Complete list of CDSCO approved drugs in India

Fedley Healthcare

26 Aug 2025 · 41 min read

Central Drugs Standard Control Organization (CDSCO), Government of India has a mandate for approval of drugs to be manufactured and imported for sale in India. The drugs approved by CDSCO can only be further licensed by State Licensing Authorities to various manufacturers in India. CDSCO often publishes the list of approved drugs/ new drugs on its website but the updation of the drugs are year wise and department wise. Also, there are numerous lists which a manufacturer has to go through to find the status of the drug which he intends to manufacture. There is no single list available mentioning the complete list of CDSCO approved drugs in India.

Looking at this scenario, we at fedleyhealthcare has taken this onus onto ourselves to compile and organize the list of approximately 5000 products. We are hereby publishing the complete list of new drugs at one place in an easy searchable format. We are committed to update this list as and when the list of new approved drugs are issued by CDSCO. This initiative has been taken after successful and widely applauded list of ban drugs and list of solubility of Active Pharmaceutical Ingredients has been published on our website.

About fedleyhealthcare : fedleyhealthcare is a one-stop destination for all pharma regulatory services. In a short span of time, we have created a niche for ourselves as regulatory consultants having expertise in a wide array of regulatory activities. Our services include but are not limited to new drug approval , medical device registration and licensure, FDC approval, Cosmetics Licensure , GMP Layouts preparation, Auditing, Training, etc. With a 100% success record, fedleyhealthcare boasts of a team, who not only help you with the filing process but performs the complete technical and administrative review of the data submitted to us. This helps to reduce the concerns raised by the regulators and helps to expedite the approval process. The transparent and supportive approach have helped us won accolades among our clients.

Sr.No Drug Name Strength Indication Date of

151

Atorvastatin calcium tablet 30/60 mg(Add. Strength)

Each film coated tablet contains :Atorvastatin calcium equivalent to Atorvastatin 30/60 mg

1. As an Adjunct to Diet to Reduce Elevated Total Cholesterol and Triglyceride Levels in Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia (Type IIa and IIIb).2. In adult patients with type II diabetes and without clinically evident coronary heart disease to reduce the risk of myocardial infarction and stroke.3. To reduce the risk of stroke in adult patients without clinically evident coronaryheart disease but multiple risk factors for coronary heart diseaseWith the condition:-To be sold by retail on the prescription of Cardiologist only.

27.09.2019

152

Desloratadine tablets 10mg(Additional strength)

Each film coated tablet contains :Desloratadine 10mg

For the treatment of Chronic Idiopathic Urticaria in patients who have not responded to the standard 5mg dose of Desloratadine.

27.09.2019

153

Diclofenac sodium Rectal Solution 25 % w/v with applicator(Add. dosage form)

Each ml contains:Diclofenac sodium 25%w/v Each Squirt (0.2ml) delivers: Diclofenac Sodium 50 mg

Mild to moderate pain in adults.

27.09.2019

154

Perampanel tablets 2mg /4mg/6mg/8mg/10mg/12mg(Additional indication)

Each film coated tablet contains :Perampanel 2mg /4mg/6mg/8mg/10mg/12mg

For the adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.With the condition:-To be sold by retail on the prescription of Neurologist only.

27.09.2019

155

Each spray Delivers:Mometasone Furoate BP............50mcgAzelastine Hydrochloride BP......140mcgBezalkonium Chloride BP...........0.02%w/w (preservative)

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

30.09.2019

156

Ribociclib Film Coated Tablet 200mg(Additional Indication)

Ribociclib Succinate 254.40 mg equivalent to Ribociclib 200 mg

Indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulestrant as initial endocrine based therapy or in women who have received prior endocrine therapy.Warning: To be sold by retail on the prescription of oncologist only.

04.10.2019

157

Cinidipine Tablet 20 mg(Additional Strength)

Each Film Coated Tablets contain Clinidipine 20mg

For the treatment of mild to moderate hypertension

11.10.2019

158

Each Film coated tablet Contains:Ebastine..............10mgMontelukast........10mg

For the treatment of allergic rhinitis in adults only

14.10.2019

159

Acalabrutinib 100mg capsules

For the treatment of patients with mantle cell lymphoma (MCL) who have received atleast one prior therapy

18.10.2019

160

Each uncoated bilayered tablets contains:Pregabalin IP (As prolonged Release).....75mgEtoricoxib IP....................60mg

In the treatment of chronic low back pain associated with neuropathic component.

18.10.2019

161

Each film coated bilayered tablet contains:Evogliptin Tartrate 6.869mg Eq. To Evogliptin.....................5mgMetformin Hydrochloride IP (as sustained release form)..................1000mg

As an adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus who are appropriate for co administration of evogliptin and Metformin. Patients with inadequate glycemic control on Metformin monotherapy alternative for combination therapy of evogliptin and metformin.

13.11.2019

162

Glycopyrronium Solution Inhalation Solution 25mcg (For nebulisation)(Add. Dosage form)

Each 2ml contains Glycopyrrolate equivalent to Glycopyrronium 25mcg in isotonic solution

For the long term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema

14.11.2019

163

Abemaciclib 50mg, 100mg, 150mg and 200mg film coated tablets

(i) Abemaciclib is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.• In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone- releasing hormone (LHRH) agonist.(ii) As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting .

18.11.2019

164

Formoterol Fumarate dihydrate IP.......5µgGlycopyrronium USP .........................7.2µg per acutation Inhalation Aerosol Preparation(In additional strength)

Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

20.11.2019

165

Ripasudil hydrochloride hydrate bulk drug and Ripasudil Eye drops 0.4% w/v

To treat glaucoma and ocular hypertension when other medicines for glaucoma have insufficient effect or cannot be used.

20.11.2019

166

Diperoxochloric acid concentrate and Diperoxochloric acid topical solution

Indicated for wound healing in diabetic neuropathic ulcers of skin and subcutaneous tissues reduction

20.11.2019

167

Cefpodoxim Proxetil Sustained Release Tablet 200/400mg(Add. Dosage form)

Each film coated sustained release Tablet contains: Cefpodoxime Proxetil, Equivalent to Cefpodoxime 200mg & 400mg

Acute bronchitis, exacerbations of chronic bronchitis, pneumonia, sinusitis, recurrent chronic tonsillitis, pharyngitis and acute otitis.

03.12.2019

168

Ivermectin Topical lotion 0.5% w/w

Each ml contains:Ivermectin 0.5% w/w

For the topical treatment of head lice infestation in patients 6months of age and older.

03.12.2019

169

Lenvatinib Capsules 4mg and 10mg(Additional Indication)

Each capsule contains Lenvatinib mesylate 4.90 mg equivalent to Lenvatinib 4mg and Lenvatinib mesylate 12.25mg equivalent to Lenvatinib 10 mg.

In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.Warning: To be sold by prescription of a “Oncologist” only.

04.12.2019

170

Bilastine Oral Solution 2.500 mg/ml(Add. Dosage form)

Each ml contains:Bilastine 2.5000 mg

Symptomatic treatment of allergic rhino- conjunctivitis (seasonal and perennial) and urticaria. Bilastine is indicated in children aged 6 to 11 years with a body weight of at least 20 kg.

10.12.2019

171

Endoxifen citrate bulk and Endoxifen tablets 8 mg

For the acute treatment of manic episodes with or without mixed features of Bipolar I disorder

10.12.2019

172

Azelnidipine bulk and Azelnidipine tablets 16 mg

For the treatment of Stage II Hypertension

10.12.2019

173

Genopep bulk and Genopep 0.05% w/w cream

Indicated for treatment of burn wound, antimicrobial therapy, scar prevention/reduction

11.12.2019

174

Pregabalin Extended Release Tablets 82.50 mg and 165mg

Each film coated Extended Release Tablet contains:Pregabalin 82.50 mg/165 mg

For treatment of peripheral neuropathic pain in adults.

12.12.2019

175

Each uncoated tablet contains:Repaglinide IP + Voglibose IP(0.5mg + 0.2mg, 0.5mg + 0.3mg, 1mg + 0.2mg & 1mg + 0.3mg)

For the treatment of Type 2 Diabetes Mellitus as an adjunct to diet and exercise to improve glycemic control.

13.12.2019

176

Alalevonadifloxacin mesylate bulk and Levonadifloxcin tablets 500mg

Indicated in adults (≥ 18 years of age) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) including diabetic foot infections and concurrent bacteraemia caused by susceptible isolates of the following: Gram-positive organisms:- Staphylococcus aureus (methicillin-resistant, methicillin-susceptible, quinolone-resistant, quinolone-susceptible isolates), Streptococcus pyogenes, Enterococcus faecalis, Streptococcus dysgalactiae ssp. dysgalactiae, Streptococcus agalactiae.

13.12.2019

177

Clobetasol Propionate Topical Foam 0.5% w/w(Add.dosage form)

Each gram of cream Contains:Clobetasol Propionate 0.05% w/wPhenoxyethanol 1.0% w/w

Treatment of Inflammatory and pruritic manifestation of corticosteroid responsive dermatoses in patients 12 years of age or older.

16.12.2019

178

Clobetasol Propionate Cream, 0.025% w/w(Add.Strength)

Each gram of cream contains:Clobetasol Propionate 0.25mg

Indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older.

16.12.2019

179

Midodrine hydrochloride bulk drug

26.12.2019

180

Lorlatinib film coated tablets 25mg and 100 mg

For the treatment of ALK fusion gene-positive unresectable advanced and/or recurrent non-small cell lung cancer with resistane or intolerance to ALK tyrosine kinase inhibitor(s)

26.12.2019

181

Levonadifloxacin L-arginine tetrahydrate bulk and Levonadifloxacin injection 800mg/100ml

30.12.2019

182

Betahistine Dihydrochloride Orally Disintegrating Strips 16mg /24 mg(New Dosage form)

Each Orally Disintegrating Strips contains:Betahistine Dihydrochloride …….16mg/24 mg

Indicated in the treatment of Menier’s syndrome, Characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss

02.01.2020

183

Posaconazole Gatro-Resistant Tablet 100 mg(Modified Release dosage form)

Each-Gastro-Resistant Tablet Contains:Posaconazole………..............100mg

For Prophylaxis of invasive Aspregilus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia form chemotherapy. Posaconazole Gastro Resistant tablets are indicated in patients 13 years of age and older Warning: To be sold by retail on the prescription of Specialist only.

03.01.2020

184

Cidofovir dihydrate bulk drug and Cidofovir injection 75 mg/ ml(5 ml single use vial)

Cidofovir is indicated for the treatment of CMV retinitis in adults with acquired immune deficiency syndrome (AIDS) and without renal dysfunction. It should be used only when other medicinal products are considered as unsuitable.

03.01.2020

185

Dacomitinib tablet 15mg, 30mg and 45mg

For the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations.

03.01.2020

186

Alpelisib film coated tablets(50mg, 150mg, 200 mg)

Alpelisib is a kinase inhibitor indicated in combination with Fulvestrant for the treatment of postmenopausal women, and men, with Hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

03.01.2020

187

Pirfenidone tablet 600 mg(Additional strength)

Each Film coated Tablet contains:Pirfenidone….600mg

For the Treatment of idiopathic pulmonary fibrosisWarning: To be sold by retail on the prescription of Pulmonologist only.

01.08.2020

188

Saroglitazar Tablet 2mg/4 mg(Additional indication)

Each uncoated tablet contains:Saroglitazar……… 2/4 mg

Type 2 Diabetes mellitus-as an add-on therapy to metformin

13.01.2020

189

Each uncoated bilayered tablet contains :Glimepiride IP + Voglibose IP + MetforminHCl IP (as ER) (1mg + 0.2mg + 500mg & 2mg + 0.2mg +500mg )

Each uncoated bilayered tablet contains :Glimepiride IP + Voglibose IP + MetforminHCl IP (as ER) (1mg + 0.2mg + 500mg & 2mg + 0.2mg + 500mg )

As 3rd line treatment of type 2 diabetes mellitus when diet, exercise and the single agents and second line therapy with two drugs do not result in adequate glycemic control.

14.01.2020

190

Enzalutamide Soft Capsule 40 mg(Additional indication)

Each soft capsules contains: Enzalutamide…40 mg

In the treatment of adult men with metastic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedWarning: To be sold by retail on the prescription of Oncologist only.

23.01.2020

191

Each Film coated tablet contains :Sildenafil + Dapoxetine (100mg + 60mg, 50mg + 60mg & 50mg + 30mg)

For the treatment of co-existing erectile dysfunction and premature ejaculation in men 18 to 64 years of age.

10.02.2020

192

Each Uncoated Bilayered Tablet Contains:S(-) Amlodipine Besylate IP eq.to S(-) Amlodipine + Telmisartan IP(5mg + 40mg & 2.5mg + 40mg)

It is indicated for the treatment of essential hypertension.

14.02.2020

193

Isavuconazole sulfate 100mg capsules

Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis

14.02.2020

194

Canagliflozin 100 mg and 300 mg Tablet(Additional Indication)

Each film coated tablet contains: Canagliflozin 100mg/300mg

To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

17.02.2020

195

Norethisterone Acetate Controlled Release Tablet 10 mg(Additional Dosage form & Indication)

Each film coated controlled release tablet contains: Norethisterone Acetate 10mg

To arrest bleeding in women with dysfunctional uterine bleeding due to hormonal imbalance.

24.02.2020

196

Each film coated tablet contains:Efonidipine Hydrochloride Ethanolate.......…...............20mgTelmisartan IP…………....40mg

It is indicated for the management of stage II hypertension.

24.02.2020

197

Lidocaine Hydrochloride 2% Solution(Additional Dosage Form)

Each ml contains:Lidocaine Hydrochloride 20mg

Indicated in adults:• For the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx.• For reducing gagging during the taking of X-ray pictures and dental impressions.

25.02.2020

198

Itraconazole Capsule 200 mg(Additonal Strength)

Each capsule contains:Itraconazole 200 mg

For the treatment of onychymycosis of the toenail due to Trichophyton rubrum or T. mentagrophytes in non-immunocompromised patients Warning: To be sold by retail on the prescription of a Specialist only.

03.03.2020

199

Nepafenac Ophthalmic suspension 0.3% w/v(Additional Indication)

Each ml contains:Nepafenac 3mg

Reeducation in the risk of postoperative macular oedema associated with cataract surgery in diabetic patientsWarning: To be sold by retail on the prescription of a Opthamologists only.

03.03.2020

200

Each uncoated bilayered tablet contains:Gliclazide IP (as extended release form)....................60mgMetformin Hydrochloride IP (as extended release form)….............1000mg

Each uncoated bilayered tablet contains:Gliclazide IP(as extended release form)....................60mgMetformin Hydrochloride IP(as extended release form)….............1000mg

For the treatment of noninsulin dependent diabetes (Type-II) in adult patients where single drug therapy, diet and exercise do not result in adequate glycaemic control.

03.03.2020

201

Azelnidipine tablets IP 8 mg

For the treatment of Stage I Hypertension

04.03.2020

202

Bisoprolol Fumarate tablet 1.25 mg(Additional strength)

Each film coated tablet contains:Biosoprolol Fumarate 1.25 mg

For the treatment of congestive heart failure (CHF)

04.03.2020

203

Pirfenidone Tablets 267 & 801 mg(Additional Strength)

Each film coated tablet contains:Pirfenidone 267mg/801 mg

For the treatment of idiopathic pulmonary fibrosisWarning: To be sold by retail on the prescription of a Pulmonologist only.

04.03.2020

204

Pegaspargase Injection 3750 IU/5ml(Additional Indication)

Each 5ml vial contains:Pegaspargase Injection 3750 IU

Injection as first-Line chemotherapeutic agent for treatment of patients with acute Lymphoblastic Leukemia (ALL)Warning: To be sold by retail on the prescription of a Oncologist only.

04.03.2020

205

Norethisterone Acetate Controlled Release Tablet 15 mg(Additional Strength)

Each film coated controlled release tablets contains:Norethisterone Acetate 15 mg

To arrest bleeding in women with Heavy Menstrual Bleeding (HMB)/abnormal Uterine Bleeding (AUB) due to hormonal imbalanceWarning: To be sold by retail on the prescription of a Gynaecologist/Obstertrician only.

09.03.2020

206

Estriol Tablets 1mg/2mg(Additional strength)

Each uncoated Tablet contains:Estriol 1mg/2mg

Estrogen deficiency symptoms due to menopauseWarning: To be sold by retail on the prescription of a Gynaecologist only.

09.03.2020

207

Busulfan Injection 60 mg/10ml(Additional Strength)

Each 10 ml vial contains: Buslfan 60mg

In combination with cyclophosphamide as a conditioning regimen prior to allogenic hematopoietic progenitor cell transplantation for chronic myelogenous leukemiaWarning: To be sold by retail on the prescription of a Oncologist only.

09.03.2020

208

Each film coated bilayered tablet Contains:Montelukast sodium eq. toMontelukast IP…………..10mgBilastine …………… …..20mg

For the treatment of allergic rhinitis in adults.

09.03.2020

209

Riboflavin Ophthalmic Solution 0.1%

It is intended to treat keratoconus and corneal ecstasia following refractive surgery

11.03.2020

210

Pixantrone 29mg powder for concentrate for solution for infusion

Indicated as 3rd line and 4th line therapy for the treatment of adult patients with multiply relapsed or refractory aggresive Non-Hodgkins B-Cell Lymphomas (NHL)

11.03.2020

211

FDC of Bilastine 20mg and Montelukast 10mg tablets

Indicated for the treatment of allergic rhinitis in adults.

11.03.2020

212

Obeticholic acid bulk drug and Obeticholi acid 5mg/10mg tablets

For the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adult with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

11.03.2020

213

Isavuconazole (as Isavuconazonium sulfate) 200mg powder for concentrate for solution for infusion

Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis.

11.03.2020

214

Ulipristal Acetate Tablet 30 mg(Additional strength& indication)

Each film coated tablet contains:Ulipristal acetate 30 mg

Emergency contraception within 120 hrs (5 days) of unprotected sexual intercourse or contraceptive failureWarning: To be sold by retail on the prescription of a Gynaecologist only.

11.03.2020

215

Canagliflozin Tablet 100/300 mg(Additional Indication)

Each film coated tablet contains: Canagliflozin 100/300 mg

To reduce the risk of end-stage kidney disease (ESKD), doubling of serum creathinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria 300mg/day.

11.03.2020

216

Each film coated bilayered tablet contains:Metoprolol Succinate IP eq. toMetoprolol Tartarate IP (as Extended Release ) + Telmisartan IP + Chlorthalidone IP (25mg + 40mg + 12.5mg & 50mg + 40mg + 12.5mg)

For the treatment of essential hypertension with stable coronary artery disease.

17.03.2020

217

Nintedanib Soft Gelatin Capsules 100/150 mg(Additional Indication)

Each soft gelatin capsule contains:Nintedanib Ethanesulfonate equivalent to Nintedanib 100/150 mg

For the treatment of systemic sclerosis associated interstitial Lung Disease (SSc-ILD)Warning: To be sold by retail on the prescription of a Pulmonologist only.

20.03.2020

218

Polymyxin B for injection 500000 IU

Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Ps. Aeruginosa. It may also be used as subconjuctival infection in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. It may be indicated in serious infections caused by susceptibel strains of the following organisms,1. H. influenzae, specifically meningeal infections2. Escherichia coli, specifically urinary tract infections3. Aerobacter aerogenes, specifically bacteremia4. Klebsiella pneumoniae, specifically bacteremia

30.03.2020

219

Each capsule contains:Glycopyrrolate USP eq. to Glycopyrronium.......... 12.5mcgFormoterol FumarateDihydrate IP……....... 12mcgFluticasone Propionate IP……250mcgDry powder for inhalation

It is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

16.04.2020

220

Sucroferric oxyhydroxide bulk and Sucroferric oxyhydroxide chewabale tablet 500mg

Phosphate binder indicated for the control of serum phosphorous levels in patients with chronic kidney disease on dialysis

18.04.2020

221

Sodium Hyaluronate…….0.15% w/vPolyethylne Glycol 400……0.4%w/vPropylene Glycol ………….0.3%w/vLubricant eye drops

For the temporary relief of burning and irritation due to dryness of the eye and for use in lubricating and rewetting of all silicone hydrogel and soft hydrophilic contact lenses.

22.04.2020

222

Each film coated bilayered tablet contains:Azilsartan Kamedoxomil eq toAzilsartan Medoxomil + Cilnidipine(40mg + 5mg & 40mg+ 10mg)

For the treatment of stage II hypertension.

24.04.2020

223

Each film coated tablet contains: Capecitabine IP + Cyclophosphamide IP eq. to anhydrous Cyclophosphamide(400mg + 21.4mg eq. to 20mg & 700mg + 32.1mg eq. to 30mg)

Each film coated tablet contains:Capecitabine IP + Cyclophosphamide IP eq. to anhydrous Cyclophosphamide(400mg + 21.4mg eq. to 20mg & 700mg + 32.1mg eq. to 30mg)

For the treatment of patients with metastatic breast cancer after failure of prior anthracycline and /or taxane chemotherapy.

28.04.2020

224

Hydrogen peroxide 0.5% w/w wipes

Cleans, disinfects and deodorizes hard non-porous inanimate environmental surfaces

29.04.2020

225

Oxaliplatin Injection 50 mg/vial & 100 mg/vial(Additional Dosage Form)

Each Vial contains:Sterile Solution of Oxaliplatin 50mg and 100mg

For the treatment of advanced colorectal cancer.Warning: To be sold by retail on the prescription of an oncologist only.

29.04.2020

226

Tropicamide IP 0.2mg + Phenylephrine Hydrochloride IP 3.1mg + Lidocaine Hydrochloride IP 10mg per ml injection.Intracameral Injection

It is indicated for cataract surgery to obtain mydriasis and intraocular anesthesia during surgical procedure.

04.05.2020

227

Metformin Hydrochloride Prolonged Release Tablets 500mg(Additional Indication)

Each Prolonged Release Tablets contains:Metformin Hydrochloride 500mg

For the treatment of Polycystic Ovary Syndrome (PCOS) with established insulin resistance WARNING: To be sold by retail on the prescription of a RMP only In the package insert - Special warnings and precautions: Pregnancy: “There are no adequate and well-controlled studies in pregnant women with Metformin and Metformin should not be used during pregnancy unless clearly needed”

05.05.2020

228

Olaparib 100 mg and 150 mg Tablets(Additional Indication)

Each Film coated tablet contains:Oloaparib…100mg/150mg.

Olaparib is indicated as monotherapy for the Maintenance treatment of adult patients with germline BRCA-mutated metastatic adenocarcinoma of the pancreas whose disease has not progressed on first-line platinum-based chemotherapy “WARNING: To be sold by retail on the prescription of Oncologist only”

06.05.2020

229

Brotezomib For injection 2.5mg/ml(Additional Pack Size)

Each Vial Contains:Bortezomib 2.5 mg

· For the treatment of patients with multiple myeloma· For the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.WARNING: To be sold by retail on the prescription of Oncologist only” which shall be in red box;

12.05.2020

230

Centhaquine citrate bulk and Centhaquine citrate injection 1.0mg/vial

Add on resuscitative agent for hypovolemic shock

15.05.2020

231

Per 1000ml contains (after mixing)Glucose Monohydrate EP.................1.100gm Magnesium Chloride Hexahydrate EP…............................0.1017gmCalcium Chloride Dihyadrate EP…..............................0.2205gmSodium Hydrogen CarbonateEP..............................….2.940gmSodium ChlorideEP…….................6.136gmSolution for haemodialysis / haemofiltration(multiBic potassium free)

MultiBic Potassium-free is indicated for intravenous use as substitution solution in haemofilteration and haemodiafilteration, and as dialysis solution in haemodailysis and haemodiafiltration.

15.05.2020

232

MultiBic 2 mmol/l potassiumPer 1000ml contains (After mixing)Potassium Chloride……..................0.1491gmSodium Chloride ……….................6.136gmSodium Hydrogen Carbonate……...2.940gmCalcium Chloride Diydrate………...0.2205gm Magnesium Chloride Hexahydrate…..................................0.1017gm Glucose Monohydrate …..................1.100gmMultiBic 4 mmol/l potassiumPer 1000ml contains (After mixing)Potassium Chloride ………………..0.2982gmSodium Chloride …………………..6.136gmSodium Hydrogen Carbonate……....2.940gmCalcium Chloride Diydrate……….. 0.2205gm Magnesium Chloride Hexahydrate…................ 0.1017gm Glucose Monohydrate……………...1.100gm Solution for Haemodialysis/Heamofiltration

MultiBic 2 mmol/l potassiumPer 1000ml contains (After mixing)Potassium Chloride……..................0.1491gmSodium Chloride ……….................6.136gmSodium Hydrogen Carbonate……...2.940gmCalcium Chloride Diydrate………...0.2205gm Magnesium Chloride Hexahydrate…..................................0.1017gm Glucose Monohydrate …..................1.100gmMultiBic 4 mmol/l potassiumPer 1000ml contains (After mixing)Potassium Chloride ………………..0.2982gmSodium Chloride …………………..6.136gmSodium Hydrogen Carbonate……....2.940gmCalcium Chloride Diydrate……….. 0.2205gm Magnesium Chloride Hexahydrate…................................ 0.1017gmGlucose Monohydrate……………...1.100gm Solution for Haemodialysis/Heamofiltration

MultiBic 2 mmol/l and 4 mmol/l Potassium is indicated for intravenous use as substitution solution in haemofiltartion and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration.

15.05.2020

233

Each film coated tablet contains:Alogliptin Benzoate 17mg eq. to Alogliptin + Metformin Hydrochloride(12.5mg + 500mg & 12.5mg + 1000mg)

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

18.05.2020

234

Per 12.5mg blister contains :Fluticasone Furoate ……..100mcgUmeclidinium bromide 74.2mcg eq. to Umeclidinium…………......62.5mcgVilanterol trifenatate 40mcg eq. to Vilanterol………………….25mcg

Indicated for maintenance treatment to prevent and relieve symptoms associate with chronic obstructive pulmonary disease (COPD).

18.05.2020

235

Disoidum PhosphateDihydarte EP...................................1870g/L Potassium Chloride EP…................0.3140g/LSodium Hydrogen Carbonate EP….2.1200g/LSodium Chloride EP…....................7.0100g/L Magnesium ChlorideHexahydrate EP...............................3.0500g/L Solution for Haemodialysis or Haemoflitration

18.05.2020

236

Sodium Citrate ……….5.2900g/LSodium Chloride……...5.0300g/LSolution for Haemofiltration

Regiocit is used as replacement fluid for continuous renal replacement therapy (CRRT) using regional citrate anticoagulation. Citrate is particularly relevant when systemic anticoagulation with heparin is contraindicated for example in patients with increased bleeding risk.

21.05.2020

237

Hydrogen peroxide 0.5% w/w spray

Cleans, disinfects and deodorizes hard non-porous inanimate environmental surfaces

28.05.2020

238

Each kit contains:A) 14 Ticagrelor tablets…….90mgEach film coated tablet contains:Ticagrelor IP……….90mgB) 7 Aspirin Gastro-resistant tablets IP…..75mgEach enteric coated tablet contains:Aspirin IP…………..75mg

For the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with acute coronary syndromes (ACS) including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG) where both Ticagrelor and Aspirin are required.

29.05.2020

239

Remdesivir Injection 5 mg/mL and Remdesivir lyophilised powder for Injection 100 mg

For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and children hospitalised with severe disease.in light of Covid 19 outbreak, for restricted emergency use in the country.

01.06.2020

240

Lymphoseek 50mcg kit (each kit contains :Tilmanocept 50mcg, Glycine 0.1mg, Sodiumascorbate 0.1mg, Trehalose dihydrate 16mg,stannous chloride dihydrate 0.015mg, sodiumhydoxide q.s, hydrochloric acid q.s, Nitrogen q.s,water for injection q.s)

241

Sodium Fluoride varnish (50mg/ml) (Dental Suspension)(New Dosage Form)

Each ml of Dental Suspension contains:Sodium Fluoride……50 mg

· For the prevention of caries in children and adults as part of a comprehensive control programme, for the:- prevention of recurring (or marginal) caries- prevention of progression of caries- prevention of decalcification around orthodontic appliances- prevention of pit and fissure (occlusal) caries.· For the desensitisation of hypersensitive teeth as part of a treatment regimen which includes the daily use of a suitable toothpaste. Warning:“To be sold by retail on the prescription of a Dentist only”

05.06.2020

242

Amoxicillin Trihydrate……759.04 mg eq. toAmoxicillin free acid……...652.78 mgPotassium Clavulanate……61.48 mg eq. toClavulanic acid…………...50.41mgper 5ml powder for reconstitution into suspension

It is indicated for short term treatment of paediatric patients with bacterial infections at the following sites when caused by amoxicillin-clavulanate-susceptible organisms:1. Upper Respiratory Tract Infections(including ENT) e.g.· Acute otitis media (AOM), persistent AOM, or recurrent AOM, typically caused by Streptococcus pneumonia Haemophilus influenzae and Moraxella catarrhalis. · Tonsillo-pharyngitis and sinusitis, typically caused by Streptococcuspneumonia.· Haemophilus Influenza Moraxella catarrhalis and Streptococcus pyogenes.2. Lower Respiratory Tract Infections e.g. lobar and bronchopneumonia typically caused by Streptococcus pneumonia Haemophilus influenza and Moraxella catarrhalis3. Skin and Soft Tissue Infections typically caused by Staphylococcus aureus and Streptococcus pyogenes.4. Urinary tract infections e.g. cystitis, pyelonephritis· Penicillin minimum inhibitory concentration (MIC) less than or equalto 4 micrograms/ml· Some members of these species of bacteria producebeta-lactamase, rendering them insensitive to amoxicillin alone.

06-08-2020

243

Paclitaxel Lipid Suspension for injection 100 mg/vial\(Additional Strength)

Each vial contains:Paclitaxel ………100 mg

1. For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.2. For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.3. As first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, it is indicated in combination with cisplatin.4. In combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.5. For the second-line treatment of AIDS- related Kaposi’s sarcoma Warning:“To be sold by retail on the prescription of a Oncologist only”

16.06.2020

244

Favipiravir bulk and Favipiravir film coated tablet200mg

Favipiravir bulk and Favipiravir film coated tablet 200mg

For the treatment of patients with mild to moderate Covid-19 disease.

19.06.2020

245

Itraconazole Oral Solution 10 mg/ml(New Dosage Form)

Each ml Contains:Itraconazole………10 mg

For the Treatment of Orophyaryngeal and Esophageal candidiasis Warning:“To be sold by retail on the prescription of a Specialist only”

25.06.2020

246

Bilastine Orodispersible Tablet 10 mg(New Dosage Form)

Each uncoated orodispersible tablet contains:Bilastine…… 10 mg

For symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticarial. Bilastine is indicated in children aged 6 to 11 years with a body weight of at least 20 kg

25.06.2020

247

Film coated bilayered tablets contains:Metformin Hydrochloride IP………………………500mgEvogliptin Tartrate………5mg(In additional Strength)

As an adjunct to diet and exercise to improve glycaemic control in adults patients with type 2 diabetes mellitus who are appropriate for co-administration of Evogliptin and Metformin. Patients with inadequate glycaemic control on Metformin monotherapy alternative for combination therapy of Evogliptin and Metformin.

26.06.2020

248

Itraconazole 50 mg Capsule(Modified Dosage Form)

Each capsule contains:Itraconazole……50 mg

for the treatment of Systematic aspergillosis, candidiasis, cryptococcosis, sportrichosis, paracoccidioidomycossis, blastomycosis and other rarely occuring systemic or tropical mycosis"WARNING: To be sold by retail on the prescription of a Specialist only”.Caution: “This Itraconazole Capsules 50mg has equivalent bioavailability with that of itraconazole capsules 100mg. One capsule of this Itraconazole Capsule 50mg is therapeutically equivalent to one 100mg capsule of conventional Itraconazole capsules100mg. The recommended dose of this Itraconazole Capsules 50mg is therefore half the recommended dose for conventional itraconazole capsules 100 mg. This Itraconazole Capsules 50mg and conventional Itraconazole Capsules 100mg are not interchangeable”.

30.06.2020

249

Meropenem dry powder for injection 2000 mg

Each Vial Contains:Meropenem Trihydrate Equivalent to Meropenem …. 2000mgSodium Carbonate Equivalent to sodium ….. 180.4 mg

• Nosocomial Pneumonia like Hospital Acquired Pneumonia (HAP)/Ventilator Associated Pneumonia• Urinary Tract Infections like Complicated Urinary Tract Infections• Intra-Abdominal infection like Complicated Intra-Abdominal Infection• Meningitis like Acute Meningitis• Septicemia• Empiric Treatment of Presumed infection in Adult Patients with Febrile Neutropenia

02.07.2020

250

Dapagliflozin 10 mg Tablet

Each Film coated tablet contains:Dapagliflozin Propanediol Monohydrate equivalent to Dapagliflozin………10 mg

Dapagliflozin is indicated in adults for the treatment of heart failure with reduced ejection fraction.

03.07.2020

251

Ceftaroline fosamil powder for concentrate for solutin for infusion

Each Vial Contains:Ceftaroline Fosamil…………..600mgL-Arginine…………………..395mg

For the tratment of the adults with complicated skin and soft tissue infections (Cssti)

06.07.2020

252

Nintedanib 100mg/150mg

Each soft Gelatin capsule contains:Nintedanib Ethanesulfonate equivalent to Nintedanib……..100mg/150mg

For the treatment of other chronic fibrosing interstitial Lung Diseases (ILDs) with a Progressive phenotype

09.07.2020

253

Ivabradine PR Tablets 10/15mg

Each film coated prolonged release tablet contains: Ivabradine hydrochloride equivalent to Ivabradine……………….10 mg / 15 mg.

For the treatment of chronic stable angina pectoris in patients with coronary artery disease and treatment of chronic heart failure.

14.07.2020

254

Paracetamol Orally Disintegrating 60/120 mg

Each Orally Disintegrating Strip Contains: Paracetamol…………………….60mg / 120 mg

For use in pediatric age group, for symptomatic treatment of pain and fever

14.07.2020

255

Film coated bilayered tablet contains:Pregabalin IP (As prolonged Release)................75mgEtoricoxib IP........60mg(In additional Strength)

For the treatment of chronic low back pain associated with neuropathic component.

15.07.2020

256

Sodium Citrate Granules 4.0 gm

Each sachet (5.6g) Contains:Sodium Citrate 4.0 g

As an alkalising agent in cystitis in women

16.07.2020

257

Glycopyrronium IP……….25mcgFormoterol Fumarate IP…..12mcgBudesonide IP…………….400mcgInhalation Powder

Indicated as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).

17.07.2020

258

Trimetazidine Hydrochloride Extended Release Capsules 80mg

Each hard gelatin capsule contains:Trimetazidine hydrochloride (as extended release pellets)… 80 mg

Indicated as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).

21.07.2020

259

Zinc chloride Ph. Eur. ……………1050 μgSodium fluoride Ph. Eur.….210.0 μgPotassium iodide Ph. Eur……..16.60 μgSodium Molybdate dihydrate Ph. Eur. …………4.850 μgSodium selenite anhydrous ……17.29 μgCopper chloride dihydrate USP ………………… 102.3 μg Manganese chloride tetrahydrate USP………….19.79 μgFerric chloride hexahydrate Ph. Eur ……………...540.0 μgChromic chloride hexahydrate USP ……………..5.330 μg Concentrate for Solution for Infusion

Zinc chloride Ph. Eur. ……………1050 μgSodium fluoride Ph. Eur.….210.0 μgPotassium iodide Ph. Eur……..16.60 μgSodium Molybdate dihydrate Ph. Eur. …………4.850 μgSodium selenite anhydrous ……17.29 μgCopper chloride dihydrate USP ………………… 102.3 μg Manganese chloride tetrahydrate USP……….19.79 μgFerric chloride hexahydrate Ph. Eur …………...540.0 μgChromic chloride hexahydrate USP ………….5.330 μg Concentrate for Solution for Infusion

To meet basal to moderately increased requirements of trace elements in intravenous nutrition.

30.07.2020

260

n-alkyl dimethyl benzyl ammonium chloride0.105% w/w spray

Cleans, disinfects, deodorizes hard, nonporous inanimate environmental surfaces

31.07.2020

261

Defetilide bulk and Dofetilide capsules 125mcg, 250mcg, 500mcg

Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/ atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because Dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients. Conversion of Atrial Fibrillation/Flutter Dofetilide is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation.

31.07.2020

262

Regorafenib Tablet 40 mg(Additional Indication)

Each film coated tablet contains:Regorafenib…..40 mg

For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with SorafenibWarning “To be sold by retail on the Prescription of an Oncologist only

03.08.2020

263

Baclofen Extended Release tablet 30mg(Additional dosage & Strength)

Each uncoated extended release tablet contains:Baclofen….30 mg

For the symptomatic treatment of neuronal spasticity due to multiple sclerosis, spinal chord, pathology & injury

04.08.2020

264

Tofacitinib Tablet 5 mg(Additional Indication)

Each film coated tablet contains:Tofacitinib citrate equivalent to tofacitinib…..5 mg

For the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs)Warning “To be the prescription of a Rheumatologist or Specialist in Internal Medicine only”

04.08.2020

265

Enzalutamide 80 mg capsules(Additional strength)

Each hard gelatin capsule contains:Enzalutamide….80mg

For the treatment adults with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after Docetaxel therapy.Warning “To be sold by retail on the Prescription of an Oncologist only”

06.08.2020

266

Oxaceprol Sustained Release Tablet 600 mg(Additional strength)

Each film coated SR tablet contains:Oxaceprol……600 mg

Treatment of pain associated with osteoarthritis of knee in adult patients

07.08.2020

267

Octyl decyl dimethyl ammonium chloride 6.670% spray

Cleans, disinfects, deodorizes hard, nonporous inanimate environmental surfaces.

07.08.2020

268

Each Uncoated tablets contains:Aceclofenac IP……..200mg (as extended release) Rabeprazole…………..20mg (as delayed release)(In additional dosage form)

It is indicated for the treatment of Painful inflammatory conditions associated with gastroduodenal ulcers.

10.08.2020

269

Each Uncoated tablets contains:Azelnidipine IP…………8mg/8mgOlmesartan Medoxomil IP ……….20mg/40mg

Each Uncoated tablets contains:Azelnidipine IP…………8mg/8mgOlmesartan Medoxomil IP………….20mg/40mg

For the treatment of patients with stage II hypertension.

14.08.2020

270

Glycopyrrolate IP……9mcgFormoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate……4.8mcgPer actuation deliver Inhalation Aerosol(In additional Strength)

Indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.

14.08.202

271

Didecyl dimethyl Ammonium Chloride………………..10.14% w/wN-Alkyl Dimethyl Benzyl Ammonium Chloride…………………6.76% w/wSurface Disinfectatnt

Antimicrobial product for use against Novel coronavirus SARS-Cov-2, the cause of COVID-19.

14.08.2020

272

Octyl Decyl Dimethyl Ammonium Chloride ……………………….6.510% w/wDioctyl Dimethyl Ammonium Chloride……………...2.604% w/wDidecyl Dimethyl Ammonium Chloride……………..3.906% w/wAlkyl dimethyl Benzyl Ammonium Chloride……………..8.680% w/wSurface Disinfectant

Octyl Decyl Dimethyl Ammonium Chloride …………….6.510% w/wDioctyl Dimethyl Ammonium Chloride……………...2.604% w/wDidecyl Dimethyl Ammonium Chloride……………..3.906% w/wAlkyl dimethyl Benzyl Ammonium Chloride……………..8.680% w/wSurface Disinfectant

Antimicrobial product for use against Novel Coronavirus SARS-Cov-2, the cause of COVID-19.

14.08.2020

273

Levofloxacin Dispersible Tablets 100 mg(New Dosage Foam)

Each dispersible tablet contains:Levofloxacin hemihydrate Equivalent to Levofloxacin ……. 100 mg

Indicated in combination with other anti-tuberculosis agents, for the treatment of tuberculosis caused by Mycobacterium tuberculosis in children.Warning “To be sold by the prescription of a Medical Specialist only”

18.08.2020

274

Trihexyphenidyl Hydrochloride 1 mg(Additional strength)

Each uncoated tablet contains:Trihexyphenidyl hydrochloride ……………… …….1 mg

It is indicated in all forms of Parkinsonism (postencephalitic, arteriosclerotic and idiopathic). It is often useful as adjuvant therapy when treating these forms of Parkinsonism with levodopa. Trihexyphenidyl is also indicated to control extrapyramidal disorders due to central nervous system drugs such as reserpine and the phenothiazines.Warning “To be sold by the prescription of Neurologist only”

18.08.2020

275

Each tablet contains:Vildagliptin………….50mg/50mgMetformin Hydrochloride (Sustained Release) IP…………………...500mg/1000mg

For the treatment of type_II diabetes mellitus when single drug therapy along with diet, exercise do not result in adequate glycemic control.

18.08.2020

276

Film coated bilayered tablet contains:Azelnidipine ………..8mg/8mg Telmisartan…………40mg/80mg

Film coated bilayered tablet contains:Azelnidipine ………..8mg/8mgTelmisartan…………40mg/80mg

For treatment of Stage-II Hypertension.

19.08.2020

277

Each vial contains:Amoxycillin Sodium IP (sterile) eq. to Amoxycillin…………125mgPotassium Clavulanate IP (sterile) eq. to Clavulanate…………..25mgInjection

For the treatment of bacterial infections.

19.08.2020

278

Each film coated tablets contains:Efonidipine Hydrochloride Ethanolate ……..20mg/20mgMetoprolol Succinate (Extended Release)…25mg/50mg

Each film coated tablets contains:Efonidipine Hydrochloride Ethanolate …………..20mg/20mgMetoprolol Succinate (Extended Release)…25mg/50mg

It is indicated for the management of Stage - II Hypertension.

25.08.2020

279

Ferric Carboxymaltose Solution for Injection/Infusion 20mg/vial(Additional Pack Size)

Each ml contains:Ferric Carboxymaltose equivalent to Elemental Iron….50 mg.

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

27.08.2020

280

Lipid Based Tacrolimus Ointment 0.1% w/w(Additional indication)

Each gram contains:Tacrolimus Monohydrate Equivalent to Tacrolimus…....0.1% w/w

For the short-term and non-continuous chronic treatment of symptomatic lichen planus (oral and mucosal forms) in nonimmunocompromised patientsWarning “To be the prescription of a Dermatologists only”

28.08.2020

281

Moxifloxacin Dispersible Tablets 100 mg(New Form dosage)

Each dispersible tablet contains:Moxifloxacin Hydrochloride Equivalent to Moxifloxacin 100 mg

Indicated in combination with other antituberculosis agents for the treatment of tuberculosis caused by Mycobacterium tuberculosis. as a second-line antimycobacterial drug when use of first line drugs is not appropriate due to resistance or intolerance

02.09.2020

282

Tapentadol Hydrochloride Nasal Spray 225 mg/ml(New Form dosage)

Each Spray (0.1 ml) contains:Tapentadol Hydrochloride22.5 mg Benzalkonium chloride (50%) 0.02%w/v (As Preservative)

For treatment of moderated to severe post-operative pain in hospital admitted patients

02.09.2020

283

Carbetocin bulk and Carbetocin injection 100 mcg/ml

Prevention of postpartum haemorrhage due to uterine atony

21.09.2020

284

Each uncoated bilayered tablets contains:Atorvastatin Calcium IP eq. to Atorvastatin……10mg/20mgClopidogrel Bisulphate IP eq. toClopidogrel ………………...75mg/75mg(In additional dosage form)

Each uncoated bilayered tablets contains:Atorvastatin Calcium IP eq. to Atorvastatin……10mg/20mgClopidogrel Bisulphate IP eq. toClopidogrel ………………...75mg/75mg

Post coronary intervention and acute syndrome.

23.09.2020

285

Favipiravir 800mg Tablet(Additional strength)

Each film coated tablet contains:Favipiravir 800 mg

For the treatment of patients with mild to moderate Covid-19 disease, in light of Covid 19 outbreak, for restricted emergency use in the country.“WARNING: To be sold on the prescription of medical specialist”

24.09.2020

286

Isotretinoin Capsules 8/16/24 mg(Additional Strength & Indication)

Each soft gelatin capsule contains:Isotretinoin…8mg /16mg/24mg

For the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, it is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.“Warning: To be sold by retail on the prescription of Dermatologist only”

29.09.2020

287

Brivaracetam Tablets(Additional Strength)

Each film coated tablet contains:Brivaracetam 25mg

As adjunctive therapy in the treatment of partialonset seizures in patients 16 years of age and older with epilepsy

01.10.2020

288

Perampanel Tablets 2 mg/4mg /6 mg/8 mg/12 mg(Additional Indication)

Each film coated tablet Contains:Perampanel 2mg/4mg/6mg/8mg/10 mg/12mg

As an adjunctive treatment of partialonset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older“Warning: To be sold by retail on the prescription of Neurologist only”

01.10.2020

289

Acotiamide 300 mg Tablet(Additional dosage foam)

Each film coated Extended release tablet contains:Acotiamide Hydrochloride Hydrate 300mg

For the treatment of bloating after meals, epigastric bloating and early satiety in functional dyspepsia

05.10.2020

290

Each Dispersible tablets contains:Lamivudine USP………..60mgAbacavir Sulphate USP…120mg

Indicated in the treatment of HIV-1 infection in children.

06.10.2020

291

Each tablet contains:Tenofovir Alafenamide Fumarate …… 25mgEmtricitabine……200mg(In additional Indication)

Indicated for use in high risk adults and adolescents weighing at least 35kg for PrEP to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex.

12.10.2020

292

Each 1.8ml solution for injection contains:Lignocaine Hydrochloride Ph. Eur…36mgAdrenaline Tartrate Ph. Eur…….0.0225mg

It is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults and in children and adolescents aged 4 to 18 years of age. It is appropriate for procedures of long durations and when there is a risk of significant bleeding into the operative field.

12.10.2020

293

Each 1.7ml solution for injection:Articaine Hydrochloride EP.....68mgAdrenaline Tartrate EP……….0.0300mg

It is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental procedures in adults. It is intended for adults, adolescents and in children over 4 years old.

14.10.2020

294

Netarsudil mesylate bulk and Netarsudilophthalmic solution 0.02%w/v

For the reduction of elevated intraocular pressure in patients with open angle galucoma or ocular hypertension

14.10.2020

295

Azathioprine 75 mg Tablet(Additional Strength)

Each film coated tablet contains:Azathioprine 75 mg

Indicated for facilitating the survival and function of organ transplants“Warning: To be sold by retail on the prescription of Medical Specialist only”

14.10.2020

296

Travoprost Eye Drops 0.004% w/v(Preserved with an ionic buffer system)

Each ml contains Travoprost .0.004% w/v

For the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension“Warning: To be sold by retail on the prescription of Ophthalmologist only”

16.10.2020

297

Risdiplam powder for oral solution 60mg

For treatment of Spinal Muscular Atrophy (SMA) in patients 2 months of age and older

16.10.2020

298

FDC of Azelnidipine 8mg and Telmisartan 40mg tablet

For the treatment of Stage-II hypertension

16.10.2020

299

Remdesivir for Injection 100 mg/vial (lyophilized)(Expansion of Indication)

Each vial Contains:Remdesivir 100 mg (lyophilized)

For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID19) in adults and children hospitalised with moderate to severe disease.In light of Covid 19 outbreak, for restricted emergency use in the country.“Warning: To be sold by retail on the prescription of specialist for use in Hospital/Institutional Setup only”

19.10.2020

300

Each Actuation delivers (Ex-actuator) contains:Glycopyrrolate IP ...................9.0mcgFormoterol Fumarate dihydrate IP eq. to Formoterol Fumarate………..4.8mcgInhalation Aerosol(In additional strength)

Indicated for the long term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease.

26.10.202

Published by Fedley Healthcare on 26 August 2025

Complete list of CDSCO approved drugs in India

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