Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA216216 for METOLAZONE Tablets
The FDA has approved application ANDA216216 for METOLAZONE oral tablets in 2.5 mg, 5 mg, and 10 mg strengths, sponsored by NE RX Pharma.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves NESHER PHARMS Metoprolol Succinate Extended‑Release ANDA076640
NESHER PHARMS received FDA approval (submission AP) for ANDA076640 covering Metoprolol Succinate extended‑release tablets (200 mg and 100 mg equivalents), though both products are listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA204552 for Aspirin and Dipyridamole Extended-Release Capsules
FDA granted approval for ANDA204552, an oral extended‑release capsule combining 25 mg aspirin and 200 mg dipyridamole, sponsored by Chartwell Molecular.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA080807 for Diphenhydramine Capsules – IMPAX Labs
FDA approved ANDA080807 submitted by IMPAX Labs for oral diphenhydramine hydrochloride capsules (25 mg and 50 mg). Both products are listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
Marshall Pharma Prednisone Tablet (5 mg) ANDA080301 Discontinued
FDA records indicate Marshall Pharma's oral prednisone 5 mg tablet (product 001) under application ANDA080301 is listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves TOLSURA (Itraconazole) Oral Capsule NDA208901
The FDA has approved TOLSURA, an oral itraconazole 65 mg capsule from Mayne Pharma, under NDA208901 as a new formulation.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Issues ANDA078545 Approval for Discontinued Lamivudine Tablet Products
The FDA’s ANDA078545 submission by Pharmobedient lists two oral lamivudine tablets (150 mg and 300 mg) that are marked as discontinued, with an approval status dated March 5 2019.
Regulatory Updates
Aug 30, 2026•1 min read
KV Pharm’s Phendimetrazine Tartrate Tablet (ANDA 084138) Discontinued
The FDA records show KV Pharm’s oral tablet of Phendimetrazine Tartrate (35 mg) under ANDA 084138 is now listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA ANDA083061: Diphenhydramine Hydrochloride Capsules Discontinued
FDA ANDA083061 lists two oral diphenhydramine hydrochloride capsule products (25 mg and 50 mg) from Perrigo, both marked discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
WHARTON LABS ANDA083665: Oral Vitamin A Capsule Discontinued
WHARTON LABS submitted ANDA083665 for an oral Vitamin A capsule containing vitamin A palmitate (50,000 units). The product is listed as discontinued.