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Results For "reference-listed-drug"

205 News Found

Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg
Drug Approval | November 14, 2025

Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg

Dexlansoprazole delayed-release capsules are a proton pump inhibitor


Alembic announces USFDA final approval for Dasatinib Tablets
Drug Approval | November 08, 2025

Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets


Alembic receives FDA final approval for Sumatriptan Injection USP
Drug Approval | November 08, 2025

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine


Glenmark Pharmaceuticals USA to launch 8.4% Sodium Bicarbonate Injection USP, 50 mEq Single-Dose Vial
News | November 05, 2025

Glenmark Pharmaceuticals USA to launch 8.4% Sodium Bicarbonate Injection USP, 50 mEq Single-Dose Vial

Glenmark will begin distribution in November 2025


FDA approves Alembic's Ticagrelor Tablets, 60 mg
Drug Approval | October 29, 2025

FDA approves Alembic's Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients


Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection
Drug Approval | October 24, 2025

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable


Glenmark Pharmaceuticals USA to launch Ropivacaine Hydrochloride Injection USP
News | October 23, 2025

Glenmark Pharmaceuticals USA to launch Ropivacaine Hydrochloride Injection USP

Glenmark’s Ropivacaine Hydrochloride Injection USP is bioequivalent and therapeutically equivalent to the reference listed drug Naropin Injection of Fresenius Kabi USA


FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL
Drug Approval | October 19, 2025

FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL

Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions


FDA approves Alembic’s Paroxetine ER tablets
Drug Approval | September 26, 2025

FDA approves Alembic’s Paroxetine ER tablets

Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder