Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA080279 for Prednisone 5mg Tablet by Inwood Labs
The FDA approved ANDA080279 for a 5 mg oral prednisone tablet submitted by Inwood Labs; the product is listed as discontinued.
Regulatory Updates
Sep 23, 2026•1 min read
SOLVAY's TRANMEP Tablet (Meprobamate 400mg) Discontinued – ANDA084369
FDA records show SOLVAY's oral tablet TRANMEP, containing 400 mg meprobamate, is listed as discontinued under application ANDA084369.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves ANDA 084872 for Meclizine Hydrochloride 25 mg Tablet (BUNDY)
The FDA has approved ANDA 084872 for a 25 mg oral tablet of Meclizine Hydrochloride marketed by BUNDY, with a discontinued marketing status.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves ANDA 080630 for Cortisone Acetate 25 mg Tablet
The FDA has approved ANDA080630 for a 25 mg oral tablet of cortisone acetate, submitted by IVAX Sub Teva Pharm, with approval dated Jan 3 1972.
Regulatory Updates
Sep 22, 2026•1 min read
Quantum Pharmics ANDA 088972 – Oral Tablet with Butalbital, Aspirin
Quantum Pharmics filed ANDA 088972 for an oral tablet combining 50 mg butalbital, 325 mg aspirin, and 40 mg caffeine; the product is listed as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Lists Discontinued Thioridazine Hydrochloride Tablet (ANDA088660) by West Ward
The FDA database shows an ANDA (ANDA088660) for an oral tablet of thioridazine hydrochloride 25 mg submitted by West Ward, currently marked as discontinued.
Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Mylan Sumatriptan Succinate Tablets (ANDA 077744)
The FDA has approved Mylan Pharmaceuticals' sumatriptan succinate tablets (25 mg, 50 mg, 100 mg) under ANDA 077744, with multiple labeling submissions recorded.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA083386 for Chlorpromazine Hydrochloride
FDA has approved ANDA083386 for chlorpromazine hydrochloride tablets (10 mg) manufactured by Upsher‑Smith Laboratories, listed as a prescription oral drug.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Accepts ANDA084026 for Watson Labs' Chlorothiazide 500 mg Oral Tablet (Discontinued)
The FDA has processed application ANDA084026 for Watson Labs' oral chlorothiazide 500 mg tablet, currently listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Linezolid 600 mg Tablet (ANDA078845) by Rising Pharma
The FDA has approved ANDA078845 for a 600 mg oral linezolid tablet marketed by Rising Pharma Holdings, Inc.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA085911 for Oxycodone 5/APAP 500 Oral Tablet
FDA approved ANDA085911 for an oral tablet containing 5 mg oxycodone and 500 mg acetaminophen, submitted by Bristol Myers Squibb; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
Ribavirin 200 mg Tablet – FDA ANDA077053 Approval
The FDA approved ANDA077053 for Ribavirin 200 mg oral tablets, sponsored by Heritage Pharma Avet. The product is listed with a discontinued marketing status.