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Results For "reference-listed-drug-product"

91 News Found

Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets
Drug Approval | March 28, 2026

Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets

Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder


Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%
Drug Approval | February 25, 2026

Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%

Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.


Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets
Drug Approval | February 07, 2026

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

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


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


Alembic receives USFDA final approval for Macitentan Tablets, 10 mg
News | August 19, 2025

Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension


Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP
Drug Approval | July 27, 2025

Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug


Alembic announces USFDA final approval for single-dose vials
Drug Approval | June 29, 2025

Alembic announces USFDA final approval for single-dose vials

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma