LIST OF APPROVED DRUG FROM 01.01.2007 TO 31.12.2007

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
93 Dexrabeprazole Sodium E. coated tablet 5mg/10mg. For duodenal ulcer, gastric ulcer and GERD. 13-06-2007.
94 Cefepime Injection (New indication) For bacterial meningitis in children. 14-06-2007.
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) + Methyl-prednisolone 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 co-infected 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 therapy including trastuzumab. 24-07-2007.
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. (Addl. Strength) As Approved 01-08-2007.
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 s.aureus.(e.g-UTI,Upper&lower 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 infected 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 16 years of age with newly diagnosed epilepsy. (ii)         As adjunctive therapy in myoclonic seizures in adults and adolescents from 12 years of age with Juvenile myoclonic epilepsy. In primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. 09-10-2007.
143 Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl (100mg) each For drug resistant malaria. 10-10-2007.
144 Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 900mg per 20ml. For breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. 11-10-2007.
145 Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet. For mild to moderate hypertension. 15-10-2007.
146 Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet For treatment of patients with both hypertension and hypercholesterolemia. 15-10-2007.
147 Omeprazole(20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength). As approved. 15-10-2007.
148 Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg)per ml. (eye drops) For inflammation after ocular surgery and where a risk of bacterial ocular infection exists. 16-10-2007.
149 Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine (2mg) +  Calcium Picolinate (200mg) tablet. For diabetic neuropathy. 16-10-2007.
150 Satranidazole (300mg) + Ofloxacin (200mg) Tablet. For diarrhoea of mixed infection in adults. 18-10-2007.
151 Methylcobalamin 500mcg+beta carotine-10.33mg+alpha lipoic acid 100mg+B6 1.5mg+B1 2mg & Cr.polynicotinate. For adult patients with diabetic neuropathy. 18-10-2007.
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 acid1.5mg+B5-5mg,+Zn.sulphate 25mg+Cr.Polynicotinate 200mcg+selenium-65mcg+inositol-1.5mg + alpha lipoic acid 100mg capsule For Vitamins and mineral deficiency states. 31.10.07
162 Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid 300mg +Benfothiamine-50mg. capsule For diabetic neuropathy 13.11.07
163 Methyl prednisolone aceponate-1mg + 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 As Approved 20.11.07
167 Ceftriaxone 2gm+ Tazobactum 250mg for injection As Approved 21.11.07
168 Methylprednisolone aceponate-1mg + Mupirocin-20mg. cream For the treatment of atopic dermatitis 21.11.07
169 Citicholine(as Sod.)-200mg/500mg/750mg 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 acid1.5mg+B6-3mg,+Zn.sulphate 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 +B6-3mg+Thiamine 10mg capsule For diabetic neuropathy 29.11.07
175 Doxophylline-400mg+Salbutamol(as sulphate)-2mg/4mg Tablets For treatment of Bronchial asthma in adults 29.11.07
176 Gatifloxacin (as sequihydrate)-3mg + Flurbiprofen sod.-0.3mg/ml eye drops. For reduction of post-operative inflammatory conditions of eye ,when bacterial infection exists. 29.11.07
177 Sertanidazole-300mg+ Ofloxacin-200mg tablet For treatment of diarrhoea of mixed infection in adults patients. 29.11.07
178 Zoledronic acid 5mg/100ml solution for infusion (addl. indication). Post-menopausal osteoporosis. 6-12-2007.
179 Olmesartan medoximil-20mg + Ramipril-5mg. tablet For treatment of essential hypertention. 12.6.07
180 Levosulpiride Tablet (50mg/100mg) (addl. strength for addl. indication). For depression and schizophrenia in adults. 12.6.07
181 Combipack of 12 Artesunate 50mg tablets & 6 Mefloquin-250mg tablets For drug resistant P.falciparum malaria infection. 12.6.07
182 Pregabalin-75mg/150mg +Methylcobalamine 500mcg cap For the treatment of adult patients with peripheral neuropathy. 12.10.07
183 Doxycycline-100mg +L.bacillus spores-5 billion For adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea 12.11.07
184 Cefprozil 250mg/500mg+Clav. Acid-62.5mg /125mg. tab For the treatment of adult patients with upper&lower RTI, Skin & Skin structure infection 12.11.07
185 Dextrometharpahan HBr-10mg+Chlorphenaramine maleate-2mg /5ml syrup. For the temporary relief of cough due to throat irritation, sneezing & ruunning nose. 12.11.07
186 Lornoxicam 8mg /2ml inj. For Short-term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery) 12.11.07
187 Apomorphine HCL-2mg/3mg Sublingual tablet. For erectile dysfunction in adult men. 12.11.07
188 Escitlopram (as oxalate)10mg + Clonazepam-0.5mg tablet (addl. Strength). For comobid depression and anxiety disorder. 12.12.07
189 Doxophylline injection-10mg /ml For bronchial asthama & COPD in adult patients, when oral therapy is in approriate. 31.12.07