17 Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional strength) As approved 14.02.07 18 Glibeneclamide 5mg + MetFormin SR 850mg tablet (additional strength) As approved 15.02.07 19 Aceclofenac injection (150mg/3ml) For short term treatment of pain due to post operative and post traumatic cAses 19.02.07 20 Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet (For additional indication) Angina pectoris in adults 20.02.07 21 Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) As approved 20.02.07 22 Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet Essential hypertension 21.02.07 23 Glatiramer Acetate injection (20mg/ml) Multiple sclerosis 21.02.07 24 Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) As approved 22.02.07 25 Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tablet For hypertension 23.02.07 26 Olopatadine Hcl. Tablet 2.5mg/5mg Allergic nAsal inflammation hives, itching with skin diseAses 26.02.07 27 Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg Essential hypertension 26.02.07 28 Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer For Duodenal ulcer, G.U, Z.E.S. & GERD 26.02.07 29 Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler additional strength) As approved 27.02.07 30 Moxonidine tablet 0.2mg/0.3mg/0.4mg For hypertension 27.02.07
48 Propofol 10mg + Lignocaem 1mg per ml injection For induction of anesthesia 04.04.07 49 Ezetimibe 10mg + Fenofibrate 160mg tablet For combined hypertipidemia 04.04.07 50 Methylprednisolone Acrponate topical solution 0.1% Atopic dermatitis (eczema) inflammatory and allergic skin reaction 04.04.07 51 Citicoline (750mg) tablet (additional strength), syrup 500mg/5ml (new dosage Form) (not For children) As approved 10.04.07 52 Ertapenem For injection (1gm/vial) Antibiotic 10.04.07 53 Letrozole 2.5mg tablet (for additional indication) For induction of ovulation in anovulatory infertility ( additional indication) 10.04.07 54 Quetiapine SR Tablets 50mg ( additional strength) As approved 10.04.07 55 Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) As approved 10.04.07 56 Sunitinib Maleate Capsules 12.5mg/25mg/50mg For G.I. Stromal tumor, advanced renal cell carcinoma 10.04.07 57 Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) Antibiotic 20.04.07 58 Aprepitant 40mg capsules (additional strength) Prevention of post-operative nausea & vomiting (additional indication) 24.04.07 59 Olopatadime Ophthalmic solution (0.2%) (additional Strength) As approved 24.04.07 60 Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 500mg calcium each For osteoporosis in postmenopausal women 01.05.07 61 Levocetirizem 2Hcl. Dispersible tablet (2.5mg) For allergic rhinitis & chronic urticaria 08.05.07 62 Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) As approved 07.05.07
indication) children. 95 Phenytoin Sodium E.R (300mg) For control of generalised tonic-clonic (grand-mal) and prevention and treatment of seizures occuring during or following neurosurgery. 14-6-2007. 96 Tranexamic acid Mouth Wash (50mg/ml) For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery. 15.6.2007. 97 Deflazacort Oral Suspension (6mg/5ml) (New dosage form) For asthma, rheumatoid arthritis when glucocorticosteriod therapy is warranted. 15-06-2007. 98 Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule. For BPH with overaction bladder in Adults only. 15-06-2007. 99 Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule. For gastric ulcer, duodenal ulcer and GERD. 18-6-2007. 100 Mebeverine HCl prolonged release capsule (200mg). For irritable bowel syndrome 19-06-2007. 101 Cilnidipine Tabs. 5mg, 10mg For the treatment of mild to moderate hypertension 21-6-2007 102 Azithromycin 500mg + Ambroxol S.R (75mg) Tablet. For RTI caused by susceptible organisms in adults. 05-07-2007. 103 Pholcodiene Syrup (4mg/5ml). For symptomatic relief of dry ticklish and unproductive coughs in children above 1 years. 06-07-2007. 104 Exenatide Injection -pre-filled pen (250mcg/ml). For adjunctive therapy to improve glycemic control in patients with Type-II diabetes mellitus, who have not achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonylurea. 06-07-2007. 105 Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic Solution. For reduction of post-operative inflammatory conditions of the eyes. 11-07-2007.
106 Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye drops. For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists. 11-07-2007. 107 Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5/1.5mg + Chromium Polynicotinate 65mcg/200mcg+ Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule For Vitamins and Mineral deficiency states in adult patients 39275 108 Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops. For post-operative steriod responsive inflammatory ocular conditions when ocular bacterial infections or a risk of bacterial infection exists. 12-07-2007. 109 Clotrimazole (10mg) + aceponate 1mg/gm of cream. For fungal infection of skin associated with inflammation. 12-7-2007. 110 Capecitabin Tablet (150mg/500mg). (for additional indication). (i). First line treatment of advanced gastric cancer in combination with platinum based regimen.(ii). Treatment of patients with locally advanced or metastatic breast cancer in combination with docetaxel following failure of cytotoxic chemotherapy. 16-07-2007. 111 Rifabutin Capsule (150mg). For treatment of pulmonary T.B only in patients with HIV. (It should never be used as a substitute to Rifampicin in T.B patients without HIV co-infection). 16-07-2007. 112 Lapatinib (as Ditosylate) (250mg) Tablet. In combination with capecitabine it is indicated in patients with advanced or metastatic breast cancer whose tumour overexpress HER2 and who have received prior 24-07-2007. infected prednisolone
therapy including trastuzumab. 113 Levocetirizine Di-HCl mouth dissolving tablets (5mg) (new dosage form). For the treatment of allergic rhinitis and chronic urticaria. 25-07-2007. 114 Idaravone Injection (1.5mg/ml). For improvement of neurologic symptoms, disorders of activitis of daily living and functional disorder associated with acute ischemic stroke. 26-07-2007. 115 Diclofenac Sodium (75mg/ml) Injection (addl. Strength). For management of painful conditions in post-operative cases, rheumatoid arthritis and osteoarthritis. 30-07-2007. 116 Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet. For LRTI, URTI and UTI. 30-07-2007. 117 Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength). As approved. 30-07-2007. 118 Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength). As approved. 30-07-2007. 119 VSL # 3 (Probiotic Blend) sachet For rotavirus diarrhoea in children. 31-07-2007. 120 Sorafenib (as Tosylate) (200mg) Tablet. For advanced renal cell carcinoma. 31-07-2007. 121 Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule. For diabetic neuropathy. 31-07-2007. 122 Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment. For plaque psoriasis. 01-08-2007. 123 Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. As Approved 01-08-2007.
(Addl. Strength) 124 Omeprazole (20mg/40mg)+Sod. Bicarbonate-600mg+ Mg.Hydroxide-700mg .chew tab. For duodenal, gastric ulcer, GERD, and erosive esophagitis, 1/8/2007 125 Deferasirox dispersible tablet (400mg) (addl. Strength). As approved 17-08-2007. 126 Tegafur (100mg) + Uracil (224mg) capsule. For first line treatment of metastatic colorectal cancer in combination with calcium folinate. 22-08-2007. 127 Bortezomib Injection (additional indication) For the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. 05-09-2007. 128 Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength). As approved. 06-09-2007. 129 Ceftazidine (2gm) + Sulbactam (1gm) Injection ( addl. strength for additional indication). For serious abdominal infection. 06-09-2007. 130 Polyethylin Glycol 400 (0.4%) + Propylene Glycol (0.3%). For temprory relief of dryness, irritation burning, stinging, grittiness or foreign body sensation caused due to environmental factors. 18-9-2007. 131 Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl. strength). As approved. 25-09-2007. 132 Levocetirizine Di-HCl syrup (2.5mg/5ml) (for use in children 2 years and above). As approved. 26-09-2007. 133 R-Sibutramine Capsule (2.5mg/5mg) As an adjunctive therapy for the management of obesity including weight loss and maintenance of weight loss in pateints whose BMI is 30Kg/m2 or higher. 26-09-2007.
134 Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet. For adult patients with infection caused susceptible micro-organisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis. 27-09-2007. 135 Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml). For diagnostic use in echocardiography doppler of macrovasculature an doppler of microvasculature. 28-09-2007. 136 Ondansetron orally disintegrating tablet (4mg/8mg) (additional dosage form) For chemotherapy induced nausea and vomiting 28-09-2007. 137 Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet. For UTI, URTI and LRTI and gonococcal urethritis. 05-10-2007. 138 Cefuroxime-125/250/500mg +Clav.Acid-31.25/62.5/125mg For adult patients with infection caused by susceptible microbs,including RTI & gonococcal urethrities) 5/10/2007 139 Amiodarone Injection (additional Indication). For cardiopulmonary resuscitation in the event of cardiac arrest related to ventricular fibrilation resistant to external electric shock. 05-10-2007. 140 Risedronate Sodium tablet (35mg) (additional indication) For osteoporosis in men at high risk of fracture. 08-10-2007. 141 Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment. For wounds and ulcers. 09-10-2007. 142 Levetiracetam Tablet (addl. indication) (i) (i) As monotherapy in partial onset seizures with or without secondary generalisation in patients with 09-10-2007.
152 Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU For osteoporosis and calcium deficiency state. 23-10-2007. 153 Etizolam Tablet (0.5mg/1mg). For anxiety disorder associated with depression. 29-10-2007. 154 Oxaprozine Tablet (600mg) For relief of signs and symptoms of osteoarthritis, rheumatoid arthritis. 30-10-2007. 155 Prulifloxacin (600mg) Tablet. For acute uncomplicated lower urinary tract infection (simple cystitis), complicated lower UTI, acute exacerbation of chronic bronchitis. 30-10-2007. 156 Cilostazole E.R Tablet (100mg/200mg). For management intermittent claudication. 30-10-2007. 157 Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength) As Approved 30-10-2007. 158 Sitagliptin Tablet (25mg/50mg/100mg). As adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes. 30-10-2007. 159 Miglitol (50mg) + Metformin HCl SR (500mg) tablet. For adult with Type-II diabetes mellitus where simple drug therapy, diet and exercise do not result in adequate glycemic control. 31-10-2007. 160 Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream. For atopic dermatitis. 31-10-2007. 161 Methyl cobalamine 500mcg+folic 25mg+Cr.Polynicotinate + alpha lipoic acid –100mg capsule For Vitamins and mineral deficiency states. 31.10.07 162 Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid –300mg +Benfothiamine-50mg. capsule For diabetic neuropathy 13.11.07
163 Methyl + salicylic acid-50mg ointment For treatment of psoriasis 19.11.07 164 Propanol 50gm+povidone iodine-1gm in 100ml solution For surgical & hygenic hand disinfection. 19.11.07 165 Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution -do- 19.11.07 166 Voglibose disp.tab.0.2mg/0.3mg As Approved 20.11.07 167 Ceftriaxone –2gm+ Tazobactum 250mg for injection As Approved 21.11.07 168 Methylprednisolone + Mupirocin-20mg. cream For the treatment of atopic dermatitis 21.11.07 169 Citicholine(as granules per sachet. As Approved 26.11.07 170 Butarphenol tartrate 10mg/ml nasal spray For management of pain in patients using opioid analgesics. 26.11.07 171 Deferasirox 100mg dis.tablet(addl. strength) As Approved 28.11.07 172 Methyl cobalamine 500mcg+folic 61.8mg+Ca.Pantothenate 10mg+ Niacinamide-50mg +chrimium-50mcg capsule For Vitamins and mineral deficiency patients. 29.11.07 173 Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsule For the treatment of diabetic Neuropathy 29.11.07 174 Methylcobalamine 500mcg+folic acid 1.5mg+ alpha lipoic acid –100mg 10mg capsule For diabetic neuropathy 29.11.07 175 sulphate)-2mg/4mg Tablets For treatment of Bronchial asthma in adults 29.11.07 176 Gatifloxacin (as + Flurbiprofen eye drops. For reduction of post-operative inflammatory conditions of eye ,when bacterial infection 29.11.07