| S.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 |