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Name/Indication/Approval in India

( Sr. No.)  Drug Name - Indication - Date of Approval

  1. R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection Chemotherapy induced nausea & vomiting 12.01.07
  2.  Torsemide 10mg + Amiloride 5mg tablets Edema Associated with congestive heart failure & hypertension 17.01.07
  3. Fexofenadine suspension (30mg/5ml) SeAsonal allergic rhinitis & chronic idiopathic urticaria 19.01.07
  4. Sildenafil Citrate 20mg Tablet For pulmonary osterial hypertension 23.01.07
  5. Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength) As approved 23.01.07
  6. FluvAstatin Tablet (As calcium) 10mg/20mg/40mg (additional strength) As approved 29.01.07
  7. Halobetazol Propionate Cream (0.05%) Corticosteroid responsive dermatomes 02.02.07
  8. Eszopiclone tablet (1mg/2mg/3mg) For insomnia 07.02.07
  9. Diltiazem Hcl. 2% gel For anal fissure 07.02.07
  10. Nalbuphine injection 10mg/20mg per ml. For moderate to severe pain 07.02.07
  11. Levonorgestrel 1.5mg tablets For emergency contraceptive 07.02.07
  12. Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer) For gAstric ulcer, duodenal ulcer, Z. E Syndrome, GERD 07.02.07
  13. levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet For lower respiratory tract infection in adult 08.02.07
  14. Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injection For testosterone deficiency (i) primary hypogonadism (ii) Hypogonadotropine hypogonadism 08.02.07
  15. Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional strength) As approved 08.02.07
  16. Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution For steroid responsive inflammatory ocular condition 14.02.07
  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
  31. Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection (additional strength) As approved 01.03.07
  32. Quetiapine (As fumarate) SR 400mg tablet (additional strength) As approved 05.03.07
  33. Cabergoline 1mg tablet (additional strength) For Hyperprolactinemia 06.03.07
  34. Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.) Antibiotic (For adult use only) 07.03.07
  35. Clindamycin 1% + Isotretinoin 0.05% gel For acne 08.03.07
  36. Estradiol topical emulsion 2.5mg/gm Vasomotor symptoms Associated with menopause 16.03.07
  37. Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler (100mcg/capsule) (New Dosage Form) As approved 16.03.07
  38. Polonosetron (As Hcl.) For Injection 0.25mg/5ml Chemotherapy induced nausea & Vomiting 20.03.07
  39. Cifixime 200mg + Erdosteine 300mg Capsules Acute Exacerbation of chronic bronchitis 21.03.07
  40. Aminophylline CR 225/350mg Asthma, COPD, Bronchitis 21.03.07
  41. Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream Acute Musenlosleteal pain 21.03.07
  42. Eberconazole cream (1%) Dermatophyte infection of skin such As T-corporis, T-c, T-Pedis 22.03.07
  43. ISMN 60mg Sr + Atenolol 50mg/100mg For angina pectoris 23.03.07
  44. Levonorgestrel 0.03mg tablet For control of fertility 23.03.07
  45. Bortezomib 2mg/vial (additional pack size) As approved 28.03.07
  46. Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg) For HIV infection 02.04.07
  47. Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule For diabetic neuropathy 02.04.07
  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
  63. Etodolac ER tablets 400mg/500mg For osteoarthritis & rheumatoid arthritis 09.05.07
  64. Levosulpiride tablet (25mg) For G.I. problem like fanatical dyspepsia, nausea, vomiting and diabetic gAstroperisis 10.05.07
  65. Rimonabant tablet 20mg For Obese Patients BMI≥ 30kg/m2 or overweight patients BMI≥ 27kg/m2 with Associated risk factors such As type-I diabetes or dyslipidemia 11.05.07
  66. Lactitol monohydrate Syrup 66.67/100ml For constipation 14.05.07
  67. S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mg For essential hypertension 16.05.07
  68. Amlexanox Oral PAste (5%) For apthous ulcers in people with normal immune system 16.05.07
  69. Lenalidomide capsule (5mg/10mg/15mg/25mg) For transfusion dependent anemia due to myalodysplastic syndrom Associated with deletion 5q cytogenic abnormality 16.05.07
  70. Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication) For surgical prophylaxis (additional indication) 18.05.07
  71. Lornoxicam tablet 4mg/ 8mg For Osteoarthritis  rheumatoid  arthritis 21.05.07
  72. Atenolol 25mg/50mg + Indapamide SR 1.5mg For essential hypertension 21.05.07
  73. Livetiracetam conc.  for infusion 100mg/ml (new dosage form) As adjunctive therapy in partial onset seizures in adults with epilepsy when oral administration is temporarily not feasible 21.05.07
  74. Eplerstat tablet 50mg For abnormality of vibration sense and abnormal change in heart rate associated with diabetic peripheral neuropathy 25.05.07
  75. Citicoline tablet 200mg (additional strength) As approved 25.05.07
  76. Varenicline (As tartrate) 0.5mg/1mg tablets As an aid to smoking cessation treatment in adults 29.05.07
  77. Azithromycin eye drops 1% Conjunctivitis 06.06.07
  78. Ciclesonide Nasal Spray 50mcg/spray For seasonal & perennial allergic rhinitis in adults, adolescents aged ≥ 12 years 08.06.07
  79. Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection Antibiotic 08.06.07
  80. Isotretinoin  0.05% + Erythromycin 2% gel For acne 08.06.07
  81. Aliskiren Tablet 150mg/300mg For hypertension 08.06.07
  82. Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength) As approved 08.06.07
  83. Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for children) As approved 08.06.07
  84. Dexrabeprazole sodium Enteric Coated tablet 5mg/10mg For Duodenal ulcer, Gastric ulcer & GERD 13.06.07
  85. Renolazine Extend ReleAse tablet (500mg) For Chronic Angina 14.06.07
  86. Phenytoin sodium ER capsules (300mg) (New dosage form) For control of generalized toni-clonic and treatment & prevention of seizures occurring during or following neurosurgery 14.06.07
  87. Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet For BPH in men with enlarged prostate 14.06.07
  88. Cefepime injection 500mg/1gm/2gm (For additional indication) For bacterial meningitis in children 14.06.07
  89. Tranexamic acid mouthwash (50mg/ml) For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery 15.06.07
  90. Deflazocort oral suspension (6mg/5ml) (new Dosage Form) As approved 15.06.07
  91. Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet For BPH with overactive bladder 15.06.07
  92. Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules For duodenal ulcer, gastric ulcer & GERD 15.06.07