CDSCO approved drugs in India

Fedley Healthcare

6 Sept 2025 · 56 min read

Sr. No.

Name of the Product

Composition

Indication

301

Lidocaine Spray 10% w/v(Additional Strength)

Each ml Contains:Lidocaine ……100 mgEthanol…….. 30.4% v/vFlavored Base …………… q .s.

Lidocaine Spray 10% w/v is indicated for the prevention of pain associated with the following procedures: Otorhinolaryngology: Anesthesia prior to minor non-invasive procedures in the nasal cavity, pharynx and epipharynx including rhinos copy and laryngoscopy. Obstetrics: During the final stages of delivery and before episiotomy and perineal suturing as supplementary pain control. Insertion of instruments and catheters into the respiratory and digestive tract: Provides surface anesthesia for the oropharyngeal and tracheal areas to reduce reflex activity, attenuate hemodynamic response and to facilitate insertion of the catheter or the passage of instruments during endotracheal intubation, laryngoscopy, bronchoscopy, esophagostomy and gastroscopy. Dental practice: Before minor dental procedures where local anesthesia is desired.

02.11.2020

302

Combipack OF Favipiravir Tablets(Combipack)

Each Combipack contains:Favipiravir Tablets 200 mg(2 tablets)Each film coated tablets contains:Favipiravir ……………..200mgFavipiravir Tablets 800 mg(16 tablets)Each film coated tablets contains:Favipiravir……………..800mg

For restricted emergency use for the treatment of patients with mild to moderate Covid-19 disease“WARNING: To be sold on the prescription of medical specialist” which shall be in box with red background.

27.11.2020

303

Each Film Coated Tablets contains:Rosuvastatin Calcium IP eq. to Rosuvastatin ……20mg Clopidogrel Bisulphate IP eq. to Clopidogrel …75mg

Post coronary intervention and acute coronary syndrome.

27.11.2020

304

Each Film Coated Tablets contains:Remogliflozin Etabonate……100mg Vildagliptin…………………..50mg

Each Film Coated Tablets contains:Remogliflozin Etabonate……100mgVildagliptin…………………..50mg

It is indicated in adults aged 18 years and older with type 2 diabetes mellitus:· To improve glycaemic control when Metformin and one of mono-components of Fixed dose combination of Remogliflozin Etabonate & Vildagliptin do not provide adequate glycaemic control.· When already being treated with the free combination of Remogliflozin Etabonate & Vildagliptin.

27.11.2020

305

Each Film Coated Tablets contains:Ivabradine Hydrochloride eq. to Ivabradine + Metoprolol Tartrate IP(7.5mg+25mg, 5mg +50mg, 5mg+25mg & 7.5mg+50mg)

For the symptomatic treatment of chronic stable angina pectoris substitution therapy in adult patients with normal sinus rhythm already controlled by Metoprolol and Ivabradine taken concomitantly at the same dose level

27.11.2020

306

Dapagliflozin 5mg + Vildagliptin 50mg + Metformin Hydrochloride IP 500mg film coated tablets(Additional strength)

Management of Type 2 Diabetes Mellitus (T2DM)

15.11.2023

307

Thyroxine Sodium Tablets 112 mcg(Additional Strength)

Each uncoated tablet contains:Thyroxine Sodium…….11 2 mcg

For the treatment of hypothyroidism

17.12.2020

308

Each Film Coated Tablets contains:Metoprolol Succinate IP eq. to Metoprolol Tartrate (as extended release)+ Chlorthalidone IP + Telmisartan IP (47.5mg eq. to 50mg + 6.25mg + 40mg & 23.75mg eq. to 25mg + 6.25mg+ 40mg)

It is indicated for the treatment of patients with uncontrolled essential hypertension and stable coronary artery disease (CAD)

21.12.2020

309

Triamcinolone Acetonide Cream 0.1%w/w(New Dosage Foam)

Each gm contains:Triamcinolone Acetonide…..1mgBenzyl alcohol (aspreservative)………….2% w/wIn a cream base………………….…q.s.

Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses."WARNING: To be sold by retail on the prescription of Dermatologist only”

22.12.2020

310

Palbociclib Tablets 75/100/125 mg

Each film coated tablet contains:Palbociclib………...….75mg/100mg/1 25 mg

1. Palbociclib is a kinase inhibitor indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) - negative advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.2. Palbociclib is a kinase inhibitor indicated in combination with Letrozole for the treatment of postmenopausal women with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine based therapy for their metastatic disease."WARNING: To be sold by retail on the prescription of an Oncologist only”

311

Lurasidone Hydrochloride Tablets 20mg(Additional Strength)

Each film coated tablets contains:Lurasidone Hydrochloride………………….20 mg

For treatment of patients with Schizophrenia"WARNING: To be sold by retail on the prescription Neurologist only”

24.12.2020

312

Hydrocortisone Sodium Succinate Injection(Additional Strength)

Each vial contains:Hydrocortisone Sodium Succinate (Buffered) Eq. to Hydrocortisone……200 mg

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (StevensJohnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hyper calcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.

28.12.2020

313

Each Film Coated Tablets contains:Carvedilol IP…………3.125mgIvabradine Hydrochloride eq. to Ivabradine…………....5mg

It is indicated for as substituted therapy in adult patients with normal sinus rhythm already controlled by Ivabradine and carvedilol taken concomitantly at the same doses level for: I. The symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients II. The treatment of chronic heart failure (II-IV NYHA-class) with systolic dysfunction.

30.12.2020

314

Each gram contains:Adapalene EP……………0.3% w/wBenzoyl Peroxide EP…….2.5% w/wTopical Gel(Additional Strength)

Each gram contains:Adapalene EP……………0.3% w/wBenzoyl Peroxide EP…….2.5% w/wTopical Gel

For the cutaneous treatment of Acne vulgaris, when comedones, numerous papules and pustules are present.

08.01.2021

315

Atropine Sulfate Ophthalmic Solution USP 0.01% w/v(Additional Strength)

Each ml Contains:Atropine Sulfate…………….0.1 mgPolyhexamethylene biguanide Hydrochloride… ……0.05mg(As Preservative)

It is indicated to control the progression of myopia in children of 5 years and above"WARNING: To be sold by retail on the prescription of Ophthalmologist only”With the Condition to conduct phase IV Clinical trial to assess long term safety of the product.

12.01.20021

316

Colistimethate Sodium For Injection IP 3 MIU/ 4.5 MIU(Additional Strength)

(i) Colistimethate Sodium for Injection IP 3 MIUEach Vial contains Colistimethate Sodium….300 0000 IU(ii) Colistimethate sodium for Injection IP 4.5 MIUEach Vial Contains: Colistimethate Sodium……..4500 000 IU

For the treatment of some serious infections caused by Gram-negative bacteria, including those of the lower respiratory tract and urinary tract, when more commonly used systemic antibacterial agents may be contraindicated or may be ineffective because of bacterial resistance."WARNING: To be sold by retail on the prescription of a Medical Specialist only”

15.01.2021

317

Each modified release bilayered tablet contains:S (-) Metoprolol Succinate eq. to S (-) Metoprolol Tartrate (as extended release) + Telmisartan IP (Immediate Release)(25 mg + 20 mg & 25mg + 40 mg)

For the treatment of essential hypertension

18.01.2021

318

Zinc Citrate Trihydrate eq. to Zinc ……………………10mgAscorbic Acid IP …………1000mgEffervescent tablets

For the treatment of Vitamin C and Zinc deficiency.

01.02.2021

319

Dapagliflozin Tablets 10 mg(Additional Indication)

Each film-coated tablets contains:Dapagliflozin propanediol monohydrate equivalent to Dapagliflozin…….. 10 mg

For the treatment of patients of Chronic Kidney Disease (CKD) up to Stage III (eGFR of greater than or equal to 30ml/min/1.73 sq.m)“WARNING: To be sold by retail on the prescription of Nephrologist only”

03.02.2021

320

Brivaracetam Oral Solution Solution 10mg/mlAdditional Dosage Foam

Each ml contains:Brivaracetam ……10mg/ml

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

03.

321

Each Capsules contains:Atorvastatin Calcium IP eq. to Atorvastatin……40mgAspirin IP…...75mg(As one gastro-resistant tablet)(Additional Strength)

Treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke, or peripheral vascular disease.

05.02.2021

322

Each 20ml vial contains:Ceftazidime pentahydrate eq. to Ceftazidime ……….2gmAvibactam Sodium eq. to Avibactam………….0.5gmPowder for concentrate for solution for infusion

· Complicated Intra-abdominal infections (cIAI)· Complicated Urinary tract infections (cUTI), including pyelonephritis· Hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP) with susceptible gram negative microorganisms. Treatment of patients with bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

12.02.2021

323

Drospirenone Tablets 4 mg(Additional Strength)

Each for uncoated TabletsDrospirenone……4 mg

Drospirenone is a Progestin intended for its use by females of reproductive potentials to prevent pregnancy

15.02.2021

324

Apomorphine Hydrochloride 5 mg/ml solution for infusion in 20ml vialApomorphine Hydrochloride 10 mg/ml solution for injection in 3ml cartridgeAdditional pack size & strength

Apomorphine Hydrochloride solution for infusion in 20ml vialEach ml contains:Apomorphine Hydrochloride……… 5mgApomorphine Hydrochloride solution for injection in 3ml cartridgeEach ml contains:Apomorphine Hydrochloride…… 10 mg

For the treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson’s disease which persist individually titrated treatment with Levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine agonists.“WARNING: To be sold by retail on the prescription of Neurologists only”

16.02.2021

325

Each uncoated tablet contains:Azelnidipine IP + Chlorthalidone IP (8mg + 6.25mg & 8mg+12.5mg)

For the treatment of essential hypertension

19.02.2021

326

Composition of Amino acid Solution 8% solution for intravenous infusion(Pack size 500ml in Glass bottle)Per 1000ml solution for infusion contains:L-isoleucine Ph. Eur 10.40 g, L-leucine Ph. Eur 13.09 gL-lysine monoacetate corresponding to L- lysine USP 9.71g corresponding to 6.88 g, L-methionine Ph. Eur. 1.10 gN-acetyl-L-cysteine Corresponding to L-Cysteine Ph. Eur 0.70 g corresponding to 0.52 g, L-phenylalanine Ph. Eur. 0.88 gL-threonine Ph. Eur. 4.0 g, L-tryptophan Ph. Eur. 0.70 gL-valine Ph. Eur. 10.08 g,L-arginine Ph. Eur 10.72 gL-histidine Ph. Eur. 2.80 g, Glycine (Amino acetic acid) Ph. Eur. 5.82 g,L-alanine Ph. Eur. 4.64 g, L-proline Ph. Eur. 5.73 gGlacial acetic acid Ph. Eur 4.42 g,Other Excipients: Water for injections Ph. Eur….q.s.

Composition of Amino acid Solution 8% solution for intravenous infusion (Pack size 500ml in Glass bottle)Per 1000ml solution for infusion contains:L-isoleucine Ph. Eur 10.40 g, L-leucine Ph. Eur 13.09 gL-lysine monoacetate corresponding to L- lysine USP 9.71g corresponding to 6.88 g, L-methionine Ph. Eur. 1.10 g N-acetyl-L-cysteine Corresponding to L-Cysteine Ph. Eur 0.70 g corresponding to 0.52 g, L-phenylalanine Ph. Eur. 0.88 g,L-threonine Ph. Eur. 4.0 g, L-tryptophan Ph. Eur. 0.70 g,L-valine Ph. Eur. 10.08 g,L-arginine Ph. Eur 10.72 gL-histidine Ph. Eur. 2.80 g, Glycine (Amino acetic acid) Ph. Eur. 5.82 g,L-alanine Ph. Eur. 4.64 g, L-proline Ph. Eur. 5.73 g ,Glacial acetic acid Ph. Eur 4.42 g,Other Excipients: Water for injections Ph. Eur….q.s.

For supply of amino acids as part of a parenteral nutrition regimen in serve forms of hepatic insufficiency with and without hepatic encephalopathy when oral or enteral nutrition is impossible or insufficient or contraindicated.

19.02.2021

327

Thyroxine Sodium Tablets 88 mcg / 200mcgAdditional Strength

Each uncoated tablet contains:Thyroxine Sodium………...88 mcg / 200 mcg

For the treatment of hypothyroidism

22.02.2021

328

Brivaracetam injection 50mg/5ml (10mg/ml)Additional dosage form & New route of administration

Each ml Contains:Brivaracetam… …….10mg

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

24.02.2021

329

Each Film Coated tablet contains:Benidipine Hydrochloride JP + Telmisartan IP (4mg + 40mg & 4mg + 80mg)

For the treatment of hypertension

26.02.2021

330

Avanafil bulk and Avanafil tablets 50mg/100mg/200mg

For the treatment of erectile dysfunction

26.02.2021

331

Riboflavin Sodium Phosphate IP eq. to Riboflavin 0.1 % w/v Ophthalmic Solution for PFS(pack size is 3.0 ml)

Riboflavin Sodium Phosphate IP eq. to Riboflavin 0.1 % w/v Ophthalmic Solution for PFS (pack size is 3.0 ml)

To treat keratoconus and corneal ectasia following refractive surgery

27.02.2021

332

Aripiprazole powder and solvent for prolong-release suspension for injection 300mg/vial and 400 mg/vial(Modified Dosage Form)

Each vial contains:Aripiprazole………300mg / 400mg(Supplied along with solvent/diluent)

Maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.“WARNING: To be sold by retail on the prescription of an Psychiatrist only”

01.03.2021

333

Rebamipide Ophthalmic Suspension 2% w/v with Stabilized Oxychloro complex (as preservative)

Each ml contains:Rebamipide…..2.0 %w/vStabilized Oxychloro Complex…..0.01% w/v(As Preservative)

Indicated for the treatment of dry eye signs and symptoms.

01.03.2021

334

Pancreatin Tablets USP 200 mg(Additional Strength/New dosage form/New Indication)

Each uncoated tablet Contains:Pancreatin ...200mgEquivalent to Lipase ……..10,440 USP unitsAmylase…………….39,150 USP unitsProtease…………...3 9150 USP units

Indicated in combination with a proton pump inhibitor in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.

01.03.2021

335

Pemetrexed for injection 100mg/500mg(Additional Indication)

Each vial contains:Pemetrexed Disodium equivalent to Pemetrexed …100mg/500mg

In combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations."WARNING: To be sold by retail on the prescription of oncologist only”

08.03.2021

336

Ibuprofen solution for infusion 400mg/100ml(New Dosage Form)

Each ml contains:Ibuprofen ……………4mg

Indicated in adults for the shortterm symptomatic treatment of acute moderate pain, and for the short-term symptomatic treatment of fever, when administration by intravenous route is clinically justified when other routes of administration are not possible.

08.03.2021

337

Cholecalciferol oral drops 800IU/ml(Additional Strength/New dosage Form)

Each ml contains:Cholecalciferol ……800IU

For the treatment of vitamin D3 deficiency

08.03.2021

338

Osimertinib Tablets 40mg and 80mg(Additional Indication)

Each film coated tablets contains:Osimertinib (as mesylate)…...4 0mg/80mg

Osimertinib as monotherapy is indicated for:The adjuvant treatment after complete tumour resection in patients with nonsmall cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations“WARNING: To be sold by retail on the prescription of oncologist only”

09.03.2021

339

Omidenepag isopropyl ophthalmic solution 0.002% w/v

For the treatment of glaucoma and ocular hypertension

12.03.2021

340

Composition of Amino acid Solution for intravenous infusion (Pack size 100ml, 250ml, 500ml in Glass bottle)Per 1000ml solution for infusion contains:Active Ingredients QualityL-isoleucine Ph. Eur 5.10 gL-leucine Ph. Eur. 10.30 gL-lysine 10.01 gmonoacetate corresponding to Llysine USP 7.1 gL-methionine Ph. Eur. 2.80 gN-acetyl-L-cysteine 0.50 g Corresponding toL-Cysteine Ph. Eur. 0.37 gL-phenylalanine Ph. Eur. 3.80 gL-threonine Ph. Eur. 4.80 gL-tryptophan Ph. Eur. 1.90 gL-valine Ph. Eur. 6.20 gL-arginine Ph. Eur. 4.90 gL-histidine Ph. Eur. 4.30 gGlycine (Amino acetic acid) Ph. Eur. 3.20 gL-alanine Ph. Eur. 6.30 gL-proline Ph. Eur. 4.30 gL-serine Ph. Eur. 4.50 gL-malic acid 1.50 gGlacial acetic acid Ph. Eur. 1.38 g Other Excipients: Water for injections Ph. Eur.

Balanced supply of protein elements in acute and chronic renal insufficiently as well as during peritoneal and hemodialysis treatment.

15.03.2021

341

Composition of Amino acid Solution 5% for intravenous infusion (Pack size 500ml in Glass bottle)Per 1000ml solution for infusion contains:Active Ingredients QualityIsoleucine Ph. Eur 2.50 gLeucine Ph. Eur. 3.70 gLysine monoacetate 4.655 gcorresponding to Lysine USP 3.30 gMethionine Ph. Eur. 2.15 gPhenylalanine Ph. Eur. 2.55 gThreonine Ph. Eur. 2.20 gTryptophan Ph. Eur. 1.00 gValine Ph. Eur. 3.10 gArginine Ph. Eur. 6.00 gHistidine Ph. Eur. 1.50 gGlycine Ph. Eur. 5.50 gAlanine Ph. Eur. 7.00 gProline Ph. Eur. 5.60 gSerine Ph. Eur. 3.25 gTaurine 0.50 gTyrosine Ph. Eur. 0.20 gOther Excipients: Glacial acetic acid Ph. Eur.Water for injections Ph. Eur.

For supply of amino acids as part of a parenteral nutrition regimen

15.03.2021

342

Composition of Amino acid Solution 10% for intravenous infusion (Pack size 500ml in Glass bottle)Per 1000ml solution for infusion contains:Active Ingredients & Quality - L-Isoleucine Ph. Eur 5.00 g , L-Leucine Ph. Eur.7.40 g, L-Lysine monoacetate 9.31 g, corresponding to Llysine USP 6.60 g,L-Methionine Ph. Eur. 4.30 g,L-Phenylalanine Ph. Eur.5.10 g,L-Threonine Ph. Eur. 4.40 g,L-Tryptophan Ph. Eur. 2.00 g, L-Valine Ph. Eur. 6.20 g,L-Arginine Ph. Eur.12.00 g,L-Histidine Ph. Eur. 3.00 g,Glycine (Amino acetic acid)Ph. Eur. 11.00 g,L-Alanine Ph. Eur.14.00 g,L-Proline Ph. Eur.11.20 g,L-Serine Ph. Eur. 6.50 g,Taurine 1.00 g, L-Tyrosine Ph. Eur. 0.40 g,Other Excipients: Glacial acetic acid Ph. Eur.,Water for injections Ph. Eur

For supply of amino acids as part of a parenteral nutrition regimen

15.03.2021

343

Each extended release tablet contains:Pseudoephedrine Hydrochloride IP…120mgFexofenadine Hydrochloride IP……..60mg(Additional Dosage form)

It is indicated for the relief of symptoms associated with allergic rhinitis in adults and children 12 years of age and older.

19.03.2021

344

Dolutegravir Dispersible Tablets 10mg(Additional Dosage Form)

Each Tablet contains:Dolutegravir sodium equivalent to Dolutegravir 10mg

In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus type1 (HIV-l) infection in adults (treatment-naive or-experienced) and in pediatric patients (treatment-naive or -experienced but integrase strand transfer inhibitor [INSTI]-naive) aged at least 4 weeks and weighing at least 3 kg"WARNING: To be sold by retail on the prescription of a Specialist only”

23.03.2021

345

Sildenafil Citrate Oral Spray 12.5% w/v(Additional Dosage Form)

Each Spray (0.2ml) deliversSildenafil citrate equivalent to Sildenafil…….25 mg

For the treatment of Erectile Dysfunction in men“WARNING: To be sold by retail on the prescription of an Urologist, Psychiatrist and Endocrinologist only”

26-03-2021

346

Dexamethasone Tablets 6 mg(Additional Strength)

Each film coated tablet contains :Dexamethasone ……6 mg

Dexamethasone is indicated for treatment of variety of disorders in which systemic glucocorticoids are indicated including: • Neurology: Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a primary or metastatic brain tumour, craniotomy or head injury. • Dermatology: Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids, e.g. erythroderma, pemphigus vulgaris. • Autoimmune disorders/rheumatology: Initial treatment of autoimmune disorders like systemic lupus erythematodes, in acute gouty arthritis ,acute arthritis carditis, ankylosing spondylitis ,psoriatic arthritis , Severe progressive course of active rheumatoid arthritis Severe systemic course of juvenile idiopathic arthritis (Still's disease).• Haematological disorder: Idiopathic thrombocytopenic purpura in adults.• Oncologists only- for steroid responsive neoplastic disease like leukemias and lymphomas in adults only.

06.04.2021

347

Betahistine Hydrochloride Orally Disintegrating tablet 8mg/16mg/24 mg(New Dosage Form)

Each Uncoated Orally Disintegrating Tablet Contains:Betahistine Hydrochloride mg/16mg/24mgExcipients q.s.

Indicated for the symptomatic treatment of vertigo caused due to conditions including Menier’s syndrome

06.04.2021

348

Each Film coated bilayered tablets contains:Mirabegron (in extended release) + Solifenacin Succinate(50mg + 5mg & 25mg + 5mg)

It is indicated for the treatment of overactive bladder (OAB)

08.04.2021

349

Each 10ml liquid sachet contains:Sodium Hyaluronate BP………….1.24%Chondroitin Sulfate Sodium BP….3.12%Poloxamer IP (407)……………….2.7%Oral Liquid

For the treatment of symptoms of Gastro Esophageal Reflux Disease (GERD)

09.04.2021

350

Pegaspargase powder for solution for injection/ infusion(New Dosage Form & Indication)

Each vial contains:Pegaspargase ……3750 U(After reconstitution each ml contains 750U of Pegaspargase)

Indicated as a component of anti-neoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients

09.04.2021

351

Each pack (200 ml) contains:Zinc Sulphate Monohydrate IP ….0.0110gSodium Citrate IP………..0.5800gPotassium chloride IP……0.3000gSodium Chloride IP………0.5200gDextrose Anhydrous IP……2.7000g

Each pack (200 ml) contains:Zinc Sulphate Monohydrate IP ….0.0110gSodium Citrate IP………………..0.5800gPotassium chloride IP……………0.3000gSodium Chloride IP………………0.5200gDextrose Anhydrous IP…………..2.7000g

For oral rehydration in various etiology

15.4.2021

352

Ozenoxacin bulk and Ozenoxacin cream 1% w/w

Indicated for the topical treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes in adult and pediatric patients 2 months of age and older

15.04.2021

353

Drospirenone Tablets 4mg(New Dosage Form)

Each Film Coated Tablet Contains:Drospirenone ………4mg

Drospirenone is a Progestin intended for its use by females of reproductive potentials to prevent pregnancy

22.04.2021

354

Baricitinib Tablets 1mg, 2mg, & 4 mg(Additional Strength & Additional Indication)

Each Film Coated Tablet Contains:Baricitinib…1 mg/2mg/4 mg

Baricitinib, in combination with Remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)“WARNING: To be sold by retail on the prescription of specialist for use in Hospital/ Institutional set up only”

01.05.2021

355

2-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose 2.34g & 5.85g sachet

As an adjunct therapy only in moderate to severe Covid-19 patients

01.05.2021

356

Remdesivir Injection 100mg/20 ml (without Cyclodextrin)

Each ml ContainsRemdesivir...5 mg

For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID19) in adults and children hospitalized with moderate to severe disease“WARNING: To be sold by retail on the prescription of specialist for use in Hospital/ Institutional set up only”

06.05.2021

357

Capmatinib 150mg and 200mg film coated tablets

Capmatinib is a kinase inhibitor indicated for the treatment of adult patient with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal epithelial transition (MET) exon 14 skipping.

12.05.2021

358

Rucaparib camsylate bulk and Rucaparib tablets 200mg/300mg

Ovarian cancer • For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. • For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDAapproved companion diagnostic for RUBRACA.Prostate cancer • For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic) associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

12.05.2021

359

Each Film Coated tablets contains:L-Tyrosine USP……………60mgHistidine Hydrochloride Monohydrate BP eq. to Histidine…………………76mgL-Tryptophan USP…………46mgL-Threonine USP………….106mgL-Lysine Acetate USP…......210mgCalcium-DL-2-hydroxy-4(methylthio)Butyrate (α-Ketoanalogue to MethionineCalcium salt) IH…...........118mgCalcium-3-Methyl-2 Oxo-Butyrate (α-Ketoanalogue to Valine Calcium salt) IH…………………………..172mgCalcium-2-Oxo-3-Phenylpropionate (α-Ketoanalogue to Phenylalanine Calcium salt) IH………………136mgCalcium-4-Methyl-2-Oxo-Valerate (α-Ketoanalogue to Leucine Calcium salt) IH…………………………….202mgCalcium-3-methyl-2-Oxo-Valerate (α-Ketoanalogue to Isoleucine Calcium salt) IH…............……..………….134mg

Each Film Coated tablets contains:L-Tyrosine USP……………60mgHistidine Hydrochloride Monohydrate BP eq. to Histidin……76mgL-Tryptophan USP…………46mgL-Threonine USP………….106mgL-Lysine Acetate USP…......210mgCalcium-DL-2-hydroxy-4(methylthio)Butyrate (α-Ketoanalogue to MethionineCalcium salt) IH…...........118mgCalcium-3-Methyl-2 Oxo-Butyrate (α-Ketoanalogue to Valine Calcium salt IH……………..172mgCalcium-2-Oxo-3-Phenylpropionate (α-Ketoanalogue to Phenylalanine Calcium salt) IH………………136mgCalcium-4-Methyl-2-Oxo-Valerate (α-Ketoanalogue to Leucine Calcium salt) I……….202mgCalcium-3-methyl-2-Oxo-Valerate (α-Ketoaalogue to Isoleucine Calcium salt) IH….......134mg

Prevention and treatment of damages due to faulty of or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40g/day or less (adult). Usually this applies to patients whose glomerular filtration rate (GFR) is less than 25ml/min

18.05.2021

360

Favipiravir Oral suspension 100mg/ml(New Dosage Form)

Each ml contains:Favipiravir…….. ....100mg

For the treatment of patients with mild to moderate Covid19 disease“Warning To be sold on prescription of medical specialist”

19.

361

Posaconazole DelayedRelease Tablets(Additional Indication)

Each Delayed Release Tablets contains:Posaconazole ……. 100mg

·For the treatment oforopharyngeal candidiasis, including oropharyngeal candidiasis refractory to Itraconazole and/or fluconazole for prophylaxisof invasive Aspergillus and Candida infections in patients, 13 years of age and older, 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 from chemotherapy.· Zygomycosis (Mucormycosis) in patients with diseases refractory to other therapy ,or or patients who are intolerant to other therapy“Warning To be sold on prescription of medical specialist”

28.05.2021

362

Trientine Tetrahydrochloride bulk and Trientine Tetrahydrochloride capsules 333 mg(Each capsule contains Trientine tetrahydrochloride 333mg equivalent to Trientine 167mg base)

Trientine Tetrahydrochloride bulk and Trientine Tetrahydrochloride capsules 333 mg (Each capsule contains Trientine tetrahydrochloride 333mg equivalent to Trientine 167mg base)

For the treatment of Wilson's disease (hepatolenticular degeneration) in patients intolerant to Penicillamine. It should be used when continued treatment with Penicillamine is no longer possible because of intolerable or life endangering side effects

08.06.2021

363

Methylcobalamin Nasal Spray 250mcg/0.1ml

For treatment and maintenance therapy of Vitamin B12 deficiency in patients

09.06.2021

364

Rucaparib tablets 250 mg

Ovarian cancer• For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.• For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDAapproved companion diagnostic for RUBRACA.Prostate cancer• For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic) associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

18.06.2021

365

Vigabatrin bulk and Vigabatrin powder for oral solution 500mg

For the treatment of1) Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin for Oral Solution, USP, 500 mg is not indicated as a first line agent.2) Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss

18.06.2021

366

Cangrelor tetra sodium bulk and Cangrelor for injection 50mg/vial

Indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revarscularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor

21.06.2021

367

Each 5ml sustained release oral suspension contains:Dextromethorphan Polistirex eq. to Dextromethorphan Hydrobromide IP 30mg Chlorpheniramine Polistirex eq. to Chlorpheniramine Maleate IP ……….4mgMethyl Paraben IP …………………10mgPropyl paraben IP ………………….1mg

For the temporary relief of cough, due to throat irritation, sneezing and running nose

23.06.2021

368

Ulinastatin for Injection 200, 000 IU (Liquid)

• For the treatment of severe sepsis.• For the treatment of mild and severe acute pancreatitis

24.06.2021

369

Rifapentine bulk and FDC of Isoniazid and Rifapntine (300mg/300mg)

Indicated for treatment of latent tuberculosis, caused by Mycobacterium tuberculosis (For use in NTEP only)

28.06.2021

370

Remogliflozin Etabonate……100mgTeneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin ………10mg

Each tablet contains:RemogliflozinEtabonate……100mgTeneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin ……10mg

It is indicated in adults aged 18 years and older with type 2 diabetes mellitus: · To improve glycaemic control when Metformin and one of monocomponents of fixed dose combination of RemogliflozinEtabonate& Teneligliptin do not provide adequate glycaemic control, · When already being treated with the free combination of RemogliflozinEtabonate& Teneligliptin.

28.06.2021

371

Clozapine Tablet 12.5 mg(Additional Strength)

Each uncoated tablet contains:Clozapine12.5 mg

Indicated in the management ofschizophrenic patients"WARNING: To be sold by retail on the prescription of Neurologist only”

29.06.2021

372

Sorafenib 400 mg Tablet(Additional Strength)

Each film coated tablets contains :Sorafenib Tosylate eq. to Sorafenib…400 mg

For the treatment of hepatocellular carcinoma, advanced renal cell carcinoma and locally advance or metastatic differentiated thyroid carcinoma refractory to radioactive iodine"WARNING: To be sold by retail on the prescription of Oncologist only”

30.06.2021

373

Lemborexant tablets 5 mg and 10 mg

Treatment for insomnia

01.07.2021

374

Each capsule contains:Tamsulosin Hydrochloride IP (as prolonged release pellet)……..0.4mgTadalafil IP (as film coated tablet)……5mg

Substitution therapy in treatment of benign prostatic hyperplasia and erectile dysfunction in patients who are already taking Tamsulosin and Tadalafil concomitantly

02.07.2021

375

Rosuvastatin Calcium IP eq. to Rosuvastatin………………..20mg(as film coated immediate release tablet) Choline Fenofibrate IP eq. to Fenofibric acid(as delayed release tablet)…..135mg

Each hard gelatin capsule contains:Rosuvastatin Calcium IP eq. to Rosuvastatin………………..20mg(as film coated immediate release tablet)Choline Fenofibrate IP eq. to Fenofibric acid(as delayed release tablet)…..135mg

For the treatment of mixed dyslipidemia

06.07.2021

376

Favipiravir Powder for Oral suspension 800mg(AdditionalDosage Form)

Each sachet contains:1.5g of Favipiravir powder contains:Favipiravir...........800 mgExcipients.....q.s

For the treatment of patients with mild to moderate Covid-19 disease“WARNING: To be sold on the prescription of medical specialist”

06.07.2021

377

Each 1 g contains:Lincomycin Hydrochloride…….0.222gSpectinomycinsulphate………..0.445g

Poultry: For prevention and treatment of Chronic Respiratory Disease(CRD)/airsacculitis caused by Mycoplasma spp. And CCRD (Complicated Chronic Respiratory Disease) associated with Mycoplasma and coliform infections ofpoultry susceptible to the combination of lincomycin and spectinomycin. Swine(pigs): For the treatment of swine dysentery, bacterial enteritis caused by Ecoli or Salmonella spp., porcine proliferative enteropathy (Ileitis) caused by Lawsoniaintracellularis and infectious arthritis caused by organismssusceptible to the combination of lincomycin and spectinomycin. [This drug combination will be used for therapeutic purpose (not for the growth promotion purpose) considering the growing concernof Antimicrobial resistance]

09.07.2021

378

Heparin Sodium Topical Solution 1000 IU/ml(Additional Indication)

Each ml contains :Heparin Sodium…..........1000 IU/mlAbsolute Alcohol……….10.00% v/vTopical Solution base…….q.s.

For Prevention of infusion associated phlebitis"WARNING: To be sold by retail on the prescription of Specialists only”

09.07.2021

379

Cetilistat bulk and Cetilistat 120 mg tablets

For the treatment of Obseity (limited to patients with both type 2 diabetes mellitus and dyslipidaemia, and with a BMI ≥ 25 kg/m2 inspite of dietary treatment and /or excersise therapy)

09.07.2021

380

Benzonatate bulk and Benzonatate capsules 100mg

For the treatment of refractory cough

15.07.2021

381

Each film coated tablet contains:Dextromethorphan Hydrobromide IP……………..10mgPhenylephrine Hydrochloride IP…..5mgChlorpheniramine Maleate IP…..2mg

Indicated for relief from the symptoms of common cold and nasal congestion and associated fever due to allergic reactions.

16.07.2021

382

Fluticasone Furoate………………..27.5mcgOxymetazoline Hydrochloride IP…50mcg Composition:Fluticasone Furoate……..0.028%w/wOxymetazoline Hydrochloride IP………………………..0.050%w/wBenzalkonium Chloride solution IP………..0.030%w/w

Each spray delivers contains:Fluticasone Furoate………………..27.5mcgOxymetazoline Hydrochloride IP…50mcg Composition:Fluticasone Furoate……..0.028%w/wOxymetazoline Hydrochloride IP………………………..0.050%w/wBenzalkonium Chloride solution IP………………………..0.030%w/w

Indicated for the treatment of symptoms of allergic rhinitis with nasal congestion

16.07.2021

383

Dydrogesterone IP……2.5mgEstradiol EP…………0.5mg

Each tablets contains:Dydrogesterone IP……2.5mgEstradiol EP…………0.5mg

For the treatment of Hormone replacement therapy (HRT) in estrogen deficiency in postmenopausal women with a uterus

16.07.2021

384

Cariprazine hydrochloride bulk and Cariprazine capsules 1.5mg/3mg/4.5mg and 6mg

For the treatment of Schizophrenia in adults. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults

16.07.2021

385

Acetylsalicylic acid effervescent Tablets 500 mg

Analgesic & Anti pyretic

16.07.2021

386

Pemetrexed for injection 1000mg (Lyophilized)(Additional Strength)

Each vial contains:Pemetrexed Disodium heptahydrate IP equivalent to Pemetrexed……1000mg

1. Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. First line treatment Should be a platinum doublet with gemcitabine, paclitaxel or docetaxel.2. In combination with cisplatin is indicated for the first line treatment of patients with locally advancedor metastatic non-small cell lung cancer other than predominantly squamous cell histology.3. As monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.4. As monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has to progressed immediately following platinum based chemotherapy.

16.07.2021

387

Amikacin Injection 750 mg/3ml & 100mg/4ml

Amikacin Injection is indicated in the treatment of serious infections due to Amikacin sensitive organisms

23.07.2021

388

Riboflavin Sodium Phosphate IP eq. to Riboflavin 0.1 % w/v with Hypromellose Ophthalmic Solution in PFS (Pack Size is 3.0ml)(Additional Pack Size)

Each ml contains:Riboflavin Sodium Phosphate IP Eq. to Riboflavin …0.1% w/vHypromellose I.P…….1.1%w/v

To treat keratoconus and corneal ectasia following refractive surgery

27.07.2021

389

Composition of Hydroxyl Ethyl Starch 6% Solution for infusion (Pack Size-250ml, 500ml) Per 1000ml solution for infusion contains:Poly (O-2-hydroxyethyl) starch….60.00gSodium Chloride Ph. Eur. ……….9.00gOther Excipients: Sodium hydroxide Ph. Eur.Hydrochloride acid Ph. Eur.,Water for injections Ph. Eur.Electrolytes: Na+, C1-154 mmo1, 154 mmo1

For the treatment and prophylaxis of hypovolaemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma

29.07.2021

390

Each Combipack contains:One Tablet of Netupitant300mg (each film coated)andOne tablet of Palonosetron Hydrochloride USP eq. to Palonosetron0.5mg (each uncoated tablet)

Each Combipack contains:One Tablet of Netupitant300mg (each film coated)andOne tablet of Palonosetron Hydrochloride USP eq. to Palonosetron0.5mg(each uncoated tablet)

For the prevention of acute and delayed nausea and vomiting associated with highly emetogenic Cisplatin-based cancer chemotherapy. · For the prevention of acute and delayed nausea and vomiting associated with moderate emetogenic cancer chemotherapy

29.07.2021

391

Gadoteridol 279.3 mg/ml for injection

For intravenous use in magnetic reasonance imaging (MRI) in adults and pediatric patients over 2 years of age for whole body MRI including the head, neck, liver, breast, musculoskeletal system and soft tissue pathologies

29.07.2021

392

Amorolfine Lotion 0.25% w/v(Additional Dosage Form)

Each ml contains:Amorolfine Hydrochloride Equivalent to Amorolfine…….0.2 5% w/v

For the treatment of dermatomycosis caused by dermatophytes, cutaneous candidiasis and pityriasisversicolor"WARNING: To be sold by retail on the prescription of an Dermatologist only”

29.07.2021

393

Magnesium chloride Hexahydrate 0.3gm + Potassium chloride 0.3gm + Sodium chloride 6.02gm + Sodium acetate Trihydrate 4.63gm + Poly (O-2-hydroxyethyl) starch 60gm per 1000ml solution for infusion(Pack size 250ml & 500ml)

For the treatment and prophylaxis of hypovolaemia in adults and children. It is not a substitute for red blood cells or coagulation factors in plasma

30.07.2021

394

Silodosin Tablet 8 mg(Additional Dosage Form)

Each film coated tablets contains :Silodosin…8 mg

For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only"WARNING: To be sold by retail on the prescription of a Urologist only”

30.07.2021

395

1. Sodium Alginate IP 250mg + Sodium Bicarbonate IP 106.5mg + Calcium Carbonate IP 187.5mg chewable tablet2. Sodium Alginate IP 250mg + Sodium Bicarbonate IP 106.5mg + Calcium Carbonate IP 162.5mg per 5ml suspension

Heartburn and Indigestion

05.08.2021

396

Remdesivir Injection 100mg/20ml (5mg/ml)(with Hydroxypropyl Betadex as Excipent)

Each ml contains:Remdesivir…5mgHydrocypropyl Betadex (As excipient)…300mg

For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and children hospitalized 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 set up only”

05.08.2021

397

Bilastine Tablets 40mg(Additional Strength)

Each film-coated tablet contains :Bilastine ……40mg.

For the treatment of Chronic Spontaneous Urticaria The firm should conduct an active PMS study. Accordingly, the firm should submit active PMS protocol for review by the committee"WARNING: To be sold by retail on the prescription of Dermatologist only”

06.08.2021

398

Enzalutamide Hard Gelatin Capsules 80mg(Additional Indication)

Each Hard Gelatin Capsule contains :Enzalutamide……..80mg

In the treatment of adult men with metastatic castrationresistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated."WARNING: To be sold by retail on the prescription of Oncologist only”

06.08.2021

399

Triptorelin powder for Injection 3.75 mg/vial(Additional Indication)

Each pack contains:One vial of Triptorelin pamoate for injectionEach single dose vial contains:(Sterile Lyophilized) Triptorelin pamoate equivalent to Triptorelin ….. 3.75 mgExcipients…….q.s.

Indicated for the adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of hormone receptor-positive early stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after completion of chemotherapy”.“WARNING: To be sold by retail on the prescription of Oncologist only”

06.08.2021

400

Lorlatinib tablets 25/100 mg(Additional Indication)

Each film-coated tablets contains:Lorlatinib……25mg/100mg

Lorlatinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) positive“WARNING: To be sold by retail on the prescription of oncologist only”

06.08.2021

401

Palbociclib Capsules and Palbociclib Tablets 75/100/125 mg (Additional Indication)

Each Hard Gelatin Capsule contains:Palbociclib……… ….75mg/100mg/125 mgEach FilmCoated Tablets contains:Palbociclib……… ….75mg/100mg/125mg

“Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)- negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy and with Fulvestrant in patients who have received prior therapy for Male patients"“WARNING: To be sold by retail on the prescription of oncologist only

06.08.2021

402

Itraconazole Capsule 130 mg(Suprabioavailable formulation)(Additional Strength, Modified Dosage form)

Each Capsule Contains:Itraconazole……… ..130 mg

Itraconazole 130 mg Capsule is indicated for the treatment of the following fungal infections in immunocompromised and non- immunocompromised adult patients:· Blastomycosis, Pulmonary and Extra pulmonary· Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, nonmeningeal histoplasmosis.· Aspergillosis, pulmonary and extra-pulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy"WARNING: To be sold by retail on the prescription of a Specialist only”

09.08.2021

403

Atorvastatin Calcium IP Eq. to Atorvastatin…………..40mg ClopidogrelBisulphate IP Eq. to Clopidogrel……………75mg (Additional Strength)

Each hard gelatin capsule contains:Atorvastatin Calcium IP Eq. to Atorvastatin…………..40mgClopidogrelBisulphate IP Eq. to Clopidogrel……………75mg(Additional Strength)

For the treatment of dyslipidemia associated with atherosclerotic arterial disease with risk of myocardial infarction, stroke or peripheral vascular disease

13.08.2021

404

Lamivudine IP…….300mg Dolutegravir Sodium eq. to Dolutegravir……….50mg

Each Film Coated Tablet contains:Lamivudine IP…….300mgDolutegravir Sodium eq. to Dolutegravir……….50mg

Indicated as a complete regimen for the treatment of human immunodeficiency virus type1 (HIV-1) infection in adults with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components.

13.08.2021

405

Ropivacaine Hydrochloride IP Eq. to anhydrous Ropivacaine Hydrochloride……………7.5mgDextrose (Monohydrate) IP……………….80mgWater for Injections IP……..q.s

Each ml contains:Ropivacaine Hydrochloride IP Eq. to anhydrous Ropivacaine Hydrochloride……………7.5mgDextrose (Monohydrate) IP……………….80mgWater for Injections IP……..q.s

For the patients undergoing lower limb orthopedic surgeries under Spinal Anesthesia.

13.08.2021

406

Darolutamide 300mg film coated tablets

Each film coated tablets contains :Darolutamide …...300mg

For the treatment of patients with nonmetastatic castration resistant prostate cancer (nmCRPC)

13.08.2021

407

Tetracosactide BP bulk and Tetracosactide injection BP 250 mcg/ml

Diagnostic test for the investigation of adrenocortical insufficiency

14.08.2021

408

Progesterone Solution for Injection (50mg/2.237ml)(Additional Strength)

Each Vial (2.237ml) Contains:Progesterone …………………. 50mg (22.35 mg/ml)Water for Injections IP…………q.s

Indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations. "WARNING: To be sold by retail on the prescription of a Gynecologists only”

17.08.2021

409

Estradiol 1.53 mg/ actuation, Transdermal spray, solution(Additional dosage form and Additional Indication)

Each actuation deliversEstradiol Ph. Eur……………… …1.53 mg(Equivalent to 1.58mg Estradiol hemihydrate)Ethanol 96% USP …………………0.09 ml(Octisalate USP and Ethanol 96% used as excipients)

Hormone Replacement Therapy (HRT) for Estrogen deficiency symptoms in Peri / postmenopausal women (in women at least 6 months since last menses or surgical menopause, with or without a uterus). The experience in treating women older than 65 years is limited Firm should conduct active Post Marketing Surveillance study to assess the safety and efficacy. Firm shouldsubmit the results of the PMS study within one year from date of approval.“WARNING: To be sold by retail on the prescription of Gynecologists only”

17.08.2021

410

Posaconazole Gastro Resistant Tablets 300 mg(Additional Indication)

Each Gastro Resistant Tablets Contains:Posaconazol … .300 mg

For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, 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 from chemotherapy. Zygomycosis (Mucormycosis). in patients with disease refractory to other therapy, or patients who are intolerant of other therapy"WARNING: To be sold by retail on the prescription of a Medical Specialist only”

17.08.2021

411

Mesalazine Prolonged Release Granules 1gm & 2gm(Additional dosage form & strength)

(i) Mesalazine Prolonged Release Granules 1gmEach Sachet Contains:Mesalazine ………… 1gmExcipients …………...q.s (as film coated granules)(ii) Mesalazine Prolonged Release Granules 2gmEach Sachet Contains:Mesalazine ………… 2gmExcipients …………... q.s (as film coated granules)

Chronic inflammatory bowel disease (Ulcerative Colitis and Crohn’s disease)

17.08.2021

412

Cyclosporine Ophthalmic Solution 0.09% w/v(Additional dosage & Additional Indication)

Each ml contains:Cyclosporine IP………………0.09 mgAqueous Buffered Vehicle…………q. s

Indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). Firm required to conduct Phase IV clinical trial. Accordingly firm should submit phase IV protocol “WARNING: To be sold by retail on the prescription of Ophthalmologist only”

23.08.2021

413

Azacitidine Tablets 300 mg(New Dosage form & Additional Indication)

Each film coated tablet contains:Azacitidine IP …………300 mg

For continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRI) following intensive induction chemotherapy and are not able to complete intensive curative therapy "WARNING: To be sold by retail on the prescription of Oncologist only”

23.08.2021

414

Minoxidil Topical Solution 2% and 5%(Additional Indication)

Minoxidil Topical Solution 2% Each ml contains:Minoxifil IP 20mg Alcohol (95%) IP equivalent to absolute alcohol 63% v/vMinoxidil Topical Solution 5% Each ml contains:Minoxifil IP 50mg Alcohol (95%) IP equivalent to absolute alcohol 40% v/v

For the treatment of androgenic alopecia in females (female pattern hair loss)"WARNING: To be sold by retail on the prescription of a Dermatologist only”

02.09.2021

415

Moxifloxacin Ophthalmic Solution 0.5% w/v(Additional Indication)

Each ml of Ophthalmic Solution contains:Moxifloxacin Hydrochloride equivalent to Moxifloxacin base…5 mg

Indicated for sterilization during the perioperative period of ophthalmic surgery“WARNING: To be sold by retail on the prescription of Ophthalmologists only”The firm should submit protocol for active PMS Study

02.09.2021

416

Pemetrexed Solution for Infusion 5mg/ml, 6mg/ml, 6.5mg/ml, 7mg/ml, 7.5mg/ml, 8mg/ml, 8.5mg/ml, 9mg/ml, 10mg/ml & 11mg/ml (100ml ready to use infusion bag(Additional Dosage Form)

Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed…5mg Sodium Chloride ………………9mgWater for Injections ………………. q. s.Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 6mgSodium Chloride ……………… 9mgWater for Injections...….…………q. s.Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 6.5mgSodium Chloride …9mgWater for Injections ………………. q.s.Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed….7mgSodium Chloride ……………….9mgWater for Injections ………………. q. s.Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 7.5mgSodium Chloride………………………9mgWater for Injections.………………. q. sEach ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed…...8mgSodium Chloride ………………………9mgWater for Injections ………………q. s.Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 8.5mgSodium Chloride .......……………….9mgWater for Injections ………………q. s.Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed….9mgSodium Chloride …………………….9mgWater for Injections ………………. q. s.Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 10mgSodium Chloride ….…………….9mgWater for Injections ….…………….q. s.Each ml Contains:Pemetrexed Disodium Heptahydrate Equivalent to Pemetrexed 11mgSodium Chloride ……………….9mgWater for Injection ..........q.s.

1. Malignant pleural mesothelioma: · In combination with Cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.2. Non-Small Cell Lung Cancer (NSCLC):· In combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology.· As a monotherapy for the second-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology.· As a monotherapy for the maintenance treatment of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.· In combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC), with no EGFRor ALK genomic tumor aberrations."WARNING: To be sold by retail on the prescription of anoncologist only”

03.09.2021

417

Isoniazid IP…………300mgRifampentine…………..300mg(Additional Indication)

Each Film Coated tablet contains:-Isoniazid IP…………300mgRifampentine…………..300mg(Additional Indication)

For the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in patients who are at risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph)

09.06.2021

418

Sodium Alginate IP……….500mg Sodium Bicarbonate IP……213mg Calcium Carbonate IP……..325mgOral Suspension

Each 10 ml contains:-Sodium Alginate IP……….500 mgSodium Bicarbonate IP……213 mgCalcium Carbonate IP……..325mgOral Suspension

Heartburn and indigestion

07.09.2021

419

Cabozantinib (S) - Maleate bulk and Cabozantinib tablets 20mg, 40mg and 60mg

Each tablets contains :Cabozantinib ……20mg, 40 mg, 60 mg

(1) For the treatment of patients with advanced renal cell carcinoma (RCC).(2) For the treatment of patients with Hepatocellular Carcinoma (HCC) who have been previously treated with sorafenib.

10.09.2021

420

1. Solution for Infusion 1000ml (NutriflexPeri)Upper Chamber contains (400mI): Isoleucine 2.34gm + Leucine 3.13gm + Lysine Hcl 2.84gm as Lysine 2.27gm + Methionine 1.96gm + Phenylanine 3.51gm + Threonine 1.82gm + Tryptophan 0.57gm + Valine 2.60gm + Arginine Monoglutamate 4.98gm as Arginine 2.70gm + Glutamic Acid 2.28gm + Histidine HCI Monohydrate 1.69gm as Histidine 1.25gm + Alanine 4.85gm + Aspartic Acid 1.50gm + Glutamic Acid 1.22gm + Glycine 1.65gm + Proline 3.40gm + Serine 3.00gm + Magnesium Acetate Tetrahydrate 0.86gm + Sodium Acetate Trihydrate 1.56gm + Potassium Dihydrogen Phosphate 0.78gm + Potassium Hydroxide 0.52gm + Sodium Hydroxide 0.50gm Lower Chamber Contains (600mI): Glucose Monohydrate 88.0gm as Anhydrous Glucose 80gm + Sodium Chloride 0.17gm + Calcium Chloride Dihydrate 0.37gm

Supply of the daily requirement of energy, amino acids, electrolytes, and fluids during Parenteral nutrition for patients with mild to moderately severe catabolism when oral or enteral nutrition is impossible, insufficient or contraindicated.

13.09.2021

421

13.09.2021

422

Tofacitinib Tablets 5mg(Additional Indication)

Each Film coated tablets contains:Tofacitinib citrate equivalent to Tofacitinib…… 5mg

In treatment of adult patient with moderately to severely active Ulcerative Colitis (UC), who have an inadequate response and who are intolerant to TNF blockers“WARNING: To be sold by retail on the prescription of Rheumatologist, Gastroenterologist, Hepatologist or “Specialist in internal Medicine only”

13.09.2021

423

Tipiracil hydrochloride bulk and FDC of1) Trifluridine 15mg + Tipiracil 6.14mgand2) Trifluridine 20mg + Tipiracil 8.19mg

Indicated for the treatment of i) adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an antiVEGF biological therapy, and if RAS wildtype, an anti-EGFR therapy ii) Adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/ neu-targeted therapy.

16.09.2021

424

Selumetinib 10mg & 25mg capsule

Each capsule contains :Selumetinib 10mg & 25mg

Indicated for the treatment of Pediatric patients 3 years of age and older with neurofibromatosis type 1 (NF1) and who have symptomatic, inoperable plexiform neurofibromas (PN).

17.09.2021

425

Biapenem sterile bulk and Biapenem for injection 300mg

Complicated urinary tract infections

17.09.2021

426

Dapagliflozin Propanedilol Monohydrate eq. to Dapagliflozin + Vildagliptin IP (as sustained release) + Metformin Hydrchloride IP (as sustained release) uncoated bilayered tablets(5mg + 100mg + 500mg & 5mg + 100mg + 1000mg)

For the treatment of patients with type 2 Diabetes mellitus.

06.02.2023

427

Prucalopride Orally Disintegrating Strips 1/2 mg(Additional Dosage Form)

Each Orally Disintegrating Strips Contains:Prucalopride succinate is equivalent to Procalopride ……… 1 mg/2 mg

For the treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief

27.09.2021

428

Each Kit contains:A) 14 nos. Rivaroxaban tablets 2.5mgEach film coated tablet contains: Rivaroxaban…………..2.5mgB) 07 nos. Aspirin tablets 75mgEach gastro resistant tablet contains: Aspirin IP………………75mg

Rivaroxaban in combination with Aspirin is indicated to reduce the risk of major cardiovascular events (Cardiovascular (CV) death, myocardia infarction (MI) and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD)

01.10.2021

429

Itraconazole Capsule BP 65 mg (Suprabioavailable formulation)(Additional Strength)

Each Capsule Contains:Itraconazole……… …65 mg

Itraconazole 65 mg Capsule (Supra-bioavailable formulation) is indicated for the treatment of the following fungal infections in immunocompromised and nonimmunocompromised adult patients: · Blastomycosis, Pulmonary and Extra pulmonary · Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis. · Aspergillosis, pulmonary and extra-pulmonary, in patients who are intolerant of or who arerefractory to amphotericin Btherapy The package insert should contain the following caution “This Itraconazole CapsulesBP 65mg (Supra-bioavailable formulation) is not interchangeable or substitutable with other Itraconazole products due to the differences in dosing between Itraconazole capsule BP 65 (Suprabioavailable formulation) and other Itraconazole products"WARNING: To be sold by retail on the prescription of a Specialist only”

08.10.2021

430

Remdesivir Injection 100mg/ml (1ml/vial) (Single dose vial)(Additional Strength)

Each ml contains:Remdesivir …………………100 mgAlcohol ……………….20% w/vBenzyl alcohol………5%w/v

For treatment of suspected or laboratory confirmed corona virus disease 2019 (COVID-19) in adults and children hospitalised with moderate to severe disease“WARNING: To be sold by retail on the prescription of specialist for use in Hospital/ Institutional set up only”

08.10.2021

431

Azacitidine Tablets 200mg(Additional Strength)

Each film coated tablet contains:Azacitidine IP …………………200 mg

For continued treatment of patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy"WARNING: To be sold by retail on the prescription of Oncologist only”

14.10.2021

432

Empagliflozin Tablets 10/25mg(additional Indication)

Each Film coated tablets contains:Empagliflozin ………… ……. 10/25mg

To reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction

25.10.2021

433

Each hard gelatin capsule contains:Pregabalin IP + Duloxetine Hydrochloride IP eq. to Duloxetine (as delayed release pellets)(75mg + 20mg, 50mg + 20mg & 75mg + 30mg) ±

Each hard gelatin capsule contains:Pregabalin IP + Duloxetine Hydrochloride IP eq. to Duloxetine(as delayed release pellets)(75mg + 20mg, 50mg + 20mg & 75mg + 30mg) ±

For the treatment of Neuropathic pain

25.10.2021

434

Each uncoated bilayered tablet contains: -Efonidipine Hydrochloride Ethanolate (as immediate release) ……………40mg S (-)Metoprolol Succinate eq. to S (-) Metoprolol Tartrate (as prolonged release)………25mg

Each uncoated bilayered tablet contains: -Efonidipine Hydrochloride Ethanolate (as immediate release) ………40mg S (-)Metoprolol Succinate eq. to S (-) Metoprolol Tartrate(as prolonged release)…...25mg

It is indicated for the management of hypertension.

26.10.2021

435

Each 10 ml contains:Sodium Alginate IP ………………1000mgPotassium Hydrogen Carbonate Ph. Eur……..……200mgOral Suspension

To treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or withdrawal of acid suppressing therapy

01.11.2021

436

Clobazam Mouth Dissolving Tablets 2.5 mg(Additional Dosage Form)

Each uncoated mouth dissolving tablet contains:Clobazam 2.5 mg

As an adjunctive therapy in patients with refractory epilepsy"WARNING: To be sold by retail on the prescription of Neurologist/Psychiatrist only”

01.11.2021

437

Pegylated Liposomal Irinotecan 4.3mg/ml(Additional Dosage Form)

Each vial contains:Pegylated Liposomal Irinotecan……4.3 mg/ml

Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5- FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy“WARNING: To be sold by retail on the prescription of Oncologist only”

01.11.2021

438

Amantadine Extended Release Tablets 129 mg and 193 mg(Additional Dosage Form)

Each extended release film coated tablets contains:Amantadine Hydrochloride equivalent to Amantadine……129 mg and 193 mg

For the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients Firm should conduct a PhaseIV Clinical Trial protocol before the Committee prior to launch of the product in the market"WARNING: To be sold by retail on the prescription of a Neurologist only”

01.11.2021

439

Gemcitabine Hydrochloride Injection 10mg/ml(220 ml ready to use infusion bag)(Additional Pack Size)

Each ml contains:Gemcitabine Hydrochloride equivalent to Gemcitabine ……10mg/ml

· Ovarian cancer – Gemcitabine injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum based therapy.· Breast cancer – Gemcitabine injection in combination with paclitaxel is indicated for the first line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated · Non-small cell lung cancer – Gemcitabine injection is indicated in combination with cisplatin for the first line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer · Pancreatic cancer – Gemcitabine injection is indicated as first line treatment for patient with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine injection is indicated for patients previously treated with 5-FU"WARNING: To be sold by retail on the prescription of an Oncologist only”

02.11.2021

440

Each 5 gram contains:Sildenafil Citrate IP eq. to Sildenafil ...100mgDapoxetine Hydrochloride eq. to Dapoxetine….......60mg Oral Jelly(In Additional Dosage form)

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

09.11.2021

441

Clindamycin Phosphate USP …1.2%Benzoyl Peroxide USP …………….5%Topical gel

For the treatment of Acne Vulgaris

09.11.2021

442

Each film coated tablet contains:-Sitagliptin Phosphate eq. to Sitagliptin IP + Metformin Hydrochloride IP(as an extendedrelease form)(100mg +1000mg & 100mg + 500mg)

It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Sitagliptin and Metformin is appropriate.

11.11.2021

443

Baricitinib Tablets 2 mg & 4 mg(Additional Indication)

Each Film Coated Tablet Contains:Baricitinib………..2 mg/4 mg

Baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)“WARNING: To be sold by retail on the prescription of specialist for use in Hospital/ Institutional set up only”

15.11.2021

444

Each Capsule contains:Aspirin (eneteric coated pellets form)…75mgAtorvastatin (As pellets form)…………20mg

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

23.11.2021

445

Faropenem Sodium for Oral Suspension 100mg/5ml(Additional Dosage Form)

Each 5ml of reconstituted suspension Contains:Faropenem Sodium equivalent to Faropenem………… …100mg

For the treatment of superficial and deep skin infections like chronic pyoderma, Pharyngitis/laryngitis and ENT infections like Otitis media, Tonsillitis, Sinusitis, Acute tracheo-bronchitis, Bacterial pneumonia, UTls like cystitis, Pyelonephritis, Lymphangitis/Lymphadenitis, Teeth Periodontitis, Scarlet fever and Whooping cough

24.11.2021

446

Teriparatide Injection solution for injection in a pre-filled pen 600 mcg/2.4 ml(Synthetic Origin)

Each ml contains:Teriparatide (Synthetic Origin)…….250 mcgMannitol ….45.4 mgGlacial Acetic Acid …………...0.41mgSodium Acetate Anhydrous ….0.1mgMetacresol….3.0 mg (as Preservative)Sodium Hydroxide IP q.s. for pH adjustmentHydrochloric Acid IP q.s. for pH adjustmentWater for Injections IP q.s. to 1.0ml

1.For the treatment of men and postmenopausal women with osteoporosis who are at a high risk of fracture. It increases bone mineral density (BMD) and reduces the risk of vertebral and non-vertebral fractures2. It is also indicated for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture Firm shall submit Phase IV clinical trial study protocol within three months of approval

25.11.2021

447

Each film coated tablets contains:-Amlodipine Besylate USP Eq. to Amlodipine………….10mgOlmesartan Medoxomil USP ……40mg(In Additional Strength)

1. For the treatment of hypertension alone or with other antihypertensive agents.2. To use as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.

25.11.2021

448

Each ml contains:-Levobupivacaine Hydrochloride eq. to Levobupivacaine………………5mgDextrose (Monohydrate) IP…… 80mgWater for injections IP………..Q.S

Each ml contains:-Levobupivacaine Hydrochloride eq. to Levobupivacaine…………5mgDextrose (Monohydrate) IP……80mgWater for injections IP………..Q.S

For spinal anesthesia in adults patients

26.11.2021

449

Calcium Polystyrene Sulphonate Suspension 15g/60ml(Additional Dosage Form)

Each 60ml contains:Calcium Polystyrene Sulphonate…….. 15gExcipients……q.s

For the treatment of hyperkalemia associated with oliguria, anuria or dialysis

30.11.2021

450

Tafamidis soft gelatin capsules 61 mg

Each Capsules contains:Tafamidis …..........61 mg

Indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRCM)

30.11.2021

Published by Fedley Healthcare on 6 September 2025

CDSCO approved drugs in India

Looking for PCD Pharma Franchise?