LIST OF APPROVED DRUG FROM 01-01-2011 to 31-12-2011 S.

No Name Of Drug Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromuim 200mcg Capsule Ropinirole ER Tablet 1 mg. (Additional Strength) Indication Date of issue

1.

For the treatment of diabetic neuropathy

03.01.11

2.

Same as approved Monotherapy for the Maintenance Treatment of Patients with locally advanced metastatic non-small lung cancer whose disease has not progressed after four cycles of Platinum based First Line Chemotherapy. For the reduction of post operative inflammatory conditions of the eye

04.01.11

3.

Erlotinib HCl Tablet 150 mg (Additional Indication)

04.01.11

4.

Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop

05.01.11

5.

Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg Tablet

For the treatment of iron deficiency anaemia

05.01.11

6.

S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet

For the treatment of patients with acute painful musculoskeletal conditions For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate

05.01.11

7.

05.01.11

8.

For the treatment of mild to moderate hypertension For the treatment of patients with diabetic polyneuropathy

05.01.11

9.

05.01.11

10.

Spironolactone IP 25mg + Furosemide IP 40mg Tablet

Additional strength Indicated either alone or as adjuvant to radical Prostatetomy or radiotherapy in Patients with Locally advanced Prostate cancer at High risk for disease Progression. Same as approved

05.01.11

11.

Bicalutamide Tablet 150 mg.(Additional Strength and Indication)

05.01.11

12.

Paracetamol Chewable Tablet 500 mg. ( Additional Dosage Form) Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel Paracetamol Fast Release Tablet 500mg (Additional Dosage Form) Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm Ferric Carboxymaltose equivalent to elemental Iron50mg/ml Injection

05.01.11

13.

For Vitamins and Minerals deficiency states in adult patients

11.01.11

14.

For the Relief of Persistent Dry irritating cough in adult patients Only. For treatment of hyper pigmentry disorders

17.01.11

15.

31.01.11

16.

Same as approved

10.02.11

17.

For bowel cleansing prior to colonoscopy in adult patients only

11.02.11

18.

For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used.

11.02.11

19.

Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml

For infections of the respiratory system in secondary and primary immunodeficiency with alteration in maturation of T cells in adults only. For the treatment of patients with chronic cholestatic liver disease.

11.02.11

20.

Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml.

11.02.11

21.

Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg

For the acute treatment of adults with schizophrenia. (a). As a prophylaxis therapy for premature infants <29 weeks of gestational age at significant risk for Respiratory Distress Syndrome (RDS). (b). For the treatment of infants <72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotrachteal intubation. Same as approved

17.02.11

22.

Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml

17.02.11

23.

Baclofen ER Capsule 10 mg/50 mg. (Additional Strength) Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength)

17.02.11

24.

Same as approved For the treatment of bacterial conjunctivitis caused by susceptible strains Advanced squmous cell carcinoma of Head and Neck SCCHN: 1. Diagnosed but unrectable locally advanced SCCHN

21.02.11

25.

Gatifloxacin Eye drop 5 mg/ml

21.02.11

26.

Paclitaxel Injection 30mg/100 mg/300 mg (additional Indication)

24.02.11 2. Recurrent SCCHN, if surgery or radiation is not feasible. 3. Palliative treatment of metastatic SCCHN.

27.

Eslicarbazepine Acetate Tablets 200mg/400mg/600mg/800mg

As an adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.

07.03.11

28.

Ketoprofen Plaster ( Size - 7cm x 10 cm) Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection Dasatinib 20mg/50mg/70mg (Additional Indication) Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet Tioconazole Vaginal Gel 65mg per gm

For the Relief of Musculoskeletal pain and Inflammation. For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase. For the treatment of iron deficiency anaemia in adults only

09.03.11

29.

15.03.11

30.

16.03.11

31.

21.03.11

32.

For the local treatment of vulvo vaginal candidiasis in adult patients. For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease. For the treatment of duodenal ulcer in adults only. For acute treatment of schizophrenia in adults only. For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only For relief of moderate to severe acute pain in adults 18 years of age or older.

22.03.11

33.

Aspirin (EC Tablets) 75mg/75mg/150mg +Rosuvastatin (Granules) 5mg/10mg/10mg Capsules

30.03.11

34. 35.

Ilaprazole Tablets 5mg/10mg Asenapine Maleate Sublingual Tablets 5mg/10mg Cefpodoxime IP 100mg/100mg/200mg/200mg +Ofloxacin IP 100mg/200mg/100mg/200mg Tablets Tapentadol Hydrochloride Tablets 50mg/75mg/100mg Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form )

05.04.11 07.04.11

36.

16.04.11

37.

18.04.11

38.

Same as approved

20.04.11

39.

S-Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per ml

For surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block.

28.04.11

40.

Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection

For the treatment of acute colicky pain in adult patients

28.04.11

41.

Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspension

For Post-Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists For the treatment of acute arthritis (including attacks of gout), chronic arthritis especially rheumatoid arthritis (chronic polyarthritis), ankylosing spondylitis (Morbus Bechterew) and other inflammatory, rheumatoid syndromes of vertebral column. For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. For the treatment of bacterial conjunctivitis.

19.05.11

42.

Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules.

19.05.11

43.

Brinzolamide Ophthalmic Suspension 1%w/v

26.05.11

44.

Besifloxacin Ophthalmic Suspension 0.6% w/v Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule

31.05.11

45. (Additional Strength) Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets 46. (Additional Strength) 1. PROBIO : Each sachet (1g) contains: 47. Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii)

Same as approved

31.05.11

Same as approved

31.05.11

For the treatment of rotavirus diarrhoea.

09.06.11

2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides . 100mg 3. PROBIO & PREBIO (D) Each sachet (1.3g) contains: Probio (CMP 5) Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides...1000mg Additional indication. (For Symptomatic Treatment of Moderate To Severe Pain.) For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only. For the treatment of agitation and aggressiveness in adult patients with cognitive impairment. Additional dosage form

48.

Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets

21.06.11

49.

Silodosin Capsules2mg/4mg/8mg

23.06.11

50.

Tiapride Hydrochloride Tablets 25mg/50mg/100mg Fexofenadine 120mg + Montelukast 10mg Chewable tablet Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : Ferrous Fumarate 75mg eq. to 24.375mg of ferrous iron

23.06.11

51.

07.07.11

52.

As contraceptive pill for women

27.07.11

53.

Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule Each Combikit contains Part A - One film coated tablet of Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets Eletriptan Hydrobromide Tablets 20mg/40mg Acyclovir 50g + Hydrocortisone 10mg Cream Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops

For the treatment of lower respiratory tract infections in adults only For the treatment of Diabetic neuropathy For the treatment of Gastrooesophageal Reflux Disease (GERD)

08.08.11

54.

10.08.11

55.

19.08.11

56.

For the treatment of HIV infection in adults.

23.08.11

57.

For the treatment of patient with acute musculoskeletal spasm associated with low back pain. Additional Strength For the treatments of Migraine with or without aura in adults For the early treatment of recurrent cold sores in adult patients to reduce likelihood of ulcerative cold sores and to shorten the lesion healing time For topical treatment of inflammatory acne vulgaris (Additional lower strength) For temporary relief of burning and irritation due to dryness of the eye For the treatment of alcoholic liver diseases like alcoholic fatty liver, alcoholic liver fibrosis, alcoholic liver cirrhosis, and hepatitis For the treatment of erectile dysfunction

24.08.11

58.

24.08.11

59.

25.08.11

60.

30.08.11

61.

30.08.11

62.

13.09.11

63.

Glutathione for Injection 600mg

14.09.11

64.

Udenafil Tablet 100mg/200mg

15.09.11

65.

Metformin (ER )1000mg/500mg +Saxagliptin 2.5 mg/5mg Tablets Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/1000mg.injection Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops

As an Adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate Additional Indication - For the treatment of urinary tract infections and lower respiratory tract infections, various bacteria For steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists For the treatment of high risk hypertensives who need anti-platelet therapy especially for prophylaxis of artherothrombotic events in patients with a history of recent stroke or established peripheral arterial disease For the symptomatic relief of allergic rhinitis. For the treatment of psoriasis vulgaris in adults only.

19.09.11

66.

21.09.11

67.

22.09.11

68.

S(-) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets

22.09.11

69.

Acrivastine Capsules 8mg

26.09.11

70.

Tacalcitol ointment 4mcg Each Combipack contains: A) One tablet of Risedronate Sodium Each film coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi-Pentahydrate) - 35 mg B) Six Capsules of FDC of Calcitriol +Calcium carbonate + Zinc Each soft gelatin capsule contains : Calcitriol IP - 0.25mcg Calcium Carbonate IP - 500mg (eq. to elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mg Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets

26.09.11

58.

For the treatment of Osteoporosis in post menopausal women

30.09.11

59.

For the treatment of hypertension: a) As initial therapy in the patient likely to need multiple drugs to achieve blood pressure control. B) In the patients whose blood pressure is not adequately controlled with the Aliskiren alone or Amlodipine (or another di-

12.10.11

hydropyridine calcium channel blocker) alone. C) As replacement therapy in patients already receiving Aliskiren and Amlodipine from separate tablets at the same dose level. Ferrous Ascorbate eq. to elemental iron 100mg + Folic acid IP 1.1mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength) Arterolane Maleate 74.

73.

For the treatment of Iron deficiency anaemia

19.10.11

Treatment of acute uncomplicated malaria infection due to Plasmodium 150mg + Piperaquine Phosphate 750mg Tablet falciparum in adults. Tafluprost Eye Drops For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension. For the treatment in the patients with inflammatory occular conditions where bacterial infection or a risk of bacterial occular infection exists

19.10.11

75. 0.0015% w/v Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v Eye Drops Diazinon Flea Drops 77. Spot on Dogs 30.0% w/w Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage Form) Epalrestat 50mg + Methylcobalamin 500mcg Tablets

21.10.11

76.

24.10.11

For dogs infected with fleas.

11.11.11

78.

For the treatment of acute inflammation conditions associated with spasm in adults only. For the treatment of Diabetic Neuropathy In combination with prednisone for treatment of patients with hormonerefractory metastatic prostrate cancer previously treated with a docetaxelcontaining treatment regimen.

15.11.11

79.

16.11.11

Cabazitaxel Injection 80. 60mg / 1.5ml

16.11.11

81.

Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solution Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg Tablets Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength) Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + Olmesartan Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet

For the treatment of seasonal allergic conjunctivitis in adults only

21.11.11

82.

For the symptomatic treatment of moderate to severe pain in adult patients For the treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is appropriate

21.11.11

83.

21.11.11

84.

For the treatment of essential hypertension

23.11.11

85.

Each Combipack contains Part (A) One Strip of FDC of Ramipril + Amlodipine Tablets;Each uncoated tablet contains Ramipril IP 5mg, Amlodipine besylate IP eq to Amlodipine 5mg B) Each Film coated tablet contains ;- Atorvastatin Calcium IP eq to Atorvastatin 10mg/20mg.

For the treatment of hypertension and as an adjunct to diet in patients to reduce elevated total cholesterol and triglyceride levels hypertension and dyslipidemia. The polypack should be used in patients for whom treatment with all of the three i.e Ramipril, Amlodipine and Atorvastatin is appropriate. For the treatment of patients with primary hypercholesterolemia. For the treatment of Patients with acute muscle/musculoskeletal spasm in adult For the treatment of patient with premenstrual syndrome in adults only For the treatment of neuropathic pain.

28.11.11

86.

Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. (Additional Strength) Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets Paracetamol IP 325mg + Pamabrom USP 25mg Tablets Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets

05.12.11

87.

07.12.11

88.

07.12.11

90.

08.12.11

Trifluridine Eye Drops 1% w/v 91.

For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2.

08.12.11

92.

Dabigatran Etexilate( as Mesilate) hard gelatin For prevention of stroke, systemic embolism and reduction of vascular Capsules 75mg/110mg/150mg mortality in adult patients with atrial fibrillation. Montelukast Sodium IP eq.to Montelukast 10mg +Olopatadine Hcl 5mg Tablets For the treatment of relief of symptoms of allergic rhinitis 1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. 2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel. For the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as detected by an FDAapproved test. For the treatment of mild to moderate hypertension in adults only and or treatment of stable coronary artery disease in patients already controlled with Perindopril & Amlodipine given concurrently at same dose level

12.12.11

93.

16.12.11

94.

Fosaprepitant (as Dimeglumine) for Injection 150mg.

16.12.11

Abiraterone Acetate Tablets 250mg 95.

16.12.11

96.

Crizotinib hard gelatin Capsules 200mg/250mg

16.12.11

97.

Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 8mg Tablets. (Additional Strength).

20.12.11

98.

Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg +Zinc Picolinate (26mg) eq. to Elemental Zinc 5.5mg Syrup

For the treatment of Iron Deficiency Anaemia

22.12.11

LIST OF APPROVED DRUG FROM 01.01.2010 T S.NO 1 2 3 4 5 PRODUCT NAME Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit Sphaeranthus Indicus Extract Tablets 700mg Febuxostat 40mg Additional Strength

For iron, folic acid & ome

For the management of pso Same As approved

Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery For the treatment of macul system) (CRVO) Buclizine Hcl 25mg Tablet (Additional Indication)

For the Symptomatic treat conjunctivitis and urticaria

Pemetrexed Disodium 500mg/100mg Powder for Injection (additional indication)

Indicated as a monotherap metastatic Non Small Cell squamous cell histology in following platinum-based doublet with gemcitabine,

7 8 9 10

Levobetaxolol HCl Opthalmic Suspension 0.5% Sarpogrelate Hydrochloride film coated Tablets 100mg Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution Aliskiren 150/160mg + Valsartan 300/320mg tablets

For lowering of intraoccul glaucoma or occular hyper For the improvement of isc chronic arterial occlusion.

For hygenic and surgical h

For the treatment of hyper

11

Piroxicam 20mg tab& Paracetamol 500mg tab combikit

For treatment of fever and inflammation, acute muscu following trauma, chronic short term management of

12

Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol Total parenteral nutrition f (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH urological surgery 8) + sodium pleate 0.3mg emulsion for infusion in 100ml.

13 14 15 16 17 18 19 20 21

Raltegravir (as Potassium) film coated Tablets 400mg Deflazacort Tablet 18mg (Additional Strength) Pregabalin SR Tablet 75mg (Additional Strength) Rivaroxaban film coated Tablets 10mg Cinnarizine 20mg + Dimenhydrinate 40mg tablets Lipid Based Amphotericin-B Gel 0.1% Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength) Milnacipran Hcl 12.5mg (Addl. Strength) Ropinirole 6mg ER Tablets (Addl. Strength)

In combination with other immunodeficiency virus (H evidence of HIV-1 replica Same as approved Same as approved

For the prevention of veno undergoing hip or knee rep

For the treatment of vertig

Indicated in the treatment caused by candida (Monili Same as approved Same as approved Same as approved

(1) Enforcement of suture procedures.

22

Coseal Surgical Sealent 2/4/8ml (Addl. Indication)

(2)Patients undergoing car and extend of post surgica

(3)Patients undergoing la adjunct to good surgical te extent of post surgical adh 23 Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets For the treatment of adult

24

Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)

For Symptomatic Treatme disease patients with norm blockers in patients inadeq whose heart rate is >60bpm Same as approved

25 26

Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize) Ketorolac Tromethamine Ophthalmic Solution 0.45%

Indicated for the treatment

27

Cytarabine Injection 100mg Additional Packsize (20ml)

In combination with other induction in acute non-lym been found useful in the tr phase of chronic myelocyt indicated in the prophylax

28

Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication)

For the relief of the sympt age and older.

29

Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium Replacement of extracellu acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for especially if acidosis is bei infusion Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier. Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets Celecoxib Mouth Dissolving Tablet 50/100/200 mg Propofol 2% w/v Injection (additionalStrength) Spironolactone 25mg + Furosemide 20mg tablets Olopatadine5mg + Ambroxol30mg tablets Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules Calcium acetate 435mg + Magnesium carbonate 235mg tablets

30

As an adjunct in abdomina and severity of postoperati

31 32 33 34 35 36 37

For the treatment of patien

For the treatment of adult skin and soft tissue infecti Same as Approved

For the Treatment of Osteo

For treatment of resistant o resistant hypertension, chr

For the management of co

For the treaetment of painf

38

For the management of hy being treated with dialysis

39

Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension.

For the treatment of the sy irratible bowel syndrome, includes smooth muscle sp gastric distress, bloting etc

40 41 42 43 44 45 46 47 48

Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo Faropenam Sodium Extended Release Tablet 225/300/450 mg Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength) Doxofylline MR Tablet 650 mg Lidocaine7.5mg + Prilocaine2.5mg per acutation spray Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets Miglitol 25 mg + Metformin 500mg tablets Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules

For the treatment in adults

For the Treatment of respi skin structure infections an

For the treatment of hyper

For the treatment of Bronc For the treatment of adult

For the treatment of the sig

For the treatment of sympt women (additional indicat Additional Strength

For the prophylaxis of mig

49 50 51 52 53 54 55 56 57 58 59 60

Citicholine 500mg + Piracetam 400mg Tablets Diclofenac 50mg + Chlorzoxazone500mg Tablets Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets Etoricoxib 1%+ Menthol 5% Spray Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules Lamotrigine Orodispersible Tablet 12.5 mg(additional strength) Trabectedin powder for Conc. solution for infusion (Additional Indication) Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets Diclofenac sodium SR Tablet 150 mg Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength) Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel

For the treatment of acute For the treatment of acute only

For the treatment of diabet

For the topical treatment o

For the treatment of patien gasteroesophageal reflux d

Additional higher strength Same as Approved

In combination with pegyl treatment of patients with

Additional higher strength

For the treatment of rheum spondilytis,gout,painful po Same as Approved

Additional higher Strength

61

62 63 64 65 66 67

1. For the treatment of dys mixed dyslipidaemia (char triglycerides and low HDlhypercholesterolemia (hete Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic familial). Acid.........1000 In combination with HMG mg Laropiprant...........20mg lowering effect of HMG-C can be used as monotherap inhibitors are considered in pharmacological treatment during therapy. For the treatment of gastric Pantoprazole Mouth Dissolving Tablet 20/40 mg disease (GERD). Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets Difluprednate Opthalmic Emulsion 0.05% w/v Tolperisone Hcl SR 450mg Tablets S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules

For the treatment of mixed

For the treatment of inflam

For the relief of painful mu

For the treatment of patien hypercholesterolemia

For secondary prophylaxis combinations in appropria

68 69 70 71 72 73

Lamotrigine 25mg Modified Release Tablet (Addl. Strength) Imatinib Mesylate 100/400mg Tablets (Addl. Indication) Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength) Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication) Ibuprofen 400mg + Chlorzoxazone 500mg Tablets Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets

Same as Approved

Adjuvant treatment of adu stromal tumours (GIST) Same as Approved

For the treatment of other Associated with diabetes.(

For the short term treatmen and spasm in adults only

For the treatment of bronc

74

Dronedarone( as Hydrochloride) film coated tablet .... 400 mg.

To reduce the risk of cardi persistent atrial fibrillation AF/AFL and associated ca diabetes, prior cerebrovasc ventricular ejection fractio be cardioverted.

75

Dosulepin Hcl Tablet 25mg/75mg (Additional Indication)

For the treatment of chron

To reduce the rate of throm thrombosis) in patients wit managed with percutaneou 76 Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.

Patients with unstable an (NSTEMI).

Patients with ST-elevati primary or delayed PCI. 77 78 79 80 81 82 83 84 Tofisopam uncoated tablet JP... 50/100mg Zotepine tablet ....25/50/100mg Armodafinil uncoated tablet ..50/150/250mg Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules .. ...150/300mcg Ranolazine ER Tablets 750mg (Additional Strength) Tacrolimus Capsules 3mg (Additional Strength) Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets Liquid paraffin 6% + White soft paraffin 15%w/v Cream

For the treatment of anxiet

For the treatment of schizo To improve wakefulness in treated obstructive sleep ap narcolepsy.

For maintenance bronchod with chronic obstructive p Same as Approved Same as approved

For the treatment of patien adults

For symptomatic relief of including atopic dermatitis

85

Levosimendan Injection 2.5mg / ml

For the short term treatmen (ADHF) in situations wher where ionotropic support i

86

Thiocholchicoside SR Tablet 16 mg

As an adjuvant treatment i disorders and vertebral sta traumatological and neuro

87

Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tablet one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg

For the treatment essential

88

Additional strength

89 90 91 92 93 94 95

Lapatinib Ditosylate Tablets 250mg (addl. Indication) Pentosan polysulfate Sodium Cpasules 100mg Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tablet Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml Telmisartan tablet 20/40/80 mg(Additional indication) Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets

In combination with letroz hormone receptor positive receptor for whom hormon

For the relief of bladder pa

For the treatment of hyper

For the treatment of gastirc Dyspepsia not responding

For the treatment of elevat hypertension or open angle

For the prevention of cardi older at high risk of cardio

For the treatment of acute inflammatory conditions in

96

Troxipide film coated Tablets 50mg /100mg

For the treatment of Gastri (erosion, hemorrhage, redn acute exacerbation stage o

97

Ambrisentan film coated Tablets 5 mg / 10mg

For the treatment of pulmo with WHO class II or III s clinical worsening.

98 99 100 101 102

Rosuvastatin Calcium Tablet(Additional Indication) Paracetamol SR 1000mg Bilayered tablet Tacrolimus PR Caps 0.5/1/5 mg

Risk reduction of MI strok without clinically evident

For symptomatic treatmen

For Prophylaxis of transpl

Rizatriptan Benzoate orally disintegrating tablet 10 mg(Additional Dosage Same as Already approved Form) Ramipril 1.25/ 2.5/5/10 mg(Additional Indication)

For the treatment ofnon-di

103

Exenatide Inj. (Additional Indication)

Use in patients with type-2 alone or in combination w glycemic control For the treatment of

104

Temozolomide lyophilised powder 100mg / vial

"Adult patients with newl with radiotherapy (RT) an

Children from the age of malignant giloma, such as showing recurrence or pro 105 Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation

For the maintenance treatm associated with chronic br

106 107 108

Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings Aceclofenac 1% w/w + Menthol 5% Spray Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets

For filling any medium siz well as for lip definition. T pain during the treatment For the treatment of acute

As 3rd line treatment of ty agents and the second line glycemic control

109

3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of Additional strength FDC of Pyrimethamine 25mg + Sulphadoxine 500mg combipack Calcium carbonate 600mg +Simethicone 80mg Chewable tablet

110

To relive the uncomfortab stomach

111

Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide250 mg + Sorbitol (70%)1.25 gm /5ml Solution Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg Tablets Irsogladine Maleate Tablet 2mg /4mg

For treatment of symptom or their equivalents) that a gastritis, peptic esophagiti

112

For secondary prevention such combination is appro

113

For gastric ulcers, improve redness and edema) caused chronic gastritis.

114

Lacosamide film coated tablet 50mg /100mg /150mg /200mg

As an adjunctive treatmen

115

Carmustine for inj. 100 mg

Indicated as palliative ther therapy with other approve following: 1.Brain tumorsglioblast ependymoma, and metasta tumors. combination with predniso 3.Hodgkins Diseaseas s drugs in patients who relap to respond to primary thera 4.Non-Hodgkins lymphom approved drugs for patient or who fail to respond to p

116

Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast Sodium Oral granule(Additional Indication) Ramosetron Dispersible Tablet 0.1 mg Amitraz 2%w/v pour on solution

For the relief of symptoms patients 2 years of age and

117 118

For the prevention and trea vomitting) associated with For the control of ticks on

119

Flupirtine Maleate Capsules 100mg

For treatment of acute and the posture and motor mus pain, dysmenorrhea and pa injuries.

120 121 122 123 124

Lidocaine Patch 350mg (Additional Pack Size) Oseltamivir Phosphate (Additional indication) Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injection Methylcobalamin 1500mcg +Pyridoxine 100mg +Nicotinamide 100mg injection

For the relief of pain assoc only to intact skin.

In the treatment of children outbreak.

For the treatment of diabet

For the treatment of diabet

1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of For the treatment of HIV i Nevirapine 200mg combipack

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 + For the treatment of vitam 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 Ramipril MR Capsules 2.5/5 mg (Additional Strength) Same As Approved

126

127

Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication)

(i) Use of Sitagliptin Phos agonist as an adjunct to die mellitus who are inadequa and a PPAR agonist. (ii) U insulin, alone or in combin

128 129 130 131 132 133

Erlotinib HCl 25/100 mg Tablet (Additional Indication) Gemcitabine HCl injection 2gm/vial (Additional Strength) Etizolam 0.25 mg tablet (Additional Strength) Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg) Cefuroxime Sodium 750/1500mg +Sulbactam Sodium 375/750mg HPMC 0.3% +Dextran 0.1% + Glycerin 0.2%

As monotherapy for maint metastatic non-small cell l platinum based first line ch Same as Approved Same As Approved

For the topical treatment o

For the treatment of mild t

For the temporary relief of use as a protection against due to minorirritations of t

134

Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid For Mineral & Vitamins d USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg

135 136 137

Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w For short term treatment o +CMC 1.74%w/w +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w. sores, leg ulcers Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg Nilotinib Capsules 200mg

For the treatment of patien

138

Imipenem 50mg + Clistatin 50mg

139 140 141 142 143

Lidocaine Lozenges 100mg (Additional Strength) Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg Etodolac 300/300mg +Thiocolchicoside 4/8mg Celecoxib 100/200mg +Diacerein 50/50mg Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg

For the treatment of chron positive chronic myelogen intolerant to prior therapy Treatment of infection cau as in neonates and infants infections 2. Urinary tract septicemia 5. bone and joi Bacterial endocarditis Same as Approved

For the treatment of essent

For the treatment of patien For the treatment of adult

For the treatment of essent

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) Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml Naftopidil Tablets 25/50/75mg

For the treatment of HIV i

145 146 147

Additional strength

Indicated for ocular surfac For the treatment of dysuri

148

Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional Indication)

A) FDC is indicated as trip thiazolidinedione) as an ad controlled on their maxima FDC is also indicated as ad adjucnjt to diet and exercis dosage of insulin and metf

149 150 151 152 153

Bimatoprost Eye Drps 0.1mg/ml S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl salicylate 5%w/w + Linseed oil 3%w/w Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg Voglibose0.3 + Metformin (SR) 500mg Amoxycillin Oral Suspension 200/400 mg per 5ml

for the treatment of hypotr including length, thickness

For the painful & inflamm ligaments and muscles

For the treatment of lower ENT infections in adult pa Additional higher strength

in the treatment of infectio organisms in the condition lower respiratory tract infe uncomplicated (anogenital

154

Olmesartan 40mg + Amlodipine 5mg (Additional Strength)

155 156 157

Doripenem 500 mg powder for injection (Additional Indication) Nadolol tablet USP 20/40/80 mg Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml)

158

Metformin 500/500mg + Repaglinide 1/2mg

159

Hydroxyzine Hydrochloride SR Tablets 25/50/75mg

Additional indication: 1. F antihypertensive agents 2. need multiple antihyperten Complicated intra-abdomi including complicated and concurrent bacteremia in the treatment of anginafor the treatment of system fungal infections in patien Indicated as an adjunct to with type 2 diabetes mellit metformin or who have ina metformin For management of pruritu and atopic contact dermato

160 161 162

Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg Fexofenadine 120mg + Montelukast 10mg Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml)

For the treatment of combi renal function

For treatment of allergic rh

for the treatment of metast

163

Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet

Additional strength

164

Ademetionine enteric coated Tablets ..200mg/400mg

For the management of int

165

Memantine HCl ER Tablet 28mg

in the treatment of modera

166 167

Buserelin Acetate injection 1mg/ml (Additional Indication) Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet

indicated for the palliative hormone-dependent advan

Additional higher strength

168

Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable For The relief of perennial Tablet and Montelukast Sodium Oral Granules (Additional Indication). of age and older.

169

Acyclovir SR Tablet 1200 mg

For the treatment of uncom

170

Lornoxicam 4mg + Eperisone 50mg tablet

For the improvement of m syndrome, scapulumeral p

171

Pirfenidone film coated tablet ...200mg

For the treatment of idiopa

172

Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate IP 0.5% w/w cream Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tablet

Additional lower strenth

173 174

Additional strength For the treatment of acute only

175

Ketorolac Tromethamine 0.4% w/v +Moxifloxacin 0.5% w/v Opthalmic solution Nilotinib Capsules 150 mg. Levocloperastine ( as Fendizoate) Suspension eq. to Levocloperastine Hcl 20mg / 5ml. Zileuton uncoated bilayered extended release tablet ...600mg

Additional lower strenth

176

Treatment of newly diagno positive chronic myeloid l

177

For the treatment of non p

178

For the prophylaxis and ch

179

Etodolac 400mg + Paracetamol IP 500mg tablet

Additional higher strength

180

Dried Aluminium Hydroxide Gel IP 600mg +Magnesium Hydroxide IP 300mg +Simethicone IP 25mg +Oxetacaine BP 10mg per 5ml syrup

For the treatment of sympt bowel syndrome, function disease which include smo hyperacidity, gastric distre

181

S(-) Metoprolol Succinate ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 75mg/75mg tablet

For the treatment of essent especially for prophylaxis

182 183

Exenatide Injection (Additional indication) Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength)

Exenatide is a glucagon lik adjunct to diet and exercis diabetes mellitus. Same as approved.

184

Drosperinone + Ethinylestradiol tablets Same as approved

For the treatment of moder contraindications to oral co should be used for the trea contraceptive for birth con For the treatment of acute only Additional dosage form

185

Etodolac USP 400mg +Tolperisone HCL 150mg tablet

186

Citicoline 500mg +Piracetam 400mg per 5 ml syrup

187

Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg per gm gel

For the topical treatment o

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 essent

189

Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsule

For the treatment of painfu

190

Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper sulphate 1 mg + Selenium as selenomethionine 70mcg For Vitamin and mineral d + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule.

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. As contraceptive pill for w to 24.375 mg of Ferrous iron)

192

Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine For the treatment of patien 2% w/w per gm cream. Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet. Levocetirizine dihydrochloride 2.5mg +Montelukast 5mg dispersible tablet Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tablet

193

For the treatment of fever

194

Additional strength

195

For the treatment of calciu

196

Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet

(Additional indication) Fo more than 18 years of age contraceptive therapy, des

197

Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream

For the treatment of mild t

198

Lubiprostone Soft Gelatin Capsules ..8mcg /24mcg

1. For the treatment of chr 2. For the treatment of irrit women > 18 years old.

199

Pazopanib (as Hydrochloride) film coated Tablets200mg / 400mg

For the treatment of patien

200

Eltrombopag (as Olamine) Tablets ...25mg / 50mg

for the treatment of throm (idiopathic) thrombocytop corticosteroids, immunogl (It should be used only in and clinical condition incr attempt to normalize plate

201

Tolperisone HCL 150mg + Paracetamol IP 500mg tablet

For the treatment of patien

202

Zaltoprofen film coated tablet 80mg JP

For anti inflammatory and low back pain, periarthriti post trauma, and post dent Same as Approved.

203

Hyoscine Butylbromide 20 mg tablet (Additional Strength)

204

Cerebroprotein Hydrolysate injection (Lyophilised) ..1050mg / 2100mg For amelioration of crania (approx) equivalent to nitrogen.30mg / 60mg respectively. aprosexia in dementia.

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 variou motility like non-ulcer dys gastroesophageal reflux di functional origin.

206 207 208

Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Form) Oxybutynin Gel 100 mg Dapoxetine ( as Hydrochloride) Tablets 30mg/60mg

Same as Approved.

For the treatment of overa incontinence, urgency and

For the treatment of prema

209 210 211

Opipramol dihydrochloride Tablet 50mg/100mg. Ondansetron Rapid Film Oral Strip 4/8 mg Acebrophylline SR Tablet 200 mg

For the Treatment of gener disturbances.

For chemotherapeutic indu

For the treatment of adult (COPD) and bronchial ast

212

Ammonium Lactate Cream 12% w/w

Indicated For the treatmen for temporary relief of itch

213 214 215

Rabeprazole Sodium Powder oral suspension ( sachet of 20 mg) (Additional dasage form) Temsirolimus Concentrate for Infusion for Injection 25mg/ml Acetyl Cysteine Eye Drops 5% w/v

Same as approved

For the treatment of advan

Indicated the relief of Dry impaired or abnormal muc

216

Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml.

Indicated for the Prophyla before dental, oral and upp

217

Deferasirox Tablet for Oral Suspension (Additional Sosage Form)

Same as approved

218

Ramelteon film coated tablets 8mg

For the treatment of insom

219

Memantine ER Tablet 7mg/14mg/21mg.

(Additional Strength)

Same as approved

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 kidn continuous haemofiltration continuous haemodialysis.

221

Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 500mcg + Chromium Picolinate USP 250mcg Tablet Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet

For Mineral & Vitamins d

222

Additional strength

223

Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v Solution

Streptococcus faecalis T-110 JPC 30 million + Clostridium butyricum TO-A 2 million + Bacillus mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules

Surgical hand scrub & hea

224

For restoration of intestinal m

LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12.2009

DRUG NAME INDICATION

ledronic Acid Injection 5mg/100ml (Addl. Indication)

For the treatement of osteoporosis in post-menopausal wom and in men who are at increased risk offracture,including t with a recent low-trauma hip fracture.

soprostol Tablet 600mcg

Addl. Strength

ebrophylline Syrup 10mg/ ml

For the treatement of adult patients with chronic obstructiv pulmonarydisease(COPD) and bronchial asthma.

(I) For the treatement and lasting prevention of flea infestations,treatmentand control of flea allergy derma prevention of heartwormdisease,treatement and prevention amectin Tropical solution (for verterinaryuse.) 60mg/120mg per ear mites in dogs and cats; (II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs.

ethylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg For the treatment of vitamin deficiency states in adults Folic Acid1.5mg + Pyridoxine3mg Capsules

etoprolol tartrate tablets 50 mg (Addl. Indication)

Adjunct to the treatement of Hyperthyroidism

nacalet (as HCl) Tablet 30/60/90mg

For the treatment of secondary hyperparathyroidism in pat with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma

ycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral pension 200mg/ml (addl. Indication)

For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation.

quid Paraffin1.25ml + Milk of Magnesia 3.75ml + dium Picosulphate 3.33mg per 5ml

For symptomatic treatment of constipation in adults

nolazine 1000mg ER Tabs (Additional Strength)

Same as approved

aluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and mg/0.8ml

For intradermal implantation and facial soft tissue augmentation

For use in following: (I) Empirical therapy for presumed f infections in febrile neutropenic patients.

spofungin acetate Injection (Addl. Indication)

(II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleu space infections. (III) Treatment of EsophagealCandidiasis.

(IV) Treatment of invasive Aspergillosis in patients who a refractory to or intolerant of other therapies (i.e, amphoter B, lipid formulations of amphotericin B, and/oritraconazol

cafungin ( as sodium) Powder for solution for infusion 50mg / l

For the treatment of patients withcandidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candid infection in patients undergoing hematopoietic stem cell transplantation (HSCT)

teprednol Etabonate Nasal spray 0.1% w/v

For prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis.

sagiline (as mesylate ) Tablet 0.5mg/1mg

For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an additio levodopa.

cotine Polacrilex Gum 2mg & 4mg (Addl. Indication)

To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.

osantel Injection100mg/ ml (forverterinary use.)

For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other producing animals.

rnoxicam 4mg + Paracetamol 500mg film coated tablets

For the short term use in acute painful & inflammatory conditions in adults

trimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + propyl Alcohol 7.5% v/v Concentrate Solution

For cleansing of physically contaminated wounds and for operative disinfection

toconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) lution

For the treatment of dandruff

ripenem (as monohydrate) Injection 250mg/500mg

For the treatment of nosocomial pneumonia in adults.

lobetasol Scalp Approved 0.05% w/v

For the relief of inflammatory andpuritic manifestation of corticosteroidrespensive dermatosis

cotine (as Polacrilex) Lozenges 2mg & 4mg

To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.

anexamic Acid Tab SR 750mg

For the treatment of menorrhagia

tahistine Mesilate Tablet 6mg/12mg

For the treatment of dizziness and feeling of dizziness resu from Meniere's disease, Meniere's syndrome and vertigo.

atacept Injection 250mg/vial (Addl. Indication)

In moderately to severly active rheumatoid arithritis in adu and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists

idulafungin Injection (Lyophilized powder) 50mg/100mg per l

For the treatment of invasive candidiasis including candidemia andesophageal candidiasis in adult patients.

droquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream

For the treatment of patients with skin hyperpigmentation

xyphylline 400 mg + Terbutaline 5mg tablets

For the treatment of asthma and chronic obstructive pulmo disease in adult patients only

droquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide For the treatment of melasma of face in adults mg per gm Cream

toconazole 2% + Zinc Pyrithone 1% Lotion

For the treatment of pityriasis and dandruff of the scalp

mivudine 30mg + Zidovudine 60mg +Nevirapine 50mg Oral spension (Tablets for oral Suspension)

For the treatment of HIV patients

benclamide 5mg + Pioglitazone 15mg + Metformin500mg film ated tablets

As 3rd line treatment of type II diabetes mellitus when die exercise and the single agents and the second line therapy two drugs do not result in adequate glycemic control

eclofenac 100mg + Tizanidine 2mg film coated tablets

For the treatment of acute low back pain in adult patients o

tinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium As sunscreen lotion for prevention of sunburn skin xide 2% lotion

trizine 5/10mg + Ambroxol 30mg per 5ml syrup

For the symptomatic relief of productive cough associated allergic rhinitis, when both anti-histamine and mucolytic a are desired

docaine Lozenges 200/300mg

For single agent anesthesia in upper gastro intestinal endoscopy.

lamine 8% + Liquid Paraffin10% lotion

As antipruritic and smoothening agent

fedipine 0.3% + Lidocaine1.5% cream

For the treatment of anal fissures

inapril 20mg + HCTZ 25mg film coated tablet

For the treatment of mild to moderate hypertension in adul patients (in whom combination therapy is appropriate) wh have been stabilized on the individual components given i same proportion

vodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving let

For the symptomatic symptoms of idiopathic Parkinson's Disease

iperidone ER Tablets 1.5mg

Addl. Strength

sartan 100mg+ HCTZ 25 mg tablet

Additional higher strength

runavir(as ethanolate) Tablet 300mg

For the treatment of human immunodeficiency virus (HIV infection in antiretroviral treatment experienced adult patie such as those patients with HIV-1 strains resistant to more one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents.

pivacaine HCl Inj.2/5/7.5/10mg

For the production of local or regionalanasthesia for surge and for acute pain management.

taphosphan 100g + Methyl Hydroxybenzoate 1gm + anocobalamin50 gm Oral powder (Veterinary Drug)

As vitamin and phosphorous supplement for livestock, shirmp and fish.

uticasone furoate Nasal spray 27.5mcg per spray

For the treatment of symptoms of allergic rhinitis.

tinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% Octocrylene 3%+ Zinc Oxide 2% lotion

A sunscreen lotion for prevention of sunburn skin

meprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium droxide 700mg sachet

Additional Strength

mbroxol 30mg + Levo salbutamol 1mg+Guiphenesin 50mg /5ml up

For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis

ontelucast 4 mg+ Levocetrizine 2.5 mg tablet

Additional lower paedriatric dose

rgical Sealant

To be indicated for use in sealing suture lines along arteria venous reconstructions.

docaine Patch 700mg in aqueous base. (50 mg per gram hesive)

For the relief of pain associated with post-herpetic neuralg should be applied only to intact skin.

matoprost Opthalmic solution 0.03%

For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

abectedin powder for concentrate for solution for infusion 1 mg/ l

For the treatment of patients with advanced soft tissue sarc after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents.

ebrophylline Syrup 10mg/ml (Additional Indication)

For the treatment of children (age 6to 12years) with chron obstructive pulmonary disease(COPD) and bronchial asthm

esalamine PR Tablets 1.2gm

For the induction of remission in patients with active, mild moderate ulcerative colitis.

ycophenolate Mofetil Tablets 750mg Additional Strength

Same as approved

torolac Tromethamine Gel 2%w/w

For the treatment of muscle, joint and post-traumatic stress

eophylline 400mg SR + Montelukast10mg Tablet

For the treatment of patients with bronchial asthma

aluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 /25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver lfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream.

For the treatment of wound of differentetiology

lmisartan 80mg + Amlodipine 5mg tablet

Additional higher strength

aluronic Acid Sodium Salt For the treatment of wound of differentetiology

Each 15gm tube contains: HyaluronicAcid Sodium Salt gm/100gm

Sterile Gauze Pads impregnated with cream: Each gauze pad ntains HyaluronicAcid Sodium Salt 50/100mg

atacept Injection 250mg/vial (additional indication)

For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis inpediatric patients 6 years of age and older who have had an inadequate respon one or more DMARD's such as MTX

trizine 10 mg + Ambroxol 75 mg SR Tablet

For symptomatic relief of productive cough associated wit allergic rhinitis, when both anti-histamine and mucolytic a are desired

clesonide 200mcg + Formoterol 6mcg +Tiotropium 9mcg MDI

Indicated as third line treatment of severe cases of COPD whenmonotherapy and second line therapy with two drugs not respond adequately.

ch film coated bilayred tablet contains: Metoprolol 25mg/50mg Chlorthalidone 12.5mg

For the tretament of patients with mild to modrate essentia hypertension

For the management of fibromylagia. (Addl. Indication)

lnacipran 25/50mg Caps

rnoxicam SR 16mg Tabs

For the symptomatic treatment of pain and inflammation i patients of osteoarthritis & rheumatoid arthritis

onosetron Hcl 0.075mg IV Inj (Addl. Strength)

Same as approved

ch film coated bilayred tablet contains: Metoprolol 25mg/50mg Chlorthalidone 6.25 mg /12.5mg

Additional strength

bendazole 400 mg + Ivermectin 6 mg tablet

For the treatment of intestinalhelminthes and suppression ofmicrofilaraemia especially with bancrofti infections

citabine Lyophilized powder for injection 50mg/20ml vial

For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo secondary MDS of all French-American-British subtypes(refractory anemia, refractoryanemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international Prognostic Sco System groups.

tapamulin Ointment 1%

For the topical treatment of bacterial skin and skin structur infections:-Primary impetigo, secondarily infected traumat lesions, secondarily infected dermatoses.

ch ml contains Calamine 15% w/v + Zinc oxide 5% w/v + ntonite 3% w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v ion

For the tretament of pruritis and prickly heat

ch 1000 ml of emulsion contains: Medium chain triglycerides 0 gm + Soya oil 80 gm + Omega-3 acid triglycerides 20 gm + g lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + pha -tocopherol 0.20 gm + Ascorbypalmitate0.30 gm + Sodium droxide max. 0.06 gm + water for injection 784 gm emulsion for usion

For the supply of fats, including essential omega-6 fatty ac and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults iforal or enteral nutrition is impossible,inadequte or contraindicated.

rtaconazole Nitrate Powder 2% w/w & Lotion 2% w/v

For the topical treatment of the superficial fungal infection the skin.

mlodipine Tablets 5mg/10mg (additional indication)

1. To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke. 2. To reduce the risk of coron revascularization procedures and the need for hospitalizati due to angina in patients with coronary artery disease.

ndamycin Phosphate Inj. 150mg/ml & ndamycin HCl Capsules 150mg/300mg (additional indication)

Prophylaxis of infection in neck and head surgery

ch 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 0 gm granules

For the treatment of chronic idiopathic constipation in adu patients only

cralose

for use as sweetner in drug formulations

rvedilolTablets 3.125/6.25/12.5/25mg (additional indication)

To reduce cardiovascular mortality in clinically stable pati who have survived the acute phase of a myocardial infarct and have a left ventricular ejection fraction of 40% (with without symptomatic heart failure)

xketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated lets

For the treatment of Acute musculoskeletal pain

egabalin SR Tablet 150/300mg

For the treatment of peripheral neuropathic pain in adults

aiphenesin ER Tablet 1200mg

For the treatment of productive cough accompanied by Ph

erolimus 5/10mg Tablets (Addl. Indication)

Treatment of advance renal cell carcinoma

mesulide ER 200mg

dditional Indication)

Acute pain in Orthopaedic, ENT, Dental and Post Operativ condition

onesetron Injection 0.25mg/5ml (Additional Indication)

For treatment of Post Operative Nausea & vomiting

ndamustine Hydrochloride Lyophilized powder Injection 100mg/ For the treatment of patients with chronic l lymphocytic leukemia.

ffeine(as Citrate)

10mg / ml Injection

For the short term treatment of apnoea of prematurity of in between 28 and < 33 weeks gestational age.

rindopril arginine 2.5mg/5mg/10mg film coated tablet

For the treatment of arterial hypertension, congestive heart failure and coronary artery disease.

ch gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w For the topical treatment of inflammatory dermatitis with secondrybacterial infection

ometasone 0.1 % + Fusidic acid 2% cream/ointment

For the treatment of dermatoses wheresecondry bacterial and/or candidialinfection is present

iocolchicoside 8 mg + Etoricoxib 60 mg tablets

Additional strength

ethadone Hydrochloride 5mg/10mg per ml syrup; 5mg/ 10mg/ mg / 40mg tablet

For the treatment of opioddependence and in maintainencetreatment for opioid dependence.

ospium Chloride film coated tablet 20mg

For the treatment of overactive bladder with the symptoms urge urinary incontinence, urgency, and urinary frequency

formoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution

For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COP including chronic bronchitis and emphysema.

lmitriptan...5.0% w/v Benzalkonium Chloride NF ... 0.01% v Nasal spray

For the acute treatment of migraine with or without aura in adults.

xmedetomidine ( as HCl) 100mcg /ml Injection

For sedation of initially and mechanically ventilated patien during treatment in an intensive care setting.

vetiracetam SR Tablet 500/750/1000mg

same as approved

atiramer Acetate Injection (20mg/ ml) & Pre-filled syringe 0mg/ml)

For the reduction of the frequency of relapses in patients w Relapsing-Remitting Multiple Sclerosis.

For the treatment of unresectablemetastatic liver tumors fr primary colorectal cancer with intra-hepatic artery rium-90 Microspheres Injection (Yttrium-90...3GBq (at the time chemotherapy (IHAC) of FUDR (Floxuridine) calibration) per vial)

liconazole Cream 1%

For the treatment of cutaneous mycosis viz. Tinea pedis, T corporis, Tinea cruris.

agnesium Valporate Prolonged release tablet 600mg

1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis migraine headache in adults. 3) For the treatment of manic episodes associated with bi polar disorders

nofovir Disoproxil Fumerate 300mg

For the treatment of chronic Hepatitis B in adults

sentan (as monohydrate) Tablets 62.5/125mg

For the treatment of pulmonary arterial hypertension (WH Group I) in patients with WHO Class III or IV symptoms, improve excercise ability and decrease the rate of clinical worsening.

rnoxicam 12 mg SR (additional strength)

same as approved

ithromycin SR Granules for oral suspension 2000mg

for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/ skin structure, non gonococcal urethritis, cervicitis

etoprolol 50/50/25 mg + Atorvastatin20/10/10 + Ramipril 10/5/2.5 mg capsules

As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequ controlled by combination of an anti-hypertensive with lip lowering agent.

ethyl Phenidate ER Tablet 10/20/30mg

For the treatment of Attention Deficit Hyperactivity Disor (ADHD)

satinib Tablets 100mg (addl. Strength)

same as approved

glibose 0.2 mg + Metformin 500mg Tablets

As 2nd line treatment of type II Diabetes mellitus when di exercise and the single agent do not result in adequate glycemic control.

For the treatment of P. falciparum resistant malaria patient

mbipack of artesunate tablet and FDC Tablet sulphadoxine + pyrimethamine mposition: A. combipack of 1 stip of ablets ofartesunate 25 mg and 1 strip of 1 tablet sulphadoxine 125mg+ pyrimethamine 6.25

combipack of 1 stip of 3 tablets ofartesunate 50 mg and 1 strip 1 tablet of sulphadoxine 500mg+ pyrimethamine 25

combipack of 1 stip of 3 tablets ofartesunate 100 mg and 1 strip 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 D.combipack of 1 stip of ablets ofartesunate 200 mg and 1 strip of 3 tablet sulphadoxine 500mg+ pyrimethamine 25 mg. same as approved

lnacipran 100mg (additional Strength)

aximin 400mg (additional Indication)

For the treatment of hepatic encephalopathy

virapine tablet 50 mg for oral suspension mg

For the treatment of HIV infection in combination with oth anti retro viral agents

svenlafaxine (as Succinate) ER Tablets 50mg/100mg

For the treatment of major depressive disorder (MDD)

saconazole Oral Suspension 40mg/ml

For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazoleand/orfluconazole. prophylaxis of invasive Aspergillus and Candida infection patients, 13 years of age and older, who are at high risk of developing these infections due to being severlyimmunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-h disease (GVHD) or those with hematologic malignancies w prolonged neutropenia from chemotherapy.

ffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) al Solution (Addl. Dosage form)

same as approved

mphotericin B Emulsion 5mg/ml (Addl. Indication)

Febrile Neutropenia in cancer patients

droxy ethyl starch 10% Solution for infusion

For the treatment of imminent or manifest hypovolemia an shock.

ratriptan (as HCl) Tablets 1/ 2.5mg

For the acute treatment of migraine with or without aura in adults.

listimethate Sodium powder for solution for injection/infusion 0000IU and 2000000IU (additional Strength)

same as approved

mvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 5 mg + Aspirin 100 mg (EC Pellets) Capsules

For secondary prevention of coronoryheart disease/stroke patients where use of such combination is appropriate

listimethate Sodium powder for solution for inhalation 0000IU/1000000IU/2000000IU

Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis

mipril MR capsule 10mg

For the treatment of hypertension/ cardiac failure and myocardial infarction

acavir Sulfate Tablet 60mg

For the treatment of HIV-1 infection in combination with o antiretroviral agents

ledronic Acid Solution for Infusion Addl. Indication

Prevention of clinical fractures after hip fracture in men an women

matriptan 85 mg + Naproxen 500 mg Tablets

Additional Strength for the treatment of migraine

eclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets

For the treatment of acute inflammation conditions associa with spasm in adults only

eclofenac(100mg) + Thiocolchicoside ( 4 mg) tablets dditional strength)

For the treatment of acute inflammation conditions associa with spasm in adults only

carbazepine 150/300/600mg Tablet (Addl. Indication

Treatment of generalized tonic-clonic seizures in adults an children for the treatment of diarrhoea of mixed infection in adult patients Indicated in the management of Schizophrenic patients

loxacin 2mg + Ornidazole 5 mg per ml Infusion

ozapine Tablet200mg (Addl. Strength)

ymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w

Is indicated for the relief of stuffy,running nose associated colds and influenza, also post nasal drip, sinusitis.

oxaparin Sodium Injection (Addl.Indication)

Treatment of acute ST-segment elevation myocardial infar including patients to be managed medically or with subseq percuaneous coronary intervention (PCI)

uvoxamine Maleate100/150mg ER Tablets

For the treatment of obsessive compulsive disorder (OCD) depression

docaine Lozenges 200/300mg (Addl. Indication)

For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract.

speridone long acting injection (Addl. Indication)

Indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of Bipo 1 disorder.

emestane 25mg Tablet (Addl. Indication)

Indicated for adjuvant treatment of Post Menopausal Wom with estrogen receptor positive early breast cancer who ha received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvan hormonal therapy.

Artesunate (25/50/100mg) + Amodiaquine 141 (67.5 mg/135/270mg) bilayerd Tablets

01.09.2009 For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function

142 Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets

01.09.2009

Buprenorphine Transdermal Patch Each For the treatment of severe opioid responsive Transdermal Patch having an area of 6.25cm, painconditions which are not adequately responding to 12.5cm, and 25cmcontains: non-opioid analgesics.For Hospital supply only. Buprenorphine5mg/10mg/20mg having 143 release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days).

03.09.09

144 Trospium Chloride ER Capsules 60 mg

For the treatment of overactive bladder with the symptoms 04.09.2009 of urge urinary incontinence, urgency and urinary frequency. 09.09.09

145 Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution For the treatment of nausea and vomiting.

18.09.2009 For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status.

146 Isosorbibe 20 mg + Hydralazine 37.5 mg tablets

Cefixime 200 mg + Dicloxacillin ER 500 mg 147 Tablets

22.09.2009 For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections 03.10.09 For the treatment of mild to moderate hypetension.

148

Chlorthalidone Tablet 6.25mg

Cefovecin( as sodium) 80mg/ ml Lyophilised 149 powder for injection (Veterinary)

03.10.09 For the treatment of skin bacterial infections in dogs and cats. For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats. 03.10.09

Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) Each pippette contains: (a) 0.4ml, 1.0ml, 150 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin

Isoflupredone AcetateSuspension for Injection For the glucocorticoid, anti-inflammatory or supportive therapy to cattle suffering from conditions such as: (2mg per ml) ( For Veterinary) (1) Overwhelming infections with severe toxicity. (2) Bovine ketosis. (3) Musculoskeletal conditions. 151 (4) Shock. (5) Parturient paresis (supportive stress therapy for milk fever).

03.10.09

Saxagliptin (as HCl) 2.5mg/ 5mg Tablets As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

24.10.09

152

Calcipotriol Gel 153 0.005%

3.10.2009 (additional dosage form) For the treatment of moderate plaque psoriasis in adults same as approved 3.10.2009

Lamotrigine MR Tablets 150mg (Addl. 154 Strength)

Metoprolol Tartrate ER Tablet 155 75mg strength)

same as approved (additional

3.10.2009

156

Valganciclovir Powder for Oral Solution 50mg/ml

9.10.2009 For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk

Dexketoprofen Trometamol Gel 12.5mg/gm For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle For the treatment of mild to moderate severe Alzheimer's Dementia Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain.

13.10.2009

157

Donepezil Hydrochloride Orodispersible 158 Tablet 5mg/10mg Dexketoprofen Trometamol Injection 50mg/2ml

15.10.2009

22.10.2009

159

Bromocriptine Mesylate Tablet IP 0.8mg, 160 (additional Indication)

22.10.2009 Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. For the treatment of depression and schizophrenia in adults Additional strength

161

Levosulpride ER Tablet 100/150/200mg

27.10.2009

Ambroxol 30 mg+ Terbutaline 2.5 mg + 162 Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup

27.10.2009

Propofol 10 mg+ Lignocaine 2.5 mg per ml 163 injection

Additional strength

27.10.2009

Mecobalamin 750 mg + Pyridoxine 164 Hydrochloride1.5 mg + Nicotinamide 45 mg tablets Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tablets Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml PourOn Solution

For the treatment of diabetic neuropathy

27.10.2009

165

For the treatment of co-existing essential hypertension and 27.10.2009 hyperlipidemia in adult patients

166

Ready to use pour-on for cattle, sheep and goats. 29.10.2009 1. For use in Cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g. house flies, to kill lice and protection against blackflies. 2. For use in sheep and goats for controlling Karoo paralysis, bont- legged and red-legged ticks

Glucosamine sulphate potassium chloride 500 For the treatment of adult patients with osteoarthritis of 167 mg + Ibuprofen IP 200mg film coated Tablets knee and/or hip joints

03.11.2009

Methylcobalamin 1500 mcg + Gabapentin SR Additional strength 168 600 mg film coated tablets 1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care For the management of seasonal allergic rhinitis (SAR)

4.11.2009

169

Propofol 1% for injection (Additional Indication)

5.11.2009

Rupatadine 10 mg + Montelukast 10 mg 170 Tablets

10.11.2009

Eperisone 50 mg + Paracetamol 500 mg 171 Tablets Lafutidine Tablets ....5mg/10mg.

For improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only

10.11.2009

172

For the treatment of: 11.11.2009 gastric ulcers, duodenal ulcers and stromal ulcers gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis. 1. Tablets 0.1mg & Injection 0.3-- for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer chemotherapy. 2. Tablets 2.5mcg & 5mcg--- for the treatment of diarrhoea predominant irritable bowel syndrome. For the treatment of pulmonary arterial hypertension

Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml

11.11.2009

173

Tadalafil tablet 20 mg (Additional Indication)

14.11.2009

174

Flurbiprofen Sodium 0.03% Ophthalmic 175 solution USP

for the reduction of post-operative inflammatory condition 14.11.2009

Dexmedetomidine HCl Injection (Additional 176 Indication)

Sedation of non-intubated patients prior to and/or during surgical and other procedure Same as approved

14.11.2009

Paliperidone ER tablet 12 mg (Additional 177 Strength)

14.11.2009

1) Triticum Vulgare Topical Cream Each 100gm of cream contains: Aqueous extract of Triticum Vulgare (dry 178 residue 200mg / 100ml) ..... 15gm 2-phenoxyethanol Eur. Ph.....1gm 2) Triticum Vulgare Vaginal Pessary Each

1) Triticum Vulgare Cream is indicated for the treatment of ulcers and bed sores. 2) Triticum Vulgare Vaginal Pessary is indicated for the treatment of phlogistic and dystrophic disorders of the female genital tract.

14.11.2009

3.5gm of vaginal pessary contains: Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm 2-phenoxyethanol Eur. Ph.....0.04gm Febuxostat Tablets 80mg / 120mg For treatment of chronic hyperuricemia in conditions where urate depression has already occured (including a history, or presence of tophus and /or gouty arthritis).

14.11.2009

179

Euphorbia Prostrata Dry Extract :100mg tablet For the treatment of 3 and 4 haemorrhoids (Addl. 180 (addl. Indication) Indication). For the treatment of 1 and 2 internal haemorrhoids.

14.11.2009

Euphorbia Prostrata dry extract ethanolic 181 80%v/v[(35-70):1] cream 1% w/w

14.11.2009

Lactobacillus Rhammnosus 1 billion cells + 182 Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules

For the treatment of acute diarrhoea in children

4.11.2009

Nimesulide 1.0% w/w + Ethanol 31% w/w 183 topical solution Diacerein Modified Release Capsule 100mg

For the local application in relieving pain in acute low backache, tendonitis, tenosinovitis and sprains Symptomatic treatment of osteoarthritis of knee & hip

17.11.2009

20.11.2009

184 For the treatment of essential hypertension

Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 185 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets Maraviroc Tablets 150mg/300mg.

24.11.2009

186

For the treatment of patients infected with CCR5- trophic HIV-1.

25.11.2009

S (+) Etodolac 150/200/300mg + Paracetamol For the symptomatic treatment of acute pain and 187 500/500/500mg Tablets inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis

25.11.2009

Tacrolimus Granules for oral suspension 0.2/1 Prophylaxis of transplant rejection in kidney, liver or heart 26.11.2009 188 mg per sachet allograft recipient Rifaximin Dispersible Tablet 200mg For infections diarrhoea in adults

26.11.2009

189 Indicating for condition required Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction

Prednisolone Sodium Phosphate Orally 190 Disintegrating Tablet 10/15/30mg

26.11.2009

Cinitapride Hydrogen Tartrate ER Tablet 3mg For the treatment of gastroesophageal reflux disease 191 (GERD) and functional inconveniences of the gastrointestinal motility Sevelamer Carbonate (Additional Indication)

26.11.2009

192

for control of serum phosphorus in patients with chronic 26.11.2009 kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl Monotherapy in the treatment of partial seizures in children ages 4-16 for the relief of musculoskeletal pain & inflammation

Oxcarbazepine Tablets (Additional 193 Indication)150/300/600 mg Ketoprofen plaster 30 mg (7cm X 10 cm)

26.11.2009

11.12.2009

194 Acipimox Capsules 250mg. As adjunctive therapy to diet and weight loss in the treatment of type IIa, IIb and IV lipid disorders. Same as approved

26.11.2009

195 Amisulpiride SR Tablet 100 mg

27.11.2009

196 Same as approved

Mycophenolate Sodium Enteric coated tablet 197 540 mg (Additional Strength)

29.10.2009

Loteprednol etabonate 0.5% w/v + For the treatement of post operative steriod responsive 198 Moxifloxacin 0.5% w/v opthalmic Suspension inflammatory ocular infections or risk of bacterial ocular infections exists Ropinirole ER tablet 2/4/8mg for the treatment of signs & symptoms of idiopathic Parkinson's disease same as approved

1.12.2009

3.12.2009

199

Diclofenac Diethyl amine transdermal patch 200 100 mg/37.5 sq cm (Additional Strength)

4.12.2009

Lornoxicam ER Tablet 8 mg (Additional 201 Strength) Flurbiprofen plaster 20 mg (7cm X 10cm)

same as approved

11.12.2009

202

for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder 1. Mild to severe chronic heart failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension For the treatment of acute and chronic infected eczematous dermatitis

11.12.2009

Carvedilol Phosphate ER tablet 203 10/20/40/80mg

11.12.2009

Halometasone monohydrate 0.05% w/w + 204 Fusidic acid 2.00% w/w cream

15.12.2009

Glimepiride 1/2 mg + Metformin 500 mg + 205 Atorvastatin 10 mg tablets

For the treatment of type II diabetes mellitus associated with dyslipidemia indicated in the treatment of Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss Indicated for the first line treatment of patients with locally advanced or metastatic non small cell lung cancer (NSLC) who have activating mutationof the EGFRTK".

17.12.2009

Betahistine Di hydrochloride CR capsule 206 24/32/48mg Gefitinib tab 250mg (Additional Indication)

17.12.2009

18.12.2009

207 Midazolam Hcl Syrup 2mg/ml

208 Guaiphenasin Syrup 133mg/5ml

For selection,anxiolysis and amnesia prior to diagnostic, 18.12.2009 therapeutic or endoscopic procedure or before induction of anesthesia. For the treatment of productive cough accompanied by phlegm for the treatment of uncomplicated urinary tract infectins (such as cystitis and urethritis) For symptomatic treatment of nasal congestion with running nose (rhinorrhea) For the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate

18.12.2009

209 Balofloxacin Tablet 100mg

22.12.2009

210

Xylometazoline 0.5 mg + Ipratropium 0.6 mg 211 Nasal spray

23.12.2009

Doxofylline 400 mg + Ambroxol 30 mg 212 Tablets Ribavirin Capsules 200mg (Addl. Strength)

23.12.2009

213

Indicated in combination with peg interferon alpha-2b for 24.12.2009 the treatment of nave adult patients with chronic hepatitis C with clinically stable HIV co-infection.

Formoterol 6 mcg + Mometasone furoate For the treatment of patients with bronchial asthma and 30.12.2009 214 100/200/400mcg Metered dose Inhaler & Dry COPD, where the use of combination is found appropriate Powder Inhalation Chlorohexidine Gluconate Gel 0.2% For the prevention of Plaque and treatment of gengivitis.

30.12.2009

215 Chlorohexidine Gluconate Mouth wash 0.1% For the prevention of Plaque and treatment of gengivitis.

30.12.2009

216
Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup For the treatment of non-productive cough 06.07.09

217

LIST OF APPROVED DRUG FROM 01.01.08 TO 31.12.08

S. Drug Name No. Me-salicylate 30% + Menthol 10% + camphor 4% Cream Indication Approval Date

For temporary relief from pain, swelling & 29.11.07 inflammation due to musculoskeletal disorder For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic drug or 28.12.07 insulin preparation in addition to diet and or exercise do not result in adequate glycemic control. Same as Approved 31.01.08

Voglibose 0.2mg/0.3mg tablet (Mouth dissolving)

Hydroxychloroquine 400mg tablets (Additional Strength)

ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets Same as Approved (Additional Strength) For the treatment of steroid responsive fungal infections including eczema and psoriasis

02.01.08

Halobetasol 0.05% + Clotrimazole 1.0% cream

04.01.08

Citicholine Syrup 750mg/5ml

For the treatment of disturbance of consciousness resulting from head injuries, brain 04.01.08 operation and acute stage of cerebral infarction in adults only For Parkinson's Disease 08.01.08 For the treatment of burns and wound infections

Levodopa 200mg + Carbidopa 50mg C.R. tablet

Nanocrystalline Silver Gel 0.002%

04.01.08

Cinitapride (as hydrogen tartrate) 1mg tablet

For the treatment of gastroesophageal reflux 04.01.08 disease and functional

inconveniences of the gastrointestinal motility 10 Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet For the treatment of adult patients with HIV 07.01.08 infection For the treatment of Urinary tract infections, respiratory tract infections, biliary tract 07.01.08 infections in adult patients prone to antibiotic associated diarrhoea Same as Approved 07.01.08

11

Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet

12

D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength)

Ceftazidime 500mg + Tobramycin 60mg per vial 13 (Injection)

For the treatment of lower respiratory tract 08.01.08 infection caused by pseudomonas aeruginosa Same as approved For the prophylaxis of surgical site infections following elective colorectal surgery 08.01.08

14 Atazanavir 300mg capsules (Additional strength)

Ertapenem for injection 1gm/vial (additional 15 indication)

15.01.08

16 Vildagliptin Tablets 50mg/100mg

As an adjunct to diet and exercise to improve glycemic control in 18.01.08 patients with type-II diabetes mellitus For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk 18.01.08 of myocardial infarction, stroke or peripheral vascular disease For the treatment of acute migraine 22.01.08

17 Atorvastatin 10mg + Aspirin 75/150mg Capsules

18

Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets

Sodium Valproate 666mg + valproic acid 290mg 19 equivalent as sodium valproate 1000mg C.R. tablet Same as Approved (Additional Strength)

24.01.08

For serious CRTI, uncomplicated and complicated UTI, Cefepime (as hydrochloride) 2000/1000/500mg + Uncomplicated skin & 20 Sulbactam (as sodium) 1000/500/250mg per vial of skin structure, infection 24.01.08 injection acute exacerbation of chronic bronchitis & intraabdominal infection. 21 Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication) Ovarian cancer, nonsmall cell lung cancer and AIDS related Kaposis Sarcoma For hepatocellular Carcenoma 22.01.08

22 Sorafenib tablets 200mg (Additional Indication)

22.01.08

23

Zanamavir inhalation powder 5mg/blister (Additional Indication)

For prophylaxes and treatment of both influenza A & B in 22.01.08 adults and children (greater than or equal to 5 years) For the prophylaxis of acute organ rejection in patients receiving 23.01.08 allogeneic hepatic transplantation

24

Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional Indication)

Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each For the treatment of 25 + 24 tablets of Calcium carbonate 1250mg osteoporosis in post(equivalent to 500mg Calcium) + cholecalciferol- menopausal women 250IU

23.01.08

26 Aceclofenac injection 150mg/ml

For short term treatment of pain due to post 23.01.08 operative and post traumatic cases For the treatment of combined hyperlipidemia in patients with normal hepatic and renal functions.

27

Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication)

25.01.08

Sodium Valproate 499.5mg + Valproic acid 28 217.5mg equivalent as sodium valproate- 750mg CR tablet (Additional Strength)

Same as Approved

24.01.08

29

Diclofenac 50mg + Serratiopeptidase 10mg enteric For the treatment of coated tablet acute pain in adults Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength)

24.01.08

30

Same as Approved

24.01.08

Cefpirome (as sulphate) 500/1000mg/2000mg + 31 Sulbactam (as sodium ) 250mg/500mg/1000mg powder for injection

For the treatment of infection caused by sensitive organisms viz. 24.01.08 lower RTI, complicated UTI, Septicemia, bacteremia For the treatment of Type-II diabetes associated with mixed dyslipidemia For the treatment of acne vulgaris For the treatment of bronchial asthma 25.01.08

Metformin HCl ER 500mg + Fenofibrate 32 80mg/160mg tablet Salicylic acid 10mg/20mg (Foaming facewash solution)

33

28.01.08 28.01.08

34 Ozagrel Hcl. Tablets 100mg/200mg

For the treatment of patients with mild to 2 Rivastigmine transdermal patch (each patch of 5m , moderately severe 35 10m2,15m2 & 20m2 contain Rivastigmine base dementia of the 28.01.08 9/18/27/36mg respectively Alzheimer type and dementia associated with Parkinsons disease For the treatment of complicated skin and Daptomycin powder for concentrate for solution for skin structure infections 36 28.01.08 infusion (350mg/500mg per vial) and for staphylococus aureus bloodstream infections (bacteremia) Dextromethorphan Orodispersible strip 37 5.5mg/11mg For the relief of persistent dry irritating cough in adult patients only 28.01.08

For the treatment of Diclofenac sodium 50mg + Dicyclomine HCl 20mg 38 acute colicky pain in per ml of injection adults

28.01.08

For decrease of intraocular pressure in patients with open angle glaucoma or ocular Travoprost 40mcg + Timolol (as Maleate) 5mg per 39 hypertension, who are 28.01.08 ml of eye drops insufficiently responsive to topical beta blockers or prostaglandin analogues Amoxicillin 250mg/125mg + Cloxacillin 40 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores For RTI, SRS of tissue infection, bons & joint infection, ENT infection 30.01.08 in adults prone to antibiotic associated diarrhoea For RTI, SRS of tissue infection, bons & joint infection, ENT infection 31.01.08 in adults prone to antibiotic associated diarrhoea

41

Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores

Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calcium For Vitamins and Pantothenate25mg+Folic Acid 1.5mg+Zinc 42 Minerals deficiency oxide22.5mg+Chromium states in adult patients picolinate65mcg+Inositol10mcg+Lutein5mg capsule

30.01.08

Methylcobalamine 750mcg + Alphalipoic acid For Vitamins and 100mg + Benfothiamine 7.5mg + B6 1.5mg + 43 Minerals deficiency Calcium pantothenate25mg + Nicotinamide 50mg + states in adult patients Folic acid0.75mg capsule

30.01.08

Mecobalamin500mcg + Alpha Lipoic Acid200mg + For Vitamins deficiency 44 Benfotiamin 10mg + Pyridoxine3mg + Biotin5mg + 30.01.08 states in adult patients Folic acid 1.5mg capsule For the treatment of lower RTI, skin & soft tissue bone & joint

45

Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules

30.01.08

infections, ENT infections in adult patients prone to antibiotic associated diarrhoea As 3rd line treatment of sever cases of COPD Tiotropium (as Tiotropium Bromide Monohydrate) when monotherapy and 46 18mcg + Formoterol Fumarate Dihydro. 12mcg + 31.01.08 second line therapy with Ciclesomide 400mcg per capsules two drugs do not respond adequately For the treatment of Metoprolol Succinate Equivalent to Metoprolol patient with both 47 Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) essential hypertension 10mg tablets and hypercholesterolemia 48 Levocetrizine Di HCl Dispersible tablet 5mg/10mg For allergic rhinitis & (New Dosage form) chronic urticaria Oseltamivir 30mg & 45mg Capsules (Additional Strength) Same as Approved

28.01.08

28.01.08

49

28.01.08

Fondaparinax Sodium injection (Additional 50 Indication)

Treatment of acute coronary syndrome 28.01.08 (ACS) with and without ST-segment elevation For remission of acute symptoms of chronic pancreatitis and postoperative reflux esophagitis

51 Camostat Mesylate tablets 100mg

29.01.08

52

Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe

For intradermal implantation and facial 30.01.08 soft tissue agumentation For the treatment of patients with chronic 30.01.08 cholestatic liver disease

53 Ursodeoxycholic acid tablets 600mg

For the extended treatment of symptomatic venous thromboembolism 54 Dalteparin Sodium Injection(Additional Indication) (VTE) proximal deep 30.01.08 thrombosis (DVT) and/or pulmonary embolism (PE), to reduce the recurrence of

VTE in patients with cancer

55

For the topical treatment Beclomethasone Dipropionate 0.25mg + Econazole of bacterial and fungal 30.01.08 10mg + Neomycin 5mg per gm of Cream infections For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who have not achieved adequate glycemic 30.01.08 control with metformin, a sulfonylurea or a combination of metformin and a sulfonylureas For the symptomatic treatment of acute pain and inflammation in patients with 30.01.08 osteoarthritis, rheumatoid arthritis and ankylosing spondylitis As adjunctive therapy in the treatment of partial 30.01.08 seizures of epilepsy For moderate to severe Alzheimer's disease 31.01.08

Exenatide injection (Each 2ml vial contains56 Exenatide 5mcg/10mcg per 0.2ml ) (Additional Strength)

57

Diclofenac Sodium 50mg + Paracetamol 500mg tablets

58 Gabapentin SR 600mg tablets

59 Memantine 5mg /10mg + Donepezil 5mg Tablets

60 Doxifluridine Capsules 100mg/200mg

For carcinoma of the stomach, colon, rectum, 31.01.08 breast, uterine, cervix and bladder For use for patients being treated by hemodialysis 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

Haemodialysis Powder/Liquid Form containing citrate

62

Carmustine (polifeprosan 20 with carmustine Implant (Wafer)

31.01.08

63 Cimetropium Bromide tablet 50mg

For the treatment of irritable bowel syndrome

31.01.08

64 CyclobenzaprineHcl. Tablets 5mg/10mg

As adjunct to rest and physical therapy for relief of muscle spasm 31.01.08 associated with acute painful musculoskeletal conditions For the topical treatment of the superficial 31.01.08 mycosis like dermatophytosis 31.01.08

65 Sertaconazole Nitrate Cream 2%,

66

Cefpodoxime 50mg + Clavulanic acid 31.25mg Same as Approved dispersible tablet & dry syrup (Additional strength)

67

Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets

For the treatment of overactive bladder with symptoms of urge 31.01.08 urinary incontinence, urgency and frequency

For the treatment of respiratory tract infection, skin and soft Amoxycillin 125mg/250mg/500mg + Lactobacillus 68 tissue infections & 1.66 billion Spores (Capsules) antibiotics associated diarrhoea in adult patients Halobetasol 0.5mg + Miconazole 20mg per gram 69 Cream For steroid responsive dermatoses associated with superficial fungal infection of skin

31.01.08

31.01.08

70

Montelucast 10mg + Levocetirizine 5mg film coated tablets

For the treatment of allergic rhinitis in adults 31.01.08 only For short term intermittent treatment of moderate to severe melasma of the face in 31.01.08 the presence of measures for sun avoidance including use of sun screen

71

Hydroquinone 2% + Tretinoin 0.025% (w/w) Momentasone 0.10% Gel

Phenylephrine 5mg + Chlorpheniramine maleate For the treatment of 72 0.5mg + Paracetamol 125mg + sodium citrate 60mg common cold and cough 31.01.08 + Menthol 1mg (per 5ml) Syrup associated with fever For treatment of painful inflammatory conditions 31.01.08 associated with gastroduodenal ulcers As third line treatment of severe cases of COPD, when monotherapy and second 31.01.08 line therapy with two drugs do not respond adequately 31.01.08

Diclofenac Sodium 100mg (SR Pellets) + 73 Rabeprazole Sodium 20mg (E.C Pellets) Capsules

74

Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler

For the treatment of VSL # (Combination of lactic acid bacteria (VSL # 75 irritable bowel 3) syndrome

76 Clostimethate Sodium of 1,00,000IU Injection

For the treatment of serious infection caused Gram-Ve bacteria including LRTI, UTI, 31.01.08 where commonly used anti bacterial agent may be infective because of bacterial resistance Same as Approved For the treatment of amoebiasis, urogenital trichomoniasis & giardiasis 20.02.08

77

Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength)

78 Metronidazole CR tablet 600mg

21.02.08

79 Quetiapine fumarate SR tablets

for the additional indication "acute manic 21.02.08 episode associated with bipolar disorder additional Strength (it should not be used routinely because of increased risk of adverse events. It should be 25.02.08 reserved for patients who are considered to be at higher risk after careful risk assessment

80

Atorvastatin Calcium 80mg tablets (Additional Strength)

81

Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tablet

For the treatment of haemorrhoid For the treatment of osteoarthritis & rheumatoid arthritis

29.02.08

82 Amtolmetin Guacil tablets 600mg

07.03.08

Brimonidine Tartrate Opthalmic solution 0.1% 83 (with purite as preservation 0.0005%) (additional strength)

For lowering of IOP in patients with open angle 07.03.08 glaucoma occular hypertension 1:- For repigmentation of idiopathic vitiligo alongwith phototherapy. 2:- For symptomatic 07.03.08 control of severe, recalcitrant, disabling psoriasis in conjunction with phototherapy Same as Approved For the treatment of bronchial asthma & COPD in adults For the treatment of steroid responsive dermatoses associated with superficial fungal infections of the skin Same as Approved For gastric ulcer, duodenal ulcer, and GERD 11.03.08

84 Methoxsalen USP-20mg Tablet

85

Cefditoren pivoxil 400mg tablets (Additional Strength)

Doxofylline ER tablets 400mg/800mg (addl. 86 Strength)

12.03.08

87 Betamethasone 0.05% +Miconazole 2% Cream

12.03.08

88

Premetrxed disodium injection 100mg/vial (Additional Strength) Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension

12.03.08

89

12.03.08

Mecobalamin 1000mcg+ Alpha Lipoic Acid 90 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ Inositol 100mg + Benfotiamine 100mg capsule

For the treatment of diabetic neuropathy

19.03.08

91

ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength)

Same as Approved

19.03.08

92

Temozolamide capsules 140mg/180mg (Addl. Strength)

Same as Approved Same as Approved For the treatment of essential hypertension

31.03.08 20.03.08 24.03.08

93 Amisulpiride 300mg tablets (Additional Strength) 94 Nifedipine SR Tablets 10mg/20mg

For symptomatic relief Ambroxol HCl. 15mg + Guiphenesin 50mg + of bronchospasm in 95 Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 bronchial asthma and ml of syrup chronic bronchitis Ambroxol HCl 30mg + Guaiphenesin 100mg + 96 Terbutaline sulphate 2.5mg per 10ml Syrup For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis For the treatment of mild to moderate psoriasis For short term use in acute painful condition in adults only Oral contraceptive in women For symptomatic treatment of acute rhinosinusitis For the treatment of mild to moderate pain, such as dental pain, dysmenorrhoea & musculoskeletal pain

26.03.08

26.03.08

97 Boswellia Serrata 0.05gm/gm of Cream

28.03.08

98 Etoricoxib injection 90mg/ml

28.03.08

99

Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets

28.03.08

100

28.03.08

101

Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg

28.03.08

102 Nepafenac Opthalmic suspension (1mg/ml)

For the treatment of pain and inflammation 31.03.08 associated with cataract surgery For pain management in patients suffering with osteoarthritis of the 31.03.08 knee, hip, shoulder and ankle

103

Hylan GF 20 Injection (Synvisc) (Additional Indication)

104 Docetaxel injection conc.

For additional indication "advanced gastric adenocarcinoma, locally advanced squamous cell carcinoma of head & 31.03.08 neck, Harmone refraetory metastatic prostrate cancer, locally advanced or metastatic breast cancer

Methylcobalamin 1000mcg + Pyridoxine Hcl IP For peripheral 105 100mg + Nicotinamide IP 100mg + D-Panthenol IP neuropathy 50mg per 2 ml of injection

31.03.08

106

Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength)

Same as Approved

01.04.08

107 Nicardipine Hcl. Injection 2.5mg/ml

For short-term treatment of hypertension when 07.04.08 oral therapy is not feasible or not desirable

Diclofenac Potassium 50mg + Serratiopeptidase (as For the treatment of 108 enteric coated pellets) 15mg capsules (Additional acute pain in adults Strength) For the treatment of adult patients with osteoarthritis of knee and or hip joints Same as Approved For the treatment of irritable bowel syndrome

08.04.08

109 Diacerin 50mg + Aceclofenac 100mg tablets

11.04.08

110

Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) Live freeze-dried lactic acid bacteria and bifidobacteria capsules Miltefosin Capsule 10mg/50mg (Additional Indication)

16.04.08

111

10.04.08

112

Treatment of cutaneous 16.04.08 leishmaniasis As an antimicrobial barrier for management of partial thickness 16.04.08 burns, incisions, skin grafts, donor sites, lacerations, abrasions

113 Silver Wound Dressing

and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic) Diacerin 50mg + Glucosamine sulphate 500mg tablets. For the treatment of adult patients with osteoarthritis of knee and hip joints

114

21.04.08

115

Clostridium Botulinum type-A toxin haemagglutinin complex (Additional Indication)

For focal spasticity, including the treatment of arm symptoms 22.04.08 associated with focal spasticity in conjunction with physiotherapy For the treatment of systemic candidiasis, mucosal candidiasis, prevention of fungal infections in patients with malignancy In combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy

116 Fluconazole Dispersible tablets 50mg

22.04.08

117

Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication)

22.04.08

As an adjunct to diet & exercise to improve Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 118 glycemic control in 500mg/1000mg Film coated tablets patients with type-two diabetes mellitus

28.04.08

119 Lansoprazole for injection 30mg/vial

For short term treatment of errosive esophagitis when patients are unable 28.04.08 to take the oral formulation For the treatment of RA in children 5 years of 28.04.08 age and above For control of serum phosphorus in patients with chronic kidney disease on dialysis For the treatment of gastric ulcer, duodenal ulcer, Zollinger Ellison Syndrome and GERD 28.04.08

120 Naproxen Suspension 125mg/5ml

Sevelamer Carbonate 400mg/800mg tablets & 121 sachet 400mg/800mg

Rabeprazole Sodium (With Sodium bicarbonate as 122 buffer) 10mg/20mg tablets

28.04.08

For the treatment of Pantoprazole Sodium (With Sodium bicarbonate as gastric ulcer, duodenal 123 buffer) 20mg/40mg tablets ulcer, Zollinger Ellison Syndrome and GERD

28.04.08

124

Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml

For the treatment of community acquired pneumonia, acute exacerabation of chronic 29.04.08 bronchitis, uncomplicated skin and skin structure infection, Pharyngitis/tonsillitis management of fibromyalgia syndrome Same as Approved 29.04.08

125 Pregabalin capsules (Addl. Indication) Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength)

126

08.05.08

127

Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets

For the treatment of essential hypertension in adult patients whose 08.05.08 blood pressure is not adequately controlled on monotherapy . For diabetes insipidus and noctural emuresis 08.05.08

128

Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength)

129

Same as Approved

14.05.08

For alcoholic liver Lecithin Liquid (each 5 ml contains lecithin 500mg 130 disease, drug induced equivalent to essential phospholipids 250mg hepatitis Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength) For the treatment of plaque psoriasis

14.05.08

131

14.05.08

132

Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solution

For the topical treatment 14.05.08 of acne vulgaris

133 Deflazocort 24mg tablets (Additional strength)

Same as Approved

14.05.08

Sodium Chondroitin sulfate 40mg + sodium 134 Hyaluronate 30mg per ml Intraocular Injection (additional strength)

For use as a surgical aid in anterior segments procedure including 14.05.08 catract extraction & intra-ocular lens implantation

For the treatment of GERD, gastric and Esomeprazole (with Sodium bicarbonate as buffer) 135 duodenal ulcer, 20mg/40mg tablets Zollinger-Ellison syndrome Telmisartan 40 mg + Atorvastatin (as calcium) 10 136 mg Tablets Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet.

14.05.08

For coexisting essential hypertension & 22.05.08 hyperlipidemia For the treatment of adult patients with major 22.05.08 depressive disorder For hypertension in patients whose blood pressure is not 28.05.08 adequately controlled in monotherapy For essential hypertension in adult patients whose blood 28.05.08 pressure is not adequately controlled on monotherapy For the treatment of secondary hyperthyroidism in patients with chronic kidney disease on dialysis For the treatment of adult patients with chronic obstructive pulmonary disease and bronchial asthma For the treatment of gastric ulcer and management of gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis or acute

137

138

Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets

139 Metolazone 2.5mg + Ramipril 2.5mg/5mg

140

Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules

29.05.08

141 Acebrophylline capsules 100mg

29.05.08

142 Sofalcone Capsule (100mg/50mg)

02.06.08

exacerbation of chronic gastritis For the relief of pain and inflammation in patients 02.06.08 with rheumatoid arthritis and osteoarthritis For the treatment of adult patients with signs 02.06.08 & symptoms of acute painful conditions

143 S(+) Etodolac ER tablets 200mg/300mg

Diclofenac Sodium 50mg + Codeine Phosphate 144 50mg tablets

Sodium Hyaluronate injectable gel (each 0.6ml. 1ml For intradermal 145 pre filled syringe contains, sodium Hyaluronate implantation and facial 03.06.08 20mg/ml, 22.5mg/ml soft tissue augmentation For invasive fungal infection in patients who are refractory to or 03.06.08 intolerant of conventional amphotericin B therapy For the treatment of Gastroeasophageal Reflux Disease (GERD) 09.06.08 in patients not responding to dexrabeprazole alone For acute low back pain & other musculoskeletal painful and 11.06.08 inflammatory condition in adults For the treatment of lower respiratory tract infection in children Same as Approved 24.06.08

146

Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension

147

Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules

148

Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets

149

Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength)

150

24.06.08

151

Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg+ Benfotiamin100mg + Pyridoxine 50mg tablets

For the treatment of diabetic Neuropathy

03.07.08

152 Ivabradine (Hcl.) 5mg/7.5mg Tablets

For the treatment of chronic stable anginapectoris in patients with normal 03.07.08 sinus rhythm who have a contraindication or intolerance for Betablockers

Methylcobalamin 1500mcg + Alpha Lipoic Acid 153 200mg + Benfotiamine 50mg + Vit B6 3mg + Biotin 5mg + Folic Acid 1.5mg capsule

For the treatment of diabetic Neuropathy

04.07.08

154

Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion)

Indicated to meet daily requirement of nitrogen (amino acids), energy 08.07.08 (glucose) for patients needing parentral Nutrition 08.07.08

155 Temoporfin 1mg/ml Injection (Additional Strength) Same as Approved Pazufloxacin Mesylate i.v. infusion 300mg/100ml 156 & 500mg/100ml Metoprolol ER + Amlodipine tablets (Additional 157 Indication) Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets

For the treatment of RTI, UTI and abdominal 09.07.08 infections in adults For coronary artery disease/ischaemic lheartt 16.07.08 disease 18.07.08 For the treatment of type_II diabetes mellitus when single drug therapy alongwith diet, 21.07.08 exercise do not result in adequate glycemic control For Testosterone replacement therapy of male hypogonadism when testosterone dificiency has been confirmed by clinical feature or biochemical tests

158

159

Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tablets

160 Testosterone Undecanoate 250mg/ml Injection

22.07.08

161 Abatacept powder for injection 250mg/vial

For adult patients with severe active rheumatoid arthritis who had an inadequate response to 22.07.08 one more DMARDs such as methotixate or TNF antagonists For the treatment of rheumatoid arthritis patients 22.07.08

162 Actarit 100mg Tablets

163

Tenofovir Fumarate 300mg + Lamivudine 300mg + For the treatment of HIV 23.07.08 Efavirenz 600mg Tablets infection in adults Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop

164

Same as Approved

23.07.08

165

For reduction of part operative inflammatory 24.07.08 condition of eyes For the reduction of post operative inflammatory 24.07.08 conditions of the eye

Ketorolac Tromethamine 4mg + Gatifloxacin 3mg 166 Eye Drops Cefadroxyl (as monohydrate) 125mg + Clavulanic 167 acid (as potassium) 31.25 per 5ml Syrup (Additional strength)

Same as Approved

25.07.08

For the treatment of secondary Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule hyperparathyroidism in 168 (Additional Indication) patients with stage 3 or stage 4 chronic kidney disease Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength)

05.08.08

169

Same as approved

05.08.08

170

Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength)

Same as approved

05.08.08

171 Olopatadine Nasal Spray (0.6%)

For the relief of the symptoms of seasonal allergic rhinitis in 05.08.08 patients 12 years of age and older

172 Loxoprofen Sodium tablet (60mg)

For the symptomatic treatment of pain and inflammation condition 14.08.08 in patients with osteoarthritis For the treatment of mild to moderate pain, reduction of fever 14.08.08

173 Dexibuprofen Suspension 50mg/5ml

174 Bromfenac Sodium Eye Drop (0.09%)

For the treatment of postoperative inflammation & reduction of 14.08.08 postoperative ocular pain in patients who have undergone cataract extraction 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

175

Ceftriaxone + Sulbactam injection (Additional Indication)

18.08.08

176 Citicoline Chewable tablet (500mg)

For the treatment of disturbance of consciousness as resulting from head 18.08.08 injuries , brain operation and acute stage of cerebral infraction in adult only 18.08.08

177

Ambroxol + loratadine + Guaifenesin Syrup (30mg For the treatment of + 5mg + 50mg per 5ml) productive cough Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) Cyclobenzaprine 7.5mg tablets (Additional Strength)

178

For the treatment of iron 18.08.08 deficiency anaemia Same as approved 18.08.08

179

For the treatment of haemo-dynamically stably patients with S-Metoprolol Succinate Oral Solution (Each Ml definite or suspected 180 contains: S-Metoprolol Succinate 9.5mg equal to Sacute Myocardial Metoprolol Tartrate 10mg) Infarction to reduce cardio-vascular mortality.

19.08.08

181

Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional Indication)

In combination with bortezumab for the treatment of progressive multiple myeloma in patients who have 23.08.08 received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant As mouthwash for oral hygeine in various oropharyngeal conditions, surgery, dental infections, and halitosis

Povidone Iodine Sachet (containing Effervescent 182 Granules) Each 2gm Sachet contains: 175mg (available iodine 17.5mg)

25.08.08

Sodium Chondroitin Sulphate + Sodium 183 Hyaluronate injection (40mg + not more than 17mg Same as approved per ml)

25.08.08

For the treatment of oedema associated with Metolazone + Spironolactone FC Tablets (2.5/5mg 184 congestive heart failure, 25.08.08 + 50mg) cirrhosis and nephritic syndrome 185 Tretinoin Microsphere Gel (0.1% W/V) 186 Misoprostol 50Mcg tablet (Additional Strength) For topical treatment of 26.08.08 acne vulgaris Same as approved 26.08.08

Ferrous Ascorbate + Folic Acid Suspension (Equiv. 187 to elemental iron 30mg + 550mcg per 5ml) (New Same as approved Dosage Form)

27.08.08

188 Guaiphenesin ER Tablet (600mg)

For the treatment of productive cough 28.08.08 accompanied by phlegm

189 Clopidogrel 300mg Tablet (addl. Strength)

As approved

02.09.08

For the treatment of 190 Capecitabine 150/500mg Tablets (addl. Indication) patients with metastatic 02.09.08 colorectal cancer Lopinavir + Ritonavir (100 + 25mg) Tablets 191 (additional strength) For the treatment of patients with HIV infection 08.09.08

in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to Ixabepilone lyophilized powder inj. 15mg/45mg per 192 treatment with an 13.09.08 vial anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. For the relief of inflammatory and pruritic manifestation of 13.09.08 non-infected corticosteroid responsive dermatoses like eczema For the treatment of milk fever, hypocalcaemia tetanies 13.09.08 and disorders of calcium metabolism in dairy cattle. for the treatment of essential hypertension 15.09.08

193 Halometasone (as monohydrate ) 0.05% Cream

194

Calcium and Magnesium 24% (Veterinary) injectable solution.

195

Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength)

196

Drotaverine + Aceclofenac (80mg + 100mg) Tablets

For the treatment of adult patients with 15.09.08 muscular pain associated with spasm For the treatment of mild to moderate hypertension in adult 15.09.08 patients whose blood pressure is not adequately controlled by

197

Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets

monotherapy

198

Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength) Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion

for the treatment of essential hypertension For the treatment of seborrhoeic dermatitis

15.09.08

199

15.09.08

200 Citicoline CR Tab 1000mg

For the treatment of patients with serious cerebral injuries of vascular traumatic nature with or without loss of consciousness & 16.09.08 for treatment of degenerative damages & chronic cerebral vascular injuries in senile dementia. 1. For the treatment of Prophylaxis & chronic treatment of Asthma in Pediatrics patients 12 months of age & older. 2. For relieving symptoms of seasonal 16.09.08 allergic rhinitis in Pediatric patients 2 years of age & older & perennial allergic rhinitis in Pediatric Patients 6 months of age & older. For the treatment of pain, swelling & 16.09.08 inflammatory conditions due to arthritis. As already approved 16.09.08

201 Montelukast Suspension 5mg/5ml

202 Etoricoxib roll on Topical Solution 1% v/v

203

Risedronate Sodium 150mg Tablet (Additional Strength)

204 Levosulpiride Inj. 25mg/ml, 2ml

For the treatment of depression and schizophrenia in adults 26.09.08 when oral therapy is not possible

205 Paliperidone ER Tablet 3mg / 6mg / 9mg

For the acute and maintenance treatment of schizophrenia

26.09.08

206

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 26.09.08 multocida, andHistophilus somni in beef, non-lactating dairy, and lactating dairy cattle For treatment of sub clinical mastitis in dairy cattle at the time of dry off asssociated with 26.09.08 staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis. For treatment of clinical mastitis in lactating dairy cattle asssociated with coagulase- negative 26.09.08 staphylococci, Streptococcus dysgalactiae, and Escherichia coli. For the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused 26.09.08 by susceptible strains of Escherichia coli or Staphylococcus saprophyticus For the relief of painful muscle spasms of the skeletal musculature 26.09.08

207

Ceftiofur HCl Suspension(as HCl salt) ----500mg (veterinary)

208

Ceftiofur HCl Suspension (as HCl salt) ----125mg (veterinary)

209 Nitrofurantoin SR Tab. 100mg

210 Tolperisone HCl Tablet 50 / 100 / 150mg

211 Etoricoxib + PCM (60mg + 500mg) Tablets

For the short term use in acute painful and 30.09.08 inflammatory condition For the treatment of disturbance of 30.09.08 consciousness resulting

212 Citicoline Oral Drops

from head injuries, brain operation & acute stage of cerebral infraction in adult. Indicated for the treatment of mastitis, metritis, pneumonia, pleuritis, fever and 30.09.08 relieving of acute pain in musculoskeletal disorders in animals For the treatment of calcium and Vitamin D deficiency states (pregnancy, lactation, growing Children) for the treatment of chloroquine resistant/multidrug resitant on complicated malaria

Paracetamol + Meloxicam + Benzyl Alcohol + 213 Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) Injection

Calcium (as Calcium Citrate Malate) + 214 Colecalciferol (as Colecalciferol Concentrate) + Folic Acid (250mg + 100IU + 50mcg) Tablets

30.09.08

215

Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup

30.09.08

216 Cabergoline 1mg Tablets (Additional indication)

For the treatment of hyperprolactinemia and 01.10.08 inhibition of lactation. In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic 08.10.08 non-small cell lung cancer other than predominantly squamous cell histology For the prevention and treatment of mycoplasma induced chronic respiratory disease in broilers and breeders, the prevention and treatment of 08.10.08 diseases due to clostridium perfringens (necrotic enteritis, wet litter, cholangiohepatitis), the prevention and treatment of ornithobacterium

217

Pemetrexed disodium500mg / 100mg powder for sol. (Addl.indication )

218

Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary)

rhinotacheale (ORT)

219 Bortezomib inj.3.5mg/vial (Additional Indication)

Treatment of patients with multiple myeloma For the treatment of vulvo-vaginal candidiasis in women

09.10.08

220 Sertaconazole Nitrate Vaginal Tab.500mg

09.10.08

221 Fosfomycin Tromethamine Sachet 3gms

For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due 09.10.08 to susceptible strains of E.Coli and Entreococcus faecalis As monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to 09.10.08 cytotoxic chemotherapy. Previous therapy should have included as anthracycline, a taxane, and capecitabine For the treatment of essential hypertension 11.10.08

222

Ixabepilone lyophilized powder (additional Indication)

223 Eprosartan Mesylate 400 mg / 600mg Tablets 224 Tretinoine Gel as Micro Sphere 0.04% % 0.1% Hydroxychloroquine Sulphate (Additional indication )

For topical treatment of 14.10.08 Acne vulgaris. For the treatment of systemic lupus erythematosus 17.10.08

225

226

Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication)

Indicated in the regular treatment of patients with moderate to severe 17.10.08 COPD with frequent symptoms and a history of exacerbations

For post operative Azithromycin + Dexamethasone (10mg + 1mg) Eye steroid responsive 227 21.10.08 Drops inflammatory ocular condition when bacterial

ocular infections or a risk of bacterial ocular infections exists. For the treatment of acute inflammation Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) 228 conditions associated Capsules with spasm in adults only 229 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel For the treatment of acne vulgaris For the treatment of acute musculoskeletal pain in patients 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.

21.10.08

24.10.08

230 Aceclofenac Roll - On 1%

24.10.08

231 Citicoline Troches 200/500mg

31.10.08

232 Amisulpride S.R.Bilayered tablet 200/400mg

For acute and chronic schizophrenic disorders, in which positive symptoms and or negative symptoms are 03.11.08 prominent, including patients characterised by predominant negative symptoms. For the treatment of hypocalcaemia and/or osteoporosis For the treatment of patients with HIV infection 04.11.08

233

Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules

Atazanavir + Ritonavir(300mg + 100mg) FC 234 Tablets

04.11.08

235 Timolol Maleate SR Eye Drops 5.0mg / ml

For the treatment of elevated intraocular pressure in patients with 08.11.08 ocular hypertension or open angle glaucoma.

1) As an adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 2)As an adjunctive Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. 236 therapy to diet to slow 08.11.08 Indication) the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDLC to target levels. For the treatment of 237 Paclitaxel inj.30/100/300mg vial (Addl. Indication) advanced gastric carcinoma 238 Montelucast + Desloratidine(10mg + 5mg) FC Tablets Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets 08.11.08

For the treatment of allergic rhinitis in adults 10.11.08 only Additional Lower Strength Additional Strength For the treatment of lumbago, integumental pain, musculoskeletal pain 10.11.08 10.11.08

239

240 Losartan + HCTZ (100 mg + 25 mg) Tablets

241 Phenyramidol HCl tablet 400mg

14.11.08

242 Salicylic Acid + Coal Tar (3% + 1%) Solution

For scaling of seborrhea, seborrheic dermatitis, 17.11.08 psoriasis of scalp For the treatment of psoriasis and fungal skin 17.11.08 infection For the acute treatment of inflammatory musculoskeletal disorders associated with painful muscle spasm in adults. Additional Lower Strength

Salicylic Acid + Coal Tar + Precipitated Sulphur 243 (3% + 1% + 3%) Ointment

244

Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets

17.11.08

245

Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) Capsules

17.11.08

Calcium Hypochlorite 4gm Sachet (Calcium 246 Hypochlorite 0.542% Other Ingredients: 99.458%)

For purification of contaminated ground water sources. Additional Lower Strength

23.11.08

247 Sumatriptan + Naproxen (50mg + 275mg) Tablets

24.11.08

For the treatment and management of patients with community Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC 248 acquired pneumonia or 25.11.08 Tablets acute bacterial sinusitis due to beta lactamase producing pathogens 249 Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets Additional Lower Strength 02.12.08

Atorvastatin + Metformin(10mg + 500mg SR) 250 Tablets

As adjunctive therapy to diet and exercise in 04.12.08 patients with diabetic dyslipidemia As monotherapy for the second-line treatment of patients with locally advanced or metastatic 04.12.08 non-small cell lung cancer other than predominantly squamous cell histology For the treatment of generalized or partial seizures as monotherapy or adjunctive therapy. For the treatment of 04.12.08 maniac episodes associated with bipolar disorders. For prophylaxis of migraine headache in adults. For the dissolution of Radiolucent collestral goll stone, chronic cholestatic liver disease 08.12.08 in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated

251

Pemetrexed disodium 500mg / 100mg powder for sol. (Addl. Indication)

252 Magnesuim Valproate Tablet 200mg/400mg

253

Ursodeoxycholic Acid 300/600 SR Tablets (Additional Strength)

with cyatic fibrosis.

254

Rifampicin + INH + Piperine (200mg + 300mg + 10mg ) Capsules

For the treatment of adult patients with 11.12.08 pulmonary tuberculosis For the treatment of adult patients with 11.12.08 pulmonary tuberculosis 12.12.08

255 Rifampicin +Piperine (200mg + 10mg ) Capsules

256

Amphotericin B Lipid suspension 50mg/ vial (Addl. Additional Strength Strength) For the treatment of cranial diabetes insipidus , primary noctumal enuresis in patients.

257 Desmopressin Acetate tablet 0.1/0.2 mg

12.12.08

Mifepristone + Misoprostol (1 tab of mifepristone 258 200mg and 4 tab of misoprostol 200mcg) Combipack

For the medical termination of intrauterine pregnancy (MTP) of up to 63 days 16.12.08 gestation based on the first day of the last menstrual period For the treatment of bipolar I disorder. (addl. 17.12.08 Indication) For the treatment of different Gastro intestinal problems like functional dyspepsia, nausea, vomiting & diabetic gastroparesis. For the treatment of schizophrenia and depression in adults.

259 Lamotrigine MR Tablets 50/100mg

260

Levosulpride Injection 25mg/2ml (Additional Strength)

17.12.08

261 Cyclobenzaprine HCl ER Capsule 15/30mg

As an adjunct to rest and physical therapy for relief of muscle spasm 17.12.08 associated with acute, painful, musculoskeletal conditions.

262

Docetaxel injection concentrate 80mg/2ml, 20mg/0.5ml (Additional Indication )

In combination with cisplatin and 5fluorouracil is indicated for the induction treatment of patients 17.12.08 with locally advanced squamous cell carcinoma of the head and neck. For the treatment of scaly dermatoses Additional Strength 18.12.08 19.12.08

263

Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion

264 Azathioprine 25mg Tablets

265 Paracetamol solution for infusion 10mg/ml

For short term treatment of moderate pain, especially following surgery and for the short 23.12.08 term treatment of fever, when administration by i.v route is clinically justified

Indicated for the treatment of lower Gemifloxacin + Ambroxol (320mg + 75mg SR) FC 266 respiratory tract Tablets infections in adult patients

24.12.08

267

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 24.12.08 including endometritis, pelvic cellutitis, and other infections of female genital tract, 6. for CNS infections including meningitis

For the treatment of Paracetamol + Phenylephrine Hydrochloride (Each fever associated with 268 24.12.08 6gm Sachet contains: 500mg + 10mg) Sachet cold, nasal congestion in adults

Carboinoxamine Maleate + Ammonium Chloride + For symptomatic 269 Sodium Citrate (Each 5 ml contains: 2 mg + 120 mg treatment of cough + 120 mg) syrup Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules Additional Lower Strength

24.12.08

270

24.12.08

LIST OF APPROVED DRUG FROM 01.01.2007 TO 31.12.2007

S.No. 1 2 3 4 5 Drug Name R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection Torsemide 10mg + Amiloride 5mg tablets Fexofenadine suspension (30mg/5ml) Sildenafil Citrate 20mg Tablet Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength) Indication Date of Approval Chemotherapy induced nausea 12.01.07 & vomiting Edema Associated with congestive heart failure & hypertension SeAsonal allergic rhinitis & chronic idiopathic urticaria For pulmonary osterial hypertension As approved 17.01.07 19.01.07 23.01.07 23.01.07

6 7 8 9 10 11 12 13

FluvAstatin Tablet (As calcium) 10mg/20mg/40mg (additional As approved strength) Halobetazol Propionate Cream (0.05%) Eszopiclone tablet (1mg/2mg/3mg) Diltiazem Hcl. 2% gel Nalbuphine injection 10mg/20mg per ml. Levonorgestrel 1.5mg tablets Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer) Corticosteroid responsive dermatomes For insomnia For anal fissure For moderate to severe pain For emergency contraceptive For gAstric ulcer, duodenal ulcer, Z. E Syndrome, GERD

29.01.07 02.02.07 07.02.07 07.02.07 07.02.07 07.02.07 07.02.07 08.02.07

levofloxacin (250mg/500mg) + For lower respiratory tract ambroxol SR 75mg tablet infection in adult

14

For testosterone deficiency (i) Testosterone cypionate primary hypogonadism (ii) (100mg/200mg) + Cotton seed 08.02.07 Hypogonadotropine oil 736/566mg per ml injection hypogonadism Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional As approved strength) Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution 08.02.07

15

16

For steroid responsive 14.02.07 inflammatory ocular condition 14.02.07

17

Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER As approved 25mg (additional strength) Glibeneclamide 5mg + MetFormin SR 850mg tablet (additional strength) Aceclofenac injection (150mg/3ml) As approved

18

15.02.07

19

For short term treatment of pain due to post operative and 19.02.07 post traumatic cAses 20.02.07

20

Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine Angina pectoris in adults 5mg/2.5mg tablet (For additional indication) Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet Glatiramer Acetate injection (20mg/ml) Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) Amlodipine (As besylate )5mg/10mg + Perindopril 4mg tablet Olopatadine Hcl. Tablet 2.5mg/5mg Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg Rabeprazole Sodium 20mg/10mg with sodium As approved

21

20.02.07

22 23 24

Essential hypertension Multiple sclerosis As approved

21.02.07 21.02.07 22.02.07

25

For hypertension Allergic nAsal inflammation hives, itching with skin diseAses Essential hypertension For Duodenal ulcer, G.U, Z.E.S. & GERD

23.02.07

26

26.02.07

27 28

26.02.07 26.02.07

bicarbonate As buffer Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) As approved (Dry powder inhaler additional strength) Moxonidine tablet 0.2mg/0.3mg/0.4mg For hypertension

29

27.02.07

30

27.02.07

31

Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As As approved sodium) 62.5mg/125mg For injection (additional strength) Quetiapine (As fumarate) SR 400mg tablet (additional strength) Cabergoline 1mg tablet (additional strength) Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.) As approved For Hyperprolactinemia

01.03.07

32 33 34 35 36

05.03.07 06.03.07

Antibiotic (For adult use only) 07.03.07 08.03.07 16.03.07

Clindamycin 1% + Isotretinoin For acne 0.05% gel Estradiol topical emulsion 2.5mg/gm Vasomotor symptoms Associated with menopause

37

Levosalbutamol MDI (50mcg/actuation) & Dry Powder inhaler As approved (100mcg/capsule) (New Dosage Form) Polonosetron (As Hcl.) For Injection 0.25mg/5ml Cifixime 200mg + Erdosteine 300mg Capsules Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream Eberconazole cream (1%) ISMN 60mg Sr + Atenolol 50mg/100mg Levonorgestrel 0.03mg tablet

16.03.07

38 39 40 41

Chemotherapy induced nausea 20.03.07 & Vomiting Acute Exacerbation of chronic 21.03.07 bronchitis 21.03.07 21.03.07

Aminophylline CR 225/350mg Asthma, COPD, Bronchitis Acute Musenlosleteal pain

42 43 44

Dermatophyte infection of skin such As T-corporis, T-c, T22.03.07 Pedis For angina pectoris For control of fertility 23.03.07 23.03.07

45 46

Bortezomib 2mg/vial (additional pack size) Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg)

As approved For HIV infection

28.03.07 02.04.07

47 48 49 50

Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin For diabetic neuropathy capsule Propofol 10mg + Lignocaem 1mg per ml injection Ezetimibe 10mg + Fenofibrate 160mg tablet For induction of anesthesia For combined hypertipidemia

02.04.07 04.04.07 04.04.07

Atopic dermatitis (eczema) Methylprednisolone Acrponate inflammatory and allergic skin 04.04.07 topical solution 0.1% reaction Citicoline (750mg) tablet (additional strength), syrup As approved 500mg/5ml (new dosage Form) (not For children) Ertapenem For injection (1gm/vial) Letrozole 2.5mg tablet (for additional indication) Quetiapine SR Tablets 50mg ( additional strength) Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) Sunitinib Maleate Capsules 12.5mg/25mg/50mg Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 500mg/100ml) Aprepitant 40mg capsules (additional strength) Olopatadime Ophthalmic solution (0.2%) (additional Strength) Antibiotic For induction of ovulation in anovulatory infertility ( additional indication) As approved 10.04.07

51

52 53 54

10.04.07 10.04.07 10.04.07

55

As approved

10.04.07

56

For G.I. Stromal tumor, 10.04.07 advanced renal cell carcinoma

57

Antibiotic

20.04.07

58

Prevention of post-operative nausea & vomiting (additional 24.04.07 indication) As approved 24.04.07

59

60

Combi pack of 1 tablet of Residronate sodium (35mg) + 6 For osteoporosis in tablet of calcium carbonate postmenopausal women equivalent to 500mg calcium each Levocetirizem 2Hcl. Dispersible tablet (2.5mg)

01.05.07

61 62 63 64

For allergic rhinitis & chronic 08.05.07 urticaria 07.05.07 09.05.07

Amlodipine (As besylate) 10mg + Perindopril 8mg tablets As approved (additional strength) Etodolac ER tablets 400mg/500mg Levosulpiride tablet (25mg) For osteoarthritis & rheumatoid arthritis

For G.I. problem like fanatical dyspepsia, nausea, vomiting 10.05.07 and diabetic gAstroperisis For Obese Patients BMI 30kg/m2 or overweight patients BMI 27kg/m2 with 11.05.07 Associated risk factors such As type-I diabetes or dyslipidemia For constipation For essential hypertension For apthous ulcers in people with normal immune system 14.05.07 16.05.07 16.05.07

65

Rimonabant tablet 20mg

66 67 68

Lactitol monohydrate Syrup 66.67/100ml S(-) Metoprolol (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mg Amlexanox Oral PAste (5%)

69

Lenalidomide capsule (5mg/10mg/15mg/25mg) Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for additional indication) Lornoxicam tablet 4mg/ 8mg Atenolol 25mg/50mg + Indapamide SR 1.5mg

For transfusion dependent anemia due to myalodysplastic syndrom Associated with 16.05.07 deletion 5q cytogenic abnormality For surgical prophylaxis (additional indication)

70

18.05.07

71 72

For Osteoarthritis rheumatoid 21.05.07 arthritis For essential hypertension 21.05.07

73

As adjunctive therapy in Livetiracetam conc. for partial onset seizures in adults infusion 100mg/ml (new dosage 21.05.07 with epilepsy when oral form) administration is temporarily

not feasible

74

Eplerstat tablet 50mg Citicoline tablet 200mg (additional strength) Varenicline (As tartrate) 0.5mg/1mg tablets Azithromycin eye drops 1% Ciclesonide Nasal Spray 50mcg/spray Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection Isotretinoin 0.05% + Erythromycin 2% gel Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength)

For abnormality of vibration sense and abnormal change in 25.05.07 heart rate associated with diabetic peripheral neuropathy As approved 25.05.07

75 76 77 78

As an aid to smoking cessation 29.05.07 treatment in adults Conjunctivitis For seasonal & perennial allergic rhinitis in adults, adolescents aged 12 years Antibiotic For acne 06.06.07 08.06.07

79 80 81 82

08.06.07 08.06.07 08.06.07 08.06.07

Aliskiren Tablet 150mg/300mg For hypertension As approved

83 84 85

Cefditorene pivoxil dispersible tablet (30mg/50mg) (New As approved Dosage form for children) Dexrabeprazole sodium Enteric For Duodenal ulcer, Gastric Coated tablet 5mg/10mg ulcer & GERD Renolazine Extend ReleAse tablet (500mg) For Chronic Angina

08.06.07 13.06.07 14.06.07

86

For control of generalized toniclonic and treatment & Phenytoin sodium ER capsules prevention of seizures 14.06.07 (300mg) (New dosage form) occurring during or following neurosurgery Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet Cefepime injection 500mg/1gm/2gm (For additional indication) Tranexamic acid mouthwash (50mg/ml) For BPH in men with enlarged 14.06.07 prostate For bacterial meningitis in children For prevention of oral hemorrhage in anticoagulant treated patients undergoing 14.06.07

87 88

89

15.06.07

oral surgery

90 91

Deflazocort oral suspension As approved (6mg/5ml) (new Dosage Form) Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules Dexrabeprazole Sodium E. coated tablet 5mg/10mg. Cefepime Injection (New indication) For BPH with overactive bladder For duodenal ulcer, gastric ulcer & GERD For duodenal ulcer, gastric ulcer and GERD. For bacterial meningitis in children.

15.06.07 15.06.07

92 93 94

15.06.07 13-06-2007. 14-06-2007.

95

For control of generalised tonic-clonic (grand-mal) and Phenytoin Sodium E.R (300mg) prevention and treatment of seizures occuring during or following neurosurgery. Tranexamic acid Mouth Wash (50mg/ml) For prevention of oral hemorrhage in anticoagulant treated patients undergoing oral surgery. For asthma, rheumatoid arthritis when glucocorticosteriod therapy is warranted. For BPH with overaction bladder in Adults only.

14-6-2007.

96

15.6.2007.

97

Deflazacort Oral Suspension (6mg/5ml) (New dosage form) Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule.

15-06-2007.

98

15-06-2007.

99 100 101 102

Omeprazole (E.coated) 40mg + For gastric ulcer, duodenal Sodium Bicarbonate 1100mg ulcer and GERD. capsule. Mebeverine HCl prolonged release capsule (200mg). Cilnidipine Tabs. 5mg, 10mg Azithromycin 500mg + Ambroxol S.R (75mg) Tablet. For irritable bowel syndrome For the treatment of mild to moderate hypertension

18-6-2007. 19-06-2007. 21-6-2007

For RTI caused by susceptible 05-07-2007. organisms in adults.

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 06-07-2007. achieved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and sulfonylurea.

105

Moxifloxacin HCL (0.5%) + For reduction of post-operative Ketorolac Tromethamine 0.5% inflammatory conditions of the 11-07-2007. Ophthalmic Solution. eyes. For post-operative steriod Levofloxacin (15mg) + responsive inflammatory Prednisolone Acetate 10mg per ocular conditions when ocular 11-07-2007. ml eye drops. bacterial infections or a risk of bacterial infection exists. Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid For Vitamins and Mineral 0.5/1.5mg + Chromium deficiency states in adult Polynicotinate 65mcg/200mcg+ patients Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule

106

107

39275

108

For post-operative steriod responsive inflammatory Loteprednol Etabonate (0.5%) + ocular conditions when ocular 12-07-2007. Levofloxacin (1.5%) Eye drops. bacterial infections or a risk of bacterial infection exists.

109

Clotrimazole (10mg) + MethylFor fungal infection of skin prednisolone aceponate 12-7-2007. associated with inflammation. 1mg/gm of cream.

110

(i). First line treatment of advanced gastric cancer in combination with platinum Capecitabin Tablet based regimen.(ii). Treatment (150mg/500mg). (for additional of patients with locally indication). 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 coinfected with HIV. (It should 16-07-2007. never be used as a substitute to Rifampicin in T.B patients without HIV co-infection). In combination with capecitabine it is indicated in patients with advanced or metastatic breast cancer whose 24-07-2007. tumour overexpress HER2 and who have received prior therapy including trastuzumab. For the treatment of allergic rhinitis and chronic urticaria.

112

Lapatinib (as Ditosylate) (250mg) Tablet.

113

Levocetirizine Di-HCl mouth dissolving tablets (5mg) (new dosage form).

25-07-2007.

114

For improvement of neurologic symptoms, disorders of activitis of daily Idaravone Injection (1.5mg/ml). 26-07-2007. living and functional disorder associated with acute ischemic stroke. Diclofenac Sodium (75mg/ml) Injection (addl. Strength). Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet. For management of painful conditions in post-operative 30-07-2007. cases, rheumatoid arthritis and osteoarthritis. For LRTI, URTI and UTI. 30-07-2007.

115

116

117

Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. As approved. Strength). Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength). As approved.

30-07-2007.

118

30-07-2007.

119

VSL # 3 (Probiotic Blend) sachet Sorafenib (as Tosylate) (200mg) Tablet. Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) Soft Gelatin Capsule.

For rotavirus diarrhoea in children. For advanced renal cell carcinoma.

31-07-2007.

120

31-07-2007.

121

For diabetic neuropathy.

31-07-2007.

122

Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm For plaque psoriasis. of ointment. Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength) Omeprazole (20mg/40mg)+Sod. Bicarbonate-600mg+ Mg.Hydroxide-700mg .chew tab. Deferasirox dispersible tablet (400mg) (addl. Strength). Tegafur (100mg) + Uracil (224mg) capsule.

01-08-2007.

123

As Approved

01-08-2007.

124

For duodenal, gastric ulcer, GERD, and erosive esophagitis,

1/8/2007

125

As approved

17-08-2007.

126

For first line treatment of metastatic colorectal cancer in 22-08-2007. combination with calcium folinate. For the treatment of patients with mantle cell lymphoma 05-09-2007. who have received at least one prior therapy. 06-09-2007.

127

Bortezomib Injection (additional indication)

128

Amlodipine (5mg) + Nebivolol As approved. (5mg) tablet (addl. Strength). Ceftazidine (2gm) + Sulbactam For serious abdominal (1gm) Injection ( addl. strength infection. for additional indication). Polyethylin Glycol 400 (0.4%) + Propylene Glycol (0.3%).

129

06-09-2007.

130

For temprory relief of dryness, irritation burning, stinging, 18-9-2007. grittiness or foreign body

sensation caused due to environmental factors. Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl. As approved. strength). Levocetirizine Di-HCl syrup (2.5mg/5ml) (for use in children As approved. 2 years and above).

131

25-09-2007.

132

26-09-2007.

133

R-Sibutramine Capsule (2.5mg/5mg)

As an adjunctive therapy for the management of obesity including weight loss and 26-09-2007. maintenance of weight loss in pateints whose BMI is 30Kg/m2 or higher. For adult patients with infection caused susceptible micro-organisms including S.aureus viz UTI, upper and lower RTI and gonoccoccal urethritis. For diagnostic use in echocardiography doppler of macrovasculature an doppler of microvasculature.

134

Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet.

27-09-2007.

135

Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml).

28-09-2007.

136

Ondansetron orally For chemotherapy induced disintegrating tablet (4mg/8mg) nausea and vomiting (additional dosage form)

28-09-2007.

137

Cefuroxime Axetil (250mg) + For UTI, URTI and LRTI and 05-10-2007. Clavulanic acid (125mg) tablet. gonococcal urethritis. For adult patients with infection caused by susceptible microbs,including 5/10/2007 s.aureus.(e.gUTI,Upper&lower RTI & gonococcal urethrities) For cardiopulmonary resuscitation in the event of cardiac arrest related to 05-10-2007. ventricular fibrilation resistant to external electric shock.

138

Cefuroxime-125/250/500mg +Clav.Acid-31.25/62.5/125mg

139

Amiodarone Injection (additional Indication).

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 09-10-2007. 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. 10-10-2007.

143

Combipack of two tablet of chloroquine phosphate (250mg) For drug resistant malaria. each + 14 tablet of Proguanil HCl (100mg) each Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 900mg per 20ml.

144

For breast cancer after failure of combination chemotherapy for metastatic disease or 11-10-2007. relapse within 6 months of adjuvant chemotherapy. 15-10-2007.

145

Olmesartan Medoxomil (20mg) For mild to moderate + Amlodipine Besylate (5mg) hypertension. Tablet. For treatment of patients with Atorvastatin Calcium (10mg ) + both hypertension and Ramipril (2.5mg/5mg) tablet hypercholesterolemia.

146

15-10-2007.

147

Omeprazole(20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength).

As approved.

15-10-2007.

148

For inflammation after ocular Moxifloxacin HCl (5mg) + surgery and where a risk of Prednisolone Acetate (10mg)per bacterial ocular infection ml. (eye drops) exists. Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + For diabetic neuropathy. Thiamine (2mg) + Calcium Picolinate (200mg) tablet. Satranidazole (300mg) + Ofloxacin (200mg) Tablet. For diarrhoea of mixed infection in adults.

16-10-2007.

149

16-10-2007.

150

18-10-2007.

151

Methylcobalamin 500mcg+beta carotine-10.33mg+alpha lipoic For adult patients with diabetic 18-10-2007. acid 100mg+B6 1.5mg+B1 2mg neuropathy. & Cr.polynicotinate. Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU Etizolam Tablet (0.5mg/1mg). For osteoporosis and calcium deficiency state. 23-10-2007.

152 153

For anxiety disorder associated 29-10-2007. with depression. For relief of signs and symptoms of osteoarthritis, rheumatoid arthritis.

154

Oxaprozine Tablet (600mg)

30-10-2007.

155

Prulifloxacin (600mg) Tablet.

For acute uncomplicated lower urinary tract infection (simple cystitis), complicated lower 30-10-2007. UTI, acute exacerbation of chronic bronchitis. For management intermittent claudication. 30-10-2007. 30-10-2007.

156 157

Cilostazole E.R Tablet (100mg/200mg).

Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. As Approved strength) Sitagliptin Tablet (25mg/50mg/100mg). Miglitol (50mg) + Metformin HCl SR (500mg) tablet.

158

As adjunct to diet and exercise to improve glycemic control in 30-10-2007. patients with type-II diabetes. For adult with Type-II diabetes mellitus where simple drug 31-10-2007. therapy, diet and exercise do

159

not result in adequate glycemic control. Mupirocin (2%) + Methylprednisolone Aceponate For atopic dermatitis. (0.1%) Cream. Methyl cobalamine 500mcg+folic acid1.5mg+B55mg,+Zn.sulphate For Vitamins and mineral 25mg+Cr.Polynicotinate deficiency states. 200mcg+selenium65mcg+inositol-1.5mg + alpha lipoic acid 100mg capsule Methylcobalamine 500mcg+folic acid1.5mg+ For diabetic neuropathy alpha lipoic acid 300mg +Benfothiamine-50mg. capsule Methyl prednisolone aceponate1mg + salicylic acid-50mg For treatment of psoriasis ointment Propanol 50gm+povidone iodine-1gm in 100ml solution Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution Voglibose disp.tab.0.2mg/0.3mg Ceftriaxone 2gm+ Tazobactum 250mg for injection For surgical & hygenic hand disinfection. -doAs Approved As Approved

160

31-10-2007.

161

31.10.07

162

13.11.07

163 164 165 166 167

19.11.07 19.11.07 19.11.07 20.11.07 21.11.07

168

Methylprednisolone aceponate- For the treatment of atopic 1mg + Mupirocin-20mg. cream dermatitis Citicholine(as Sod.)200mg/500mg/750mg granules As Approved per sachet. Butarphenol tartrate 10mg/ml nasal spray For management of pain in patients using opioid analgesics.

21.11.07

169

26.11.07

170

26.11.07

171

Deferasirox 100mg dis.tablet(addl. strength)

As Approved

28.11.07

172

Methyl cobalamine 500mcg+folic acid1.5mg+B63mg,+Zn.sulphate 61.8mg+Ca.Pantothenate 10mg+ Niacinamide-50mg +chrimium-50mcg capsule Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsule

For Vitamins and mineral deficiency patients.

29.11.07

173

For the treatment of diabetic Neuropathy

29.11.07

174

Methylcobalamine 500mcg+folic acid 1.5mg+ For diabetic neuropathy alpha lipoic acid 100mg +B63mg+Thiamine 10mg capsule Doxophylline400mg+Salbutamol(as sulphate)-2mg/4mg Tablets For treatment of Bronchial asthma in adults

29.11.07

175

29.11.07

176

For reduction of post-operative Gatifloxacin (as sequihydrate)inflammatory conditions of 3mg + Flurbiprofen sod.29.11.07 eye ,when bacterial infection 0.3mg/ml eye drops. exists. Sertanidazole-300mg+ Ofloxacin-200mg tablet Zoledronic acid 5mg/100ml solution for infusion (addl. indication). For treatment of diarrhoea of mixed infection in adults patients. 29.11.07

177

178 179 180

Post-menopausal osteoporosis. 6-12-2007. 12.6.07 12.6.07

Olmesartan medoximil-20mg + For treatment of essential Ramipril-5mg. tablet hypertention. Levosulpiride Tablet (50mg/100mg) (addl. strength for addl. indication). Combipack of 12 Artesunate 50mg tablets & 6 Mefloquin250mg tablets Pregabalin-75mg/150mg +Methylcobalamine 500mcg cap Doxycycline-100mg +L.bacillus spores-5 billion For depression and schizophrenia in adults.

181

For drug resistant P.falciparum 12.6.07 malaria infection. For the treatment of adult patients with peripheral neuropathy. For adult patients prone to intrabdominal bacterial infection & Antibiotic associated diarrhoea 12.10.07

182

183

12.11.07

184

For the treatment of adult Cefprozil 250mg/500mg+Clav. patients with upper&lower Acid-62.5mg /125mg. tab RTI, Skin & Skin structure infection

12.11.07

185

Dextrometharpahan HBr10mg+Chlorphenaramine maleate-2mg /5ml syrup.

For the temporary relief of cough due to throat irritation, sneezing & ruunning nose. For Short-term treatment of mild to moderate pain, when oral administration is inappropriate(i.e after dental surgery) For erectile dysfunction in adult men.

12.11.07

186

Lornoxicam 8mg /2ml inj.

12.11.07

187

Apomorphine HCL-2mg/3mg Sublingual tablet.

12.11.07

188

Escitlopram (as oxalate)10mg + For comobid depression and Clonazepam-0.5mg tablet (addl. anxiety disorder. Strength). Doxophylline injection-10mg /ml

12.12.07

189

For bronchial asthama & COPD in adult patients, when 31.12.07 oral therapy is in approriate.

LIST OF DRUGS APPROVED DURING 2006

Name Of Drug S.No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Ciclesonide Inhaler 80/160mcg per actuation Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg Doxofylline Tablet (400mg) Zanamavir inhalation powder 5mg/blister Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength) Cefetamet Pivoxil Hcl oral suspension 250mg/ml Voriconazole Powder for oral soluion (40mg/ml) Desflurane liquid for inhalation (240mg/bottle). Aceclofenac 200mg (S.R) tablet Cefprozil Powder for oral suspension (125mg/5ml) Nebivolol (as HCl) 5mg + Valsartan 80mg Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.) Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet Atenolol 50mg + HCTZ 25mg (addl. Strength) Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet Erdosteine Powder for oral suspension 35mg/ml Moxifloxacin Eye Ointment (5mg/gm) Dexibuprofen Tablet (200mg/300mg/400mg) Pegaptinib Sodium Injection (0.3mg). Antibiotic For hypertension For BPH For osteoporosis For hypertension For BPH For chronic obstructive bronchitis For ophthalmic use. For OA, RA & ankylosing spondylitis Pharmacological Classification

For neovascular (wet) age related mac degeneration. For persistent Asthma For hypertension For bronchial asthma & COPD. For influenzae

For replacement therapy in males with T deficiency. Anti-biotic Anti-fungal NSAID

For induction & maintenance of anaesth

20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet Levetiracetam Oral Solution (100mg/ml). Atomoxetine 60mg capsule (Addl. Strength) Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. Fluorescein Sodium Solution for Injection (100mg/ml) Cefditeron (as pivoxil) 200mg tablet Sodium Hyaluronate Cream 0.2% Saquinavir (500mg) tablet (addl. Strength) Eflornithine HCl Cream (139mg/gm) Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial Tobramycin Inhalation solution (300mg/5ml) Lactulose Enema (20%) Haloperidol Tablet (0.5mg) (addl. Lower strength) Cholestyramine Powder for oral suspension (4gm/sachet) Doxofylline Syrup (20mg/ml) Resperidone Tablet & Syrup (addl. Ind ) D-trans Fentantyl Transdermal patches Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R Oseltamivir formulation (additional indication) Atazanavir (100/150/200mg) Nicorandil E.R Tablet (10mg/20mg) Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet Nadifloxacin Gel 1% Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler Midazolam (as maleate) 7.5mg/15mg tablet Olmesartan (as Medoxomil) 10mg (addl. Strength) Pregabalin Capsule 25/50/100/200mg (addl. Strength) Oxcarbazepine S.R 450mg/900mg (addl. Strength). Ciclesonide rotacaps (200/400mcg) Itopride 150mg capsule (S.R) Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet Ibandronic Acid Tablet (150mg) addl. Strength Zonisamide capsule 25/50mg (addl. Strength) Perflutren liquid microsphere injectable suspension Cyclosporin Eye drops (0.1%) (addl. Strength) Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). Icodextrin 7.5% peritoneal dialysis solution

For HIV-1 infection Anti-epileptic For ADHD For OA & RA Ophthalmological diagnostic agent Anti-biotic For leg ulcer, diabetic ulcer etc. Anti-AIDS Chronic congestive heart failure

For reduction of unwanted facial hair in w

For chronic pulmonary infection cystic fib As approved earlier. For hypercholesterolaemia For bronchial asthma & COPD. For pain For GERD

For constipation & hepatic encepthalopa

Acute mania & mixed episode in bipolar

For Prophylaxis of influenzae in adult an years of age Anti-HIV in adults. Angina Pectoris For hypertension Acne vulgaris For Asthma & COPD For insomnia Anti-hypertensive Same as approved. Anti-epileptic For Asthma For GERD For hypertension For production cough Same as approved. Same as approved. For diagnostic use For Ophthalmic use For Ophthalmic use For hypertension For dermatoses For deep vein thrombosis For peritoneal dialysis

61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98

Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) Olopatadine Ophthalmic solution( 0.1%) Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. Methyl Prednisolone Aceponate Cream (0.1%) Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) Levofloxacin 0.5% Ear drops Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) Buclizine HCl tablet (25mg) & Syrup 6mg/5ml Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength) Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. Solifenacin Succinate Tablet (5mg/10mg). Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). Deferasirox dispersible tablet 125/250/500mg. Lamivudine 40mg + Stavudine 10mg dispersible tablet. Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup Cefixime 200mg + Pot. Clavulanate (125mg) tablet ISMN SR 30mg + Aspirin75/150mg tablet (addl. Strength). Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment. Sodium Hyaluronate Injection (1%). Forskolin Eye drop (1%). Baclofen E.R capsule (30mg) Amisulpiride Tablet (50/100/200mg) Quetiapine S.R tablet 200/300mg. Lumiracoxib Tablet (100/200/400mg). Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet

Anti-epileptic Anti-biotic Anti-HIV For allergic conjunctivitis For iron deficiency anemia For atopic dermatitis

As loading dose for prevention of in-sten PCI For otitis media Anti-hypertensive As appetite stimulant Anti-biotic For reduction of IOP

Irritable bowel syndrome For overactive bladder with urge urinary urgency & urinary frequency For insomnia

For chronic iron overload due to blood tr For HIV infection For productive cough Anti-biotic Same as approved For plaque psoriasis For OA For open angle glaucoma For spasticity For schizophrenic disorder For psychotic disorder

Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. For vitamin C deficiency

For OA, RA acute pain & primary dysme For HIV-1 infection

Oxandrolone Tablet (2.5/10mg) To promote weight gain Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup Mucolytic Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg tablet Anti Diabetic L- Lysine Hcl Ointment (150mg/gm) Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet ISMN SR 60mg + Metoprolol Succinate ER 25/50mg Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet For wounds of various etiology

For SAR, PAR & Chronic idiopathic urtic For RA, OA & ankolysing spondylosis

For Panic disorder with or without agora

For angina & Hypertension For prevention of acute coronary syndro with CAD prophylaxis against stroke

99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125

Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg each) Pravastatin 40mg tablet (Additional strength) Olanzapine powder For oral suspensian (10mg/5ml) Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj. Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream Premetrexed(Disodium) powder For solution For Inj. 500mg/vial Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet Tiropramide Hcl (100mg) tablet Eperisone Hcl (50mg ) tablet Caroverine cap. 20mg & Inj. 40mg/2ml Paclitaxel nanoparticle Inj. (20mg/ml) Amoxycillin 250mg + Dicloxacillin 250mg cap. Rifaximine 200mg tab. Tigecycline powder For Inj. 50mg/vial Stavudine SR 100mg tablet Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet

For P. Falciparam malaria As Approved For schizophrenia in adults Antibiotic Anti HIV For mixed infection of skin Anti Cancer

Ant- diabetic For abdominal spasmodic pain, colics of track, abdominal colics For neck-shoulder orm syndrome scapu arthritis and low back pain For abdominal pain & tinnitus in adult For metastatic breast cancer Anti biotic

For infections diarrhea in adults For skin & skin structure infection & intra infection Anti HIV Antibiotic

Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler Anti asthratic Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps Anti asthmatic Abacavir Sulphate syrup 20mg/ml S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet Cefadroxil 500mg + Clavulanic acid 125mg tablet Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup Human Insulin (r-DNA) Powder inhaler Fulvestrant Inj. 250mg/5ml prefilled syringe S(-) Pantoprazole (as Sodium) Inj. 20mg/vial For HIV Infection FOR GERD Antibiotic Antibiotic Antibiotic For type-I & Type-2 Diabetes Anti Cancer

For peptic ulcer, GERD & Zollinger Ellis

126 127 128 129 130 131 132 133

Dasatinib tablet 20mg/50mg/70mg tablet Telbivudine 600mg tablet Aprepitant cap (80mg/125mg) Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet Gemifloxacin (as msylate) 320mg tablet Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg Paromomycin Inj. 375mg/ml

For the treatment of adults with chronic myeloid or lymphoid blast phase chronic leukemai (CML) For chronic hepatitis B infection For essential hypertension Antibiotic Antibiotic Antibiotic For visceral leishmaniasis (Kalaazar)

For chemotherapy induced nausea & vo

134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153

Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab. Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg Epinastine Hcl (0.05%) Opthlamic solution Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication) Feracrylum 1% mouth gargle 10mg/ml Aceclofenac Inj. (150mg/ml) combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack) Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg MDI Amlodipine 25mg + Metoprolol 25mg (additional lower strength) Estrogen vaginal tablet 25mcg Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional strength) Cefixime dispersible tablet 400mg (new dosage Form) Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg Ciclesonide 160mcg/320mcg cap. for inhalation Rabeprazole 20mg (EC) + Itopride SR 150mg Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg Atorvastatin 5mg + Fenofibrate 160mg (additional strength) Aceclofenac Inj. 50mg/ml (additional strength) Amisulpride 400mg tablet (additional strength) Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication Atazanavir 150mg + Ritonavir 50mg capsules Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet Ampicillin 250mg + Dicloxacillin 250mg tablet Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) Gabapentin ER 450/600/900mg tablet Aceclofenac dispersible tablet 100mg (new dosage form)

Antibiotic For anxiety For allergic conjunctivitis For prostatitis As hacmostatic agent in dental surgery

For pain in post operative & post trauma As Approved For Asthma & COPD For atropic viginitis For GERD Antibiotic Antibiotic Anti hypertensive Anti asthmatic For GERD Anti hypertensive As Approved As Approved As Approved

154 155 156 157 158 159 160 161

For cervical ripening, prevention of post haemorrhage & First trimester of aborati mifepristone Anti HIV For IBS Antibiotic For acute Musculoskeletal pain For diarrhea As Approved

For naturopathic pain & partial Seizures

LIST OF DRUGS APPROVED DURING 2005

S.No 267 268 269 Name Of Drug Centbucridine (0.5%) + Feracrylem (3%) Atenolol (25mg, 50mg) + HCTZ (12.5mg) Levocetirizine Syrup (2.5mg/5ml) Pharmacological Classification For hemorrhoid & anal fissure Anti-Hypertensive For allergic rhinitis & urticaria Date of Approval 11-012005 13-012005 13-012005

270 271

Pitavastatin (1mg/2mg) Tablet Ofloxacin (200mg) + Ornidazole (500mg)

Lipid Lowering agent For diarrhea of mixed infection For alteration of intestinal bacterial flora

Bacillus calusii spores suspension (2billion/5ml vial) 272 Lamivudine (40mg) +Nevirapine (70mg 273 +Stavudine (10mg) (in 5ml) powder for suspension 274 275 Diflorasone Diacetate Cream (0.5mg/gm) Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet Fluconazole (2%) + Zinc Pyrethione (1%) suspension Azelaic acid Cream (15%)

14-012005 20-012005 28-012005

Anti-HIV.

28-012005 08-022005 15-022005 22-022005 22-022005 22-022005 23-022005 25-022005 28-022005 02-032005 04-032005 04-032005 09-032005

For corticosteroid responsive dermatoses For Contraceptive in women

276 277 278 279 280 281

For acute painful musculoskeletal condition in adult For primary dysmenorrhoea and pain associated with menorrhagia in women For seborrhoic dermatitis For the treatment of inflammatory papules and pustules of mild to moderate rosacea For non-productive cough in adults

Levodropropizine oral suspension (30mg/5ml) Duloxetine HCl (60mg) tablet (additional strength) Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 1mg/5ml Syrup Levofloxacin Ophthalmic Solution (0.5%) Metformin Oral Solution (100mg/ml) Tirofiban (0.25mg/ml injection)

For productive cough

282

283 284

For susceptible bacterial conjunctivitis For type-II diabetes mellitus For acute coronary syndrome including patients undergoing PTCA or atherectomy For GERD not responding to Omeprazole.

285

(additional strength) Omeprazole (20mg)

10-032005

286

Enteric coated + Domperidone (30mg) (S.R.) capsule Stavudine powder for suspension Erdosteine (150mg/300mg) Capsules For HIV-1 infusion For chronic obstructive bronchitis 11-032005 01-042005 11-032005

287

288 Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream For plaque psoriasis

289

Levetiracetam (250mg,500mg, 290 750mg) Tablets Esomeprazole Sodium For injection 291

As adjunctive therapy in treatment of partial onset seizures in adults with epilepsy. For GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate For perinial allergic rhinitis As sweetener in pharmaceutical preparation For opioid dependence For HIV infection For Hypertension

04-042005 04-042005

292 293 294 295

Rupatadine (10mg) tablet Acesulfame Potassium Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solution S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) R(-) Ondansetron (2mg/4mg) tablet Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate Gliclazide M.R. (30mg/60mg)+

05-042005 05-042005 06-042005 08-042005 15-042005 15-042005 26-042005 27-042005

296

297

298

For chemotherapeutic induced nausea and vomiting For intraocular irrigating during intraocular surgical procedures For type-II diabetes

299

Metformin HCl (500mg) ER Tablet Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) Simvastatin (10/20mg) + Ezetimibe (10mg) Tab Oral Contraceptive For primary Hypercholesterolemia 11-052005 11-052005 11-052005 12-052005 17-052005 18-052005 20-052005

300 301

Ramipril (5mg) + Telmisartan (40mg) tablet 302 303 Intralipid 30% Montelukast Granules (4mg/pack) 304 Bortezomib for injection (3.5mg/vial) Nelfinavir 625mg tablet (addl.strength) 306 Sevelamer (400mg/800mg) tablet 307 308 S(-)Pantoprazole (10mg/20mg) tablet

For Hypertension

For patients with essential fatty acid deficiencies For Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older For the treatment of myeloma patients For HIV patients

305

For control of serum phosphorus in patients with chronic kidney disease and hemodialysis. For gastric ulcer, duodenal ulcer & GERD

20-052005 20-052005

309 310 311 312

Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) R (-) Ondansetron oral Solution (1mg/5ml) Gatifloxacin (200mg) +Ornidazole (500mg) tablet Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg) Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin Emtricitabine (200mg) capsule Eplerenone Tablet (25mg/50mg) Strontium Ranelate Granules (2gm/Sachet) Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet Midazolam Maleate Bulk Calcium Polycarbophil (500mg) Tablet FDC of Papain + Urea Ointment Testosterone Gel 1%.

For Plaque psoriasis For Chemotherapy induced nausea and vomiting For diarrhoea of mixed infection in adults For HIV infection in adults

24-052005 24-052005 06-062005 07-062005 07-062005 08-062005 09-062005 10-062005 14-062005 14-062005 30-062005 05-072005 06-072005 11-072005 12-072005

For HIV infection in adults

313

For pain, swelling etc For HIV infection in adults For hypertension For post-menopausal women with Osteoporosis For pediatric patients with HIV infection For urogenital infection in adults. Anesthetic IBS For debriment of necrotic tissues. For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism For metastatic non-small cell lung cancer. For dry eye syndrome For neuropathic pain Anti-hypertension Addl. Strength Anti-hypertension Anti-bacterial Anti-bacterial For Parkinsons disease

314 315 316 317 318

319 320 321 322

323 Erlotinib Hydrochloride (25mg/100mg/150mg Tablet Chloroquine Phosphate eye drops (0.3mg/ml) Mecobalamine E.R. tablet (1500mcg) Olmesartan Medoxomil (5mg/20mg/40mg) Tablet Ursodeoxycholic Acid (500mg) S.R Tablet FDC of Amlodipine (5mg) + Bisoprolol (2.5mg) FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) Injection Feropenem Sodium (150mg/200mg) Tablet Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet

324 325 326 327 328 329 330 331 332

13-072005 13-072005 19-072005 21-072005 20-072005 21-072005 21-072005 21-072005 25-072005

Saquinavir (as mesylate) 500mg Tablet 333 Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg). FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet Phenytoin Sodium (300mg) tablet FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) Tablet Tenofovir Disoproxil Fumarate Tablet (300mg) Sucralfate (7%) + Povidone Iodine (5%) Ointment Bivalirudin Injection (250mg/vial) Efavirenz Oral Solution (30mg/ml) Didanosine Powder for oral solution (2gm/4gm per bottles) Sodium Valproate (750mg/1000mg) C.R. Tablet Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet Acitretin Dried IVY Leaf Extract (0.7gm/100ml) Nimesulide 1% + Methyl Salicylate 5%. Feracrylum (1%) + Metronidazole 1%) FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet Ketorolac Tromethamine 0.4% Eye drops (addl. Strength) Levetiracetam Oral Solution (100mg/ml) Zinc (Gluconate) oral solution (20mg/5ml) Trimebutine Maleate Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength) Oseltamivir (as phosphate) Capsule (75mg) & oral suspension (12mg/ml)

Addl. Strength. For Parkinsons disease For Hypercholesterolemia Anti-histaminic & mucolytic For neuropathic pain in adults. Addl. Strength For psoriasis vulgaris. Anti-diabetic Anti-HIV Anti-infective Anti-coagulant in PTCA Anti-AIDS Anti-AIDS Addl. Strength Anti-epileptic For sever psoriasis in adults. Cough Syrup Aerosol For local application in acute pain. Antiseptic gel. For hyper-homocysteinemia Ophthalmic Anti-epileptic For acute diarrhoea For irritable bowel syndrome For Hypertension For influenzae

25-072005 25-072005 26-072005 29-072005 05-082005 05-082005 12-082005 12-082005 17-082005 18-082005 25-082005 25-082005 26-082005 26-082005 08-092005 09-092005 15-092005 16-092005 16-092005 16-092005 20-092005 22-092005 05-102005 10-102005 17-102005 25-102005

334 335 336 337 338 339

340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358

358 359 360 361

Cetirizine HCl drops (10mg/ml) Lanthanum Carbonate Chewable tablet (250mg/500mg) Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. Sodium Hyaluronate 0.1% eye drops (addl. Strength) FDC of S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet. Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet Voglibose (0.2mg/0.3mg) Tablet Lactitol Sachet (10gm/20gm). Aspirin Bolus (Vet.) 6gm/bolus) Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops Pregabalin capsule (75/150/300mg) Methotrexate Topical gel (1%) Addl. Strength Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml. Testosterone Spray (25mg) Omeprazole Powder for suspension (20mg/Sachet) Doxazosin (as Mesylate) 4mg/8mg E.R. Tablet Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) FDC of Olmesartan Medoxomil (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) Phenylephrine 2.5% Eye drops Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml). Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg Travoprost Eye drops (40mcg/ml)

Anti-histaminic For the treatment of hyperphosphatemia. For relief of productive cough. Ophthalmic use. For essential hypertension

08-112005 09-112005 10-112005 10-112005 11-112005

362

363 364 365 366 367 368 369

For HIV infection Anti-diabetic For the treatment of constipation. For Veterinary use. For dyspepsia, colicy pain & GERD. For Ophthalmic use. For neuropathic pain. Psoriasis. Ophthalmic

11-112005 17-112005 21-112005 21-112005 22-112005 24-112005 25-112005 25-112005 25-112005 29-112005 30-112005 30-112005 30-112005 02-122005 02-122005 05-122005 07-122005 08-122005 08-122005 08-122005

370

371 372 373 374 375 376

For replacement therapy in males with testosterone deficiency. Anti-ulcer For hypertension For hypertension For essential hypertension Ophthalmic For chronic Hepatitis-B infection. Ophthalmic For spasmodic pain For hypertension For glaucoma & ocular hypertension.

377 378 379 380 381 382

383

384 385 386 387 388

Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for injection. Atomoxetine (as HCl) Sachet (10/18/25/40mg) Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength). Zonisamide (100mg) capsule Methimazole Tablet ( 5mg/10mg) Caspofungin Acetate injection (50mg/70mg per vial).

For LRTI

08-122005

For ADHD Ophthalmic Anti-epileptic For hyperthyroidism. For invasive candidiasis fungal infection.

15-122005 16-122005 21-122005 22-122005 23-122005

LIST OF DRUGS DURING 2004

S.NOName Of DrugPharmacological ClassificationDate of Approval 188 Dutasteride For BPH 16-02-2004 189 Gefitinib Anti-cancer 17-02-2004 190 Imidapril Anti-hypertensive 23-02-2004 191 Adefovir Dipivoxil Anti-Viral (Hepatitis-B) 04-03-2004 192 Etoricoxib

NSAID 05-03-2004 193 Diacerein For Osteoarthritis 12-03-2004 194 Nitazoxanide Anti-Diarrhoeal 17-03-2004 195 Trolamine Cream (0.67%) For Topical use 20-03-2004 196 Neotame Sweetening Agent 22-04-2004 197 Oxybutynine E.R. tablets For Neurogenic bladder disorder 05-05-2004 198 Cabergoline 1 mg/2 mg/4 mg tablets For Parkinsons disease 07-05-2004 199

Rabeprazole Sodium Injection 20 For organ rejection 21-05-2004 205 Cefdinir Dispersible tablet (125mg) Anti-biotic 27-05-2004 206 Linezolid (600 mg) Tablet For Osteomyelitis in adults 30-05-2004 207 FDC of Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye drops For post-operative inflammatory and bacterial infection of eyes. 15-06-2004 208 Cefprozil Dispersible Tablet (125 mg/ 250 mg) Anti-biotic 22-06-2004 209 Divalproex Sodium E.R. Tablets (750mg/1000 mg) Anti-Epileptic 24-06-2004 210 Lithium Carbonate ER (450mg) tablet Anti-Depression 28-06-2004

211 Nimesulide Injection 75mg/ml. For short-term treatment of post-operative pain. 28-06-2004 212 FDC of Esomeprazole 20 mg/40 mg + Domperidone 30 mg SR Capsule For GERD 29-06-2004. 213 Aceclofenac (100 mg) + Paracetamol(500 mg) For acute painful condition in adults 29-06-2004 214. FDC of Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 400 mg tablets Anti-AIDS 15-07-2004 215. Levosalbutamol Tablet 1 mg/2mg & Syrup 1 mg/5 ml. For Obstructive airway disease 16-07-2004 216. Memantine HCl tablet 5 mg/10 mg. For dementia of Alzheimers type 19-07-2004 217. Pimcrolimus 10 mg/gm cream For atopic dermatitis

23-07-2004 218. FDC of Rabeprazole (20 mg) + Mosapride S.R. (15 mg) Tablet For GERD 27-07-2004 219. Rebamipide 100 mg tablet For gastric ulcer 28-07-2004 220. Cefetamet Pivoxil Suspension 250 mg/5ml Anti-biotic 09-08-2004 221. Diclofenac Transdermal patch 100 mg/50 Cm2 For Osteoarthritis & soft tissue injury 10-08-2004 222 . Fluconazole Gel (0.5%) Anti-fungal 12-08-2004 223. FDC of Atorvastatin (10 mg/20 mg) + Ezetimibe (10 mg) Table For Hypercholesterolemia 13-08-2004 224 . Miglitol Tablet 25 mg/50 mg/100 mg

Anti-Diabetic 18-08-2004 225. FDC of Buprenorphin 2 mg + Naloxone (0.5 mg) For Opiod Dependency 19-08-2004 226. FDC of Sucralfate 0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per gram of cream For bedsore, haemorrhoid fistula and anal fussure 19-08-2004 227. Citicholine Tablet 500 mg & Injection 250 mg/ml Membrane permeability enhancer 20-08-2004 228. FDC of Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tablet Anti-diabetic 20-08-2004 229. Lamotrigine S.R. tablet 50 mg/100 mg/200 mg Anti-Epileptic 26-08-2004 230 Moxifloxacin Eye drops (0.5%) For bacterial conjunctivitis 26-08-2004231 Risperidone long-acting suspension for injection 25 mg/37.5 mg/50 mg per vial

For Schizophrenia 26-08-2004232 Escitalopram (10mg) + Clonazepam (0.5mg) For co-morbid depression & anxiety disorder. 27-08-2004234 Everolimus Tablets Immunosuppressant 30-08-2004235 Dorzolamide (20 mg) + Timolol (5 mg) per ml For reduction of elevated IOP. 01-09-2004236 Gemcitabine (1.4 gm/vial) Anti-cancer 01-09-2004237 b -arteether Injection (150 mg/2 ml) Anti-malaria 01-09-2004238 Ziprasidone powder for injection(after reconstitution 20 mg/ml) Anti-psychotic 03-09-2004239 Voriconazole Tablet Anti-fungal 09-09-2004240 FDC of Nebivolol Anti-hypertensive 14-09-2004241 (5 mg) + S(-) Amlodipine (2.5 mg ) tablet (50 mg/200 mg) Infusion (200 mg/vial) Eye drops (0.25 mg/ 0.5 mg/0.75 mg/1.0 mg)

Amlodipine (5 mg) + Ramipril (2.5 mg) tablet Anti-hypertensive 24-09-2004242 FDC of Rabeprazole Sodium (20 mg) + Domperidone(30 mg) S.R Capsule For GERD 04-10-2004243 Cefuroxime Axetil ER tablets Anti-biotic 06-10-2004244 Diclofenac Transdermal Patch (200 mg/75 cm2) For pain relief. 06-10-2004245 Gatifloxacin Eye Ointment (1%) Ophthalmic use 06-10-2004246 Nimesulide Injection (100 mg/ml) Veterinary use 08-10-2004247 Isotretinoin Gel (0.05%) For acne 11-10-2004248 FDC of Epi-Growth Factor (1 gm) + Silversulphadiazine Cream For Burns 19-10-2004249 FDC of Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg) For co-existing hypertension & hyperlipidemia 20-10-2004250 (Veterinary) (500 mg/1000mg)

Levosalbutamol rotacaps (100 mcg/capsule) & inhaler (50 mcg /actuation) For obstructive airway disease. 20-10-2004251 Celecoxib Injection (100 mg/ml) For acute pain 28-10-2004252 Orlistat (120 mg) Capsule Anti-obesity 27-10-2004253 Duloxetine HCl (20,30,40mg) Tablet Anti-depressant 02-11-2004254 Deflazacort (1,6,30mg) tablet Anti-asthma, anti-arthritis. 02-11-2004255 Atomoxetine HCl (10,18, 25 & 40mg ) capsule For ADHD 09-11-2004256 Ursodeoxycholic acid S.R. Capsule (450mg) For dissolution of gall stones 01-12-2004257 Methylphenidate HCl (18, 36, 54 mg) E.R. tablet For ADHD 08-12-2004258 FDC of Lovastatin (20mg) + Nicacin ER (500mg) tablet For Lipid-lowering 20-12-2004259

FDC of Gatifloxacin (400mg) + Ambroxol HCl (75mg) tablet RTI in adults. 21-12-2004260 FDC of Nebivolol HCl (5mg) + Hydrochlorothiazide (12.5mg) tablet Anti-hypertensive 22-12-2004261 FDC of Atorvastatin Calcium (10mg) + Finofibrate (160mg) tablet For hyperlipidemia 22-12-2004262 Calcium Polycarbophil (500mg) tablet For constipation 23-12-2004263 Pantoprazole (40mg) + Domperidone (20mg) ( 10mg IR + 10mg SR) GERD 23-12-2004264 Imiquimod Cream 5% w/w For warts in adults 28-12-2004265 Entacapone (200mg) tablet For Parkinsons disease 30-12-2004

LIST OF DRUGS APPROVED DURING 2003

Sl.No.

Name of Drug Cefprozil Cilostazol Escitalopram Oxalate. Anastrazole Rizatriptan Gadobenate(Dimeglumine IV Injection) Tacrolimus Ointment

Pharmacological Classification Antibiotic For intermittent claudication. Anti depressant Anti cancer Anti migrain MRI Contrast Medium Immuno-modulator

Date of Approval 10-01-2003 23-01-2003 24.01.2003 10.02.2003 27.02.2003 07.03.2003 10-03-2003

149 150 151 152 153 154 155

156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187

Metolazone Tiotropium Bromide Gadoversetamide Injection Torsamide Cyproterone Tablet Aripiprazole Azelaic Acid Bendrofluazide Imipenem +Cilastatin Vinpocetin Tirofiban HCl I.V Teriparatide Cladribine Tadalafil S-Atenolol Rosuvastatin Tazarotene Aceclofenac Ibopamine HCl Trandolapril Dorzolamide Fenoverine Risedronate Sodium Fondaparinax Sodium Metadoxine Valgancyclovir Isopropyl Unoprostone Amorolfine Fluvastatin Sodium Modafinil Sufentanil Citrate Ezetimibe

Diuretic Anti asthematic MRI Contrast Medium Diuretic For Prostatic Cancer Anti schizophrenia Anti-Acne Diuretic Anti-Bacterial Anti-pychotic Anti-Platelet For Osteoporosis Anti-Cancer For Erectile Dysfunction Anti-hypertensive Lipid lowering Agent Anti-Acne NSAID Opthalmic Anti-Hypertensive Opthalmic Anti-spasmodic For Osteoporosis LMWH For Hepatic Disorder For CMV Ophthalmic Anti-Fungal Lipid Lowering Agent For sleeping disorder Anesthetic Agent Lipid Lowering Agent

23.04.2003 16.04.2003 04.06.2003 09.06.2003 10-06-2003 11.06.2003 08-07-2003 24.07.2003 25-07-2003 01.08.2003 12.08.2003 04-09-2003 09-09-2003 11-09-2003 11-09-2003 12-09-2003 12.09.2003 15-09-2003 03-10-2003 03-10-2003 03-10-2003 08-10-2003 17-10-2003 22-10-2003 24-10-2003 20-11-2003 25-11-2003 25-11-2003 25-11-2003 15-12-2003 17-12-2003 18-12-2003

LIST OF DRUGS APPROVED DURING 2001

Sl.No.

Name of Drug Bimatoprost (Ophthalmic Sol.) Meropenem Inj. Fosinopril Sodium Divalproax Sodium Zaleplon Tizanidine SR Thymogen Inj. Montelukast Sodium Methyl Cobalamin Mifepristone Dexarazoxane Injection Tranexamic Acid

Pharmacological Classification Anti-Glaucoma Beta-lactum Antibiotic Antihypertensive Antiepileptic Sedative-Hypnotic Multiple Sclerosis Anticancer Antiasthmatic (Leukotriene Receptor Antagonist) Peripheral Neuropathy Progesterone Antagonist Cardio Protective Agent Antifibrinolytic

Date of Approval 08.01.2002 08.01.2002 10.01.2002 17.01.2002 17.01.2002 06.02.2002 12.02.2002 13.02.2002 13-02.2002 13.02.2002 26.02.2002 06.03.2002

93 94 95 96 97 98 99 100 100A 101 102 103

104 105 106 107 108 109 110 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148

Bicalutamide Loteprednol Etabonate Ophtalmic Sol. Apraclonidine Ophthalmic Sol. Mizolastine Miltefosine Ziprasidone HCl ABACAVIR Nadifloxacin Cream Meloxicam Inj. (Vet) Mesalazine SR Tamsulosin HCl Famciclovir Nateglinide Lercanidine HCl Itopiride Capsules Alprostadil Injection Vimpocetine Quetiapine Fumerate Isotretinoin Soft Gel Cap. Nebivolol HCl Sirolimus Drotrecogin alpha Pygenum Africum Valdecoxib Thalidomide S (-) Amlodipine Besylate Cabergoline Butarphenol Tartarate Gemtuzumab Quinapril Valacyclovir Fosphenytoin Sod. Ceftiofur Sodium & CeftiofurHCl Metaxalone Meglumine gadoteric Cefepine HCl Acamprosate Calcium Aztreonam Tegaserod Maleate Parecoxib Inj. Balsalezide Disodium Cefetemet-piroxil Telmisartan Levocetrizine Poractant a Reboxetine

Anticancer Corticosteroid, ophthalmic anti-inflammatory Alpha 2-adrenoreceptor agonist Antiallergic For Kalazar For Schizophrenia Anti HIV Antibacterial; antiacne NSAID Bowel disease (inflammatory) For BPH Antiviral Antidiabetic Antihypertensive Gastro Prokinetic Agent For Erectile Dysfunction Vasodilator Antipsychotic For Acne vulgaris Antihypertensive Immunosuppressant For severe sepsis For BPH NSAID For Leprosy Anti-hypertensive For hyperprolactemia Opoid Analgesic For Myeloid Leukemia Anti Hypertensive Anti-viral Anti-Epileptic Antibiotic (For Veterinary Use) Muscle Relaxant Contrast media Anti-Biotic For Alcohol dependency Anti-Bacterial For irritable bowel syndrome NSAID For ulcerative colitis Antibacterial Antihypertensive Anti-Histaminic For respiratory distress in preterm babies Anti-depressant

07.03.2002 15.03.2002 15.03.2002 15.03.2002 15.03.2002 18.03.2002 22.03.2002 28.03.2002 02.04.2002 04.04.2002 04.04.2002 11.04.2002 01.05.2002 07.05.2002 09.05.2002 09.05.2002 13.05.2002 31.05.2002 21.06.2002 12.07.2002 15.07.2002 23.07.2002 30.07.2002 01.08.2002 12.08.2002 16.08.2002 05.09.2002 11.09.2002 12.09.2002 19.09.2002 25.09.2002 01.10.2002 08.10.2002 08.10.2002 16.10.2002 30.10.2002 30.10.2002 01.11.2002 01.11.2002 01.11.2002 12.11.2002 14.11.2002 25.11.2002 12.12.2002 24.12.2002 31.12.2002

LIST OF DRUGS APPROVED DURING 2001

Sl.No.

Name of Drug Sildenafil Citrate Triflusal Thymosin Alfa-1 Inj. Vinorelbin Tartrate Inj. Broncho-Vaxom Indinavir Sulphate Butenafine HCl cream Mirtazapine Clopidogrel Mosapride Donepezil HCl Bupropion SR Raloxifene HCl Efavirenz Moxifloxacin Misoprostol Human Recombinant Granulocyte Colony Stimulating Factor Inj. Nelfinavir Mesylate Ciprofloxacin 1g SR Tolterodine-L-Tartrate Ebastine Leflunomide Citalopram Hydrobromide Gatifloxacin Linezolid Genirelix Racecadotril Cefdinir Iobitridol Estemestane Decapeptide Oxcarbazepine Desloratidine Zolendronic Acid Zafirlukast Ropinirole Esomeprazole Mag. Etanercept-Recomb.

Pharmacological Classification Male Erectile Dysfunction Platelet Aggregation Inhibitor Immunomodulator (for chronic Hepatitis-B) Antineoplastic aggregation inhibitor Antiasthamatic, immune boosting drug Antiviral (Anti-HIV) Antifungal Antidepressant Antithrombotic; platelet aggregation inhibitor Prokinetic agent, GERD For Alzheimer's Dementia Smoking cessation adjunct Menopausal osteoporosis Anti-HIV Antibacterial Antiulcer agent Haemopoietic stimulant, antineutropenic Anti-HIV Antibacterial Overactive Bladder Antiallergic Anti-rheumatoid Arthritis Antidepressant Antibacterial Antibacterial Antigonadotropin releasing hormone (fertility drug) Antidiarrhoel Antibacterial Contrast Medium Antineoplastic For Vitiligo Antiepileptic Antiallergic For Hypercalcaemia Antiasthmatic (Leukotriene Receptor Antagonist) Dopamine Agonist (for Parkinson's Disease) Antiulcer Antirheumatic, Tumor Necrosis Factor Receptor

Date of Approval 08.01.2001 17.01.2001 17.01.2001 17.01.2001 Feb, 2001 01.02.2001 14.02.2001 14.02.2001 22.02.2001 12.03.2001 20.03.2001 10.04.2001 04.05.2001 06.06.2001 26.06.2001 21.06.2001 29.06.2001

52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68

69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89

02.07.2001 Aug, 2001 13.09.2001 28.09.2001 01.10.2001 03.10.2001 03.10.2001 04.10.2001 08.10.2001 10.10.2001 10.10.2001 17.10.2001 18.10.2001 22.10.2001 30.10.2001 30.10.2001 05.11.2001 03.12.2001 03.12.2001 04.12.2001 07.12.2001

90 91 92

Imatinib Mesylate Valsartan Rabeprazole

Anticancer Antihypertensive Antiulcer; Proton pump inhibitor

09.12.2001 10.12.2001 27.12.2001

LIST OF DRUGS APPROVED DURING 2000

Sl.No.

Name of Drug Oxiconazole Temozolomide Olanzapine Fluvoxamine Maleate Celecoxib Nevirapine Repaglinide Ganciclovir Trapidil Cerivastatin Rofecoxib Irbesartan Rosiglitazone Maleate Granisetron Rituximab Trastuzumab Rosiglitazone Moclobemide Candesartan Venlafaxine Hdrochloride Paroxetine Hydrochloride Iomeprol Capecitabine Daclizumab Pioglitazone Hydrochloride Didanosine Octy.lonium Bromide Pravastatin

Pharmacological Classification Antifungal Antineoplastic Antipsychotic Antidepressant NSAID Anti HIV Antidiabetic Antiviral Adjunct in angioplasty Lipid lowering agent NSAID Antihypertensive Antidiabetic Antiemetic Antineoplastic Antineoplastic Antidiabetic Antidepressant Antihypertensive Antidepressant Antidepressant Contrast medium Antineoplastic Immunosuppressive agent Antidiabetic AntiHIV Irritable bowel syndrome Lipid lowering agent

Date of Approval 17.01.2000 17.01.2000 27.01.2000 21.02.2000 22.02.2000 06.03.2000 23.03.2000 05.04.2000 11.05.2000 11.05.2000 26.06.2000 26.06.2000 28.06.2000 05.07.2000 10.07.2000 10.07.2000 14.07.2000 28.07.2000 31.08.2000 18.09.2000 04.10.2000 05.10.2000 12.10.2000 12.10.2000 17.10.2000 15.11.2000 12.12.2000 20.12.2000

24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51

LIST OF DRUGS APPROVED DURING 1999

Sl.No.

Name of Drug Glimepiride Mycophenolate Mofetil Meloxicam Tetrabenazine Doxazosin Mesylate

Pharmacological Classification Antidiabetic agent Immunosuppressant NSAID Pre-Synaptic monoamine depleting agent Antihypertensive agent

Date of Approval 22.01.99 07.02.99 16.02.99 10.03.99 11.03.99

1 2 3 4 5

6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

Nafarelin Acetate Milrinone Lactate Inj. Brimonidine Tartrate Nabumetone Zolpidem Basiliximab Inj. Topotecan Hydrochloride Fludarabine Phosphate IV Inj. Zuclopenthixol Acetate Piperacillin - Tazobactam Inj. Topiramate Eptifibatide Atorvastatin Sulpiride Bambuterol Bulaquine Fenofibrate Sibutramine Hydrochloride

Antiendometriotic agent; gonadotropin inhibitor Cardiotonic Alpha2-adrenoreceptor agonist, adjunct in glaucoma NSAID Sedative-Hypnotic Immunosuppressant Antineoplastic Antineoplastic Antimaniac & antischizoprenic Antibiotic Antiepileptic Platlet Aggregation Inhibitor Antihyperlipidemic; HMGCoA reductase inhibitor Antipsychotic Bronchodilator Antimalarial Lipid lowering agent Appetite suppressant

17.03.99 17.05.99 18.05.99 18.05.99 28.05.99 28.05.99 15.06.99 26.06.99 29.07.99 13.08.99 23.08.99 25.08.99 17.09.99 26.10.99 13.12.99 21.12.99 22.12.99 23.12.99