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List of Approved Drug for Marketing in India
(
from 01.01.2010 to 31.12.2010)

S.No.
Drug Name
Indication
Approval Date
1
Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit
For iron, folic acid & omega-3-fatty acid deficiency 
08.01.10
2.
Sphaeranthus Indicus Extract Tablets
700mg
For the management of psoriasis
08.01.10
3
Febuxostat 40mg Additional Strength
Same As approved
16.01.10
4
Dexamethasone Intravitreal Implant 0.7mg
(in solid polymer drug delivery system)

For the treatment of macular edema following branch retinal vein occlusion (CRVO)

16.01.10
5
Buclizine Hcl 25mg Tablet (Additional
Indication)
For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness
16-Jan-10
6
Pemetrexed Disodium 500mg/100mg
Powder for Injection (additional indication)
Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.  First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel.
16.01.10
7
Levobetaxolol HCl Opthalmic Suspension 0.5%
For lowering of intraoccular pressure in patients with chronic open-angle glaucoma or occular hypertension.
16.01.10
8
Sarpogrelate Hydrochloride film coated
Tablets 100mg
For the improvement of ischemic symptoms including ulcer, associated with chronic arterial occlusion.
16.01.10
9
Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution
For hygenic and surgical hand disinfection
18.01.10
10
Aliskiren 150/160mg + Valsartan  300/320mg tablets
For the treatment of hypertension
19.01.10
11
Piroxicam 20mg tab& Paracetamol 500mg tab combikit 
For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes.
19.01.10
12
Soybean oil 60gm + Triglycerides
(medium chain) 50gm + olive oil  purified
fish oil 30gm + dl-alpha-tocopherol 163-
225mg + glycerol (anhydrous) 25gm +
Egg lecithin 12gm + sodium hydroxide (to
approx pH 8) + sodium pleate 0.3mg
emulsion for infusion in 100ml.

Total parenteral nutrition following major abdominal, major thoracic or major urological surgery

19.01.10
13
Raltegravir (as Potassium) film coated Tablets 400mg
In combination with other anti retroviral agents for  the treatment of human immunodeficiency virus (HIV-1) infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy.
27.01.10
14
Deflazacort Tablet 18mg (Additional Strength)
Same as approved
30.01.10
15
Pregabalin SR tablet 75mg (Additional Strength)
Same as approved
30.01.10
16
Rivaroxaban film coated Tablets 10mg
For the prevention of venous thromboembolism in patients (VTE) in adult patients undergoing hip or knee replacement surgery.
30.01.10
17
Cinnarizine 20mg + Dimenhydrinate 40mg tablets 
For the treatment of vertigo
03.02.10
18
Lipid Based Amphotericin-B  Gel 0.1%
Indicated in the treatment of cutaneous and mucocutaneous mycotic infections caused by candida (Monilia) species.
05.02.10
19
Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength)
Same as approved
06.02.10
20
Milnacipran Hcl 12.5mg (Addl. Strength)
Same as approved
06.02.10
21
Ropinirole 6mg ER Tablets (Addl. Strength)
Same as approved
6.02.10
22
Coseal Surgical Sealent 2/4/8ml (Addl. Indication)
(1)  Enforcement of suture and staple lines in lung resection procedures.                                     (2)Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation.                 (3)Patients undergoing laparotomy or laproscopic abdomino-pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post surgical adhesion formation.
06.02.10
23
Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets 
For the treatment of adult patients with peripheral neuropathy
09.02.10
24
Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)
For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm.
10.02.10
25
Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize)
Same as approved
10.02.10
26
Ketorolac Tromethamine Ophthalmic Solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
10.02.10
27
Cytarabine Injection 100mg Additional Packsize (20ml)
In combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children.  It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.  Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia.
10.02.10
28
Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication)
For the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older.
10.02.10
29
Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm  + Magnesium chloride  hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion 
Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present
11.02.10
30  
Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier.
As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement.
11.02.10
31
Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets
For the treatment of patients with acute painful musculoskeletal conditions
12.02.10
32
Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets
For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections
12.02.10
33
Celecoxib Mouth Dissolving Tablet 50/100/200 mg
For the Treatment of Osteoarthritis and Rheumatoid Arthritis
25.02.10
34
Propofol 2% w/v Injection (additionalStrength)
Same as Approved
27.02.10
35
Spironolactone 25mg + Furosemide 20mg tablets
For treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis
5.3.10
36
Olopatadine5mg + Ambroxol30mg tablets 
For the management of cough in adult patients only 
5.3.10
37
Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules
For the treaetment of painful diabetic neuropathy in adults only
5.3.10
38
Calcium acetate 435mg + Magnesium carbonate 235mg tablets
For the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis
5.3.10
39
Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension.
For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc.
5.3.2010
40
Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo
For the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp
5.3.10
41
Faropenam Sodium Extended Release Tablet 225/300/450 mg
For the Treatment of respiratory tract infections, urinary tract infection, skin and skin structure infections and gynaecological infections
8.3.10
42
Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength)
For the treatment of hypertension only
10.3.10
43
Doxofylline MR Tablet 650 mg
For the treatment of Bronchial Asthma and COPD in Adults
11.3.10
44
Lidocaine7.5mg + Prilocaine2.5mg per acutation spray
For the treatment of adult male patients with premature ejaculation
12.3.10
45
Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg
For the treatment of the sign and symptoms of idiopathic parkinsons disease
13.3.2010
46
Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets 
For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication)
16.3.10
47
Miglitol 25 mg + Metformin 500mg tablets
Additional Strength
16.3.2010
48
Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules 
For the prophylaxis of migraine
16.3.2010
49
Citicholine 500mg + Piracetam 400mg Tablets 
For the treatment of acute stroke 
16.3.2010
50
Diclofenac 50mg + Chlorzoxazone500mg Tablets
For the treatment of acute inflammation conditions associated with spasm in adults only
16.3.2010
51
Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets
For the treatment of diabetic neuropathy in adults
16.3.2010
52
Etoricoxib 1%+ Menthol 5% Spray 
For the topical treatment of acute musculoskeletal pain
16.3.2010
53
Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules
For the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD)
17.3.2010
54
Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules 
Additional higher strength
17.3.2010
55
Lamotrigine Orodispersible Tablet 12.5 mg(additional strength)
Same as Approved
20.3.2010
56
Trabectedin powder for Conc. solution for infusion (Additional Indication)
In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinum- sensitive ovarian cancer
20.3.2010
57
Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets 
Additional higher strength
23.3.2010
58
Diclofenac sodium SR Tablet 150 mg
For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondilytis,gout,painful post perative pain following dental surgery etc.
26.3.2010
59
Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength)
Same as Approved 
26.3.2010
60
Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel
Additional higher Strength
26.3.2010
61
Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic Acid.........1000 mg
Laropiprant...........20mg
1. For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDl-cholesterol) and in patients with primary hypercholesterolemia (heterozygous familial and non-familial).
2. In combination with HMG-CoA reductase inhibitors (statins), when cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet or other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy.
26.3.2010
62
Pantoprazole Mouth Dissolving Tablet 20/40 mg
For the treatment of gastric ulcer, duodenal ulcer & gastroesophageal reflux disease (GERD).
30.3.2010
63
Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets 
For the treatment of mixed infections with roundworms and tapeworms in dogs 
30.3.2010
64
Difluprednate Opthalmic Emulsion 0.05% w/v
For the treatment of inflammation and pain 
associated with ocular surgery. 
30.3.2010
65
Tolperisone Hcl SR 450mg Tablets
For the relief of painful muscle spasms of the skeletal muscualture.
31.3.2010
66
S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets
For the treatment of patients with both essential hypertension and hypercholesterolemia
1.4.2010
67
Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules
For secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate 
5.4.2010
68
Lamotrigine 25mg Modified Release Tablet (Addl. Strength)
Same as Approved
5.4.2010
69
Imatinib Mesylate 100/400mg Tablets (Addl. Indication)
Adjuvant treatment of adult patients following resection of gastro-intestinal stromal tumours (GIST)
5.4.2010
70
Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength)
Same as Approved
5.4.2010
71
Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication)
For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata.
5.4.2010
72
Ibuprofen 400mg + Chlorzoxazone 500mg Tablets
For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only
7.4.2010
73
Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets
For the treatment of bronchial asthma in adults
7.4.2010
74
Dronedarone( as Hydrochloride) film coated tablet .... 400 mg. 
To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted.
8.4.2010
75
Dosulepin Hcl Tablet 25mg/75mg (Additional Indication)
For the treatment of chronic pain.
8.4.2010
76
Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.
To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
• Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). 
• Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
13.4.2010
77
Tofisopam uncoated tablet JP... 50/100mg
For the treatment of anxiety and depression.
13.4.2010
78
Zotepine tablet ....25/50/100mg
For the treatment of schizophrenia
15.4.2010
79
Armodafinil uncoated tablet ..50/150/250mg
To improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy.
23.4.2010
80
Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules ….. ...150/300mcg
For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
24.4.2010
81
Ranolazine ER Tablets 750mg (Additional Strength)
Same as Approved
24.4.2010
82
Tacrolimus Capsules 3mg (Additional Strength)
Same as approved
24.4.2010
83
Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets
For the treatment of patients with typhoid fever and urinary tract infection in adults 
26.4.2010
84
Liquid paraffin 6% + White soft paraffin 15%w/v Cream 
For symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis
29.4.2010
85
Levosimendan Injection 2.5mg / ml
For the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient and in cases where ionotropic support is considered appropriate.
30.4.2010
86
Thiocolchicosde SR Tablet 16mg
As an adjuvant treatment in painful spasms associated with degenerative vertebral disorders and vertebral static problems, torticollis dorsal pain, low back pain, traumatological and neurological disorders.
31.4.2010
87
Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tablet 
For the treatment essential hypertension 
04.05.2010
88
one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg 
Additional strength 
04.05.2010
89
Lapatinib Ditosylate Tablets 250mg (addl. Indication)
In combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
10/05/2010
90
Pentosan polysulfate Sodium Cpasules  100mg
For the relief of bladder pain or discomfort associated with interstitial cystitis.
11/05/2010
91
Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tablet
For the treatment of hypertension not controlled with monotherapy 
12.05.2010
92
Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules 
For the treatment of gastirc ulcer,gastroesophageal reflux disease(GERD) & Dyspepsia not responding to omeprazole alone
12.05.2010
93
Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml
For the treatment of elevated intraocular pressure in patient with ocular hypertension or open angle glaucoma.
14.05.2010
94
Telmisartan tablet 20/40/80 mg(Additional indication)
For the prevention of cardiovascular morbidity and mortality in patient 55 years older at high risk of cardiovascular disease
14.05.2010
95
Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets
For the treatment of acute low back pain and other musculoskeletal painful & inflammatory conditions in adult patients
20.05.2010
96
Troxipide  film coated Tablets 50mg /100mg
For the treatment of Gastric ulcers and for amelioration of gastric mucosal lesions (erosion, hemorrhage, redness and edema) in the diseases such as acute gastritis, acute exacerbation stage of chronic gastritis. 
20/05/2010
97
Ambrisentan film coated Tablets 5 mg / 10mg
For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
24/05/2010
98
Rosuvastatin Calcium Tablet(Additional Indication)
Risk reduction of MI stroke and arterial evascularisation procedure in patients without clinically evident CHD but with multiple risk factor
24.05.2010
99
Paracetamol SR 1000mg Bilayered tablet 
For symptomatic treatment of pain and fever
24.05.2010
100
Tacrolimus PR Caps 0.5/1/5 mg
For Prophylaxis of transplant rejection in adult kidney or liver allograft rejection
24.05.2010
101
Rizatriptan Benzoate orally disintegrating tablet 10 mg(Additional Dosage Form)
Same as Already approved
24.05.2010
102
Ramipril 1.25/ 2.5/5/10 mg(Additional Indication)
For the treatment ofnon-diabetic overt glomerular or incipient nephropathy
24.05.2010
103
Exenatide Inj. (Additional Indication)
Use in patients with type-2 diabetes mellitus who are using a thiazolidinedione alone or in combination with metformibn but have not achieved adequate glycemic control
24.05.2010
104
Temozolomide lyophilised powder 100mg / vial
For the treatment of 

 "Adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment."     

  Children from the age of three years, adolescents and Adult patients with malignant giloma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

24/05/2010
105
Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation 
For the maintenance treatment of asthma and for the treatment of COPD associated with chronic bronchitis
25.05.2010
106
Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings 
For filling any medium sized depression of the skin via mid dermis injection as well as for lip definition. The presence of lidocaine is meant to reduce the patients pain during the treatment
28.05.2010
107
Aceclofenac 1% w/w + Menthol 5% Spray 
For the treatment of acute painful inflammatory conditions in adults only
28.05.2010
108
Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets
As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control
28.05.2010
109
3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack
Additional strength 
28.05.2010
110
Calcium carbonate 600mg +Simethicone 80mg Chewable tablet
To relive the uncomfortable symptoms of acid indigestion, heart burn, gas or sour stomach
28.05.2010
111
Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution 
For treatment of symptoms of hyperacidity (e.g. heartburn, epigastric discomfort, or their equivalents) that are often associated with dyspepsia, peptic ulcers, gastritis, peptic esophagitis and indicated for relief of flatulence 
28.05.2010
112
Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg Tablets
For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate 
01.06.2010
113
Irsogladine Maleate Tablet  2mg /4mg
For gastric ulcers, improvement of gastric mucosal lesion (erosion, hemorrhage, redness and edema) caused by acute gastritis and acute exacerbation stage of chronic gastritis.
05/06/2010
114
Lacosamide film coated tablet 50mg /100mg /150mg /200mg
As an adjunctive treatment of partial onset seizures in patients > 17 years of age.
10/06/2010
115
Carmustine for inj. 100 mg
Indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:

1.Brain tumors—glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
2.Multiple myeloma—in combination with prednisone.
3.Hodgkin’s Disease—as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
4.Non-Hodgkin’s lymphomas—as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
10.06.2010
116
Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast Sodium Oral granule(Additional Indication)
For the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.
12.06.2010
117
Ramosetron Dispersible Tablet 0.1 mg
For the prevention and treatment of gastrointestinal symptoms(nausea and vomitting) associated with ematogenic cancer chemotherapy
12.06.2010
118
Amitraz 2%w/v pour on solution 
For the control of ticks on cattle and ostriches
12.06.2010
119
Flupirtine Maleate Capsules 100mg
For treatment  of acute and chronic pain  ,i.e, for painful increased muscle tone of the posture and motor muscles, primary headache,                                    tumor pain, dysmenorrhea and pain after traumatologic / orthopaedic operations and injuries.
12/06/2010
120
Lidocaine Patch 350mg (Additional Pack Size)
For the relief of pain associated with post-
herpetic neuralgia. It should be applied only to intact skin.
17.06.2010
121
Oseltamivir Phosphate (Additional indication)
In the treatment of children 6 to 12 months of age during a pandemic influenza outbreak.
19/06/2010
122
Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injection  
For the treatment of diabetic neuropathy in adults
23/06/2010
123
Methylcobalamin 1500mcg +Pyridoxine 100mg +Nicotinamide 100mg injection 
For the treatment of diabetic neuropathy in adults
23/06/2010
124
1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg  & 2 tablet of Nevirapine 200mg combipack   
For the treatment of HIV infection in adults
23/06/2010
125
Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg  + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule
For the treatment of vitamin deficiency states in adults
23/06/2010
126
Ramipril MR Capsules 2.5/5 mg (Additional Strength)
Same As Approved
03/07/10
127
Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication)
(i) Use of Sitagliptin Phosphate in combination with Metformin and a PPARγ agonist as an adjunct to diet & exercise in adult patients with type-2 Diabetes mellitus who are inadequately controlled on combination therapy with Metformin and a PPARγ agonist. (ii) Use of Sitagliptin Phosphate in combination with insulin, alone or in combination with Metformin.
03/07/10
128
Erlotinib HCl 25/100 mg Tablet (Additional Indication)
As monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum based first line chemotherapy.
03/07/10
129
Gemcitabine HCl injection 2gm/vial (Additional Strength)
Same as Approved
03/07/10
130
Etizolam 0.25 mg tablet (Additional Strength)
Same As Approved
03/07/10
131
Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg)
For the topical treatment of acute musculoskeletal pain
06/07/10
132
Cefuroxime Sodium 750/1500mg +Sulbactam Sodium 375/750mg
For the treatment of mild to moderate lower respiratory tract infection 
06/07/10
133
HPMC 0.3% +Dextran 0.1% + Glycerin 0.2%
For the temporary relief of burning and irritation due to dryness of the eye and for use as a protection against further irritation. For the temporary relief of discomfort due to minorirritations of the eyes or to exposure to wind or sun 
06/07/10
134
Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg
For Mineral & Vitamins deficiency states in adult patients
06/07/10
135
Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w.
For short term treatment of chronic wounds including stage III & IV pressure sores, leg ulcers 
06/07/10
136
Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg 
For the treatment of patients with co-morbid depression and axiety 
08/07/10
137
Nilotinib Capsules 200mg
For the treatment of chronic and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included imatinib.
10/07/10
138
Imipenem 50mg + Clistatin 50mg
Treatment of infection caused by susceptible bacteria for the following indication as in neonates and infants (below 3 months of age) 1. Lower respiratory tract infections 2. Urinary tract infections 3. Intra-abdominal infections 4. Bacterial septicemia 5. bone and joint infections 6. Skin and Skin structure infections 7. Bacterial endocarditis 
14/07/10
139
Lidocaine Lozenges 100mg (Additional Strength)
Same as Approved
15/07/10
140
Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg
For the treatment of essential hypertension 
16/07/10
141
Etodolac 300/300mg +Thiocolchicoside 4/8mg 
For the treatment of patients with acute painful musculoskeletal conditions
19/07/10
142
Celecoxib 100/200mg +Diacerein 50/50mg
For the treatment of adult patients with osteoarthritis of knee and/or hip joints 
19/07/10
143
Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg
For the treatment of essential hypertension 
19/07/10
144
1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg  (Each Co-pack contains :- 1 capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of  Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg)
For the treatment of HIV infections in adults 
19/07/10
145
Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg
Additional strength 
19/07/10
146
Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml
Indicated for ocular surface anaesthesia during ophthalmologic procedures.
30/07/10
147
Naftopidil Tablets 25/50/75mg
For the treatment of dysuria associated with benign prostratic hyperplasia.
30/07/10
148
Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional Indication)
A) FDC is indicated as triple combination therapy with a PPARy agonist (i.e a thiazolidinedione) as an adjunct to diet and exercise in patients inadequtely controlled on their maximal tolerated dose of metfomin and a PPARy agonist. B) FDC is also indicated as add-on to insulin(i.e triple combination therapy) as an adjucnjt to diet and exercise to improve glycemic contrl in patients when stable dosage of insulin and metformin alone do not provide adequte control. 
02/08/10
149
Bimatoprost Eye Drps 0.1mg/ml
for the treatment of hypotrichosis of the eye-lashes by increasing their growth including length, thickness & darkness.
05/08/10
150
S(+) Etodolac 5/10%w/w + Camphor 4%w/w  + Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/w 
For the painful & inflammatory conditions associated with joint, tendons, ligaments and muscles  
05/08/10
151
Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg
For the treatment of lower RI, Skin and soft tissue, bone and joint infections and ENT infections in adult patients prone to antibiotic induced diarrhoea
06/08/10
152
Voglibose0.3 + Metformin (SR) 500mg
Additional higher strength
06/08/10
153
Amoxycillin Oral Suspension 200/400 mg per 5ml
in the treatment of infections due to susceptible strains of the designated micro-organisms in the condition of E.N.T infection, skin & skin structure infection, lower respiratory tract infection, genito-urinary tract infection, gonorrhea, acute uncomplicated (anogenital & urethral) infections.
09/08/10
154
Olmesartan 40mg + Amlodipine 5mg (Additional Strength)
Additional indication: 1. For the treatmenmt of hypertension alone or with other antihypertensive agents 2. To use as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals 
09/08/10
155
Doripenem 500 mg powder for injection (Additional Indication)
Complicated intra-abdominal infections and complicated urinary tract infections, including complicated and uncomplicated pyelonephritis and cases with concurrent bacteremia
10/08/10
156
Nadolol tablet USP 20/40/80 mg
in the treatment of angina-pectoris, cardiac arrythmias & essential hypertension.
20/08/10
157
Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml)
for the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy.
20/08/10
158
Metformin 500/500mg + Repaglinide 1/2mg 
Indicated as an adjunct to diet and excersice to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a meglitinide & metformin or who have inadequte glycemic control on a meglotinide alone or metformin 
20/08/10
159
Hydroxyzine Hydrochloride SR Tablets 25/50/75mg
For management of pruritus due to allergic conditions such as chronic urticaria and atopic contact dermatoses, and in histamine - mediated pruritus.
20/08/10
160
Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg
For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function
23/08/10
161
Fexofenadine 120mg + Montelukast 10mg
For treatment of allergic rhinitis in adults only
31/08/10
162
Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml)
for the treatment of metastatic colorectal cancer .
31.08.10
163
Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet 
Additional strength 
31.08.10
164
Ademetionine enteric coated Tablets ..200mg/400mg
For the management of intrahepatic cholestasis and liver disease.
01.09.10
165
Memantine HCl ER Tablet 28mg
in the treatment of moderate to severe Alzheimer's disease.
06.09.10
166
Buserelin Acetate injection 1mg/ml (Additional Indication)
indicated for the palliative (initial & maintenance treatment) of patients with hormone-dependent advanced carcinoma of the Prostate gland (Stage D).
08.09.10
167
Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet 
Additional higher strength
09.09.10
168
Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable Tablet and Montelukast Sodium Oral Granules (Additional Indication).
For The relief of perennial allergic rhinitis in adults & pediatrics patients 6 months of age and older.
11.09.10
169
Acyclovir SR Tablet 1200 mg
For the treatment of uncomplicated Herbis Zoster in immunocompetent patients.
11.09.10
170
Lornoxicam 4mg + Eperisone 50mg tablet
For the improvement of myotonic conditions caused by neck shoulder arm syndrome, scapulumeral periarthiritis and low back pain in adult patients only 
13.09.10
171
Pirfenidone film coated tablet ...200mg
For the treatment of idiopathic pulmonary fibrosis.
14.09.10
172
Beclomethasone Dipropionate IP  0.025% w/w + Neomycin sulphate IP 0.5% w/w  cream
Additional lower strenth 
15.09.10
173
Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet
Additional strength
21.09.10
174
Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tablet 
For the treatment of acute inflammation conditions associated with spasm in adults only
21.09.10
175
Ketorolac Tromethamine 0.4% w/v +Moxifloxacin 0.5% w/v Opthalmic solution
Additional lower strenth 
21.09.10
176
Nilotinib Capsules 150 mg.
Treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase.
29/09/10
177
Levocloperastine ( as Fendizoate) Suspension eq. to Levocloperastine Hcl  20mg / 5ml.
For the treatment of non productive cough in adult patients
29.09.10
178
Zileuton uncoated bilayered extended release tablet ...600mg
For the prophylaxis and chronic treatment of asthma in adults.
30.09.10
179
Etodolac 400mg + Paracetamol IP 500mg tablet
Additional higher strength
01.10.10
180
Dried Aluminium Hydroxide Gel IP 600mg +Magnesium Hydroxide IP 300mg +Simethicone IP 25mg +Oxetacaine BP 10mg per 5ml syrup
For the treatment of symptoms of functional gastrointestinal disorders like irritable bowel syndrome, functional dyspepsia, peptic ulcer, gasteroesophagal reflux disease which include smooth muscle spasms, flatulence, abdominal distension, hyperacidity, gastric distress, bloting etc.
05.10.10
181
S(-) Metoprolol Succinate ER Eq. to      S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tablet 
For the treatment of essential hypertension who need antiplatelet therapy especially for prophylaxis of atherombotic event.
07.10.10
182
Exenatide Injection (Additional indication)
Exenatide is a glucagon like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.
09.10.10
183
Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength)
Same as approved.
09.10.10
184
Drosperinone + Ethinylestradiol tablets Same as approved
For the treatment of moderate acne vulgaris in adult females, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. It should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
09.10.10
185
Etodolac USP 400mg +Tolperisone HCL  150mg tablet
For the treatment of acute inflammation conditions associated with spasm in adults only
11.10.10
186
Citicoline 500mg +Piracetam 400mg per 5 ml syrup
Additional dosage form 
11.10.10
187
Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg per gm gel
For the topical treatment of painful muscles spasms of skeletal musculature
11.10.10
188
Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet 
For the treatment of essential hypertension 
12.10.10
189
Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsule
For the treatment of painful diabetic neuropathy in adults only
12.10.10
190
Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg  + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule.
For Vitamin and mineral deficiency 
13.10.10
191
Combipack of 21 tablets of FDC of  Ethinylestradiol IP 0.03 mg + Levonorgestrel IP 0.15 mg and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron)  
As contraceptive pill for women 
13.10.10
192
Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream.
For the treatment of patients suffering from neuralgia
13.10.10
193
Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet.
For the treatment of fever associated with cold, nasal congestion in adults
13.10.10
194
Levocetirizine dihydrochloride 2.5mg +Montelukast 5mg dispersible tablet 
Additional strength
13.10.10
195
Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tablet
For the treatment of calcium and Vitamin D deficiency states 
13.10.10
196
Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet
(Additional indication) For the treatment of moderate acne vulgaris in women more than 18 years of age who have no therapy contraindications to oral contraceptive therapy, desire contraceptiopn, and have achieved menarche 
13.10.10
197
Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream
For the treatment of mild to moderate inflammed cutaneous mycoses
13.10.10
198
Lubiprostone Soft Gelatin Capsules ..…8mcg /24mcg
1. For the treatment of chronic constipation in adults.
2. For the treatment of irritable bowel syndrome with constipation (IBS-C) in women > 18 years old.
16.10.10
199
Pazopanib (as Hydrochloride) film coated Tablets…200mg / 400mg
For the treatment of patients with advanced renal cell carcinoma.
16.10.10
200
Eltrombopag (as Olamine) Tablets ...25mg / 50mg
for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
(It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts).
16.10.10
201
Tolperisone HCL 150mg + Paracetamol IP 500mg tablet
For the treatment of patients with acute painful musculoskeletal conditions
21.10.10
202
Zaltoprofen film coated tablet …80mg JP
For anti inflammatory and analgesic activity in rheumatoid arthritis, osteoarthritis, low back pain, periarthritis of shoulder, cervicobrachial syndrome, postoperative, post trauma, and post dental extraction.
31.10.10
203
Hyoscine Butylbromide 20 mg tablet (Additional Strength)
Same as Approved.
04.11.10
204
Cerebroprotein Hydrolysate  injection (Lyophilised) …..1050mg / 2100mg (approx)   equivalent to nitrogen….30mg / 60mg respectively. 
For amelioration of cranial injury, cerebrovascular pathological sequelae and aprosexia in dementia.
04.11.10
205
Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur.
                                                               (2.) Syrup...0.1 mg / ml Ph. Eur.
                                                            (3.) Injection...1 mg / 2mlPh. Eur.
For the treatment of various disorders associated with altered gastrointestinal motility like non-ulcer dyspepsia (NUD) and / or chronic gastritis, gastroesophageal reflux disease (GERD), nausea and vomiting of organic or functional origin.
04.11.10
206
Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Form)
Same as Approved.
04.11.10
207
Oxybutynin Gel 100 mg
For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency.
04.11.10
208
Dapoxetine ( as  Hydrochloride) Tablets …30mg/60mg
For the treatment of premature ejaculation  (PE) in men 18 to 64 years of age.
13.11.10
209
Opipramol dihydrochloride Tablet 50mg/100mg.
For the Treatment of generalised anxiety disorder(GAD) and somatic disturbances.
13.11.10.
210
Ondansetron Rapid Film Oral Strip 4/8 mg
For chemotherapeutic induced nausea and vomiting.
16.11.10
211
Acebrophylline SR Tablet 200 mg
For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.
23.11.10
212 Ammonium Lactate Cream 12% w/w Indicated For the treatment of Dry,scaly skin(xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these condition.  03.12.2010
213 Rabeprazole Sodium Powder oral suspension   ( sachet of 20 mg) (Additional dasage form) Same as approved 03.12.2010
214 Temsirolimus Concentrate for Infusion for Injection 25mg/ml  For the treatment of advanced renal cell carcinoma 11.12.2010
215 Acetyl Cysteine Eye Drops 5% w/v Indicated the relief of Dry eye symptoms associated with defecient tear secretion, impaired or abnormal mucus Production. 14.12.2010
216 Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml. Indicated for the Prophylaxis against alpha-hemolytic(viridans group) sreptococci before dental, oral and upper respiratory tract surgery. 14.12.2010
217 Deferasirox Tablet for Oral Suspension  (Additional Sosage Form) Same as approved 14.12.2010
218 Ramelteon film coated tablets 8mg For the treatment of insomnia characterized by difficulty with sleep onset. 15.12.2010
219 Memantine ER Tablet 7mg/14mg/21mg.    (Additional Strength) Same as approved 17.12.2010
220 Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. Before   reconstitution:
  1000ml of electrolyte solution in Compartment A contains:
Calcium Chloride. 2H2O .....5.145gm
Magnesium Chloride. 2H2O.... 2.033gm
  Lactic Acid....5.4gm
• 1000ml of buffer solution in Compartment B      contains:
Sodium Chloride....6.45gm
Sodium Bicarbonate....3.090gm )
For treatment of acute kidney disease (renal failure),  as substitution solution in continuous haemofiltration and haemodiafiltration and as a dialysis solution in continuous haemodialysis.
23.12.2010
221 Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg  + Chromium Picolinate USP 250mcg Tablet   For Mineral & Vitamins deficiency states in adult patients 23.12.2010
222 Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet  Additional strength  29.12.2010
223 Chlorhexidine gluconate IP 1%w/v  + Ethyl Alcohol IP 61%w/v Solution  Surgical hand scrub & healthcare personnel hand wash 29.12.2010

 

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