosuppleasant |
15.07.2002 |
| Tegaserod Maleate |
For Irritable Bowel Syndrome |
01.11.2002 |
| Telmisartan |
Anti - Hypertensive |
25.11.2002 |
| Thalidomide |
For Leprosy |
12.08.2002 |
| Valacyclovir |
Anti - Viral |
25.09.2002 |
| Valdecoxib |
NSAID |
01.08.2002 |
| Cefprozil |
Antibiotic |
1.10.2003 |
| Cilostazol |
For Intermittent Claudication |
23.1.2003 |
| Escitalopram Oxalate |
Anti-Depressant
|
24.1.2003 |
| Anastrazole |
Anti-Cancer
|
10.2.2003 |
| Rizapriptan |
Anti-Migrain
|
27.2.2003 |
| Gadobenate (Dimeglumine IV Injection) |
MRI Contrast Medium
|
7.3.2003 |
| Tacrolimus Ointment |
Immuno-Modulator
|
10.3.2003 |
| Metolazone |
Diuretic
|
23.4.2003 |
| Tiotropium Bromide |
Anti-Asthemetic
|
16.4.2003 |
| Gadoversetamide Injection |
MRI Contrast Medium
|
4.4.2003 |
| Torsamide |
Diuretic
|
9.6.2003 |
| Cyproterone Tablet |
For Prostatic Cancer
|
10.6.2003 |
| Aripiprazote |
Anti-Schizophrenia
|
11.6.2003 |
| Azelaic Acid |
Anti-Acne
|
8.7.2003 |
| Bendrofluazide |
Diuretic
|
24.7.2003 |
| Implenem + Cilastatin |
Anti-Bacterial
|
25.7.2003 |
| Vinpocetin |
Anti-Pychotic
|
1.8.2003 |
| Tirofiban HCL I.V. |
Anti-Platelet
|
12.8.2003 |
| Teriparatide |
For Osteoporosis
|
4.9.2003 |
| Cladribine |
Anti-Cancer
|
9.9.2003 |
| Tadalafil |
For Erectile Dysfunction
|
11.9.2003 |
| S-Atenolol |
Anti-Hypertensive
|
11.9.2003 |
| Rosuvastatin |
Lipid Lowering Agent
|
12.9.2003 |
| Tazarotene |
Anti-Acne
|
12.9.2003 |
| Aceclofenac |
NSAID
|
15.9.2003 |
| Ibopamine HCL |
Opthalmic
|
3.10.2003 |
| Trandolapril |
Anti-Hypertensive
|
3.10.2003 |
| Dorzolamide |
Opthalmic
|
3.10.2003 |
| Fenoverine |
Anti-Spasmodic
|
8.10.2003 |
| Risedronate Sodium |
For Osteoporosis
|
17.10.2003 |
| Fondaparinax Sodium |
LMWH
|
22.10.2003 |
| Metadoxine |
For Hepatic Disorder
|
24.10.2003 |
| Valgancyclovir |
For CMV
|
20.11.2003 |
| Isopropyl Unoprostone |
Opthalmic
|
25.11.2003 |
| Amorolfine |
Anti-Fungal
|
25.11.2003 |
| Fluvastatin Sodium |
Lipid Lowering Agent
|
25.11.2003 |
| Modafinil |
For Sleeping Disorder
|
15.12.2003 |
| Sufentanil Citrate |
Anesthetic Agent
|
17.2.2003 |
| Ezetimibe |
Lipid Lowering Agent
|
18.12.2003 |
| Dutasteride |
For BPH |
16.02.04 |
| Gefitinib |
Anti-Cancer |
17.02.04 |
| Imidapril |
Anti-hypertensive |
23.02.04 |
| Adefovir Dipivoxil |
Anti-Viral (Hepatitis-B) |
04.03.04 |
| Etoricoxib |
NSAID |
05.03.04 |
| Diacerein |
For Osteoarthritis |
12.03.04 |
| Nitazoxanide |
Anti-Diarrhoel |
17.03.04 |
| Trolamine Cream (0.67%) |
For Topical use |
20.03.04 |
| Neotame |
Sweeteni Agent |
22.04.04 |
| Oxybutynine E.R. tablets |
For Neurogenic bladder disorder |
05.05.04 |
| Cabergoline 1 mg/2 mg/4 mg tablets |
For Parkinson disease |
07.05.04 |
| Rabeprazole Sodium Injection 20 mg/via |
For Gastric and Deudonal Ulcers & GERD |
12.05.04 |
| Alfuzosin E.R. tablets (10 mg) |
For BPH |
14.05.04 |
| Tiagabine HCL tablet (2/ 4/ 12/ 16 mg) |
Anti-Epiletic |
14.05.04 |
| Racecadotril Sachet (10/30 mg) |
Anti-Diarrhoel |
18.05.04 |
| Ibandronic Acid Inj (1 mg/1 ml) |
For Anti-Cancer |
18.05.04 |
| Tacrolimus Capsule (0.5mg / 1mg / 5mg) |
For Organ rejection |
21.05.04 |
| Cefdinir Disoersible tablet (125mg) |
Anti-biotic |
27.05.04 |
| Linezolid (600mg) tablet |
For Osteomyelitis in adults |
30.05.04 |
| FDC of Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye drops |
For post-operative inflammatory and bacterial infection of eyes |
15.06.04 |
| Cefbrozil Dispersible Tablet (125mg / 250mg) |
Anti-biotic |
22.06.04 |
| Divalproex Sodium E.R. Tablets (750mg / 1000mg) |
Anti-Epiletic |
24.06.04 |
| Lithium Carbonate E.R. (450mg) tablet |
Anti-Depression |
28.06.04 |
| Nimesulide Injection 75mg/ml |
For short-term treatment of post-operative Dain |
28.06.04 |
| FDC of Esomeprazole 20mg / 40mg + Domperidone 30mg SR Capsule |
For GERD |
29.06.04 |
| Aceclofenac (100mg) + Paracetamol (500mg) |
For acute painful condition in adults |
29.06.04 |
| FDC of Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 400 mg Tablets |
Anti-AIDS |
15.7.2004 |
| Memantic HCL Tablet 5mg / 10mg |
For dementia of Alzimer's type |
19.7.2004 |
| Pimcrolimus 10mg /gm Cream |
For atopic dermatitis |
23.7.2004 |
| FDC of Rabeprazole (20mg) + Mosapride S.R. (15mg) Tablet |
For GERD |
27.7.2004 |
| Rabamipide 100mg Tablet |
For Gastric Ulcer |
28.7.2004 |
| Cefetamet Pivoxil Suspension 250mg / 5ml |
Anti-biotic |
9.8.2004 |
| Diclofenac Transdermal Patch 100mg / 50cm2 |
For Osteoarthritis & Soft tissue injury |
10.8.2004 |
| FluconazoleGel (0.5%) |
Anti-fungal |
12.8.2004 |
| FDC of Atorvastatin (10mg / 20mg) + Ezetimibe (10mg) Tablet |
For Hypercholesterolemia |
13.8.2004 |
| Miglitol |
|
18.8.2004 |
| Miglitol Tablet 25mg / 50mg / 100mg |
Anti-diabetic |
18.8.2004 |
| FDC of Buprenorphin 2mg + Nalaxone (0.5mg) |
For Opiod Dependency |
19.8.2004 |
| FDC og Suralfate 0.07 + Metronidazole 0.01gm + Lignoxcaine 0.04gm Per gram of Cream |
For bedsore, haemorrhold fistula and anal fissure |
19.8.2004 |
| Citicholine Tablet 500mg & Injection 250mg /ml |
Membrane permeability enhancer |
20.8.2004 |
| FDCof Glibenclamide 2.5mg / 5mg + Metformin SR 500mg Tablet |
Anti-diabetic |
20.8.2004 |
| Lamotrigine S.R. tablet 50mg / 100mg 200mg |
Anti-epileptic |
26.8.2004 |
| Moxifloxacin Eye drops (0.5%) |
For bacterial conjuntivitis |
26.8.2004 |
| Risperidone long-acting Suspension for injection 25mg / 37.5mg / 50mg per vial |
For Schizorphrenia |
26.8.2004 |
| Escitalopram (10mg) + Clonezepam (0.5mg) |
For comorbid depression & anxiety disorder |
27.8.2004 |
| Everolimus Tablet (0.25mg /0.5mg / 0.75mg 1.0mg) |
Immunosuppressant |
30.8.2004 |
| Dorzolamide (20mg) + Timolol (5mg) per ml Eye drops |
For reduction of elevated IOP |
1.9.2004 |
| Gemcitabine (1.4gm / vial) |
Anti-cancer |
1.9.2004 |
| b - arteether Injection (150mg / 2ml) |
Anti=-malaria |
1.9.2004 |
| Ziprasidone powder for injection (after reconstitution 20mg / ml) |
Anti-psychotic |
3.9.2004 |
| Vorconazole Tablet (50mg / 200mg) Infusion (200mg / vial) |
Anti-fungal |
9.9.2004 |
| FDC of Nebivolol (5mg ) + S(-) Amlodipine (2.5mg) tablet |
Anti-hypertensive |
14.9.2004 |
| FDC of Valdecoxib (20mg) + Paracetamol (500mg) tablet |
For pain relief in adults |
20.9.2004 |
| Amlodipine (5mg) + Ramipril (2.5mg) tablet |
Anti-hypertensive |
24.9.2004 |
| FDC of Rabeprazole Sodium (20mg) + Domperidone (30mg) S.RCapsule |
For GERD |
4.10.2004 |
| Cefuroxime Axetil ER tablets (500mg / 1000mg) |
Anti-biotic |
6.10.2004 |
| Diclofenac Transdermal Patch (200mg / 75cm2) |
Fore pain relief |
6.10.2004 |
| Gatifloxacin Eye Ointment (1%) |
Opthalmic use |
6.10.2004 |
| Nimesulide injection (100mg / ml) (Veterinary) |
Veterinary use |
8.10.2004 |
| Isotretionin Gel (0.05%) |
For acne |
11.10.2004 |
| FDCof Epi-growth Factor (1gm) + |
|
20.10.2004 |
| FDC of Epi-growth Factor (1gm) + Silversulphadiazine Cream |
For Burns |
10.10.2004 |
| FDC of Amlodipine (5mg / 10mg) + Atrovastatin (10 / 20 / 40/mg) |
For co-existing hypertension & hyperlipedimeia |
20.10.2004 |
| Levosalbutamol rotacaps (100 mcg / capsules) & inhaler (50mcg / actuation) |
For obstructive airway disease |
20.10.2004 |
| Cefecoxib Injection (100mg / ml) |
For acute pain |
28.10.2004 |
| Orilistat (120mg) Capsule |
Anti-obesity |
27.10.2004 |
| Duloxetine HCL (20,30,40mg) Tablet |
Anti-depresant |
2.1.2004 |
| Deflazacort (1,6,30mg) tablet |
Anti-asthma
Anti-arthritis |
2.11.2004 |
| Atomoxetine HCL |
|
9.11.2004 |
| Atomoxatine HCL (10,18,25 & 40mg) capsule |
For ADHD |
9.11.2004 |
| Ursodeoxycholic acid S.R. Capsules (450mg) |
For dissolution of gall stones |
1.12.2004 |
| Methylphenidate HCL (18,36,54mg) E.R. (500mg) tablet |
ForADHD |
8.12.2004 |
| FDC of Lovastatin (20mg) + Niacin ER (500mg) tablet |
For Lipid lowering |
20.12.2004 |
| FDC of Gatifloxacin (400mg) + Ambroxyl HCL (75mg) tablet |
RTT in adults |
21.12.2004 |
| FDC of Nebivolol HCL (5mg) + Hydrochlorothiazide (12.5mg) tablet |
Anti-hypertensive |
22.12.2004 |
| FDC of AtrovastatinCalcium (10mg) + Finofibrate (160mg) tablet |
Anti-hypertensive |
22.12.2004 |
| Calcium Polycarbophil (500mg) tablet |
For constipation |
23.12.2004 |
| Pantoprazole (40mg) + Domperidone (20mg) |
GERD |
23.12.2004 |
| Imiquimod Cream 5% w/w |
For warts in adults |
28.12.2004 |
| Imiquimod Cream 5% w/w |
For warts in adults |
28.12.2004 |
| Entacapone (200mg) tablet |
For parkinson's disease |
30.12.2004 |
| Centbucridine (0.5%) + Fercrylem (3%) |
For hemorrhoid & anal fissures |
11.1.2005 |
| Atenlol (25mg, 50mg) + HCTZ (12.5mg) |
Anti-hypertensive |
13.1.2005 |
| Levocetrizine Syrup (2.5mg / 5ml) |
For allergic rhinitis & urticaria |
13.1.2005 |
| Pitavastatin (1mg / 2mg) Tablet |
Lipid Lowering agent |
14.1.2005 |
| Ofloxacin (200mg) + Ornidazole (500mg) |
For diarrhea of mixed infection |
20.1.2005 |
| Bacillus calusii spores suspension (2billion / 5ml vial) |
For alteration of intestinal bacterial flora |
28.1.2005 |
| Lamivudine (40mg) + Nevirapine (70mg ) + Stavudine (10mg) (in5ml) powder for suspension |
Anti-HIV |
28.1.2005 |
| Diflorasone Diacetate Cream (0.5mg / gm) |
For corticosteroid responsive dermatoses |
3.2.2005 |
| FDC of Epi-Growth Factor (1gm) + Silversulphadiazine Cream |
For Co-existing hypertension &
Hyperlipidemia |
19.10.2004 |
| Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings |
For Contraceptive in Women |
15.2.2005 |
| Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet |
For acute painful musculoskeletal condition in adult |
22.2.2005 |
| Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet |
For primary dysmenorrhoea and pain associated with menorrhagia in women |
22.2.2005 |
| Fluconazole (2%) + Zinc Pyrethione (1%) suspension |
For seborrhoic dermatitis |
22.2.2005 |
| Azelaic acid Cream (15%) |
For the treatment of inflammatory papules and pustules of mild to moderate rosacea |
23.2.2005 |
| Levodropropizine oral Suspension (30mg / 5ml) |
For non-productive cough in adults |
25.2.2005 |
| Duloxetine HCL (60mg) tablet (additional strength) |
**** |
28.2.2005 |
| Desloratadine (2.5mg) + Ambroxol (30mg) + Guiphenasine (50mg) + Menthol 1mg / 5ml Syrup |
For Productive cough |
2.3.2005 |
| Levofloxacin Opthalmic Solution (0.5%) |
For susceptible bacterial conjunctivitis |
4.3.2005 |
| Metformin Oral Soltion (100mg / ml) |
For type-II diabetes mellitus |
4.3.2005 |
| Tirofiban (0.25mg / ml ) injection |
For acute coronary syndrome including patients undergoing PTCA or atherectomy |
9.3.2005 |
| Omeprazole (20mg) Enteric coated + Domperidone (30mg) S.R. Capsules |
For GERD not responding to Omeprazole |
10.3.2005 |
| Stavudine Powder for suspension |
For HIV-1 infusion |
11.3.2005 |
| Erdosteine (150mg / 300mg) Capsules |
for chronic obstructive bronchitis |
11.3.2005 |
| Tazarotene (1mg) + Mometasone Furoate (1mg) per gram cream |
For plaque psoriasis |
1.4.2005 |
| Levetiracetam (250mg / 500mg / 750mg) Tablets |
As adjunctive therapy in treatment of partial onset seizures in adults with epilepsy. |
4.4.2005 |
| Esomeprazole sodium For injection |
For GERD in patients with esophagitis and / or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate |
4.4.2005 |
| Rupatadine (10mg) tablet |
For perinial allergic rhinitis |
5.4.2005 |
| Acesulfame Potassium |
As sweetener in pharmaceutical preparation |
5.4.2005 |
| Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet |
For opioid dependence |
6.4.2005 |
| Lamivudine (40mg) + Stavudine (10mg / 5ml) reconstituted solution |
For HIV infection |
8.4.2005 |
| S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg / 25mg / 50mg) |
For Hypertension |
15.4.2005 |
| R(-) Ondansetron (2mg / 4mg) tablet |
For chemotherapeuptic induced nausea and vomiting |
15.4.2005 |
| Balanced salt intra ocular irrigating solution enriched with glutathoine Dextrose, bicorbonate |
For intraoocular irrigating during intraocular surgical procedures |
26.4.2005 |
| Gliclazide M.R. (30mg / 60mg) + Metformin HCL (500mg) ER Tablet |
For type-II diabetes |
27.4.2005 |
| Drosperinone (3mg) + Ethinylestradiol ( 0.035mg) tablet |
Oral Contraceptive |
11.5.2005 |
| Simvastatin (10 20mg) + Ezetimibe (10mg)ntablet |
For primary Hypercholesterolemia |
11.5.2005 |
| Ramipril (5mg) + Telmisartan (40mg) tablet |
For Hypertension |
11.5.2005 |
| Intralipid 30% |
For patients with essential fatty acid deficiencies |
12.5.2005 |
| Montelukast Granules (4mg / pack) |
For prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older |
17.5.2005 |
| Bortezomib for injection (3.5mg / vial) |
For the treatment of myeloma patients |
18.5.2005 |
| Nelfinavir 625mg tablet (adult strength) |
For HIV patients |
20.5.2005 |
| Sevelamer (400mg / 800mg) tablet |
For control of serum phosporus in patients with chronic kidney disease and hemodialysis |
20.5.2005 |
| S(-) Pantoprazole (10mg / 20mg) tablet |
For gastric ulver, Duodenal ulcer & GERD |
20.5.2005 |
| Tazarotene (0.05%) + Mometasone Furoate (0.01%) Cream ( adult strength) |
For Plaque psoriasis |
24.5.2005 |
| R(-) Ondansetron Oral Solution (1mg / 5ml) |
For Chemotheraphy induced nausea and vomiting |
24.5.2005 |
| Gatifloxacin (200mg) + Ornidazole (500mg) tablet |
For diarrhoea of mixed infection in adults |
6.6.2005 |
| Combikit of 2 tablet of Stavudine (40mg) +Lamvudine (150mg) each & 1 tablet of Efavirenz (600mg) |
For HIV Infection in a adult |
7.6.2005 |
| Combikit of 2 tablet Lamivudine (150mg) + Zidovudine (300mg) eacj and 1 tablet of Egavirenz (600mg) |
For HIV Infection in adults |
7.6.2005 |
| Aceclofenac gel 1.5% alongwith linseed oil, menthol, salicylate, capsaicin |
For pain, swelling etc. |
8.6.2005 |
| Emtricitabine (200mg) Capsules |
For HIV Infection in adults |
9.6.2005 |
| Eplerenone (25mg / 50mg) Tablet |
For Hypertension |
10.6.2005 |
| Strontium Ranelate Granules (2gm / sachet) |
For Post-menopausal women with Osteoporesis |
14.6.2005 |
| Lamvidine (30mg / 60mg) + Stavudine (6mg / 12mg) + Nevirapine (50mg / 100mg) Dispersible Tablet |
For peadiatric patients with HIV infection |
14.6.2005 |
| Nitazoxanide (500 mg) + Ofloxacin (200 mg) Tablets |
For Urogenital infection in adults |
30.6.2005 |
| Midazolam Maleate Bulk |
Anesthetic |
5.7.2005 |
| Calcium Polycarbophil (500 mg ) Tablet |
IBS |
6.7.2005 |
| FDC of Papain + Urea Ointment |
For debriment of necrotic tissues |
11.7.2005 |
| Testosterone Gel 1% |
For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism |
12.7.2005 |
| Erlotinib Hydrochloride (25mg / 100mg / 150mg) Tablets |
For metastatic non-small cell Lung Cancer |
13.7.2005 |
| Chloroquine Phosphate Eye drops (0.3 mg/ml) |
For dry Eye syndrome |
13.7.2005 |
| Mecobalamine E.R. Tablet (150mg) |
For neuropathic pain |
19.7.2005 |
| Olmesartan Medoxomil (5mg / 20mg / 40mg) Tablet |
Anti-hypertension |
21.7.2005 |
| Ursodeoxycholic Acid (500mg) S.R. Tablets |
Addl. Strength |
20.7.2005 |
| FDC of Amlodipine (5mg) + Bisoprolol (2,5mg) |
Anti-hypertension |
21.7.2005 |
| FDC of Ceftriaxone (500mg / 100mg) + Tazobactum (12.5mg / 62.5mg) Injection |
Anti-bacterial |
21.7.2005 |
| Feropenem Sodium (150mg / 200mg) Tablet |
Anti-bacterial |
21.7.2005 |
| Levodopa (50mg / 100mg / 150mg) + Carbidopa (12.5mg / 25mg / 37.5mg) + Entacapone (200mg) Tablet |
For Parkinson's disease |
25.7.2005 |
| Saquinavir (as mesylate) 500mg Tablet |
Addl. Strength |
25.7.2005 |
| Pramipexole Di-hydrochloride Tablet (0.125mg / 0.25mg / 0.5mg / 1mg / 1.5mg) |
For Parkinson's Disease |
25.7.2005 |
| FDC of Atrovastatin (10mg) + Niacin (375mg / 500mg) E.R. Capsules |
For Hypercholesterolemia |
26.7.2005 |
| FDC of Levocetrizine (5mg) + Ambroxol (75mg S.R) Capsule |
Anti-histaminic & Mucolytic |
29.7.2005 |
| FDC of Gabapentin (300mg) + Methycobalamin (500Mcg) Tablet |
For neuropathic pain in adults |
5.8.2005 |
| Phenytoin Sodium (300mg) Tablet |
Addl. Strength |
5.8.2005 |
| FDC of Calciptriol (50mg) + Betamethasone Dipro (0.5mg/gm) Ointment |
For psoriasis vulgaris |
12.8.2005 |
| FDC of Glimepiride (1mg / 2mg) + Pioglitazone (15mg) + Metformin (500mg E. R. ) Tablet |
Anti-diabetic |
12.8.2005 |
| Tenofovir Disoproxil Fumarate Tablet (300mg) |
Anti-HIV |
17.8.2005 |
| Sucralfate (7%) + Povidone Iodine (5%) Ointment |
Anti-Infective |
18.8.2005 |
| Bivalirudin Injection (250mg/vial) |
Anti-coagulant in PTCA |
25.8.2005 |
| Efavirenz Oral Solution (30mg/ml) |
Anti-AIDS |
25.8.2005 |
| Didanosine Powder for oral solution (2mg / 4gm per bottles) |
Anti-AIDS |
26.8.2005 |
| Sodiium Valporate (750mg / 1000mg) C.R. Tablet |
Addl. Strength |
26.8.2005 |
| Oxycarbazepine S.R. (150mg / 300mg/ 600mg) Tablet |
Anti-epileptic |
8.9.2005 |
| Acitretin |
For sever psoriasis in adults |
9.9.2005 |
| Dried IVY Leaf Extract (7.5mg/100ml) |
Cough Syrup |
15.9.2005 |
| Nimesulide 1% + Methyl Salicylate 5% |
Aerosol for Local application in aute pain |
16.9.2005 |
| Feracrylum (1%) + Metronidazole (1%) |
Antiseptic Gel |
16.9.2005 |
| FDC of Methylcobalami (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid ( 5mg) Tablet |
For hyper-homocysteinemia |
16.9.2005 |
| Trimebutine Maleate |
For irritable bowl syndrome |
10.10.2005 |
| Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength) |
For Hypertension |
17.10.2005 |
| Oseltamivir (as phosphate) Capsule (75mg) & oral suspension (12mg/ml) |
For influenzae |
25.10.2005 |
| Cetirizine HCl drops (10mg/ml) |
Anti-histaminic |
8.11.2005 |
| Lanthanum Carbonate Chewable tablet (250mg/500mg) |
For the treatment of hyperphosphatemia. |
9.11.2005 |
| Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. |
For relief of productive cough. |
10.11.2005 |
| Sodium Hyaluronate 0.1% eye drops (addl. Strength) |
Ophthalmic use. |
10.11.2005 |
| FDC of S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet. |
For essential hypertension |
11.11.2005 |
| Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet |
For HIV infection |
11.11.2005 |
| Voglibose (0.2mg/0.3mg) Tablet |
Anti-diabetic |
17.11.2005 |
| Lactitol Sachet (10gm/20gm). |
For the treatment of constipation. |
21.11.2005 |
| Aspirin Bolus (Vet.) 6gm/bolus) |
For Veterinary use. |
21.11.2005 |
| Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet |
For dyspepsia, colicy pain & GERD. |
22.11.2005 |
| Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops |
For Ophthalmic use. |
24.11.2005 |
| Pregabalin capsule (75/150/300mg) |
For neuropathic pain. |
25.11.2005 |
| Methotrexate Topical gel (1%) Addl. Strength |
Psoriasis. |
25.11.2005 |
| Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml. |
Ophthalmic |
25.11.2005 |
| Testosterone Spray (25mg) |
For replacement therapy in males with testosterone deficiency. |
29.11.2005 |
| Omeprazole Powder for suspension (20mg/Sachet) |
Anti-ulcer |
30.11.2005 |
| Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet |
For hypertension |
30.11.2005 |
| Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) |
For hypertension |
30.11.2005 |
| FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) |
For essential hypertension |
2.12.2005 |
| Phenylephrine 2.5% Eye drops |
Ophthalmic |
2.12.2005 |
| Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml). |
For chronic Hepatitis-B infection. |
5.12.2005 |
| Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops |
Ophthalmic |
7.12.2005 |
| Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet |
For spasmodic pain |
8.12.2005 |
| Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg |
For hypertension |
8.12.2005 |
| Travoprost Eye drops (40mcg/ml) |
For glaucoma & ocular hypertension. |
8.12.2005 |
| Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection. |
For LRTI |
8.12.2005 |
| Atomoxetine (as HCl) Sachet (10/18/25/40mg) |
For ADHD |
15.12.2005 |
| Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength). |
Ophthalmic |
16.12.2005 |
| Zonisamide (100mg) capsule |
Anti-epileptic |
21.12.2005 |
| Methimazole Tablet ( 5mg/10mg) |
For hyperthyroidism. |
22.12.2005 |
| Caspofungin Acetate injection (50mg/70mg per vial). |
For invasive candidiasis fungal infection. |
23.12.2005 |
| Cefprozil Powder for oral suspension (125mg/5ml) |
Antibiotic |
6.1.2006 |
| Nebivolol (as HCl) 5mg + Valsartan 80mg |
For hypertension |
17.1.2006 |
| Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.) |
For BPH |
19.1.2006 |
| Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet |
For osteoporosis |
1.2.2006 |
| Atenolol 50mg + HCTZ 25mg (addl. Strength) |
For hypertension |
3.2.2006 |
| Ciclesonide Inhaler 80/160mcg per actuation |
For persistent Asthma |
6.2.2005 |
| Pegaptinib Sodium Injection (0.3mg). |
For neovascular (wet) age related macular degeneration. |
6.2.2006 |
| Dexibuprofen Tablet (200mg/300mg/400mg) |
For OA, RA & ankylosing spondylitis |
6.2.2006 |
| Moxifloxacin Eye Ointment (5mg/gm) |
For ophthalmic use. |
6.2.2006 |
| Erdosteine Powder for oral suspension 35mg/ml |
For chronic obstructive bronchitis |
6.2.2006 |
| Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet |
For BPH |
6.2.2006 |
| Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg |
For hypertension |
7.2.2006 |
| Doxofylline Tablet (400mg) |
For bronchial asthma & COPD. |
8.2.2006 |
| Zanamavir inhalation powder 5mg/blister |
For influenzae |
13.2.2006 |
| Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength) |
For replacement therapy in males with Testosterone deficiency. |
15.2.2006 |
| Cefetamet Pivoxil Hcl oral suspension 250mg/ml |
Anti-biotic |
16.2.2006 |
| Voriconazole Powder for oral soluion (40mg/ml) |
Anti-fungal |
21.2.2006 |
| Aceclofenac 200mg (S.R) tablet |
NSAID |
22.2.2006 |
| Desflurane liquid for inhalation (240mg/bottle). |
For induction & maintenance of anaesthesia. |
22.2.2006 |
| Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) |
As loading dose for prevention of in-stent restenosis in PCI |
22.2.2006 |
| Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet |
For HIV-1 infection |
23.2.2006 |
| Levetiracetam Oral Solution (100mg/ml). |
Anti-epileptic |
24.2.2006 |
| Atomoxetine 60mg capsule (Addl. Strength) |
For ADHD |
27.2.2006 |
| Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. |
For OA & RA |
28.2.2006 |
| Fluorescein Sodium Solution for Injection (100mg/ml) |
Ophthalmological diagnostic agent |
2.3.2006 |
| Cefditeron (as pivoxil) 200mg tablet |
Anti-biotic |
3.3.2006 |
| Sodium Hyaluronate Cream 0.2% |
For leg ulcer, diabetic ulcer etc. |
16.3.2006 |
| Saquinavir (500mg) tablet (addl. Strength) |
Anti-AIDS |
20.3.2006 |
| Tobramycin Inhalation solution (300mg/5ml) |
For chronic pulmonary infection cystic fibrosis. |
22.3.2006 |
| Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial |
Chronic congestive heart failure |
22.3.2006 |
| Eflornithine HCl Cream (139mg/gm) |
For reduction of unwanted facial hair in women. |
22.3.2006 |
| Lactulose Enema (20%) |
For constipation & hepatic encepthalopathy |
28.3.2006 |
| Doxofylline Syrup (20mg/ml) |
For bronchial asthma & COPD. |
30.3.2006 |
| Cholestyramine Powder for oral suspension (4gm/sachet) |
For hypercholesterolaemia |
30.3.2006 |
| Haloperidol Tablet (0.5mg) (addl. Lower strength) |
As approved earlier. |
30.3.2006 |
| Resperidone Tablet & Syrup (addl. Ind) |
Acute mania & mixed episode in bipolar-I disorder. |
4.4.2006 |
| D-trans Fentantyl Transdermal patches |
For pain |
5.4.2006 |
| Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R |
For GERD |
8.4.2006 |
| Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet |
For hypertension |
24.4.2006 |
| Nicorandil E.R Tablet (10mg/20mg) |
Angina Pectoris |
24.4.2006 |
| Atazanavir(100/150/200mg) |
Anti-HIV in adults. |
24.4.2006 |
| Oseltamivir formulation (additional indication) |
For Prophylaxis of influenzae in adult and children >14 years of age |
24.4.2006 |
| Midazolam (as maleate) 7.5mg/15mg tablet |
For insomnia |
10.5.2006 |
| Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler |
For Asthma & COPD |
10.5.2006 |
| Nadifloxacin Gel 1% |
Acne vulgaris |
10.5.2006 |
| Olmesartan (as Medoxomil) 10mg (addl. Strength) |
Anti-hypertensive |
18.5.2006 |
| Ciclesonide rotacaps (200/400mcg) |
For Asthma |
19.5.2006 |
| Oxcarbazepine S.R 450mg/900mg (addl. Strength). |
Anti-epileptic |
19.5.2006 |
| Pregabalin Capsule 25/50/100/200mg (addl. Strength) |
Same as approved. |
19.5.2006 |
| Itopride 150mg capsule (S.R) |
For GERD |
22.5.2006 |
| Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet |
For production cough |
24.5.2006 |
| Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg |
For hypertension |
24.5.2006 |
| Zonisamide capsule 25/50mg (addl. Strength) |
Same as approved. |
25.5.2006 |
| Ibandronic Acid Tablet (150mg) addl. Strength |
Same as approved. |
25.5.2006 |
| Perflutren liquid microsphere injectable suspension |
For diagnostic use |
31.5.2006 |
| Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops |
For Ophthalmic use |
2.6.2006 |
| Cyclosporin Eye drops (0.1%) (addl. Strength) |
For Ophthalmic use |
2.6.2006 |
| Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. |
For hypertension |
5.6.2006 |
| Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream |
For dermatoses |
6.6.2006 |
| Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. |
For iron deficiency anemia |
8.6.2006 |
| Olopatadine Ophthalmic solution( 0.1%) |
For allergic conjunctivitis |
8.6.2006 |
| Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) |
Anti-HIV |
8.6.2006 |
| Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet |
Anti-biotic |
8.6.2006 |
| Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg |
Anti-epileptic |
8.6.2006 |
| Icodextrin 7.5% peritoneal dialysis solution |
For peritoneal dialysis |
8.6.2006 |
| Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). |
For deep vein thrombosis |
8.6.2006 |
| Methyl Prednisolone Aceponate Cream (0.1%) |
For atopic dermatitis |
15.6.2006 |
| Levofloxacin 0.5% Ear drops |
For otitis media |
27.6.2006 |
| Buclizine HCl tablet (25mg) & Syrup 6mg/5ml |
As appetite stimulant |
28.6.2006 |
| Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) |
Anti-hypertensive |
28.6.2006 |
| Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops |
For reduction of IOP |
5.7.2006 |
| Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength) |
Anti-biotic |
5.7.2006 |
| Solifenacin Succinate Tablet (5mg/10mg). |
For overactive bladder with urge urinary incontinence urgency & urinary frequency |
6.7.2006 |
| Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. |
Irritable bowel syndrome |
6.7.2006 |
| Deferasirox dispersible tablet 125/250/500mg. |
For chronic iron overload due to blood transfusion |
10.7.2006 |
| Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). |
For insomnia |
10.7.2006 |
| Lamivudine 40mg + Stavudine 10mg dispersible tablet. |
For HIV infection |
12.7.2006 |
| Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. |
For vitamin C deficiency |
12.7.2006 |
| Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment. |
For plaque psoriasis |
20.7.2006 |
| ISMN SR 30mg + Aspirin75/150mg tablet (addl. Strength). |
Same as approved |
20.7.2006 |
| Cefixime 200mg + Pot. Clavulanate (125mg) tablet |
Anti-biotic |
20.7.2006 |
| Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup |
For productive cough |
20.7.2006 |
| Sodium Hyaluronate Injection (1%). |
For OA |
26.7.2006 |
| Forskolin Eye drop (1%). |
For open angle glaucoma |
27.7.2006 |
| Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet |
For HIV-1 infection |
1.8.2006 |
| Lumiracoxib Tablet (100/200/400mg). |
For OA, RA acute pain & primary dysmenorrhoea |
1.8.2006 |
| Quetiapine S.R tablet 200/300mg. |
For psychotic disorder |
1.8.2006 |
| Amisulpiride Tablet (50/100/200mg) |
For schizophrenic disorder |
1.8.2006 |
| Baclofen E.R capsule (30mg) |
For spasticity |
1.8.2006 |
| Oxandrolone Tablet (2.5/10mg) |
To promote weight gain |
4.8.2006 |
| erdosteine 150mg + guaiphenesin 50mg + terbutaline 1.25mg per 5ml syrup |
mucolytic |
12.8.2006 |
| rosiglitazone (as maleate)2mg + glibenclamide 5mg + Metformin 500mg tablet |
Antidiabetic |
8.8.2006 |
| L - Lysine Hcl Ointment (150mg / gm) |
For Wound of Various Etiology |
8.8.2006 |
| Levocitrizine 2 Hcl 5mg + Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules |
For SAR, PAR & Chronic idiopathic uritcatia |
9.8.2006 |
| Alprazolam SR 0.25mg + Sertaline (As Hcl) 25mg/50mg tablet |
For Panic Disorder with or without agoraphobia |
9.8.2006 |
| Dexibuprofen 200mg/300mg + Paracetamol 500mg tablet |
FOR RA, OA & ankolysing spondylosis |
10.8.2006 |
| ISMN SR 60mg + Metprolol Succinate ER 25 / 50mg |
For angina & Hypertension |
10.8.2006 |
| Aspirin 75mg / 150mg + Glycine 37.5mg / 75mg tablet |
For the prevention of acute coronary syndrome in patients with CAD prophylaxis against stroke |
10.8.2006 |
| Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (asHcl) 100mg each |
For P. Falciparam malaria |
10.8.2006 |
| Pravastatin 40mg tablet (Additional Strength) |
As Approved |
10.8.2006 |
| Olanzapine powder For oral suspension (10mg)/5ml |
For schizoprenia in adults |
11.8.2006 |
| Cefepem (as Hcl) 0.5 / 1gn + Amikacin (as sulphate) 0.125 / 0.250gm Inj. |
Antibiotic |
11.8.2006 |
| Lamivudine 20mg + Nevirapine 35mg + stavudine 5mg tablet |
Anti HIV |
11.8.2006 |
| Nadifloxacin (10mg / gm) + Mometasone Furoate (1mg / gm) cream |
For mixed infection of skin |
17.8.2006 |
| Premetrexed (Disodium) Powder For Solution for Inj. 500mg/vial |
Anti Cancer |
21.8.2006 |
| Gliclazide 40mg/80mg + Metfomin Hcl 500mg + Rosiglitazone 2mg tablet |
Anti - diabetic |
22.8.2006 |
| Tiropramide Hcl ( 100mg) tablet |
For abdominal spasmodic pain, colics of hepatobiliary track, abdominal colics |
22.8.2006 |
| Eprisone Hcl (50mg) tablet |
For neck - shoulder orm syndrome scapula hum oral per arthritis and low back pain |
23.8.2006 |
| Caroverine cap.(20mg & Inj. 40mg / 2ml) |
For abdominal pain and tinnitus in adult |
23.8.2006 |
| Paclitaxel nanoparticle Inj. (20mg/ml) |
for metastatic breast cancer |
23.8.2006 |
| Amoxyycillin 250mg + Dicloxacillin 250mg cap. |
Antibiotic |
28.8.2006 |
| Rifaximine 200mg tab |
For infection diarrhea in adults |
28.8.2006 |
| Tigecycline powder for Inj. 50mg/vial |
for skin and skin structure infection and intra abdominal infection |
28.8.2006 |
| Stavudine SR 100mg tablet |
Anti Hiv |
29.8.2006 |
| Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per mml dry syrup & tablet |
Antibiotic |
29.8.2006 |
| ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler |
Antiasthratic |
29.8.2006 |
| Ciclsonide 100mcg/200mcg/400mcg + Formotorol Fumarate 6mg rotacaps |
Antiasmatic |
29.8.2006 |
| Abacavir Sulphate syrup 20mg/ml |
for HIV Infection |
29.8.2006 |
| S(-) Pantoprazole (as sodium) 20mg (E.C.) + Domeperidome SR 30mg tablet |
For GERD |
29.8.2006 |
| Cefadroxil 500mg + Clavulinic acid 125mg tablet |
Antibiotic |
1.1.1975 |
| Crfadroxil 250mg + Clavulinic acid 62.5mg per 5ml syrup |
Antibiotic |
29.8.2006 |
| Human Insulin (r - DNA) Powder inhaler |
For type-1 & type-2 Diabetes |
29.8.2006 |
| Fulvestrant Inj. 250mg/5ml Prefilled syringe |
Anticancer |
30.8.2006 |
| S(-) Pantoprazole (as Sodium) Inj.250mg/vial |
For peptic ulcer, GERD & Zollinger Ellison Syndrome |
30.8.2006 |
| Dasatinib tablet 20mg/50mg/70mg tablet |
For chronic hepatitis B infection |
30.8.2006 |
| Telbivudine 600mg tablet |
For chronic hepatitis B infection |
30.8.2006 |
| Aprepitant cap (80mg/125mg) |
for Chemotheraphy induced nausea & Vomiting |
30.8.2006 |
| Telbivudine 600mg tablet |
For Chronic hepatitis B infection |
30.8.2006 |
| Aprepitant cap (80mg/125mg) |
For chemotheraphy induced Nausea and vomiting |
30.8.2006 |
| Telmisartran 40mg + Amlodipine (as Besylate) 5mg tablet |
For essential hypertension |
30.8.2006 |
| Gemifloxacin (as myslate) 320mg tablet |
Antibiotic |
30.8.2006 |
| ceftazidime 500mg/1000mg + |
|
30.8.2006 |
| ceftazidime 500mg/1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection |
Antibiotic |
30.8.2006 |
| Cefepime (AS Hcl) 500mg/1000mg + Tazobactum (as sodium) 62.5mg/125mg |
Antibiotic |
30.8.2006 |
| Paramomycin Inj. 375mg/ml |
For Visceral Leishmaniasis (Kalaazar)
|
30.8.2006 |
| Cefixime 100mg + Cloxacillin (as Sodium) 500mg +Lactobacillus (45million spore) tab |
Antibiotic |
30.8.2006 |
| Alprazolam dispersible tablet 0.125mg/0.25mg/0.50mg |
for anxiety |
20.8.2006 |
| epinastine Hcl (0.05%) Opthalmic solution |
For allergic conjunctivitis |
22.8.2006 |
| Levofloxacin tablet (250mg/500mg) & Infusion 5mg/ml (for additional indication |
For prostatitis |
26.8.2006 |
| Feracrylum 1% mouth gargle 10mg / ml |
As Hacmostatic agent in dental surgery |
28.8.2006 |
| Aceclofenac Inj. (150mg / ml) |
For pain in post operative & post traumatic cases |
28.9.2006 |
| combipack of one cap. of aprepitant. 125mg & two cap. of aprepitant 80mg each (combipack) |
As Approved |
10.10.2006 |
| Formoterol fumarate 6mcg + fluficasone propinate 50mcg/125mcg/250mcg MDI |
For Asthma & COPD |
14.10.2006 |
| Estrogen vaginal tablet 25mcg |
For Atropic Viginitis |
2.11.2006 |
| Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules |
For GERD |
11.11.2006 |
| Cefixime 200mg + Cloxacilin 500mg (ER) + Lactobacillus 90 million Spore tab. ( aditional strength) |
Antibiotic |
13.11.2006 |
| Cefixime dispersible tablet 400mg (new dosage Form) |
Antibiotic |
22.11.2006 |
| Trandolopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg |
Antihypertensive |
23.11.2006 |
| Ciclesonide 160mcg/320mcg cap. for inhalation |
Antiasthmatic |
28.11.2006 |
| Rabeprazole 20mg (EC) + Itopride SR 150mg |
For GERD |
30.11.2006 |
| Metoprolol succinate 25mg/50mg ER + HCTZ 12.5mg |
Antihypertensive |
30.11.2006 |
| Atorvastatin 5mg + Fenofibrate 160mg (additional strength) |
As Approved |
1.12.2006 |
| Acaclofenac Inj. 50mg/ml ( Additional strength) |
As Approved |
1.12.2006 |
| Amisulpride 400mg tablet (additional strength) |
As Approved |
1.12.2006 |
| Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication |
For Cervical ripening, prevention of post partum haemorrhage & First trimester of abortion with mifepristone |
12.12.2006 |
| Atazanavir 150mg + Ritonavir 50mg capsules |
Anti HIV |
12.12.2006 |
| Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet |
For IBS |
12.12.2006 |
| Mebeverine Hcl 135 mg + Chlordiazepoxide 5mg tablet |
For IBS |
13.12.2006 |
| Ampicillin 250mg + Dicloxacillin 250mg tablet |
Antibiotic |
13.12.2006 |
| Etoricoxib 10mg ++ Methyl Salicylate 100mg+ Mentol 50mg + Linseedoril 30mg Per gm. of Gel |
For acute Musculoskeletol pain |
14.12.2006 |
| Racecdotril dispersible tablet (10mg/30mg) (new dosage form) |
for Diarrhoea |
15.12.2006 |
| Gabapentine ER 450/600/900mg taBLET |
For naturopathic pain & partial Seizures |
15.12.2006 |
| R-Ondansetron (AS Hcl. Dihydrate) (1mg/ml) injection |
Chemotheraphy induced nausea & vomiting |
12.1.2007 |
| Torsemide 10mg + Amiloride 5mg tablets |
Edema Associated with congestive heart failure & hypertension |
17.1.2007 |
| Fexofenadine suspension (30mg/5ml) |
Seasonal allergic rhinitis & chronic idiopathic urticaria |
19.1.2007 |
| Sildenafil Citrate 20mg tablet |
For pulmonary osterial hypertension |
23.1.2007 |
| Pioglitazone 15mg/30mg + Metformin ER 1000mg tablet (additional strength) |
As Approved |
23.8.2006 |
| Fluastatin Tablet (As calcium) 10mg/20mg/40mg (additional strength) |
As Approved |
1.1.2007 |
| Halobetazole propionate cream (0.05%) |
Coticosteroid responsive dermatomes |
2.2.2007 |
| Eszopiclone tablet (1mg/2mg/3mg) |
For insominia |
2.2.2007 |
| Dilitazem Hcl. 2% gel |
For anal fissure |
7.2.2007 |
| Nalbhupine injection 10mg/20mg per ml. |
For moderate to severe pain |
7.2.2007 |
| Levonorgestrel 1.5mg tablets |
For Emergency contraceptive |
7.2.2007 |
| Pantaprazole sodium 20mg/40mg tablet (with sodium bicarbonate as buffer) |
For gastric ulcer, duodenal ulcer , Z, E Syndrome, GERD |
7.2.2007 |
| Levofloxacin (250mg/500mg) + ambroxal SR 75mg tablet |
For Lower respiratory tract infection in adult |
8.2.2007 |
| Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566 per ml injection |
For testosterone deficiency (i) primary hypogonadism (ii) hypogonadotropine hypogonadism |
8.2.2007 |
| Rosaglitazone 1mg + Metformin Hcl 500mg tablet (additional strength) |
As Approved |
8.2.2007 |
| Loteprednol Etabonate 5mg + Tobramycin 3mg per ml opthalmic solution |
For steroid responsive inflammatory ocular condition |
14.2.2007 |
| Amlodipine (As besylate) 5mg + Metoprolol (As Succinate) ER 25mg (additional strength) |
As approved |
14.2.2007 |
| Glibenclamide 5mg + Metformin SR 850mg tablet (additional strength) |
As Approved |
15.2.2007 |
| Aceclofenac injection (150mg/3ml) |
For short term treatment of pain due to post operative and post traumatic cases |
19.2.2007 |
| Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet (for additional indication) |
Angina pectoris in adults |
20.2.2007 |
| Ramipril 10mg + HCTZ 12.5mg tablet (for additional srength) |
As Approved |
20.2.2007 |
| Amlodipine (As Besylate) 5mg/5mg/10mg + Valsartan 80mg/160mg/160mg tablet |
Essential hypertension |
21.2.2007 |
| Glatiramer Acetate injection (20mg/ml) |
Multiple sclerosis |
21.2.2007 |
| Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) |
As Approved |
22.2.2007 |
| Amlodipine (As besylate) 5mg/10mg + Perindopril 4mg tablet |
For hypertension |
23.2.2007 |
| Olopatadine Hcl. Tablet 2.5mg/5mg |
Allergic nasal inflammation hives, itching with skin diseases |
26.2.2006 |
| Metoprolol (As succinate) 50mg/25mg ER) 25mg/50mg tablet (for additional indication) |
|
26.2.2007 |
| Metoprolol (As Succinate) ER 25mg/50mg + Ramipril 2.5mg/ 5mg |
Essential hypertension |
26.2.2007 |
| Rabeparazole Sodium 20mg/10mg with sodium bicarbonate as buffer |
For Duodenal ulcer, G.U, Z.E.S & GERD |
26.2.2007 |
| Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler additional strength) |
As Approved |
27.2.2007 |
| Mononidine tablet 0.2mg/0.3mg/0.4mg |
for hypertension |
27.2.2007 |
| Ceftriaxone (As sodium) 125mg/250mg + Sulbactum (As sodium) 62.5mg/125mg For injection (additional strength) |
As Approved |
1.3.2007 |
| Quetiapine (As fumarate) SR 400mg tablet (additional strength) |
As approved |
5.3.2007 |
| Carbogoline 1mg tablet (additional strength) |
for Hyperprolactinemia |
6.3.2007 |
| Levofloxacin Oral Solution (each240ml bottle contains levofloxacin 125mg/5ml.) |
Antibiotic |
6.3.2007 |
| Clindamycin 1% + Isotretinoin 0.05% gel |
For acne |
8.3.2006 |
| Estradiol topical emulsion 2.5mg/gm |
Vasomotor symptoms Associated with menopause |
16.3.2007 |
| Levosal |
|
20.3.2007 |
| Levosalbutamol MDI (50mcg/actuation) & Dry powder inhaler (100mcg/capsule) (new dosage form) |
As Approved |
16.3.2007 |
| Polononsetron (As Hcl) For injection 0.25mg/5ml |
Chemotheraphy induced nausea & Vomiting |
20.3.2007 |
| Cifixime 200mg |
|
21.3.2007 |
| Cifixime 200mg + Erdosteine 300mg Capsules |
Acute Exacerbation of chronic brnchitis |
21.3.2007 |
| Aminophylline CR 225/350mg |
Asthma, COPD, Bronchitis |
21.3.2007 |
| Etoricoxib 10mg + Methyl Salicylate 20mg Per gm. of Cream |
Acute Musenlosleteal pain |
21.3.2007 |
| Eberconazole cream(1%) |
Dermatophyte infection of skin such as T-corporis, T-c, T-pedis |
22.3.2007 |
| ISMN 60mg SR + Atenolol 50mg/100mg |
For Angina pectoris |
23.3.2007 |
| Levonorgestrel 0.03mg tablet |
For control of fertility |
23.3.2007 |
| Bortizomib 2mg/vial (additional pack size) |
As Approved |
28.3.2007 |
| Comb kit of two ca[psule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg) |
For HIV infection |
2.4.2007 |
| Mecobalamine 500mcg + Alpha lipoic acid 100mg soft gelatin capsule |
For diabetic neuropathy |
2.4.2007 |
| Propolol 10mg + Lignocaem 1mg per ml injection |
For induction of anesthesia |
4.4.2007 |
| Ezetimibe 10mg + Fenofibrate 160mg tablet |
for combined hyperlipidemia |
4.4.2007 |
| Methyl prednisalone Acrponate topical solution 0.1% |
Atopic dermatitis (eczema)inflammatory and allergic skin reaction |
4.4.2007 |
| Citicoline (750mg) tablet (additional strength) syrup 500mg/ml (new dosage form ) (not for children) |
As Approved |
10.4.2007 |
| Ertapenem for injection ("1gm/vial) |
Antibiotic |
10.4.2007 |
| Letrozole 2.5mgtablet (for additional indication) |
For induction of ovulation in anovulatory infertility (additional strength) |
10.4.2007 |
| Quetiapine SR tablets 50mg (additional strength) |
As Approved |
10.4.2007 |
| Metoprolol (AS suucinate) 25mg |
|
10.4.2007 |
| Metoprolol (As succinate) 25mg |
|
10.4.2007 |
| Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) |
As Approved |
10.4.2007 |
| Sunitinib Maleate capsules 12.5mg/25mg/50mg |
For G.I. Stromal Tumour, advanced renal cell carcinoma |
10.4.2007 |
| Comb pack of 1bottle of Ciprofloxacin injection (200mg/100ml) & 1Bottle of ornidazole injection500mg/100ml) |
Antibiotic |
10.4.2007 |
| Aprepitant 40mgcapsules (adittional strength) |
Prevention of post operative nausea & vomiting (additional strength) |
24.4.2007 |
| Olopatadime Opthalmic solution (0.2%) (additional strength) |
As Approved |
24.4.2007 |
| Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium each |
For osteoporosis |
1.5.2007 |
| Levocetrizem 2Hcl. Dispersible tablet (2.5mg) |
For allergic rhinitis & chronic urticaria |
8.5.2007 |
| Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) |
As Approved |
7.5.2007 |
| Etodolac ER tablets 400mg/500mg |
For osteo arthritis & rheumatoid arthritis |
9.5.2007 |
| Levosulpride tablet (25mg) |
For G.I problem like fanatical dyspesia, nausea, vomiting and diabetic gastroperisis |
10.5.2007 |
| Rimonabant tablet 20mg |
For obese patients BMI>30kg/m2 or overweight patients BMI>27kg/m2 with associated risk factors such as type- 1 diabetes or dyslipidemia |
11.5.2007 |
| Lactitol monohydrate syrup 66.67/100ml |
For constipation |
14.5.2007 |
| S(-) Metoprolol (As succinate)25mg |
|
16.5.2007 |
| S(-) Metoprolol (As succinate)25mg + S(-) Amlodipine (As besylate 2.5/5mg |
For essential hypertension |
16.5.2007 |
| Lenalidomide capsule (5mg/10mg/15mg/25mg) |
For transfusion dependent anemia due to myalodysplastic syndrome associated with deletion 5q cytogenic abnormality |
16.5.2007 |
| Cefotaxim (As sodium)0.5mg/1gm + sulbactum (As sodium)250mg/500mg injection (for additional indication) |
For surgical prophylaxis (additional indication) |
18.5.2007 |
| Lornoxicam tablet 4mg/8mg |
For Osteoarthritis rheumatoid arthritis |
21.5.2007 |
| Atenolol 25mg/50mg |
|
21.5.2007 |
| Atenolol 25mg/50mg + Indapamide |
For essential hypertension |
21.5.2007 |
| Livertiracetem conc. for infusion 100mg/ml (new dosage form) |
As adjunctive theraphy in partial onset seizures in adults with epilepsy when oral administration is temporarily not feasible |
21.5.2007 |
| Citicoline tablet 200mg (additional strength) |
As Approved |
25.5.2007 |
| Varenicline (As tartarate) 0.5mg/1mg tablets |
As an aid to smoking cessation treatment in adults |
29.5.2007 |
| Azithromycin eye drops 1% |
Conjunctivitis |
29.5.2007 |
| Ciclesonide nasal spray 50mcg/spray |
For seasonal & perennial allergic rhinitis in adults, adolescents aged > 12 years |
8.5.2007 |
| Ceftyazidine 500mg/100mg + Sulbactum (As sodium) 250mg/500mg for injection |
Antibiotic |
8.6.2007 |
| Eplerstat tablet 200mg (additional strength) |
As Approved |
25.5.2007 |
| Aliskiren tablet 150mg/3 |
|
8.6.2007 |
| Aliskiren tablet 150mg/300mg |
for hypertension` |
8.6.2007 |
| Isotreninoin 0.05% + Erythromycin 2% gel |
For Acne |
8.6.2007 |
| Glimepiride 1mg/2mg + Metformin SR 1000mg tablet (additional strength) |
As Approved |
8.5.2007 |
| Cefditorene pivoxil dispersible tablet (30mg/50mg) (new dosage form for children) |
As Approved |
8.6.2007 |
| Dexrabeparazole sodium enteric coated tablet 5mg/10mg |
For Duodenal ulcer, gastric ulcer & GERD |
13.6.2007 |
| Renolazine Extend release tablet (500mg) |
For Chronic Angina |
14.6.2007 |
| Phenytoin sodium ER capsules (300mg) (new dosage form) |
For control of generalized toni-clonic and treatment & prevention of seizures occuring during or following neurosurgery |
14.6.2007 |
| Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet |
For BPH in men with enlarged prostate |
14.6.2007 |
| Cefipime injection 500mg/1gm/2gm (for addditonal indication) |
For bacterial meningitis in children |
15.6.2007 |
| Tranexamic acid mouth wash (50mg/ml) |
For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery |
15.6.2007 |
| Deflozocort oral suspension (6mg/5ml) (new dosage form) |
As Approved |
15.6.2007 |
| Tolterodine tartrate ER 4mg + Tamsulocin Hcl ER 0.4mg tablet |
For BPH with ovractive bladder |
15.6.2007 |
| Omeparazole 20mg/40mg + sodium bicarbonate 110mg capsules |
For duodenal ulcer, gastric ulcer & GERD |
15.6.2007 |
| Dexrabeparazole sodium enteric coated tablet 5mg/10mg |
For duodenal ulcer, gastric ulcer and GERD |
13.6.2007 |
| Cefipime injection (new indication) |
For bacterial meningitis in children |
14.6.2007 |
| Tranexamic acid mouth wash (50mg/ml) |
For prevention of oral hemorrhage in anticoagulant treated patients undergoing surgery |
15.6.2007 |
| Deflozocort oral suspension (6mg/5ml) (new dosage form) |
For asthma, rheumatoid arthritis when glucocorticosteroid theraphy is warranted |
15.6.2007 |
| Tolterodine tartrate ER 4mg + Tamsulocin Hcl ER 0.4mg tablet |
For BpH with overaction bladder in adults only |
15.6.2007 |
| Omeparazole(E. Coated) 40mg + sodium bicarbonate 110mg capsules |
For gastric ulcer, duodenal ulcer and GERD |
18.5.2007 |
| Mebeverine Hcl prolonged release capsule (200mg) |
For irritable bowel syndrome |
19.6.2007 |
| Azithromycin 500mg + Ambroxal S.R (75mg) tablet |
For RTI caused by susceptible organisms in adults |
5.7.2007 |
| Pholcodiene syrup (4mg/5ml) |
For symptomatic relief of dry ticklish and unproductive coughs in children above 1 years |
6.7.2007 |
| Exenatide injection pre-filled pen (250mcg/ml) |
For adjunctive theraphy to improve glycemic control in patients with type-II diabetis mellitus, who have not achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonyl urea |
6.7.2007 |
| Moxifloxacin Hcl (0.5%) + Ketorolac Tromethamine 0.5% opthalmic solution |
For reduction of post operative inflammatory condition of eyes |
11.7.2007 |
| Levofloxacin (15mg) + Prednisalone acetate 10mg per ml eye drops |
For post operative steroid resposive inflammatory ocular conditions of the eyes |
11.7.2007 |
| Lotoprednol Etabonate (0.5%) + Levofloxacin (1.5%) eye drops |
For post operative steroid responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists |
12.7.2007 |
| Clotrimazole (10mg) + Methyl-prednisalone aceponate 1mg/gm of cream |
For fungal infection of skin associated with inflammation |
12.7.2007 |
| Capecitabin tablet (150mg/500mg) for additional indication |
First line treatment of advanced gastric cancer in combination with platinum based regimen.
Treatment of patients with locally advanced or metastatic breast cancer in combination with docetaxel following failure of cytotoxic chemotheraphy |
16.7.2007 |
| Rifabutin capsule (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 |
16.7.2007 |
| Lapatinib (as Ditosylate) (250mg) tablet |
In combination with capecetabine it is indicated in patients with advanced or metastatic breast cancer whose tumour overexpress HER2 and who have received prior theraphy including trastuzumab |
24.7.2007 |
| Levocetrizine Di-Hcl mouth dissolving tablets (5mg) new dosage form |
For treatment of allergic rhinitis and chronic urticaria |
25.7.2007 |
| Idaravone injection (1.5mg/ml) |
For improvement of neurologic symptoms, disorders of activitis of daily living and functional disorder associated with acute ischemic stroke |
26.7.2007 |
| Diclofenac sodium (75mg/ml) injection (additional strength) |
For management of painful conditions in post operative cases rheumatoid arthritis and osteoarthritis |
30.7.2007 |
| Cefpodoxime (as proxetil (100mg/200mg) + clavulanic acid 62.5/125mg) tablet |
For LTRI, UTRI and UTI |
30.7.2007 |
| Atorvastatin (40mg) + Ezetimibe (10mg) tablet (additonal strength) |
As Approved |
30.7.2007 |
| Cefepime (250mg) + Tazobactam (31.25mg) injection (additional strength) |
As Approved |
30.7.1975 |
| VSL # 3 (probiotic blend) sachet |
for rotavirus diarrhoea in children |
31.7.2007 |
| Sorafenib (as Tosylate) (200mg) tablet |
For advanced renal cell carcinoma |
31.7.2007 |
| Methyl cobalamine (500mcg) + Alpha lipoic acid (100mg) + pyridoxime (3mg) + folic acid (1.5mg) soft gelatin capsule |
|
31.7.2007 |
| Methyl cobalamine (500mcg) + Alpha lipoic acid (100mg) + pyridoxime (3mg) + folic acid (1.5mg) soft gelatin capsule |
For diabetic neuropathy |
1.1.1975 |
| Halobetasol propionate (0.5mg) + salicylic acid 30mg per gm of ointment |
For plaque soriasis |
1.8.2007 |
| Omeparazole 20mg/40mg + sodium bicarbonate 600mg + Mg. Hydroxide-700mg.chew tab |
For duodenal ulcer, gastric ulcer GERD and erosive oesophagitis |
1.8.2007 |
| Defirasirox dispersible tablet (400mg) (additional strength) |
As approved |
17.8.2007 |
| Tegafur (100mg) + uracil (224mg) capsule |
for first line treatment of metastatic colorectol cancer in combination with calcium folinate |
8.8.2007 |
| Bortizomib injection (additional indication) |
For the treatment of patients with mantle cell lymphoma who have received at least one prior theraphy |
5.9.2007 |
| Amlodipine (5mg) + Nebivolol (5mg) tablet (additional strength) |
As Approved |
6.9.2007 |
| Ceftazidine (2mg) + Sulbactum (1gm) injection (additional strength for additional indication |
For serious abdominal infection |
6.9.2007 |
| Polyethlin glycol 400 (0.4%) + propylene glycol (0.3%) |
For temporary relief of dryness iritation burning, stinging, grittiness or foreign body sensation caused due to environmental factors |
18.9.2007 |
| Respiridone ER (long-acting injection 12.5mg/vial) (additional strength) |
As Approved |
25.9.2007 |
| Levocetrizine Di-Hcl syrup (2.5mg/5ml) (for use in children 2 years and above |
As Approved |
26.9.2007 |
| R-sibutramine capsule (2.5mg/5ml) |
As an adjunctive theraphy for the management of obesity including weight loss and maintenance of weight loss in patients whose BMI is 30kg/m2 or higher |
26.9.2007 |
| Cefuroxime Axetil (250mg) + clavulanic acid (125mg) tablet |
For adult patients with infection caused suscepible microorganism including S.aureus Viz Uti, upper and lower RTI and gonococcal urethritis |
27.9.2007 |
| Sulphur Hexafluoride powder and solvent for dispersion for injection (45mcg/ml) |
For diagnostic use in echocardiography doppler of macrovasculature |
28.9.2007 |
| Ondansetron orally disintegrating tablet (4mg/8mg) (additional dosage form) |
Fro chemotheraphy induced nausea and vomiting |
28.9.2007 |
| Cefiroxime-125/250/500mg + clavulinic acid-31.25/62.5/125mg |
For adult patients with infection caused by susceptible microbs, including S.aureus (e.g-UTI,Upper & lower RTI &Gonoccocal Urethritis |
5.9.2007 |
| Amiodarone injection (additional indication ) |
For cardiopulmonary resuscitation in the event of cardiac arrest related to ventricular fibrillation resistant to external electric shock |
5.10.2007 |
| Residronate sodium tablet (35mg) (additional indication) |
For osteoporosis in men at high risk of fracture |
8.10.2007 |
| Sucralfate (70mg) + Metronidazole (10mg) + Povidone iodine (50mg) per gram of ointment. |
For inffected wounds and ulcers |
9.10.2007 |
| Levetiracetem tablet (additional indication) |
(i)As monotheraphy in partial onset seizures with or without secondary generalisation in patients with 16years of age with newly dianosed epilepsy
(ii)As adjunctive theraphy in myoclonic seizures in adults and adolescents from 12years of age with idiopathic generalised toni-clonic seizures in adults and adolescents from 12years of age with idiopathic generalised epilepsy |
9.10.2007 |
| Combipack of two tablet of chloroquine phospate (250mg) each + 14 tablet of proguanil HCl (100mg) each |
For drug resistant malaria |
10.10.2007 |
| Paclitaxel (protein bound particle) for injectable suspensiion (paclitaxel 100mg) + Albumin Human 900mgper20ml |
For breast cancer after failure of combination chemotheraphy for metastatic disease or relapse within 6months of adjuvant chemotheraphy |
11.10.2007 |
| Olmesartan Medoxomil (20mg) + Amlodipine Besylate(5mg) Tablet. |
For mild to moderate hypertension |
15.10.2007 |
| Atorvastatin calcium (10mg) + Ramipril (2.5mg/5ml) |
For treatment of patients with both hypertension and hypercholestrolemia |
15.10.2007 |
| Omeparazole(20mg) + sodium bicarbonate (1100mg) tablet (additional strength) |
As Approved |
15.10.2007 |
| Moxifloxacin Hcl (5mg) + prednisalone Acetate (10mg) per ml (eye drops) |
For inflammation after ocular surgery |
16.10.2007 |
| Methyl cobalamine (500mcg) + Alpha lipoic acid (100mg) + pyridoximeHcl(1.5mg) + Thiamine (2mg) + Calcium picolonate (200mg) tablet |
For diabetic neuropathy |
16.10.2007 |
| Satranidazole (300mg) + Ofloxacin (200mg) tablet |
For diarrhoea of mixed infection in adults |
18.10.2007 |
| Methyl cobalamine (500mcg + betacarotine-10.33mg + alpha lipoic acid 100mg + B6 1.5mg + B1 2mg & Cr.polyniiocotinate |
For adult patients with diabetic neuropathy |
18.10.2007 |
| Calcium pidolate equivalent to calcium 500mg + Vit-D3 250IU |
For osteoporosis and calcium deficiency state |
23.10.2007 |
| etizolam tablet (0.5mg/1ml) |
For anxiety disorder associated with depression |
29.10.2007 |
| Oxaprozine tablet (600mg) |
For relief of signs and symptoms of osteoarthritis, rheumatoid arthritis |
30.10.2007 |
| Prulifloxacin (600mg) tablet |
For acute uncomplicated lower urinary tract infection (simple cyctitis), complicated lower UTI, acute exacerbation of chronic bronchitis |
30.10.2007 |
| Cilostazole ER tablet (100mg/200mg) |
for management intermittent claudication |
30.10.2007 |
| Atorvastatin calcium (10mg) + Fenofibrate (145mg) (additional strength) |
As Approved |
10.10.2007 |
| Sitagliptin tablet (25mg/50mg/100mg) |
As adjunct to diet and exercise to improve glycemic control in patients |
30.9.2007 |
| Miglitol (50mg) + Metformin Hcl SR (500mg) tablet |
For adult with type -II diabetis mellitus where simple drug theraphy diet and exercise do not result in adequate glycemic control |
31.10.2007 |
| Mupirocin (2%) + Methylprednisalone aceponate (0.1%) cream |
For atopic dermatitis |
31.10.2007 |
| Methylcobalamine 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 minerals deficiency states |
31.10.2007 |
| Methylcobalamine 500mcg+folic acid 1.5mg + alpha lipoi acid - 300mg + Benfetiamin-50mg. capsule |
For diabetic neuropathy |
13.11.2007 |
| Methyl prednisalone aceponate-1mg + salicylic acid-50mg ointment |
For treatment of soriasis |
19.11.2007 |
| Propanol 50gm + povidone iodine - 1gm in 100ml solution |
For surgical & hygenic hand disinfection |
19.11.2007 |
| Propanol - 18gm + ethanol (100%) - 45mg in 100ml solution |
For surgical & hygenic hand disinfection |
19.11.2007 |
| Voglibose disp.tab.0.2mg/0.3mg |
As Approved |
20.11.2007 |
| Ceftriaxone 2gm + Tazobactum 250mg for injection |
As Approved |
21.11.2007 |
| Methyl prednisalone aceponate-1mg + Mupirocin-20mg.cream |
For the treatment of atopic dermatitis |
21.11.2007 |
| Citicholine (As sodium) - 200mg/500mg/750mg granules per sachet |
As Approved |
26.10.2007 |
| Buterphenol tartrate 10mg/ml nasal spray |
For management of pain in patients using opioid analgesics |
26.11.2007 |
| Defirasirox 100mg dispersible tablet (400mg) (additional strength) |
As Approved |
28.11.2007 |
| Methylcobalamine 500mcg + folic acid 1.5mg + B-6-3mg+thiamine 10mg capsule |
For diabetic neuropathy |
29.11.2007 |
| Doxophyline-400mg+salbutamol (as sulphate) - 2mg/4mg Tablets |
For treatment of bronchial asthma in adults |
29.11.2006 |
| 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 |
| Seratanidazole-300mg + ofloxacin-200mg tablet |
For treatment of diarrhoea of mixed infection in adults patients |
29.11.2006 |
| Zoledronic acid 5mg/100ml solution for infusion (additional strength) |
Post menopausal osteoporosis |
12.12.2007 |
| Olmesartan Medoxomil (20mg) + Ramipril (5mg) Tablet. |
For treatment of essential hypertension |
12.6.2007 |
| Levosulpride tablet (50mg/100mg) additional strength for additional; indication |
For depression and schizoprenia in adults |
12.6.2007 |
| Combipack of 12Artesunate - 50mg tablets & 6 Mefloquine 250mg tablets |
For drug resistant P.falciparum malaria infection |
12.6.2006 |
| Pregabalin - 75mg/150mg + Methylcobalamine 500mcg cap |
Doxycycline - 100mg + L. bacillus spores - 5 billion |
12.6.2007 |
| doxycyclin - 100mg + L.bacillus spores - 5 billion |
For adult patients prone to intraabdominal bacterial infection & Antibiotic associated diarrhoea |
12.6.2007 |
| Cefprozil 250mg/500mg + Clav. acid - 62.5mg / 125mg.tab |
For the treatment of adult patients with upper & lower RTI, Skin & Skin structure infection |
12.6.2007 |
| Dextrometharpahan HBr-10mg + Chlorphenaramine maleate - 2mg/5ml syrup |
For the temporary relief of cough due to throat irritation, sneezing & running nose |
12.6.2007 |
| Lornoxicam 8mg/2ml inj. |
For Short term treatment of mild to moderate pain, when oral administration is inappropriate (i.e after dental surgery) |
12.6.2007 |
| Apomorphine Hcl - 2mg/3mg Sublingual tablet |
For erectile dysfunction in adult men |
12.6.2007 |
| Escitlopram (as oxalate) 10mg + clonazepam-0.5mg tablet (additional strength) |
For comobid depression and anxiety disorder |
12.6.2007 |
| Doxophylline injection - 10mg/ml |
for bronchial asthma & COPD in adult patients when oral theraphy is in appropriate |
31.12.2007 |
| Me-salicylate 30% + Menthol 10% + camphor 4% Cream |
For temporary relief from pain, swelling & inflammation due to musculoskeletol disorder |
2.1.2008 |
| Hydroxychloroquine 400mg tablets(Additional Strength) |
Same as Approved |
31.1.2008 |
| Hydroxychloroquine 400mg tablets(Additional Strength) |
Same as Approved |
31.1.2008 |
| ISMN 60mg SR + Metoprolol Succinate equivalent to metoprolol tartarate 25mg/50mg tablets (additional Strength) |
Same as Approved |
2.1.2008 |
| Halobetasol 0.05% + Clotrimazole 1.0% Cream |
For the treatment of steroid responsive fungal infections including eczema and psoriasis |
4.1.2008 |
| Cticholine 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 |
4.1.2008 |
| Nanocrystalline Silver Gel 0.002% |
For the treatment of burns and wound infections |
4.1.2008 |
| Cinitapride (as hydrogen tartrate) 1mg tablet |
For the treatment of gastroesophageal reflux disease and functional inconvenience of the gastrointestinal motility |
4.1.2008 |
| Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet |
For the treatment of adult patients with HIV infection |
7.1.2008 |
| Cefixime 200mg/100mg +Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet |
For the treatment of Urinary tract infections, respiratory tract infections in adult patients prone to antibiotic associated diarrhoea |
7.1.2008 |
| D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) |
Same as Approved |
7.1.2008 |
| Ceftazidime 500mg + Tobramucin 60mg per vial (Injection) |
For the treatment of lower respiratory tract caused by pseudomonas |
8.1.2008 |
| Atazanavir 300mg capsules (Additional Strength) |
Same as Approved |
8.1.2008 |
| Ertapenem for injection ("1gm/vial) (additional indication) |
For the prophylaxis of surgical site infections following elective colorectal surgery |
15.1.2008 |
| Vildagilptin Tablets 50mg/100mg |
As an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes mellitus |
18.1.2008 |
| Atorvastatin10mg + Aspirin 75/150mg Capsules |
For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease |
18.1.2008 |
| Smatriptan (as succinate) 50mg + Naproxen sodium 550mg tablets |
For the treatment of acute migraine |
22.1.2008 |
| Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C. R. tablet (Additional Strength) |
Same as Approved |
24.1.2008 |
| Cefepime (as hydrochloride) 2000/1000/500/250mg per vial of injection |
For serious CRTI, uncomplicated and complicated UTI, Uncomplicated skin & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection |
24.1.2008 |
| Paclitaxel Nanoparticle Solution for injection 20mg/ml (Additional indication) |
For hepatocellular Carcenoma |
22.1.2008 |
| Paclitaxel Nanoparticle Solution for injection 20mg/ml (Additional indication) |
Ovarian cancer, non-small cell lung cancer and AIDS related Kaposis Sarcoma |
22.1.2008 |
| Zanamavir inhalation powder 5mg/blister (Additional Indication) |
For prophylaxes and treatment of both influenza A & B in adults and children (greater than or equal to 5 years) |
22.1.2008 |
| Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 tablets of Calcium carbonate 1250mg |
|
23.1.2008 |
| 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 |
23.1.2008 |
| Aceclofenac injection (150mg/ml) |
For short term treatment of pain due to post operative and post traumatic cases |
23.1.2008 |
| Aceclofenac injection (150mg/ml) |
For short term treatment of pain due to post operative and post traumatic cases |
23.1.2008 |
| Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) |
For the treatment of uncomplicated and complicated UTI, uncompicated skin and structure infections and complicated intra-abdominal infections |
25.1.2008 |
| Sodium Valproate 499.5mg + valprroic acid 217.5mg equivalent as sodium valproate-750mg CR tablet (Additional Strength) |
Same as Approved |
24.1.2008 |
| Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet |
For the treatment of acute pain in adults |
24.1.2007 |
| Gabapentin 100mg+ methylcobalamin 500 mcg tablets (Additional Strength) |
Same as Approved |
24.1.2008 |
| Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactum (as sodium) 250mg/500mg/1000mg powder for injection |
For the treatment of infection caused by sensitive organism viz. lower RTI, complicated UTI, Septicemia, bacteremia |
24.1.2008 |
| Metformin HCI ER 500mg + Fenifibrate 80mg/160mg tablet |
For the treatment of Type-II diabetes associated with mixed dyslipidemia |
25.1.2008 |
| Salicylic acid 10mg/20mg (Foaming face wash solution) |
For the treatment of acne vulgaris |
28.1.2008 |
| Ozagrel HCL. Tablets 100mg/200mg |
For the treatment of bronchial asthma |
28.1.2008 |
| For the treatment of patients with mild to moderately severe dementia of the Alzheimer type and dementia associated with Parkinsons disease |
|
28.1.2008 |
| Rivastigmine transdermal patch (each patch of 5m2, 10m2,15m2 & 20m2 contain rivastigmine base 9/18/27/36mg respectively |
For the treatment of patients with mild to moderately severe dementia of the ALheimer type and dementia associated with Parkinsons disease |
28.1.2008 |
| 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) |
28.1.2008 |
| Dextromethorphan Orodisprsible strip 5.5mg/11mg |
for the relief of persistent dry irritating cough in adult patients only |
28.1.2008 |
| Diclofenac sodium 50mg + Dicyclomine HCL 20mg per ml of injection |
For the treatment of acute colicky pain in adults |
28.1.2008 |
| Travoprost 40mcg + Timolol (as Maleate) 5mg pe ml of eye drops |
For decrease of intraocular pressure in patients with open angle gluacoma or ocular hypertension, who are insuffienciently responsive to topical beta blockers or prostoglandin analogues |
28.1.2008 |
| 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 |
30.1.2008 |
| Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lacto-Bacillus 1.7 Billion Spores |
For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea |
31.1.2008 |
| 250mg +Lactobacillus 2 billion spores capsules |
ENT infections in adult patients prone to antibiotic associated diarrhoea |
30.1.2008 |
| Tiotropium (as Tiotropium Bromide Monohydrate ) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules |
As 3rd line treatment of patient with both essential hypertension and hypercholesterolemia |
31.1.2008 |
| |
|
28.1.2008 |
| Levocetrizine Di-HCL Dispersible tablet 5mg/10mg (New Dosage form) |
For allergic rhinitis & chronic urticaria |
1.1.1975 |
| 250mg + Lactobacillus 2 billion spores capsules |
ENT infections in adult patients prone to antibiotic associated diarrhoea |
30.1.2008 |
| Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate dihydro. 12mcg + Ciclesomide 400mcg per capsules |
As 3rd line treatment of sever cases of COPD when monotheraphy abd second line theraphy with two drugs do not respond adequately |
31.1.2008 |
| Metoprolol Succinate Equivalent to Metoprolol Tartarate (ER 25/50mg) + Atorvastatin (As calcium)10mg tablets |
For the treatment of patient with both essential hypertension and hypercholestrolemia |
28.1.2008 |
| Levocetrizine Di HCL Dispersiblwe tablet 5mg/10mg (New Dosage form) |
For allergic rhinitis & chronic urticaria |
28.1.2008 |
| Oselltamivir 30mg & 45mg Capsules (Additional Strength) |
Same as Approved |
28.1.2008 |
| Fondaparinax Sodium injection (Addittional Strength) |
Treatment of acute coronary syndrome (ACS) with and without ST-segment elevation |
28.1.2008 |
| Camostat Mesylate tablets 100mg |
For remission of acute symptoms of chronic pancreatitis and post-operative reflux esophagitis |
29.1.2008 |
| Hyaluronic acid salt 25mg + Cross-linked Hyaluronic acid 25mg per ml in prefilled syringe |
For intradermal implantation and facial soft tissue agumentation |
30.1.2008 |
| Ursodeoxycholic acid tablets 600mg |
For treatment of patients with chronic cholestatic liver disease |
30.1.2008 |
| Dalteparin Sodium Injection (Additional indication) |
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 |
30.1.2008 |
| Beclometahsone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of cream |
For the topical treatment of bacterial and fungal infections |
30.1.2008 |
| Exenatide injection (Each 2ml vial contains - Exenatide 5mcg/10mcg per 0.2ml) (Additional Strength) |
For adjunctive theraphy to improve glycemic control in patients with typeIIdiabetis mellitus, who have not achieved adequate glycemic control with metformin, a sulfonyl are or a combination of metformin and a sulfonylureas |
30.1.2008 |
| Diclofenac Sodium 50mg + Paracetamol 500mg tablets |
For the symptomatic treratment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis |
30.1.2008 |
| Gabapentin SR 600mg tablets |
As adjunctive theraphy in thee treatment of partial seizures of epilepsy |
30.1.2008 |
| Memantine 5mg/10mg + Donepezil 5mg Tablets |
For moderate to severe Alzheimes disease |
31.1.2008 |
| Doxifluridine Capsules 100mg/200mg |
For carcinoma of the stomach, colon, rectum, breast, uterine, cervix and bladder |
31.1.2008 |
| Haemodialysis Powder/liquid Form containing citrate |
For use for patientsd being treated by hemodialysis |
31.1.2008 |
| 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 |
31.1.2008 |
| Cimetropium Bromide tablet 50mg |
For the treatment of irritable bowel syndrome |
31.1.2008 |
| Cyclobenzaprine Hcl. Tablets 5mg/10mg |
As adjunct to rest and physical theraphy for relief of muscle spasm associated with acute painful musculoskeletal conditions |
31.1.2008 |
| Sertaconazole Nitrate Cream 2% |
For the topical treatment of the superficial mycosis like dermatophytosis |
31.1.2008 |
| Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (additional strength) |
Same as Approved |
31.1.2008 |
| Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets |
For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency |
31.1.2008 |
| 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 |
31.1.2008 |
| Halobetasol 0.5mg +Miconazole 20mg per gram Cream |
For steroid responsive dermatoses associated with superficial fungal infection of skin |
31.1.2008 |
| Montelucast 10mg + Levocetrizine 5mg film coated tablets |
For the treatment of allergic rhinitis in adults only |
31.1.2008 |
| Hydroquinone 2% + Treinoin 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 |
31.1.2008 |
| 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 |
31.1.2008 |
| Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E. C Pellets) Capsules |
For treatment of painful inflammatory conditions associated with gastroduodenal ulcers |
31.1.2008 |
| Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler |
As third line treatment of severe cases of COPD, when monotheraphyand second line theraphy with two drugs do not respond adequately |
31.1.2008 |
| VSL# (Combination of Lactic acid bacteria (VSL # 3) |
For the treatment of irritable bowel syndrome |
31.1.2008 |
| Clostimethate Sodium of 1,00,000 IU Injection |
For the treatment of serious infection caused Gram -Ve bacteria including LRTI, UTI, where commonly used anti bacterial agent may be infective because resistance |
31.1.2008 |
| Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength) |
same as Approved |
2.2.2008 |
| Metronidazole CR tablet 600mg |
For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis |
2.2.2008 |
| Quetiapine fumarate SR tablets |
For the additional indication "acute manic episoe associated with bipolar disorder |
21.2.2008 |
| Atorvastatin Calcium 80mg tablets (Additional Strength) |
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 |
25.2.2008 |
| Euphorbia prostrata Dry Extract (ethanolic 80% (V/V) (35-70) : 100 mg tablet |
For the treatment of haemorrhoid |
29.2.2008 |
| Amtolmetin Guacil tablets 600mg |
For the treatmetn of ostoearthritis & rheumatoid arthritis |
7.3.2008 |
| Brimonidine Tartarate Opthalmic solution 0.1% (with purite as preservation 0.0005%) (additional strength) |
For lowering of IOP in patients with open angle gluacoma occular hypertension |
7.3.2008 |
| Methoxsalen USP-20mg Tablet |
1. For repigmentation of idiopathicvitiligo along with phototheraphy
2. For symptomatic control of severe, recalcitrant, disabling psoriasis in conjunction with phototheraphy |
7.3.2008 |
| Cefditoren pivoxil 400mg tablets (Additional Strength) |
same as Approved |
11.3.2008 |
| Doxofylline ER tablets 400ng/800mg (Addl. Strength) |
For the treatment of bronchial asthma &COPD in adults |
12.3.2008 |
| Betamethasone 0.05% + Micanazole 2% Cream |
For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin |
12.3.2008 |
| Premetrxed disodium injection 100mg/vial (additional Strength) |
Same as Approved |
12.3.2008 |
| Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension |
For gastric ulcer, duodenal ulcer, and GERD |
12.3.2008 |
| ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) |
same as Approved |
19.3.2008 |
| Temozolide capsules 140mg/180mg (addl. Strength) |
same as Approved |
31.3.2008 |
| Amisulpiride 300mg tablets (additional Strength) |
same as Approved |
20.3.2008 |
| Nifedipine SR Tablets 10mg/20mg |
For the treatment of essential hypertension |
24.3.2008 |
| Ambroxal HCL. 15mg + Guiphenesin 50mg + Terbutalin Sulphate 1.25mg + Menthol 2.5mg per 5ml of syrup |
For symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis |
26.3.2008 |
| Boswellia Serrata 0.05gm/gm of Cream |
For the treatment of mild to moderate psoriasis |
26.3.2008 |
| Etoricoxib injection 90mg/ml |
For short term use in acute painful condition in adults only |
28.3.2008 |
| Drosperinone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) |
Oral Contraceptive in women |
28.3.2008 |
| Nimesulide 100mg ER + Levocetrizine HCL 5mg Tablets |
For symptomatic treatment of acute rhinositis |
28.3.2008 |
| Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg |
For the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain |
28.3.2008 |
| Nepafenac Opthalmic suspension (1mg/ml) |
For the treatment of pain and inflammation associated with cataract surgery |
31.3.2008 |
| Hylan GF 20 Injection (Synvisc) (Additional Indication) |
For pain management in patients suffering with ostoearthritis of the knee, hip, shoulder and ankle |
31.3.2008 |
| Docetaxel injection conc. |
For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & neck, Harmone refractory metastatic prostrate cancer, locally advanced or metastatic breast cancer |
31.3.2008 |
| Methylcobalamin 1000mcg + pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D-Panthenol IP 50mg per 2 ml of injection |
For pheripheral neuropathy |
31.3.2008 |
| Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Strength) |
Same as Approved |
1.4.2008 |
| Nicardipine Hcl. Injection 2.5mg/ml |
For short term treatment |
7.4.2008 |
| Diclofenac potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength) |
For the treatment od acute pain in adults |
8.4.2008 |
| Diacerin 50mg + Aceclofenac 100mg tablets |
For the treatment of adult patients with osteoarthritis of knee and or hip joints |
11.4.2008 |
| Rabeprazole sodium Enteric coated pellets 15.4% W/W (20mg/129.83mg) |
Same as approved |
16.4.2008 |
| Live freeze - dried lactic acid bacteria and bifidobacteria capsules |
For the treatment of irritable bowel syndrome |
10.4.2008 |
| Miltefosin Capsule 10mg/50mg (Additional Indication) |
Treatment of cutaneous leishmaniasis |
16.4.2008 |
| Silver Wound Dressing |
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) |
16.4.2008 |
| Diacerin 50mg + Glucosamine sulphate 500mg tablets |
For the treatment of adults patients qwith osteoarthritis of knee and or hip joints |
16.4.2008 |
| Clostridium Botulium type - A toxin haemagglutinin complex (Additional Indication) |
For focal Spasticity, including the treatment of arm symptoms associated with focal spaticity in conjunction with physiotheraphy |
22.3.2008 |
| Fluconazole Dispersible tablets 50mg |
For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy |
22.4.2008 |
| Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication) |
In combination with dexamethosone for the treatment of multiple myloma patients who have received at least one prior theraphy |
22.4.2008 |
| Sitagliptin (As Phosphate ) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets |
As an adjunct to diet & excercise to improve glycemic control in patients with type-two diabetis mellitus |
28.4.2008 |
| Lansoprazole for injection 30mg/vial |
For short term treatment of errosive esophagitis when patients are unable to take the oral formulation |
28.4.2008 |
| Sevelamer Carbonate 400mg/800mg tablets & Sachet 400mg/800mg |
For control of serum phosphate in patients with chronic kidney disease dialysis |
28.4.2008 |
| Rabeprazole Sodium (With Sodium Bicarbonate as buffer) 10mg/20mg tablets |
For the treatment of gastric ulcer duodenal ulcer, Zollinger Ellison Syndrome and GERD |
28.4.2008 |
| Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml |
For the reatmetn of community acquired pneumonia, acute exacerbation of chronic bronchitis uncomplicated skin and skin structure infection, pharyngitis/tonsilitis |
29.4.2008 |
| Pregabalin capsules (Additional Indication) |
Management of fibromulagia Syndrome |
29.4.2008 |
| Pregabalin 75mg/150mg + Methlycobalamin 750mcg capsules (Additional Strength) |
Same as Approved |
8.5.2008 |
| Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets |
For the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on monotheraphy |
8.5.2008 |
| Losartan pottasium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength) |
Same as Approved |
14.4.2008 |
| Lecithin Liquid (each 5ml contains lecithin 500mg equivalent to essential phospholipids 250mg |
For alcoholic liver disease, drug induced hepatitis |
14.5.2008 |
| Halobetasol 0.05% + Salicylic aicd 6% Ointment (Additional Strength) |
For the treatment of plaque psoriasis |
14.5.2008 |
| Deflazocort 24mg tablets (Additional Strength) |
Same as Approved |
14.5.2008 |
| Sodium Chondroitin sulfate 40mg + Sodium Hyaluronate 30mg per ml Intraocular Injection (Additional Strength) |
For use as a surgical aid in anterior segments procedure including cataract extraction & intra-ocular lens implantation |
14.5.2008 |
| Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets |
For the treatment of GERD, gastric and doudenal ulcer, Zollinger -Ellison syndrome |
14.5.2008 |
| (As Calcium) 10mg Tablets |
& hyperlipidemia |
22.5.2008 |
| Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet |
For the treatment of adult patients with major depressive disorder |
22.5.2008 |
| Metolazone 2.5mg + Ramipril 2.5mg/5mg |
For essential hypertension in adult patients whose blood pressure is not adequately controlled on mono theraphy |
28.5.2008 |
| Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules |
For the treatment of secondary hyperthyroidism in patients with kidney disease on dialysis |
29.5.2008 |
| Acebrophylline capsules 100mg |
For the treatment od adult patients with chronic obstructive pulmonary disease and bronchial asthma |
29.5.2008 |
| Sofalcone Capsule (100mg/50mg) |
For the treatment of gastric ulcer and management of gastric mucosal leisons (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute exacerbation of chronic gastriritis |
29.5.2008 |
| S(+) Etodolac ER tablets 200mg/300mg |
For the releif of pain and inflammation in patients with rheumatoid arthritis and osteoarthritis |
2.6.2008 |
| Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets |
For the treatment of adult patients with signs & symptoms of acute painful conditions |
2.6.2008 |
| Sodium Hyaluronate injectable gel (each 0.6ml. 1ml prefilled syringe contains, sodium hyaluronate 20mg/ml, 2.5mg/ml |
For intradermal implantation and facial soft tissue augmentation |
3.6.2008 |
| Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension |
For invasive fungal infection in patients who are refractory to or intolerant of conventional amphotericin B theraphy |
3.6.2008 |
| Dexrabeprazole 10mg (EC) + Domeeridone 30mg SR Capsules |
For the treatmetn of Gastroeasophageal Reflux Disease (GERD) in patients not responding to dexrabeprazole alone |
8.6.2008 |
| Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets |
For acute low back pain & other musculoskeletol painful and inflammatory condition in adults |
11.6.2008 |
| Ceftaxime sodium + Sulbactum sodium for injection (Additional Indication) |
For the treatment of lower respiratory tract infection in children |
24.6.2008 |
| Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (Additional Strength) |
Same as Approved |
24.6.2008 |
| Ivabradine (Hcl.) 5mg/7.5mg Tablets |
Anginapectoris in patients with normal sinus rhythm who have a contraindication or intolerance for Beta-blockers |
3.7.2008 |
| 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 |
8.7.2008 |
| Temoporfin 1mg.ml Injection (Additional Strength) |
Same as Approved |
8.7.2008 |
| Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100ml |
For the treatment of RTI, UTI and abdominal infe ctions in adults |
9.7.2008 |
| Metoprolol ER + Amlodipine tablets (Additional Indication) |
For coronary artery disease/ischaemic heart disease |
16.7.2008 |
| Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets |
- |
18.7.2008 |
| Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tablets |
For the treatment of typeII diabetis mellitus when single drug theraphy along with diet, exercise do not result in adequate glycemic control |
21.7.2008 |
| Testosterone Undecanoate 250mg/ml Injection |
For testosterone replacement theraphy of male hypogonadism when testosterone deficiency has been confirmed by clinical feature or biochemical tests |
22.7.2008 |
| Abatacept powder for injection 250mg/vial |
For adult patients with severe active rheumatoid arthritis who had an inadequate response to one more DMARDs such as methotrixate or TNF antagonists |
22.7.2008 |
| Actarit 100mg Tablets |
For the treatment of rheumatoid arthritis patients |
22.7.2008 |
| Tenofovir Fumarate 300mg + Lamivudine + Efavirenz 600mg Tablets |
For the treatment of HIV infection in adults |
22.7.2008 |
| Bacillus Clausii Spores (2 Billion Capsules (additional dosage form) |
Same as approved |
23.7.2008 |
| Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop |
For reduction of part operative inflammatory condition of eyes |
24.7.2008 |
| Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup (Additional Strength) |
Same as Approved |
24.7.2008 |
| Doxercalciferol (0.5/2.5mcg) soft |
For the treatment of secondary hyperparathyroidism in patients with |
5.8.2008 |
| Doxercalciferol (0.5/2.5mcg) SoftGelatin Capsule (Additional Indication) |
For the treatment of secondary hyperparathroidism in patients with stage 3 or stage 4 chronic kidney disease |
8.8.2008 |
| Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg) (Additional Strength) |
Same as approved |
1.1.1975 |
| Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) |
Same as Approved |
5.8.2008 |
| Olopatadine Nasal Spray (0.6%) |
For the releif of teh symptoms of seasonal allergic rhinitis in patients 12 years of age and older |
5.8.2008 |
| Loxoprofen Sodium tablet (60mg) |
For the symptoms treatment of pain and inflammation condition in patients with osteoarthritis |
14.8.2008 |
| Dexibuprofen Suspension 50mg/5ml |
For the treatment of mild to moderate pain, reductin of fever |
14.8.2008 |
| Bromfenac Sodium Eye Drop (0.09%) |
For the treatment of postoperative inflamamtion & reduction of postoperative ocular pain in patients who have undergone cataract extraction |
14.8.2008 |
| Ceftriaxone + Sulbactum injection (Additional Indication) |
For the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis |
18.8.2008 |
| Citicholine Chewable Tablet (500mg) |
For the treatment of productive cough |
18.8.2008 |
| Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg +1.5 mg + 22.5mg) |
For the treatment of iron deficiency anaemia |
18.8.2008 |
| Cyclobenzaprine 7.5mg tablets (additional Strength) solution (Each ml contains S-Metoprolol Succinate 9.5mg equal to S-Metoprolol Tartarate 10mg) |
For the treatment of haemodynamically stably patients with definite or suspected acute myocardial infarction to reduce cardio-vascular mortality |
18.8.2008 |
| Doxorubicin Hcl pegylated Liposomal Injection (20/50MG) (Additional Indication) |
In Combination with bortezumab for the treatment of progressive multiple myeloma in patients who have received atlast one prior theraphy and who have already undergone are unsuitable for bone marrow transplant |
23.8.2008 |
| Povidone Iodine Sachet (Containing Effervescent Granules) Each 2gm sachet contains:175mg (Available iodine 17.5mg) |
As mouth wash for oral hygiene in various oropharyngel conditions, surgery, dental infections and halitosis |
25.8.2008 |
| Sodium Chondroitin Sulphate + Sodium Hyaluronate Injection (40mg + notmore than 17mg per ml) |
Same as approved |
25.8.2008 |
| Metolazone + Spironolactone FC Tablets (2.5/5mg +50mg) |
For topical treatment of acne vulgaris |
25.8.2008 |
| Misoprostol Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form) |
Same as approved |
26.8.2008 |
| Gui |
|
27.8.2008 |
| Guaiphenesin ER Tablet (600mg) |
For the treatment of productive cough accompanied by phlegm |
28.8.2008 |
| Zoledronic Acid Injection 5mg/100ml (Addl. Indication) |
For the treatment of osteoporosis in post-menopausal women and in men who are at increased risk of fracture, including those with a recent low-trauma hip fracture. |
7.1.2009 |
| Misoprostol Tablet 600 mcg |
Addl. Strength |
9.1.1997 |
| Acebrophylline Syrup 10mg/ml |
For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma |
9.1.2009 |
| Selamectin Tropical solution (for verterinary use.) 60mg/120mg per ml |
i) for the treatment and lasting prevention of flea infestations, treatment and control of flea allergy dermatitis, prevention of heartworm disease, treatment and prevention of ear mites in dogs and cats:
ii) For the treatment and prevention of sarcoptic mange, round worms and for control of tick infestations in dogs. |
9.1.2009 |
| Methylcobalamin 1500mcg + Calcium 200mg + Calcitriol 0.25 mcg+ Folic Acid. 5mg +Pyridoxine3mg Capsules |
For the treatment of vitamin deficiency states in adults |
14.1.2009 |
| Metoprolol tartrate tablets 50 mg (Addl. Indication) |
Adjunct to the treatment of Hyperthroidism |
14.1.2009 |
| Cinacalet(as HCl) Tablet 30/60/90 mg |
For the treatment of secondary hyper parathyriodism in patients with chronickidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma |
14.1.2009 |
| Mycophenolate mofetil Capsule 250mg, Tablets 500mg, Oral suspension 200mg/ml (Addl. Indication) |
For the prophylaxis of acute organ rejection in patients receiving allogenic hepatic transplantation |
23.1.2009 |
| Liquid Paraffin 1.25ml+Milk of Magnesia 3.75ml+Sodium Picosulphate 3.33mg per 5ml |
For symptomatic treatment of constipation in adults |
29.1.2009 |
| Ranolazine 100mg ER Tablets (Additional Strength) |
Same as approved |
31.1.2009 |
| Hyaluronic acid (Cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml |
For intradermal implantation and facial soft tissue augmentation |
31.1.2009 |
| Caspofungin acetate Injection (Addl. Indication) |
For use in following: (I)Empirical theraphy for presumed fungal infections in febrile neutropenic patients.
II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleural space infections
III) Treatment of Esophageal Candidiasis. |
31.1.2009 |
| Micafungin (as sodiumP Powder for solution for infusion 50mg/vial |
For the treament of patients with candidemia, acute disseminated candidisis, candida peritonitis, abscess and esophageal candiadsis. For the prophylaxis of candida infection in patients undergoing hematopoietic stem cell transplatation (HSCT) |
31.1.2009 |
| Loteprednol Etabonate Nasal spray 0.1% w/v |
For the prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis |
31.1.2009 |
| Rasagiline (as mesylate) Tablet 0.5mg/1mg |
For the treatment of signs and symptoms of idiopathic Parkinsons disease as initial monothraphy and as an addition to levodopa |
31.1.2009 |
| Nicotine Polacrilex Gum 2mg (Addl. Indication) |
To reduce the withdrawl symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco |
3.2.2009 |
| Closantel Injection 100mg/ml (for verterinary use.) |
For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals including milch and other food producing animals |
5.2.2009 |
| Lornoxicam 4mg + Paracetomol 500mg film coated tablets |
For the short term use in acute painful & inflammtory conditions in adults |
5.2.2009 |
| 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 |
9.2.2009 |
| Ketoconazole 2%w/v + Prepared Coal Tar 2%w/v (I.P. 1966) Solution |
For the tretment of dandruff |
9.2.2009 |
| Doripenem (as monohydrate) injection 250mg/500mg |
for the treatment of nosocomial pnuemonia in adults |
16.2.2009 |
| Halobetasol Scalp Approved 0.05% w/v |
For the relief of inflammatory and puritic manifestation of corticosteroid respensive dermatosis |
18.2.2009 |
| Nicotine (As Polacrilex) Lozenges 2mg & 4mg |
To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco |
18.2.2009 |
| Tranexamine Acid Tab SR 750mg |
For the treatment of menorrhagia |
20.2.2009 |
| Anidulafungin Injection (lyophilized powder) 50mg/100mg per vial |
For the treatment of invasive candidiasis including candidemia ans oesophageal candidiasis in adult patients |
23.2.2009 |
| Hydroquinone 2% + Treinoin 0.05% + hydrocortisone 1%Cream |
For the treatment of patients with skin hyperpigmentation |
23.2.2009 |
| Doxophylline 400mg+Terbutaline 5mg tablets |
For the treatment of asthma and chronic obstructive pulmonary disease in adult patients only |
23.2.2009 |
| Hydroquinone 20mg + Tretinoin 0.25mg + Flucinolone Acetonide 0.1mg per gm Cream |
For the treatment of melasma of face in adults |
23.2.2009 |
| Ketoconazole 2% + Zinc Pyrithone 1% Lotion |
For the treatment of pityriasis and dandruff of the scalp |
23.2.2009 |
| Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg oral Suspension (Tablets for oral Suspension) |
For the treatment of HIV patients |
23.2.2009 |
| Glibenclamide 5mg + Pioglitazone 15mg + Metformin 500mg film coated tablets |
As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line theraphy with two drugs do no result in adequate glycemic control |
23.2.2009 |
| Glibenclamide 5mg + Pioglitazone 15mg + Metformin 500mg film coated tablets |
As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line theraphy with two drugs do no result in adequate glycemic control |
23.2.2009 |
| Aceclofenac 100mg + Tizanidine 2mg film coated tablets |
For the treatment of acute low back pain in adult patients only |
23.2.2009 |
| Octinoxate 7.5% + Avobenzone 3% + oxybenzone 3% + Titanium dioxide 2% lotion |
As sunscreen lotion for prevention of sunburn skin |
23.2.2009 |
| 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 |
23.2.2009 |
| Lidocaine Lozenges 200/300mg |
For single agent anaesthesia in upper gastro intestinal endoscopy |
26.2.2009 |
| Calamine 8% + Liquid Paraffin 10% lotion |
As antipruritic and smoothening agent |
26.2.2009 |
| Nifedipine 0.3% + Lidocaine 1.5% cream |
for the treatment of anal fissures |
26.2.2009 |
| Quinapril 20mg + HCTZ 25mg film coated tablet |
For the treatment of mild to moderate hypertension in adult patients (in whom combination theraphy is appropriate) who have been stabilized on the individual components given in the same proportion |
26.2.2009 |
| Paliperidone ER tablets 1.5mg |
Addl.Strength |
4.2.2009 |
| Paliperidone ER tablets 1.5mg |
Addl.Strength |
4.3.2009 |
| Losartan 100mg + HCTZ 25 mg tablet |
Additional higher strength |
16.3.2009 |
| Darunavir(as ethonalate) Tablet 300mg |
For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experiences adult patients, such as those patients with HIV-I strains resistant to more than one protease inhibitor when co administered with 100mg ritonavir, and with other antiretiroviral agents |
19.3.2009 |
| Ropivacaine HCL Inj. 2/5/7.5/10mg |
For the production of local or regional anaesthesia for surgery and cute pain management |
19.3.2009 |
| Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin 50 gm Oral powder (Veterinary Drug) |
As vitamin and phosporous supplement for livestock, shrimp and fish |
19.3.2009 |
| Octinoxate 7.5% + Avobenzone 2% + oxybenzone 3 % + octocrylene 3 % + Zinc Oxide 2 % lotion |
A sunscreen lotion for prevention of sunburn skin |
19.3.2009 |
| Omeprazole 20/40mg + Sodium Bicarbonate 600mg + Magnesium hydroxide 700mg sachet |
Additional Strength |
19.3.2009 |
| Fluticasone furoate Nasal spray 27.5mcg per spray |
For the treatment of symptoms of allergic rhinitis |
19.3.2009 |
| Ambroxol 30mg + Levo salbutamol 1mg + Guiphenesin 50mg/5ml syrup |
For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis |
19.3.2009 |
| Montelucast 4mg + Levocetrizine 2.5mg tablet |
Additional lower paediatric dose |
19.3.2009 |
| Surgical Sealant |
To be indicated for use in sealing suture lines along arterial and venous reconstructions |
26.3.2009 |
| Lidocaine Patch 700mg in aqueous base (50mg per gram adhesive) |
For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin |
26.3.2009 |
| Bimatoprost opthalmic solution 0.03% |
for the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness |
30.3.2009 |
| Trabectedin powder for concetrate for solution for infusion 1mg/vial |
For the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifofamide, or who are unsuited to receive these agents |
30.3.2009 |
| Acebrophylline Syrup 10mg/ml (Additional Indication) |
For the treatment of children (age 6 to 12 years) with chronic obstructive pulmonary disease(COPD)bronchialasthma |
30.3.2009 |
| Mesalamine PR Tablets 750mg Additional Strength |
Same as approved |
30.3.2009 |
| Mycophenalate Mofetil tablets 750mg Additional Strength |
Same as approved |
31.3.2009 |
| Ketorolac Tromethamine Gel 2% w/w |
For the treatment of muscle, joint and post-traumatic stress. |
31.3.2009 |
| Theophylline 400mg SR + Montelucast 10mg Tablet |
For the treatment of patients with bronchial asthma |
31.3.2009 |
| Hyaluronic Acid Sodium Salt 0.2gm + Silver Sulafiazine 1.0 gm.25 gm tube hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/100gm gauze pads impregnated with cream |
For the treatment of wound of different etiology |
31.3.2009 |
| Telmisartan 80mg + Amlodipine 5mg tablet |
Additional higher strength |
31.3.2009 |
| Hyaluronic Acid Sodium Salt I) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm ii) Sterile Gauze Padds impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mg |
For the treatment of wound of different etiology
|
31.3.2009 |
| Hyaluronic Acid Sodium Salt I) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm ii) Sterile Gauze Padds impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mg |
For the treatment of wound of different etiology
|
31.3.2009 |
| Cetrizine 10mg + Ambroxol 75mg SR Tablet |
For symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired |
13.4.2009 |
| Cetrizine 10mg + Ambroxol 75mg SR Tablet |
For symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired |
13.4.2009 |
| Cetrizine 10mg + Ambroxol 75mg SR Tablet |
For symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired |
13.4.2009 |
| Ciclesonide 200mcg + Formoterol 6mcg + Titropium 9mcg MDI |
Indicated as third line treatment of severe cases of COPD, when monotheraphy and second line therapy with two drugs do not respond adequately |
13.4.2009 |
| Each film coated bi layered tablet contains: Metoprolol 25mg/50mg + Chlothalidone 12.5mg |
For the treatment of patients with mild to moderate essential hypertension |
13.4.2009 |
| Milnacipran 25/50mg Caps (Addl. Indication) |
For the management of fibromylagia |
15.4.2009 |
| Lornoxicam SR 16mg Tabs |
For the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis |
15.4.2009 |
| Palonosetron Hcl 0.075mg IV Inj (Addl. Strength) |
Same as approved |
25.4.2009 |
| Each film coated bilayered tablet contains: Metoprolol 25mg/50mg + Chlothalidone 6.25mg/12.5mg |
Additional Strength |
25.4.2009 |
| Albendazole 400mg + Ivermectin 6mg tablet |
For the treatment of intestinal helminthes and suppression of microfilaraemia especially with bancrofti infections |
25.4.2009 |
| Decitabine Lyophilized powder for injection 50mg/20ml 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 with excess blasts, refractory anemia with ecess blasts n transformation,and chronic myelomonocytic leukemia) and intermediate - 1, intermediate- 2, and high risk international prognostic Scoring System groups |
25.4.2009 |
| Retapamulin Ointment 1% |
For the topical treatment of bacterial skin and skin structure infections: Primary impetigo, secondarily infected dermatoses. |
25.4.2009 |
| each ml contains Calamine 25% w/v + Zinc oxide 5% w/v + Betonite 3% w/v + Glycerin 5% w/v + Sodium citrate 0.05% w/v lotion |
For the treatment of pruritis and prickly heat |
25.4.2009 |
| Each 1000 ml of emulsion contains: Medium chain troglycerides 100gm + Soya oil 80gm + Omega-3 acid triglycerides 20 gm + egg lecithin 12gm + dlyverl 25gm + Sodium oleate 0.30gm + Alpha - tocopherol 0.20gm + Ascorbypalmitate 0.30gm + 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, inadequate or contraindicated |
14.4.2009 |
| Sertaconazole Nitrate powder 2% w/w & Lotion 2% w/v |
For the topical treatment of the superficial fungal infections of the skin |
2.5.2009 |
| Amlodipine Tablets 5mg/10mg (additional indication) |
To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke
To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease. |
2.5.2009 |
| Clindamycin phosphate Inj. 150mg/ml & Clindamycin HCL capsules 150 mg/300mg (additional indication) |
Prophylaxis of infection in neck and head surgery |
2.5.2009 |
| Each 15gm sachet contains: Lactulose 10 gm+ Ispaghula husk 3.50gm granules |
For the treatment of chronic idiopathic constipation in adult patients only |
16.5.2009 |
| Sucralose |
For use as sweetener in drug formulations |
19.5.2009 |
| Carvedilol Tablets 3.125/6.25/12.5/25mg (additional indication) |
To reduce cardiovasculr 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) |
19.5.2009 |
| Dexketoprofen 12.5 mg/25mg + Paracetomol 500mg film coated tablets |
For the treatment of Acute musculoskeletol pain |
18.5.2009 |
| Pregabalin SR tablet 150/300mg |
For the treatment of peripheral neuropathic pain in adults |
16.5.2009 |
| Guaiphenesin ER Tablet 1200mg |
For the treatment of productive cough accompanied by phlegm |
16.5.2009 |
| Everolimus 5/10 Tablets (Additional Indication) |
Treatment of advance renal cell carcinoma |
5.5.2009 |
| Nimesulide ER 200mg (Additional Indication) |
Acute pain in Orthopaedic, ENT, Dental and post operative condition |
16.5.2009 |
| Palonestron Injection 0.25mg/5ml (Additional Indication) |
For treatment of Post Operative Nausea & vomiting |
16.5.2009 |
| Bendamustine hydrochloride Lyophilized powder Injection 100mg/vial |
For the treatment of patients with chronic lymphocytic leukemia |
16.5.2009 |
| Caffeine (as citrate) 10mg/ml Injection |
For the short term treatment of apnoea of prematurity of infants between 28 and <33 weeks gestational age |
16.5.2009 |
| Caffeine (as citrate) 10mg/ml Injection |
For the short term treatment of apnoea of prematurity of infants between 28 and <33 weeks gestational age |
16.5.2009 |
| Caffeine (as citrate) 10mg/ml Injection |
For the short term treatment of apnoea of prematurity of infants between 28 and <33 weeks gestational age |
16.5.2009 |
| Perindopril arginine 2.5mg/5mg/10mg film coated tablet |
For the treatment of arterial hypertension, congestive heart failure and coronary artery disease. |
16.5.2009 |
| Each gm contains: halobetasol 0.05% w/w + Muciprocin 2.0% w/w gel |
For the topical treatment of inflammatory dermatitis with secondary bacterial infection |
16.5.2009 |
| Mometasone 0.1% + Fusidic acid 2% cream/oinmetn |
For the treatment of dermatoses where secondary bacterial and or candidial infection is present |
25.5.2009 |
| Thiocolchicoside 8mg + Etoricoxib 60mg tablets |
Additional strength |
25.4.2009 |
| Methadone Hydrochloride 5mg/10mg perml syrup: 5mg/10mg/20mg/40mg tablet |
For the treatment of opiod dependence and in maintenance treatment for opioid dependence |
28.5.2009 |
| Trospium Chloride film coated tablet 20mg |
For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frquency |
9.5.2009 |
| Methadone Hydrochloride 5mg/10mg perml syrup: 5mg/10mg/20mg/40mg tablet |
For the treatment of opoid dependence and in maintenance treatment for opoid dependence |
28.5.2009 |
| Trospium Chloride film coated tablet 20mg |
For the treatment of over-active bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency |
28.5.2009 |
| Arformoterol (as Tartrate) 15 mvg / 2ml Inhalation Solution |
for the long term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema |
29.5.2009 |
| Zolmitripatan 5.0 % w/v Benzalkonium Chloride NF 0.01% w/v Nasal spray |
For the acute treatment of migraine with or without aura in adults |
9.5.2009 |
| Dexmedetomidine (as HCL) 100mcg / ml Injection |
For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting |
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