Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA077302 for Actavis Extended‑Release Amphetamine Combination Capsules
The FDA approved ANDA077302 for Actavis Pharma’s oral extended‑release capsules containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate in multiple strengths.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves ANDA077060 for Metformin Hydrochloride Extended‑Release Tablet by Zydus Lifesciences
The FDA has granted approval for ANDA077060, authorizing the prescription extended‑release metformin hydrochloride tablet (500 mg) marketed by Zydus Lifesciences.
Regulatory Updates
Sep 24, 2026•1 min read
FDA Approves ANDA211623 for Generic Carbamazepine Extended‑Release Tablets
The FDA has approved ANDA211623 for carbamazepine extended‑release tablets (100 mg, 200 mg, 400 mg) submitted by Unique Pharm, with labeling cleared in Jan 2024.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves ANDA076667 for Fexofenadine HCl and Pseudoephedrine HCl OTC Tablet
The FDA approved ANDA076667 for an over‑the‑counter extended‑release oral tablet containing 60 mg fexofenadine HCl and 120 mg pseudoephedrine HCl, marketed by Dr. Reddy’s.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077968 for Alprazolam Extended‑Release Tablets (IMPAX Labs)
The FDA approved ANDA077968 on May 24, 2007 for IMPAX Labs' oral extended‑release alprazolam tablets, all listed as discontinued products.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Approval for AdaRe Pharm’s Potassium Chloride Extended‑Release Tablets (ANDA 076368)
The FDA approved ANDA 076368 for two extended‑release potassium chloride tablets (10 mEq and 20 mEq) marketed by AdaRe Pharm and manufactured by Sun Pharmaceutical.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves AUVELITY Extended-Release Tablet (NDA 215430)
The FDA has approved AUVELITY, an oral extended‑release tablet combining bupropion hydrochloride and dextromethorphan hydrobromide under NDA 215430.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA212645 for Paroxetine Extended‑Release Tablets
The FDA has approved ANDA212645 for paroxetine extended‑release tablets (12.5 mg, 25 mg, 37.5 mg) marketed by Cadila Pharm Ltd and Modavar Pharmaceuticals.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Zydus Pharms Indomethacin Extended‑Release Capsule (ANDA202711)
FDA has approved ANDA202711 for Zydus Pharms' prescription indomethacin 75 mg extended‑release oral capsule, with labeling supplements filed in 2017, 2019, 2021 and 2024.
Regulatory Updates
Sep 16, 2026•1 min read
PRAMIPEXOLE DIHYDROCHLORIDE Extended‑Release Tablets Approved (ANDA202353)
FDA approved multiple oral extended‑release tablet products of pramipexole dihydrochloride under ANDA202353, covering five strengths and several labeling supplements.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Teva’s Methylphenidate Extended‑Release Capsules (ANDA 078873)
The FDA approved ANDA 078873 for Teva’s methylphenidate hydrochloride extended‑release capsules (40 mg, 50 mg, 60 mg). All listed products are currently discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA077078 for Metformin Hydrochloride Extended‑Release Tablets
The FDA has approved the ANDA077078 application for metformin hydrochloride 750 mg extended‑release tablets marketed by Zydus Lifesciences.