Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves Amici Pharma’s Generic Pravastatin Sodium Tablets (ANDA 077491)
The FDA has approved the ANDA 077491 for Pravastatin Sodium tablets from Amici Pharma, covering strengths from 10 mg to 80 mg.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Mylan Nisoldipine Extended‑Release Tablets (ANDA 079051) – Discontinued Products
The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Actavis Labs Metoprolol Succinate Extended‑Release Tablets (ANDA 076862)
Actavis Labs FL Inc received FDA approval for its metoprolol succinate extended‑release tablets under ANDA 076862, covering a prescription 50 mg product and a discontinued 25 mg product.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Lupin ANDA209272 for Metoprolol Succinate ER Tablets
FDA approved Lupin's ANDA209272 for metoprolol succinate extended‑release tablets in four strengths, all currently listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Apotex Sotalol Hydrochloride Tablets (ANDA 076214)
The FDA has approved Apotex’s generic sotalol hydrochloride tablets (80 mg, 120 mg, 160 mg) under ANDA 076214, with labeling updates through 2023.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Teva Generic Carvedilol Tablets (ANDA 076373)
The FDA has granted approval for Teva Pharmaceuticals' generic carvedilol oral tablets, covering strengths from 3.125 mg to 25 mg under ANDA 076373.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves NESHER PHARMS Metoprolol Succinate ER Tablet (ANDA077176)
The FDA approved NESHER PHARMS' ANDA077176 for metoprolol succinate extended‑release tablets (50 mg eq). The product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
NESHER PHARMS ANDA077779 for Metoprolol Succinate ER Tablet Approved by FDA
FDA approved ANDA077779 for metoprolol succinate extended‑release tablets from NESHER PHARMS; product listed as discontinued.
Regulatory Updates
Aug 27, 2026•1 min read
FDA Approves Atenolol (ANDA076900) Oral Tablets
The FDA has approved the ANDA076900 for Atenolol tablets (25 mg, 50 mg, 100 mg) manufactured by Zydus Lifesciences and Zydus Pharmaceuticals USA.
Regulatory Updates
Aug 26, 2026•1 min read
FDA Approves ANDA076620 for Fosinopril Sodium Tablets Submitted by Actavis Labs
The FDA granted approval for ANDA076620 on Oct 15, 2004, covering three oral fosinopril sodium tablet strengths submitted by Actavis Labs, all currently listed as discontinued.