No |
Name Of Drug |
INDICATION |
DATE OF APPROVAL |
1 |
ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets (Additional Strength) |
Same as Approved |
02.01.08 |
2 |
Halobetasol 0.05% + Clotrimazole 1.0% cream |
For the treatment of steroid responsive fungal infections including eczema and psoriasis |
04.01.08 |
3 |
Citicholine 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 |
04.01.08 |
4 |
Levodopa 200mg + Carbidopa 50mg C.R. tablet |
For Parkinson's Disease |
08.01.08 |
5 |
Nanocrystalline Silver Gel 0.002% |
For the treatment of burns and wound infections |
04.01.08 |
6 |
Cinitapride (as hydrogen tartrate) 1mg tablet |
For the treatment of gastroesophageal reflux disease and functional inconveniences of the gastrointestinal motility |
04.01.08 |
7 |
Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet |
For the treatment of adult patients with HIV infection |
07.01.08 |
8 |
Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet |
For the treatment of Urinary tract infections, respiratory tract infections, biliary tract infections in adult patients prone to antibiotic associated diarrhoea |
07.01.08 |
9 |
D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) |
Same as Approved |
07.01.08 |
10 |
Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) |
For the treatment of lower respiratory tract infection caused by pseudomonas aeruginosa |
08.01.08 |
11 |
Atazanavir 300mg capsules (Additional strength) |
Same as approved |
08.01.08 |
12 |
Ertapenem for injection 1gm/vial (additional indication) |
For the prophylaxis of surgical site infections following elective colorectal surgery |
15.01.08 |
13 |
Vildagliptin Tablets 50mg/100mg |
As an adjunct to diet and exercise to improve glycemic control in patients with type-II diabetes mellitus |
18.01.08 |
14 |
Atorvastatin 10mg + Aspirin 75/150mg Capsules |
For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease |
18.01.08 |
15 |
Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets |
For the treatment of acute migraine |
22.01.08 |
16 |
Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C.R. tablet (Additional Strength) |
Same as Approved |
24.01.08 |
17 |
Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 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. |
24.01.08 |
18 |
Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication) |
Ovarian cancer, non-small cell lung cancer and AIDS related Kaposis Sarcoma |
22.01.08 |
19 |
Sorafenib tablets 200mg (Additional Indication) |
For hepatocellular Carcenoma |
22.01.08 |
20 |
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) |
22.01.08 |
21 |
Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional Indication) |
For the prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplantation |
23.01.08 |
22 |
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 |
23.01.08 |
23 |
Aceclofenac injection 150mg/ml |
For short term treatment of pain due to post operative and post traumatic cases |
23.01.08 |
24 |
Hydroxychloroquine 400mg tablets (Additional Strength) |
Same as Approved |
31.01.08 |
25 |
Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) |
For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions. |
25.01.08 |
26 |
Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate- 750mg CR tablet (Additional Strength) |
Same as Approved |
24.01.08 |
27 |
Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet |
For the treatment of acute pain in adults |
24.01.08 |
28 |
Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength) |
Same as Approved |
24.01.08 |
29 |
Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection |
For the treatment of infection caused by sensitive organisms viz. lower RTI, complicated UTI, Septicemia, bacteremia |
24.01.08 |
30 |
Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet |
For the treatment of Type-II diabetes associated with mixed dyslipidemia |
25.01.08 |
31 |
Salicylic acid 10mg/20mg (Foaming facewash solution) |
For the treatment of acne vulgaris |
28.01.08 |
32 |
Ozagrel Hcl. Tablets 100mg/200mg |
For the treatment of bronchial asthma |
28.01.08 |
33 |
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 Alzheimer type and dementia associated with Parkinsons disease |
28.01.08 |
34 |
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) |
28.01.08 |
35 |
Dextromethorphan Orodispersible strip 5.5mg/11mg |
For the relief of persistent dry irritating cough in adult patients only |
28.01.08 |
36 |
Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection |
For the treatment of acute colicky pain in adults |
28.01.08 |
37 |
Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops |
For decrease of intraocular pressure in patients with open angle glaucoma or ocular hypertension, who are insufficiently responsive to topical beta blockers or prostaglandin analogues |
28.01.08 |
38 |
Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores |
For RTI, SRS of tissue infection, bons & joint infection, ENT infection in adults prone to antibiotic associated diarrhoea |
30.01.08 |
39 |
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 |
31.01.08 |
40 |
Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calcium Pantothenate25mg+Folic Acid 1.5mg+Zinc oxide22.5mg+Chromium picolinate65mcg+Inositol10mcg+Lutein5mg capsule? |
For Vitamins and Minerals deficiency states in adult patients |
30.01.08 |
41 |
Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid0.75mg capsule? |
For Vitamins and Minerals deficiency states in adult patients |
30.01.08 |
42 |
Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg + Pyridoxine3mg + Biotin5mg + Folic acid 1.5mg capsule? |
For Vitamins deficiency states in adult patients |
30.01.08 |
43 |
Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules |
For the treatment of lower RTI, skin & soft tissue bone & joint infections, ENT infections in adult patients prone to antibiotic associated diarrhoea |
30.01.08 |
44 |
Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg + Ciclesomide 400mcg per capsules |
As 3rd line treatment of sever cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately |
31.01.08 |
45 |
Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 10mg tablets |
For the treatment of patient with both essential hypertension and hypercholesterolemia |
28.01.08 |
46 |
Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form) |
For allergic rhinitis & chronic urticaria |
28.01.08 |
47 |
Oseltamivir 30mg & 45mg Capsules (Additional Strength) |
Same as Approved |
28.01.08 |
48 |
Fondaparinax Sodium injection (Additional Indication) |
Treatment of acute coronary syndrome (ACS) with and without ST-segment elevation |
28.01.08 |
49 |
Camostat Mesylate tablets 100mg |
For remission of acute symptoms of chronic pancreatitis and post-operative reflux esophagitis |
29.01.08 |
50 |
Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe |
For intradermal implantation and facial soft tissue agumentation |
30.01.08 |
51 |
Ursodeoxycholic acid tablets 600mg |
For the treatment of patients with chronic cholestatic liver disease |
30.01.08 |
52 |
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 |
30.01.08 |
53 |
Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream |
For the topical treatment of bacterial and fungal infections |
30.01.08 |
54 |
Exenatide injection (Each 2ml vial contains- Exenatide 5mcg/10mcg per 0.2ml ) (Additional Strength) |
For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who have not achieved adequate glycemic control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas |
30.01.08 |
55 |
Diclofenac Sodium 50mg + Paracetamol 500mg tablets |
For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis |
30.01.08 |
56 |
Gabapentin SR 600mg tablets |
As adjunctive therapy in the treatment of partial seizures of epilepsy |
30.01.08 |
57 |
Memantine 5mg /10mg + Donepezil 5mg Tablets |
For moderate to severe Alzheimer's disease |
31.01.08 |
58 |
Doxifluridine Capsules 100mg/200mg |
For carcinoma of the stomach, colon, rectum, breast, uterine, cervix and bladder |
31.01.08 |
59 |
Haemodialysis Powder/Liquid Form containing citrate |
For use for patients being treated by hemodialysis |
31.01.08 |
60 |
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 |
31.01.08 |
61 |
Cimetropium Bromide tablet 50mg |
For the treatment of irritable bowel syndrome |
31.01.08 |
62 |
CyclobenzaprineHcl. Tablets 5mg/10mg |
As adjunct to rest and physical therapy for relief of muscle spasm associated with acute painful musculoskeletal conditions |
31.01.08 |
63 |
Sertaconazole Nitrate Cream 2%, |
For the topical treatment of the superficial mycosis like dermatophytosis |
31.01.08 |
64 |
Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength) |
Same as Approved |
31.01.08 |
65 |
Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets |
For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency |
31.01.08 |
66 |
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 |
31.01.08 |
67 |
Halobetasol 0.5mg + Miconazole 20mg per gram Cream |
For steroid responsive dermatoses associated with superficial fungal infection of skin |
31.01.08 |
68 |
Montelucast 10mg + Levocetirizine 5mg film coated tablets |
For the treatment of allergic rhinitis in adults only |
31.01.08 |
69 |
Hydroquinone 2% + Tretinoin 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 |
31.01.08 |
70 |
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 |
31.01.08 |
71 |
Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules |
For treatment of painful inflammatory conditions associated with gastroduodenal ulcers |
31.01.08 |
72 |
Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler |
As third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately |
31.01.08 |
73 |
VSL # (Combination of lactic acid bacteria (VSL # 3) |
For the treatment of irritable bowel syndrome |
31.01.08 |
74 |
Clostimethate Sodium of 1,00,000IU Injection |
For the treatment of serious infection caused Gram-Ve bacteria including LRTI, UTI, where commonly used anti bacterial agent may be infective because of bacterial resistance |
31.01.08 |
75 |
Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength) |
Same as Approved |
20.02.08 |
76 |
Metronidazole CR tablet 600mg |
For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis |
21.02.08 |
77 |
Quetiapine fumarate SR tablets |
for the additional indication "acute manic episode associated with bipolar disorder |
21.02.08 |
78 |
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 |
25.02.08 |
79 |
Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tablet |
For the treatment of haemorrhoid |
29.02.08 |
80 |
Amtolmetin Guacil tablets 600mg |
For the treatment of osteoarthritis & rheumatoid arthritis |
07.03.08 |
81 |
Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.0005%) (additional strength) |
For lowering of IOP in patients with open angle glaucoma occular hypertension |
07.03.08 |
82 |
Methoxsalen USP-20mg Tablet |
1:- For repigmentation of idiopathic vitiligo alongwith phototherapy. 2:- For symptomatic control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy |
07.03.08 |
83 |
Cefditoren pivoxil 400mg tablets (Additional Strength) |
Same as Approved |
11.03.08 |
84 |
Doxofylline ER tablets 400mg/800mg (addl. Strength) |
For the treatment of bronchial asthma & COPD in adults |
12.03.08 |
85 |
Betamethasone 0.05% +Miconazole 2% Cream |
For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin |
12.03.08 |
86 |
Premetrxed disodium injection 100mg/vial (Additional Strength) |
Same as Approved |
12.03.08 |
87 |
Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension |
For gastric ulcer, duodenal ulcer, and GERD |
12.03.08 |
88 |
Mecobalamin 1000mcg+ Alpha Lipoic Acid 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ Inositol 100mg + Benfotiamine 100mg capsule? |
For the treatment of diabetic neuropathy |
19.03.08 |
89 |
ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) |
Same as Approved |
19.03.08 |
90 |
Temozolamide capsules 140mg/180mg (Addl. Strength) |
Same as Approved |
31.03.08 |
91 |
Amisulpiride 300mg tablets (Additional Strength) |
Same as Approved |
20.03.08 |
92 |
Nifedipine SR Tablets 10mg/20mg |
For the treatment of essential hypertension |
24.03.08 |
93 |
Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 ml of syrup |
For symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis |
26.03.08 |
94 |
Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup |
For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis |
26.03.08 |
95 |
Boswellia Serrata 0.05gm/gm of Cream |
For the treatment of mild to moderate psoriasis |
28.03.08 |
96 |
Etoricoxib injection 90mg/ml |
For short term use in acute painful condition in adults only |
28.03.08 |
97 |
Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) |
Oral contraceptive in women |
28.03.08 |
98 |
Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets |
For symptomatic treatment of acute rhinosinusitis |
28.03.08 |
99 |
Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg |
For the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain |
28.03.08 |
100 |
Nepafenac Opthalmic suspension (1mg/ml) |
For the treatment of pain and inflammation associated with cataract surgery |
31.03.08 |
101 |
Hylan GF 20 Injection (Synvisc) (Additional Indication) |
For pain management in patients suffering with osteoarthritis of the knee, hip, shoulder and ankle |
31.03.08 |
102 |
Docetaxel injection conc. |
For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer |
31.03.08 |
103 |
Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D-Panthenol IP 50mg per 2 ml of injection |
For peripheral neuropathy |
31.03.08 |
104 |
Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength) |
Same as Approved |
01.04.08 |
105 |
Nicardipine Hcl. Injection 2.5mg/ml |
For short-term treatment of hypertension when oral therapy is not feasible or not desirable |
07.04.08 |
106 |
Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules (Additional Strength) |
For the treatment of acute pain in adults |
08.04.08 |
107 |
Diacerin 50mg + Aceclofenac 100mg tablets |
For the treatment of adult patients with osteoarthritis of knee and or hip joints |
11.04.08 |
108 |
Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) |
Same as Approved |
16.04.08 |
109 |
Live freeze-dried lactic acid bacteria and bifidobacteria capsules |
For the treatment of irritable bowel syndrome |
10.04.08 |
110 |
Miltefosin Capsule 10mg/50mg (Additional Indication) |
Treatment of cutaneous leishmaniasis |
16.04.08 |
111 |
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) |
16.04.08 |
112 |
Diacerin 50mg + Glucosamine sulphate 500mg tablets. |
For the treatment of adult patients with osteoarthritis of knee and hip joints |
21.04.08 |
113 |
Clostridium Botulinum type-A toxin haemagglutinin complex (Additional Indication) |
For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy |
22.04.08 |
114 |
Fluconazole Dispersible tablets 50mg |
For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy |
22.04.08 |
115 |
Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication) |
In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy |
22.04.08 |
116 |
Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets |
As an adjunct to diet & exercise to improve glycemic control in patients with type-two diabetes mellitus |
28.04.08 |
117 |
Lansoprazole for injection 30mg/vial |
For short term treatment of errosive esophagitis when patients are unable to take the oral formulation |
28.04.08 |
118 |
Naproxen Suspension 125mg/5ml |
For the treatment of RA in children 5 years of age and above |
28.04.08 |
119 |
Sevelamer Carbonate 400mg/800mg tablets & sachet 400mg/800mg |
For control of serum phosphorus in patients with chronic kidney disease on dialysis |
28.04.08 |
120 |
Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tablets |
For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD |
28.04.08 |
121 |
Pantoprazole Sodium (With Sodium bicarbonate as buffer) 20mg/40mg tablets |
For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD |
28.04.08 |
122 |
Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml |
For the treatment of community acquired pneumonia, acute exacerabation of chronic bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis |
29.04.08 |
123 |
Pregabalin capsules (Addl. Indication) |
management of fibromyalgia syndrome |
29.04.08 |
124 |
Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength) |
Same as Approved |
08.05.08 |
125 |
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 monotherapy . |
08.05.08 |
126 |
Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets |
For diabetes insipidus and noctural emuresis |
08.05.08 |
127 |
Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength) |
Same as Approved |
14.05.08 |
128 |
Lecithin Liquid (each 5 ml contains lecithin 500mg equivalent to essential phospholipids 250mg |
For alcoholic liver disease, drug induced hepatitis |
14.05.08 |
129 |
Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength) |
For the treatment of plaque psoriasis |
14.05.08 |
130 |
Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solution |
For the topical treatment of acne vulgaris |
14.05.08 |
131 |
Deflazocort 24mg tablets (Additional strength) |
Same as Approved |
14.05.08 |
132 |
Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection (additional strength) |
For use as a surgical aid in anterior segments procedure including catract extraction & intra-ocular lens implantation |
14.05.08 |
133 |
Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets |
For the treatment of GERD, gastric and duodenal ulcer, Zollinger-Ellison syndrome |
14.05.08 |
134 |
Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg Tablets |
For coexisting essential hypertension & hyperlipidemia |
22.05.08 |
135 |
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 |
22.05.08 |
136 |
Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets |
For hypertension in patients whose blood pressure is not adequately controlled in monotherapy |
28.05.08 |
137 |
Metolazone 2.5mg + Ramipril 2.5mg/5mg |
For essential hypertension in adult patients whose blood pressure is not adequately controlled on monotherapy |
28.05.08 |
138 |
Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules |
For the treatment of secondary hyperthyroidism in patients with chronic kidney disease on dialysis |
29.05.08 |
139 |
Acebrophylline capsules 100mg |
For the treatment of adult patients with chronic obstructive pulmonary disease and bronchial asthma |
29.05.08 |
140 |
Sofalcone Capsule (100mg/50mg) |
For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute exacerbation of chronic gastritis |
02.06.08 |
141 |
S(+) Etodolac ER tablets 200mg/300mg |
For the relief of pain and inflammation in patients with rheumatoid arthritis and osteoarthritis |
02.06.08 |
142 |
Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets |
For the treatment of adult patients with signs & symptoms of acute painful conditions |
02.06.08 |
143 |
Sodium Hyaluronate injectable gel (each 0.6ml. 1ml pre filled syringe contains, sodium Hyaluronate 20mg/ml, 22.5mg/ml |
For intradermal implantation and facial soft tissue augmentation |
03.06.08 |
144 |
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 therapy |
03.06.08 |
145 |
Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules |
For the treatment of Gastroeasophageal Reflux Disease (GERD) in patients not responding to dexrabeprazole alone |
09.06.08 |
146 |
Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets |
For acute low back pain & other musculoskeletal painful and inflammatory condition in adults |
11.06.08 |
147 |
Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) |
For the treatment of lower respiratory tract infection in children |
24.06.08 |
148 |
Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength) |
Same as Approved |
24.06.08 |
149 |
Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg+ Benfotiamin100mg + Pyridoxine 50mg tablets |
For the treatment of diabetic Neuropathy |
03.07.08 |
150 |
Ivabradine (Hcl.) 5mg/7.5mg Tablets |
For the treatment of chronic stable anginapectoris in patients with normal sinus rhythm who have a contraindication or intolerance for Beta-blockers |
03.07.08 |
151 |
Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule |
For the treatment of diabetic Neuropathy |
04.07.08 |
152 |
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 |
08.07.08 |
153 |
Temoporfin 1mg/ml Injection (Additional Strength) |
Same as Approved |
08.07.08 |
154 |
Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100ml |
For the treatment of RTI, UTI and abdominal infections in adults |
09.07.08 |
155 |
Metoprolol ER + Amlodipine tablets (Additional Indication) |
For coronary artery disease/ischaemic lheartt disease |
16.07.08 |
156 |
Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets |
? |
18.07.08 |
157 |
Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tablets |
For the treatment of type_II diabetes mellitus when single drug therapy alongwith diet, exercise do not result in adequate glycemic control |
21.07.08 |
158 |
Testosterone Undecanoate 250mg/ml Injection |
For Testosterone replacement therapy of male hypogonadism when testosterone dificiency has been confirmed by clinical feature or biochemical tests |
22.07.08 |
159 |
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 methotixate or TNF antagonists |
22.07.08 |
160 |
Actarit 100mg Tablets |
For the treatment of rheumatoid arthritis patients |
22.07.08 |
161 |
Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets |
For the treatment of HIV infection in adults |
23.07.08 |
162 |
Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) |
Same as Approved |
23.07.08 |
163 |
Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop |
For reduction of part operative inflammatory condition of eyes |
24.07.08 |
164 |
Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops |
For the reduction of post operative inflammatory conditions of the eye |
24.07.08 |
165 |
Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup (Additional strength) |
Same as Approved |
25.07.08 |
166 |
Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication) |
For the treatment of secondary hyperparathyroidism in patients with stage 3 or stage 4 chronic kidney disease? |
05.08.08 |
167 |
Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength) |
Same as approved |
05.08.08 |
168 |
Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) |
Same as approved |
05.08.08 |
169 |
Olopatadine Nasal Spray (0.6%) |
For the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older |
05.08.08 |
170 |
Loxoprofen Sodium tablet (60mg) |
For the symptomatic treatment of pain and inflammation condition in patients with osteoarthritis |
14.08.08 |
171 |
Dexibuprofen Suspension 50mg/5ml |
For the treatment of mild to moderate pain, reduction of fever |
14.08.08 |
172 |
Bromfenac Sodium Eye Drop (0.09%) |
For the treatment of postoperative inflammation & reduction of postoperative ocular pain in patients who have undergone cataract extraction |
14.08.08 |
173 |
Ceftriaxone + Sulbactam injection (Additional Indication) |
for the treatment of acute bacterial otitis media, skin & soft structure infections, UTI, uncomplicated gonorrhoea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra abdominal infections, meningitis, surgical prophylaxis |
18.08.08 |
174 |
Citicoline Chewable tablet (500mg) |
For the treatment of disturbance of consciousness as resulting from head injuries , brain operation and acute stage of cerebral infraction in adult only |
18.08.08 |
175 |
Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml) |
For the treatment of productive cough |
18.08.08 |
176 |
Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) |
For the treatment of iron deficiency anaemia |
18.08.08 |
177 |
Cyclobenzaprine 7.5mg tablets (Additional Strength) |
Same as approved |
18.08.08 |
178 |
S-Metoprolol Succinate Oral Solution (Each Ml contains: S-Metoprolol Succinate 9.5mg equal to S-Metoprolol Tartrate 10mg) |
For the treatment of haemo-dynamically stably patients with definite or suspected acute Myocardial Infarction to reduce cardio-vascular mortality. |
19.08.08 |
179 |
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 at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant |
23.08.08 |
180 |
Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg) |
As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental infections, and halitosis |
25.08.08 |
181 |
Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml)? |
Same as approved |
25.08.08 |
182 |
Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg) |
For the treatment of oedema associated with congestive heart failure, cirrhosis and nephritic syndrome |
25.08.08 |
183 |
Tretinoin Microsphere Gel (0.1% W/V) |
For topical treatment of acne vulgaris |
26.08.08 |
184 |
Misoprostol 50Mcg tablet (Additional Strength) |
Same as approved |
26.08.08 |
185 |
Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) (New Dosage Form) |
Same as approved |
27.08.08 |
186 |
Guaiphenesin ER Tablet (600mg) |
For the treatment of productive cough accompanied by phlegm |
28.08.08 |
187 |
Clopidogrel 300mg Tablet (addl. Strength) |
As approved |
02.09.08 |
188 |
Capecitabine 150/500mg Tablets (addl. Indication) |
For the treatment of patients with metastatic colorectal cancer |
02.09.08 |
189 |
Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength) |
For the treatment of patients with HIV infection |
08.09.08 |
190 |
Ixabepilone lyophilized powder inj. 15mg/45mg per vial |
in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. |
13.09.08 |
191 |
Halometasone (as monohydrate ) 0.05% Cream? |
For the relief of inflammatory and pruritic manifestation of non-infected corticosteroid responsive dermatoses like eczema |
13.09.08 |
192 |
Calcium and Magnesium 24% (Veterinary) injectable solution.? |
For the treatment of milk fever, hypocalcaemia tetanies and disorders of calcium metabolism in dairy cattle. |
13.09.08 |
193 |
Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength) |
for the treatment of essential hypertension? |
15.09.08 |
194 |
Drotaverine + Aceclofenac (80mg + 100mg) Tablets |
For the treatment of adult patients with muscular pain associated with spasm |
15.09.08 |
195 |
Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets |
For the treatment of mild to moderate hypertension in adult patients whose blood pressure is not adequately controlled by monotherapy |
15.09.08 |
196 |
Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength) |
for the treatment of essential hypertension? |
15.09.08 |
197 |
Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion |
For the treatment of seborrhoeic dermatitis |
15.09.08 |
198 |
Citicoline CR Tab 1000mg |
For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia. |
16.09.08 |
199 |
Montelukast Suspension 5mg/5ml |
1. For the treatment of Prophylaxis & chronic treatment of Asthma in Pediatrics patients 12 months of age & older. 2. For relieving symptoms of seasonal allergic rhinitis in Pediatric patients 2 years of age & older & perennial allergic rhinitis in Pediatric Patients 6 months of age & older.? |
16.09.08 |
200 |
Etoricoxib roll on Topical Solution 1% v/v |
For the treatment of pain, swelling & inflammatory conditions due to arthritis. |
16.09.08 |
201 |
Risedronate Sodium 150mg Tablet (Additional Strength) |
As already approved? |
16.09.08 |
202 |
Levosulpiride Inj. 25mg/ml, 2ml? |
For the treatment of depression and schizophrenia in adults when oral therapy is not possible |
26.09.08 |
203 |
Paliperidone ER Tablet 3mg / 6mg / 9mg |
For the acute and maintenance treatment of schizophrenia |
26.09.08 |
204 |
Ceftiofur Crystalline free acid Suspension equi to Ceftiofur ---- 200 mg(veterinary) |
For treatment of bovine respiratory disease (BRD, Shipping fever, pneumonia) associated with Mannhenia haemolytica, Pasteurella multocida, andHistophilus somni in beef, non-lactating dairy, and lactating dairy cattle |
26.09.08 |
205 |
Ceftiofur HCl Suspension(as HCl salt) ----500mg (veterinary) |
For treatment of sub clinical mastitis in dairy cattle at the time of dry off asssociated with staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. |
26.09.08 |
206 |
Ceftiofur HCl Suspension (as HCl salt) ----125mg (veterinary) |
For treatment of clinical mastitis in lactating dairy cattle asssociated with coagulase- negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. |
26.09.08 |
207 |
Nitrofurantoin SR Tab. 100mg |
For the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus |
26.09.08 |
208 |
Tolperisone HCl Tablet 50 / 100 / 150mg? |
For the relief of painful muscle spasms of the skeletal musculature |
26.09.08 |
209 |
Etoricoxib + PCM (60mg + 500mg) Tablets? |
For the short term use in acute painful and inflammatory condition |
30.09.08 |
210 |
Citicoline Oral Drops |
For the treatment of disturbance of consciousness resulting from head injuries, brain operation & acute stage of cerebral infraction in adult. |
30.09.08 |
211 |
Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) Injection |
Indicated for the treatment of mastitis, metritis, pneumonia, pleuritis, fever and relieving of acute pain in musculoskeletal disorders in animals |
30.09.08 |
212 |
Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets |
For the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing Children) |
30.09.08 |
213 |
Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup |
for the treatment of chloroquine resistant/multidrug resitant on complicated malaria |
30.09.08 |
214 |
Cabergoline 1mg Tablets (Additional indication) |
For the treatment of hyperprolactinemia and inhibition of lactation. |
01.10.08 |
215 |
Pemetrexed disodium500mg / 100mg powder for sol. (Addl.indication ) |
In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology |
08.10.08 |
216 |
Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary) |
For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment of diseases due to clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and treatment of ornithobacterium rhinotacheale (ORT) |
08.10.08 |
217 |
Bortezomib inj.3.5mg/vial (Additional Indication) |
Treatment of patients with multiple myeloma |
09.10.08 |
218 |
Sertaconazole Nitrate Vaginal Tab.500mg |
For the treatment of vulvo-vaginal candidiasis in women |
09.10.08 |
219 |
Fosfomycin Tromethamine Sachet 3gms |
For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of E.Coli and Entreococcus faecalis |
09.10.08 |
220 |
Ixabepilone lyophilized powder (additional Indication) |
As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to cytotoxic chemotherapy. Previous therapy should have included as anthracycline, a taxane, and capecitabine |
09.10.08 |
221 |
Eprosartan Mesylate 400 mg / 600mg Tablets |
For the treatment of essential hypertension |
11.10.08 |
222 |
Tretinoine Gel as Micro Sphere 0.04% % 0.1% |
For topical treatment of Acne vulgaris. |
14.10.08 |
223 |
Hydroxychloroquine Sulphate (Additional indication ) |
For the treatment of systemic lupus erythematosus |
17.10.08 |
224 |
Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication) |
Indicated in the regular treatment of patients with moderate to severe COPD with frequent symptoms and a history of exacerbations |
17.10.08 |
225 |
Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops |
For post operative steroid responsive inflammatory ocular condition when bacterial ocular infections or a risk of bacterial ocular infections exists. |
21.10.08 |
226 |
Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules |
For the treatment of acute inflammation conditions associated with spasm in adults only |
21.10.08 |
227 |
Adapalene 0.1% + Benzoyl Peroxide 2.5% gel |
For the treatment of acne vulgaris |
24.10.08 |
228 |
Aceclofenac Roll - On 1% |
For the treatment of acute musculoskeletal pain in patients |
24.10.08 |
229 |
Citicoline Troches 200/500mg |
For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness and for treatment of degenerative damages and chronic cerebral vascular injuries in senile dementia. |
31.10.08 |
230 |
Amisulpride S.R.Bilayered tablet 200/400mg |
For acute and chronic schizophrenic disorders, in which positive symptoms and or negative symptoms are prominent, including patients characterised by predominant negative symptoms. |
03.11.08 |
231 |
Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules |
For the treatment of hypocalcaemia and/or osteoporosis |
04.11.08 |
232 |
Atazanavir + Ritonavir(300mg + 100mg) FC Tablets |
For the treatment of patients with HIV infection |
04.11.08 |
233 |
Timolol Maleate SR Eye Drops 5.0mg / ml |
For the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma. |
08.11.08 |
234 |
Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. Indication) |
1) As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 2)As an adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels. |
08.11.08 |
235 |
Paclitaxel inj.30/100/300mg vial (Addl. Indication) |
For the treatment of advanced gastric carcinoma |
08.11.08 |
236 |
Montelucast + Desloratidine(10mg + 5mg) FC Tablets |
For the treatment of allergic rhinitis in adults only |
10.11.08 |
237 |
Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets |
Additional Lower Strength |
10.11.08 |
238 |
Losartan + HCTZ (100 mg + 25 mg) Tablets |
Additional Strength |
10.11.08 |
239 |
Phenyramidol HCl tablet 400mg |
For the treatment of lumbago, integumental pain, musculoskeletal pain |
14.11.08 |
240 |
Salicylic Acid + Coal Tar (3% + 1%) Solution |
For scaling of seborrhea, seborrheic dermatitis, psoriasis of scalp |
17.11.08 |
241 |
Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment |
For the treatment of psoriasis and fungal skin infection |
17.11.08 |
242 |
Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets |
For the acute treatment of inflammatory musculoskeletal disorders associated with painful muscle spasm in adults. |
17.11.08 |
243 |
Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) Capsules |
Additional Lower Strength |
17.11.08 |
244 |
Calcium Hypochlorite 4gm Sachet (Calcium Hypochlorite 0.542% Other Ingredients: 99.458%) |
For purification of contaminated ground water sources. |
23.11.08 |
245 |
Sumatriptan + Naproxen (50mg + 275mg) Tablets |
Additional Lower Strength |
24.11.08 |
246 |
Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC Tablets |
For the treatment and management of patients with community acquired pneumonia or acute bacterial sinusitis due to beta lactamase producing pathogens |
25.11.08 |
247 |
Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets |
Additional Lower Strength |
02.12.08 |
248 |
Atorvastatin + Metformin(10mg + 500mg SR) Tablets |
As adjunctive therapy to diet and exercise in patients with diabetic dyslipidemia |
04.12.08 |
249 |
Pemetrexed disodium 500mg / 100mg powder for sol. (Addl. Indication) |
As monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology |
04.12.08 |
250 |
Magnesuim Valproate Tablet 200mg/400mg |
For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. For the treatment of maniac episodes associated with bipolar disorders. For prophylaxis of migraine headache in adults. |
04.12.08 |
251 |
Ursodeoxycholic Acid 300/600 SR Tablets (Additional Strength) |
For the dissolution of Radiolucent collestral goll stone, chronic cholestatic liver disease in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cyatic fibrosis. |
08.12.08 |
252 |
Rifampicin + INH + Piperine (200mg + 300mg + 10mg ) Capsules |
For the treatment of adult patients with pulmonary tuberculosis |
11.12.08 |
253 |
Rifampicin +Piperine (200mg + 10mg ) Capsules |
For the treatment of adult patients with pulmonary tuberculosis |
11.12.08 |
254 |
Amphotericin B Lipid suspension 50mg/ vial (Addl. Strength) |
Additional Strength |
12.12.08 |
255 |
Desmopressin Acetate tablet 0.1/0.2 mg |
For the treatment of cranial diabetes insipidus , primary noctumal enuresis in patients. |
12.12.08 |
256 |
Mifepristone + Misoprostol (1 tab of mifepristone 200mg and 4 tab of misoprostol 200mcg) Combipack |
For the medical termination of intrauterine pregnancy (MTP) of up to 63 days gestation based on the first day of the last menstrual period |
16.12.08 |
257 |
Lamotrigine MR Tablets 50/100mg |
For the treatment of bipolar I disorder. (addl. Indication) |
17.12.08 |
258 |
Levosulpride Injection 25mg/2ml (Additional Strength) |
For the treatment of different Gastro intestinal problems like functional dyspepsia, nausea, vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults. |
17.12.08 |
259 |
Cyclobenzaprine HCl ER Capsule 15/30mg |
As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions. |
17.12.08 |
260 |
Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml (Additional Indication ) |
In combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. |
17.12.08 |
261 |
Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion |
For the treatment of scaly dermatoses |
18.12.08 |
262 |
Azathioprine 25mg Tablets |
Additional Strength |
19.12.08 |
263 |
Paracetamol solution for infusion 10mg/ml |
For short term treatment of moderate pain, especially following surgery and for the short term treatment of fever, when administration by i.v route is clinically justified |
23.12.08 |
264 |
Gemifloxacin + Ambroxol (320mg + 75mg SR) FC Tablets |
Indicated for the treatment of lower respiratory tract infections in adult patients |
24.12.08 |
265 |
Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection |
1. For LRTI infections, 2. for UTI - Complicated and uncomplicated, 3. for bacterial septicemia, 4. for bone and joint infections, 5. for gynaecologic infections including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis |
24.12.08 |
266 |
Paracetamol + Phenylephrine Hydrochloride (Each 6gm Sachet contains: 500mg + 10mg) Sachet |
For the treatment of fever associated with cold, nasal congestion in adults |
24.12.08 |
267 |
Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg + 120 mg) syrup |
For symptomatic treatment of cough |
24.12.08 |
268 |
Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules |
Additional Lower Strength |
24.12.08 |