LIST OF APPROVED DRUG FROM 01-01-2012 to Till Date
# Drug Name Indication
1 Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w Ointment For the prevention and treatment of surgical wound infections in adult patients undergoing surgery.
2 Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained released pellets) 8mg/16mg  Capsules. (New Dosage Form) For the treatment of acute inflammation conditions associated with spasm in adults only
3 Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Indication) In the regular treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with frequent symptoms and a history of exacerbations.
4 Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard Gelatin Capsules. (New Dosage Form). For the treatment of Patients with acute musculoskeletal spasm associated with low back pain.
5 Degarelix for Injection 80mg / 120mg per vial For the treatment of adult patients with advanced hormone dependent prostate cancer.
6 Linagliptin film coated Tablet 5mg As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

 Important limitations of use:
1. Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. 2. Has not been studied in combination with insulin.     
7 Eribulin mesylate solution for injection 0.88mg / 2ml vial For the treatment of patients with locally advanced  or metastatic breast cancer who have progressed after at least two chemotherapeutic  regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
8 Plerixafor Injection 20mg/ml In combination with Granulocyte Colony Stimulating Factor (G-CSF) to enhance mobilisation of  hematopoietic stem cells to the peripheral blood for collection and subsequent autologous hematopoeitic stem cells transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma whose cells mobilise poorly.
9 Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension per 10 gm Intramammary Suspension For the treatment of clinical mastitis in lactating dairy cows for bacteria susceptible to the combination of cephalexin and kanamycin such as Staphylococcus aureus, Streptococcus dysgalactiae, Streptococcus uberis and Escheria coli.
10 Mucotrol Concentrated Oral Gel Wafer. For the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including oral mucositis/stomatitis (may be caused by chemotherapy or radiotherapy).
Irritation due to oral surgery and traumatic ulcers caused by braces or ill fitting dentures of diseases and for diffuse apthous ulcers.

11

Ulinastatin for Injection 50000 IU / 100000 IU

For the treatment of severe sepsis.

03.04.12

12 Sterile Solution for Peritoneal Dialysis
;Each 1000 ml contains:  Calcium chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + L- Alanine 0.951 g/l + L- Arginine 1.071 g/l + L- Isoleucine 0.85 g/l + L- Histidine 0.714 g/l + L- Leucine 1.02 g/l + L- Lysine (as Hcl) 0.955 g/l + L-Methionine 0.85 g/l + L- Phenylalanine 0.57 g/l + L-Proline 0.595 g/l + L- Serine 0.51 g/l + L- Threonine 0.646 g/l + L-Tryptophan 0.27 g/l + L-Tyrosine 0.3 g/l + L-Valine 1.393 g/l + Magnesium chloride hexahydrate 0.051 g/l + Sodium chloride 5.38 g/l + Sodium lactate 4.48 g/l
As Nutritional supplements for malnourished renal failure patients (Albumin concentration lower than 35 g/litre) being maintained on peritoneal dialysis. 18.04.12
13 Blonanserin Tablet 2mg/4mg/8mg

For the treatment of Schizophrenia in adult patients when first line treatment is ineffective.

24.04.12
14 Etravirine Tablet 100mg In combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents.
It should be used only in situations where other treatments have failed or cannot be used because of side effects.
26.04.12

15

Ticagrelor Tablet 90mg

For the prevention of thrombiotic events (cardiovascular death, myocardial infarction and stroke) in patients with Acute coronary syndromes (ACS) unstable angina, non ST elevation Myocardial infarction (STEMI) including patients managed medically, and those who are managed with percutaneous those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).

03.05.12

16

Clenbuterol Hydrochloride Solution for injection 30mcg/ml

For the treatment of equine respiratory diseases in horses
where airway obstruction due to bronchospasm and/or accumulation of mucus is contributing factor and improved muco-ciliary clearance is desirable. The product should be used alone or as an adjuvant therapy. The product is of particular value in cases of:
Acute, sub-acute and chronic infections where the presence of mucus and/or micro-organisms may stimulate bronchospam e.g. Bronchitis, broncholitis and Bronchopneumonia
- Acute, sub-acute and chronic respiratory allergies.
 - Chronic obstructive pulmonary disease (COPD)

01.07.2012

17

Apixaban Tablets 2.5mg

Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.

03.08.2012

18

Ethyl esters of iodized fatty acids of poppy seed oil solution for injection 48%.

In Diagnostic Radiology:
Lymphography and 
Diagnosis of liver lesions.
(Diagnosis of the spread of malignant lesions, whether hepatic or not, by selective hepatic arterial injection).

In Interventional Radiology:
Embolization with surgical glues.
(In association with surgical glues during vascular embolizations). 

In Endocrinology:
 Prevention of iodine deficiency disorders.
(This treatment should only be used when other methods of supplementation, particularly iodization of salt and/or drinking water, cannot be undertaken)

22.08.2012

19

Conivaptan Hydrochloride Injection 20mg/4ml.

For the treatment of euvolemic  hyponatremia (e.g. the syndrome of inappropriate secretion of antidiuretic hormone , or in the setting  of hypothyroidism, adrenal insufficiency, pulmonary disorders, etc.) in hospitalized patients.

21.08.2012

20

Colesevelam Hydrochloride Tablets 625mg & Sachets  for oral suspension 3.75gm/1.875gm.

Indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin).
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

29.08.2012

21

Tolvaptan Tablets 15/30mg

For the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirhossis, and syndrome of inappropriate antidiuretic hormone (SIADH).

06.09.2012

22

Agomelatine Tablets 25mg

For the treatment of major depression in adult patients aged 18 – 65 years only with normal liver functions.

10.09.2012

23

Almotriptan Tablet 6.25mg/12.5mg

For acute treatment of migraine attacks with a history of migraine with or without aura in adults.

05.10.12

24

Choline Fenofibrate DR Capsule 45mg/135mg & DR Tablet 45mg/135mg.

For treatment of mixed lipidemia in combination with statins, severe hypertriglyceridemia.

01.11.12

25

Trimethoxysilyl Quaternary Ammonium Chloride solution for spray inanimate surfaces for disinfection 0.71%.

Surface protectant and disinfectant for persistent disinfection of all inanimate surfaces. Effective upto 14 days.

16.11.12



# Name Of Drug Indication Date of issue
1

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

For the treatment of diabetic neuropathy

03.01.11

2

Ropinirole ER Tablet 1 mg.                  (Additional Strength)

Same as approved

04.01.11

3

Erlotinib HCl Tablet 150 mg                  (Additional Indication)

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.

04.01.11

4

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

For the reduction of post operative inflammatory conditions of the eye

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

For the treatment of patients with acute painful musculoskeletal conditions

05.01.11

7

Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler

For the treatment of bronchial asthma where use of inhaled corticosteroid therapy found appropriate

05.01.11

8

Amlodipine Besilate IP Eq. to Amlodipine 5mg  + Indapamide USP SR 1.5mg Tablet

For the treatment of mild to moderate hypertension

05.01.11

9

Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet

For the treatment of patients with diabetic polyneuropathy

05.01.11

10

Spironolactone IP 25mg  + Furosemide IP 40mg Tablet

Additional strength

05.01.11

11

Bicalutamide Tablet 150 mg.(Additional Strength and Indication)

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

05.01.11

12

Paracetamol Chewable Tablet 500 mg.                               ( Additional Dosage Form)

Same as approved

05.01.11

13

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

15

For Vitamins and Minerals deficiency states in adult patients

11.01.11

14

Dextromethorphan  Extended Release Oral  Suspension 30 mg per 5 ml

For the Relief of Persistent Dry irritating cough in adult patients Only.

17.01.11

15

Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel

For treatment of hyper pigmentry disorders

31.01.11

16

Paracetamol Fast Release Tablet 500mg             (Additional Dosage Form)

Same as approved

10.02.11

17

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

For bowel cleansing prior to colonoscopy in adult patients only

11.02.11

18

Ferric Carboxymaltose equivalent to elemental Iron…50mg/ml Injection

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.

11.02.11

20

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

For the treatment of patients with chronic cholestatic liver disease.

11.02.11

21

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

For the acute treatment of adults with schizophrenia.

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

(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.

17.02.11

23

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

Same as approved

17.02.11

24

Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength)

Same as approved

21.02.11

25

Gatifloxacin Eye drop 5 mg/ml

For the treatment of bacterial conjunctivitis caused by susceptible strains

21.02.11

26

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

Advanced squmous cell carcinoma of Head and Neck SCCHN:
1. Diagnosed but unrectable locally                advanced SCCHN
2. Recurrent SCCHN, if surgery or radiation is not feasible.
3. Palliative treatment of metastatic SCCHN.

24.02.11

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)

For the Relief of Musculoskeletal pain and Inflammation.

09.03.11

29

Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection

For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only

15.03.11

30

Dasatinib 20mg/50mg/70mg  (Additional Indication)

Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase.

16.03.11

31

Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet

For the treatment of iron deficiency anaemia in adults only

21.03.11

32

Tioconazole Vaginal Gel 65mg per gm

For the local treatment of vulvo vaginal candidiasis in adult patients.

22.03.11

33

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

For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease.

30.03.11

34

Ilaprazole Tablets 5mg/10mg

For the treatment of duodenal ulcer in adults only.

05.04.11

35

Asenapine Maleate Sublingual Tablets 5mg/10mg

For acute treatment of schizophrenia in adults only.

07.04.11

36

Cefpodoxime IP 100mg/100mg/200mg/200mg +Ofloxacin IP 100mg/200mg/100mg/200mg Tablets

For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only

16.04.11

37

Tapentadol Hydrochloride Tablets 50mg/75mg/100mg

For relief of moderate to severe acute pain in adults 18 years of age or older.

18.04.11

38

Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet
(Additional dosage form )

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

19.05.11

42

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

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.

19.05.11

43

Brinzolamide Ophthalmic Suspension 1%w/v

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

26.05.11

44

Besifloxacin Ophthalmic Suspension 0.6% w/v

For the treatment of bacterial conjunctivitis.

31.05.11

45

Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule
(Additional Strength)

Same as approved

31.05.11

46

Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets
(Additional Strength)

Same as approved

31.05.11

47

1.  PROBIO :
Each sachet (1g) contains:
Total Probiotic.... Not less than  1.25 Billion CFU (Lactobacillus acidophilus,  Lactobacillus rhamnosus, Bifidobacterium longum,  Saccharomyces boulardii)
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 

For the treatment of rotavirus diarrhoea.

09.06.11

48

Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets

Additional indication. (For Symptomatic Treatment of Moderate To Severe Pain.)

21.06.11

49

Silodosin Capsules2mg/4mg/8mg

For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only.

23.06.11

50

Tiapride Hydrochloride Tablets 25mg/50mg/100mg

For the treatment of agitation and aggressiveness in adult patients with cognitive impairment.

23.06.11

51

Fexofenadine 120mg + Montelukast 10mg Chewable tablet

Additional dosage form

07.07.11

52

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

As contraceptive pill for women

27.07.11

53

Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets

For the treatment of lower respiratory tract infections in adults only

08.08.11

54

Alpha Lipoic acid 100mg + Folic acid  1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets

For the treatment of Diabetic neuropathy

10.08.11

55

Levosulpride (SR)  75mg + Rabeprazole sodium IP  (EC Pellets) 20mg Capsule

For the treatment of Gastro-oesophageal Reflux Disease (GERD)

19.08.11

56

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

For the treatment of HIV infection in adults.

23.08.11

57

Diclofenac sodium  (SR) 100mg  + Eperisone Hydrochloride (SR) 150mg Capsules

For the treatment of patient with acute musculoskeletal spasm associated with low back pain.

24.08.11

58

Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets

Additional Strength

24.08.11

59

Eletriptan Hydrobromide Tablets 20mg/40mg

For the treatments of Migraine with or without aura in adults

   25.08.11

60

Acyclovir 50g + Hydrocortisone 10mg Cream

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

30.08.11

61

Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w  topical gel

For topical treatment of inflammatory acne vulgaris (Additional lower strength)

30.08.11

62

Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops

For temporary relief of burning and irritation due to dryness of the eye

13.09.11

63

Glutathione for Injection 600mg

For the treatment of alcoholic liver diseases like alcoholic fatty liver, alcoholic liver fibrosis, alcoholic liver cirrhosis, and hepatitis

14.09.11

64

Udenafil Tablet 100mg/200mg

For the treatment of erectile dysfunction

15.09.11

65

Metformin  (ER )1000mg/500mg +Saxagliptin 2.5 mg/5mg Tablets

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

19.09.11

66

Ceftriaxone Sodium eq.  to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/1000mg.injection

Additional Indication - For the treatment of urinary tract infections and lower respiratory tract infections, various bacteria

21.09.11

67

Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops

For steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists

22.09.11

68

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

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

22.09.11

69

Acrivastine Capsules 8mg

For the symptomatic relief of allergic rhinitis.

26.09.11

70

Tacalcitol ointment 4mcg

For the treatment of psoriasis vulgaris in adults only.

26.09.11

71

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

For the treatment of Osteoporosis in post menopausal women

30.09.11

72

Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets

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-hydropyridine calcium channel blocker) alone. C) As replacement therapy in patients already receiving Aliskiren and Amlodipine from separate tablets at the same dose level.

   12.10.11

73.

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)

 

For the treatment of Iron deficiency anaemia

19.10.11

74.

Arterolane Maleate
150mg + Piperaquine Phosphate 750mg Tablet

Treatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults.

19.10.11

75.

Tafluprost Eye Drops
0.0015% w/v

For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.

21.10.11

76.

Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg  + Difluprednate 0.5mg +  Benzalkonium Chloride IP (As preservative) 0.01% w/v Eye Drops

For the treatment in the patients with inflammatory occular conditions where bacterial infection or a risk of bacterial occular infection exists

24.10.11

77.

Diazinon Flea Drops
Spot on Dogs 30.0% w/w

For dogs infected with fleas.

11.11.11

78.

Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release pellets) 16mg Capsule. (New Dosage Form)

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

15.11.11

79.

Epalrestat 50mg + Methylcobalamin 500mcg Tablets

For the treatment of Diabetic Neuropathy

16.11.11

80.

Cabazitaxel Injection
60mg / 1.5ml

In combination with prednisone for treatment of patients with hormone-refractory metastatic prostrate cancer previously treated with a docetaxel-containing treatment regimen.

16.11.11

81.

Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solution

For the treatment of seasonal allergic conjunctivitis in adults only

21.11.11

82.

Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP  (As Sustained Release Layer) 75mg Tablets

For the symptomatic treatment of moderate to severe pain in adult patients

21.11.11

83.

Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength)

For the treatment of asthma where the use of corticosteroid and long acting beta agonist in combination is appropriate

21.11.11

84.

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 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.

28.11.11

86.

Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. (Additional Strength)

For the treatment of patients with primary hypercholesterolemia.

05.12.11

87.

Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets

For the treatment of Patients with acute muscle/musculoskeletal spasm in adult

07.12.11

88.

Paracetamol IP 325mg + Pamabrom USP 25mg Tablets

For the treatment of patient with pre-menstrual syndrome in adults only

07.12.11

90.

Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets

For the treatment of neuropathic pain.

08.12.11

91.

Trifluridine Eye Drops 1% w/v

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 Capsules 75mg/110mg/150mg

For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation.

12.12.11

93.

Montelukast Sodium IP eq.to Montelukast 10mg +Olopatadine Hcl 5mg Tablets

For the treatment of relief of symptoms of allergic rhinitis

16.12.11

94.

Fosaprepitant (as Dimeglumine) for Injection 150mg.

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.

16.12.11

95.

Abiraterone Acetate Tablets 250mg

In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel.

16.12.11

96.

Crizotinib  hard gelatin Capsules 200mg/250mg

For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) – positive as detected by an FDA-approved test.

16.12.11

97.

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

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

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