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Results For "tentative-approval"

251 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


Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%
Drug Approval | December 20, 2025

Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension


Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension
News | December 12, 2025

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb


Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER
Drug Approval | November 23, 2025

Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER

Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis


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 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


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