Approved Drugs
Indian drug-approval records, from 2026 back to 1961. Drug names, strengths, indications and approval dates from the supplied documents.
38 distinct documents2026 → 1961 newest first
All years
Newest to oldest3,281 extracted entriesPage 1 of 66
| Year | Drug / formulation | Strength | Indication / action | Approval / issue date |
|---|---|---|---|---|
| 2026 | Brexpiprazole Tablets 0.25/0.5/1/2/3/4 mg Original PDF | Not separately supplied | Brexpiprazole is indicated for treatment of schizophrenia. | 16.02.2026 |
| 2026 | Brexpiprazole Bulk Drug Original PDF | Not separately supplied | Not applicable as it is a bulk drug | 24.02.2026 |
| 2026 | Sotorasib 240mg Film Coated Tablets. Original PDF | Not separately supplied | Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy | 10.03.2026 |
| 2025 | Tafamidis Bulk Drug Original PDF | Not separately supplied | Not applicable as it is a bulk drug | 16.01.2025 |
| 2025 | Letermovir Bulk Drug &Letermovir Tablets 240mg and 480 mg Original PDF | Not separately supplied | Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV- seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). It is also indicated for prophylaxis of CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative[D+/R-]) | 17.01.2025 |
| 2025 | Fexuprazan hydrochloride Bulk Drug and Fexuprazan hydrochloride Tablets 40mg Original PDF | Not separately supplied | Indicated for the treatment of erosive esophagitis(EE). | 10.02.2025 |
| 2025 | Edoxaban Tosylate Monohydrate Bulk Drug Original PDF | Not separately supplied | Not applicable as it is a bulk drug | 11.02.2025 |
| 2025 | Edoxaban Tablets 15mg, 30mg and 60mg Original PDF | Not separately supplied | In prevention of stroke and systemic embolism in adult patients with non- valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack(TIA). For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults. | 20.02.2025 |
| 2025 | Sodium Zirconium Cyclosilicate powder for Oral Suspension (LOKELMA) 5g/10g Original PDF | Not separately supplied | Indicated for the treatment of Hyperkalaemia in adult patients. | 05.03.2025 |
| 2025 | Rimegepant Oral disintegrating tablets (ODT) 75 mg Original PDF | Not separately supplied | For Acute treatment of migraine with or without aura in adults with a previous insufficient response to triptans. | 27.03.2025 |
| 2025 | Doravirine Bulk Drug and Doravirine Tablets 100mg Original PDF | Not separately supplied | Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no prior antiretroviral treatment history only(treatment naïve) | 28.03.2025 |
| 2025 | T ucatinib hemiethanolate bulk drug & Tucatinib tablets 50 mg and 150 mg Original PDF | Not separately supplied | Indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. | 08.04.2025 |
| 2025 | Zanubrutinib capsules 80 mg Original PDF | Not separately supplied | It is indicated for the treatment of adult patients with: 1. Mantle cell lymphoma (MCL) who have received at least one prior therapy. 2. Waldenstrom’s macrogloubulinemia (WM) 3. Relapsed or refractory marginal zone lymphoma(MZL) who have received at least one anti-CD20- based regimen. 4. Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma(SLL). 5. Relapsed or refractory follicular lymphoma (FL),in combination with obinutuzumab, after two or more lines of systemic therapy. | 08.04.2025 |
| 2025 | Linaclotide Bulk Drug & Linaclotide Capsule 72 mcg & Linaclotide Capsule 145 mcg Original PDF | Not separately supplied | Indicated in adults for the treatment of Chronic idiopathic constipation. | 21.04.2025 |
| 2025 | Siponimod Hemifumarate Bulk Drug & Siponimod Tablets 0.25 mg/1mg/2mg Original PDF | Not separately supplied | For the treatment of patients with secondary progressive multiple sclerosis (SPMS) with active disease as evidenced by relapses or imaging features of inflammatory activity. | 09.05.2025 |
| 2025 | Ivosidenib 250 mg film coated tablet Original PDF | Not separately supplied | It is indicated 1. In combination with Azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia(AML) with an isocitrate dehydrogenase- 1(IDH1) R132 mutation who are not eligible to receive standard Induction chemotherapy. 2. As a monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. | 14.05.2025 |
| 2025 | Tegoprazan Tablet 50 mg Original PDF | Not separately supplied | Indicated for: • Erosive Gastroesophageal Reflux Disease • Non-erosive Gastroesophageal Reflux Disease • Gastric Ulcer | 28.05.2025 |
| 2025 | Tegoprazan Tablet 25 mg Original PDF | Not separately supplied | Maintenance of healed Erosive Gastroesophageal Reflux disease | 08.07.2025 |
| 2025 | FDC of Relugolix, Estradiol and Norethindrone Acetate Tablets (40 mg+ 1 mg+ 0.5mg) Original PDF | Not separately supplied | Indicated for the management of heavy menstural bleeding associated with uterine Leiomyomas(Fibroids) in premenopausal women. | 16.07.2025 |
| 2025 | Lutetium Lu-177 Vipivotide Tetraxetan solution for injection or infusion 1000MBq/m L – reg. Original PDF | Not separately supplied | Lutetium (Lu-177) Vipivotide Tetraxetan is indicated for the treatment of adult patients with prostate-specific membrane antigen(PSMA)- positive metastatic castration-resistant prostate cancer (m CRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. | 23.07.2025 |
| 2025 | Stamicis 1mg kit for Radiopharmaceutical Preparation Original PDF | Not separately supplied | After radiolabelling with sodium pertechnetate(99mTc) solution, the solution of technetium(99mTc) sestamibi obtained is indicated for: • Myocardial perfusion scintigraphy for detection and localization of coronary artery disease (angina pectoris and myocardial infraction). • Assessment of global ventricular function. First –pass technique for determination of ejection fraction and/or ECG- triggered, gated SPECT for evaluation of left ventricular ejection fraction, volumes and regional wall motion. • Scintimammography for the detection of suspected breast cancer when mammography is equivocal, inadequate or indeterminate. • Localization of hyperfunctioning parathyroid tissue in patients with recurrent or persistent disease in both primary and secondary hyperparathyroidism, and in patients with both primary hyperparathyroidism scheduled to undergo initial surgery of the of the parathyroid glands. | 23.07.2025 |
| 2025 | Upadacitinib Bulk Drug and Upadacitinib Extended Release Tablets 15mg,30mg and 45mg Original PDF | Not separately supplied | For the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. | 19.08.2025 |
| 2025 | Pitolisant Bulk drug and Pitolisant Tablets 4.45 mg and 17.8 mg Original PDF | Not separately supplied | For treatment of excessive day time sleepiness (EDS) or cataplexy in adult patients with narcolepsy | 27.08.2025 |
| 2025 | Etrasimod Tablets 2mg Original PDF | Not separately supplied | Etrasimod is indicated for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (US) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent. | 16.09.2025 |
| 2025 | Erdafitinib Tablets 3 mg, 4 mg and 5 mg. Original PDF | Not separately supplied | Indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Limitations of Use: Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. | 01.10.2025 |
| 2025 | Erdafitinib Bulk Drug Original PDF | Not separately supplied | Not applicable as it is a bulk drug | 08.10.2025 |
| 2025 | Vorasidenib Tablets 10 mg/ 40 mg Original PDF | Not separately supplied | Vorasidenib is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, subtotal resection, or gross total resection. | 15.10.2025 |
| 2024 | Tirzepatide 2.5mg /0.5ml, 5mg/0.5ml, 7.5mg/0.5 ml,10mg/0.5 ml,12.5mg/0.5 ml,15mg/0.5 ml solution for injection in a prefilled pen Original PDF | Not separately supplied | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | 19-01 2024 |
| 2024 | Plazomicin injection 500mg/10ml (50mg/ml) Original PDF | Not separately supplied | Indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganism(s) Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae | 02-02-2024 |
| 2024 | Etifoxine Hydrochloride Bulk drug & Etifoxine Hydrochloride capsules 50 mg Original PDF | Not separately supplied | Indicated for psychosomatic manifestations of anxiety | 21-03-2024 |
| 2024 | Vonoprazan fumarate Bulk drug& Vonoprazan tablets 10mg/20 mg Original PDF | Not separately supplied | Treatment of reflux esophagitis(RE) Treatment of gastric ulcer (GU) Treatment of duodenal ulcer(DU) Prevention of recurrence of gastric ulcer or duodenal ulcer during low- dose aspirin administration. Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration. Adjunct to Helicobacter pylori eradication associated with: Gastric ulcer, Duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early-stage cancer, or Helicobacter pylori gastritis. | 08-05-2024 |
| 2024 | rdESAT-6 and rCFP-10 (Cy-Tb) injection (Additional indication) Original PDF | Not separately supplied | For Detection of Latent-TB for population of age group 1 year and above. For detection of Latent-TB for population below 1 year in implementation research mode under National program only. | 16-05-2024 |
| 2024 | Selpercatinib Capsules 40 mg & 80mg Original PDF | Not separately supplied | Adult patients with metastatic RET fusion-positive non-small cell lung cancer(NSCLC) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET mutant medullary thyroid cancer (MTC) who require systemic therapy. Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory(if radioative iodine is appropriate) | 16-05-2024 |
| 2024 | Nelarabine bulk drug & Nelarabine Injection 250mg/50ml(5mg/ml) Original PDF | Not separately supplied | For the treatment of patients with T-cell Lymphoblastic leukemia and T-cell Lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens | 31.05.2024 |
| 2024 | Enmetazobactam bulk drug & Cefipime 2gm and Enmetazobactam 500mg Dry powder for injection Original PDF | Not separately supplied | Indicated for the treatment of patients 18 years of age and older for: Complicated urinary tract infection(CUTI) including acute pyelonephritis Hospital-acquired pneumonia (HAP), including ventilator- associated pneumonia (VAP) Bacteremia with complicated urinary tract infection or hospital- acquired pneumonia | 31.05.2024 |
| 2024 | Methenamine Hippurate bulk drug &Methenamine Hippurate Tablets USP 1gm Original PDF | Not separately supplied | Prophylaxis and treatment of urinary tract infections, Prevention of urinary tract infections, especially in catheter carriers, Asymptomatic bacteriuria, long- term therapy in prevention of recurrent cystitis . | 09.07.2024 |
| 2024 | Sodium Phenylbutyrate USP bulk drug& Sodium Phenylbutyrate Oral Powder USP Original PDF | Not separately supplied | Indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamyl phosphate synthetase (CPS), ornithine transcarbamylase(OTC),or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (Complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset diseases(partial enzymatic deficiency, presenting after the first month of life ) who have a history of hyperammonemic encephalopathy. | 09.07.2024 |
| 2024 | Elobixibat Hydrate Bulk Drug and Elobixibat Tablets 5 mg Original PDF | Not separately supplied | For treatment of chronic constipation (except for constipation associated with organic diseases) | 15.07.2024 |
| 2024 | Tedizolid Phosphate Bulk & Tedizolid Phosphate Tablets 200mg Original PDF | Not separately supplied | Indicated for the treatment of acute bacterial skin and skin structure infections(ABSSSI) in adults and adolescents 12years of age and older. | 19.07.2024 |
| 2024 | Remifentanil Hydrochloride EP Bulk Original PDF | Not separately supplied | Not supplied | 31.07.2024 |
| 2024 | Pimavanserin Tartrate Bulk & Pimavanserin Capsules 34 mg Original PDF | Not separately supplied | For the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. | 02.08.2024 |
| 2024 | Elagolix Sodium Bulk & Elagolix tablets 150mg and Elagolix tablets 200 mg Original PDF | Not separately supplied | For the management of moderate to severe pain associated with endometriosis. | 09.08.2024 |
| 2024 | Brigatinib Tablets,30mg,90mg, and 180mg Original PDF | Not separately supplied | Indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase(ALK)- positive advanced non-small cell lung cancer(NSCLC) previously not treated with an ALK inhibitor. Brigatinib is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib. | 18.09.2024 |
| 2024 | Mavacamten capsules 2.5mg,5 mg,10mg,15 mg Original PDF | Not separately supplied | Mavacmten is indicated for the treatment of symptomatic (NEW York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy(oHCM) in adult patients. | 08.10.2024 |
| 2024 | Ferumoxytol Bulk Drug &Ferumoxytol Injection 510 mg Elemental Iron/17mL(30mg/mL) Original PDF | Not separately supplied | It is an iron replacement product indicated for the treatment of iron deficiency anemia(IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have chronic kidney disease(CKD) | 08.10.2024 |
| 2024 | Belumosudil Tablet 200 mg Original PDF | Not separately supplied | For the treatment of patients 12 years and older with chronic Graft- versus-Host Disease(cGvHD) after failure of at least two prior lines of systemic therapy | 22.11.2024 |
| 2024 | Lumateperone Tosylate Bulk Drug & Lumateperone capsules 42 mg Original PDF | Not separately supplied | Indicated for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as mono therapy and as adjunctive therapy with lithium or valproate. | 26.12.2024 |
| 2024 | Trelagliptin Succinate Bulk & Trelagliptin Tablets 25 mg, 50 mg, and 100 mg Original PDF | Not separately supplied | For treatment of Type 2 diabetes. | 26.12.2024 |
| 2023 | Fesoteroterodine Fumarate Extended Release Tablets 4mg and 8mg and Fesoteroterodine Fumarate Bulk Original PDF | Not separately supplied | Indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. | 06-01-2023 |
| 2023 | Trifarotene 50 microgram/g (0.005% w/w) Cream Original PDF | Not separately supplied | Indicated for the cutaneous treatment of Acne Vulgaris of the face and /or trunk in patients 12 years of age and older. | 13-01-2023 |
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