Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA 086892 for Chlordiazepoxide Hydrochloride Capsules
The FDA granted approval (ANDA 086892) for Lederle's oral capsule containing 5 mg chlordiazepoxide hydrochloride, listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA077247 for Carboplatin Injectable Products (Discontinued)
FDA approved ANDA077247 for three carboplatin injectable products from Fresenius Kabi USA; all listed strengths are marked discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Lists ANDA087397 for Watson Labs BETHANECHOL CHLORIDE Tablet (Discontinued)
FDA records ANDA087397 for Watson Labs' oral tablet BETHANECHOL CHLORIDE 50 mg, currently marked discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Tentative Approval for Tolterodine Oral Tablets (ANDA 076953)
Ranbaxy received a tentative FDA approval for two oral tablet strengths of Tolterodine tartrate (1 mg and 2 mg) under ANDA 076953.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA078152 for Oral Ondansetron Tablets (4 mg & 8 mg)
The FDA has approved ANDA078152 for prescription oral ondansetron tablets in 4 mg and 8 mg strengths, submitted by AvKARE, Glenmark and BluePoint.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Fluoxetine Oral Solution (ANDA077849) by Lannett Company
The FDA has approved ANDA077849 for a fluoxetine oral solution (20 mg/5 mL) manufactured by Lannett Company, adding a new prescription product to the market.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Novitium Pharma Escitalopram Oxalate ANDA077550
FDA has approved Novitium Pharma's ANDA077550 covering discontinued oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) with original approval in 2015 and a labeling supplement in 2023.
Regulatory Updates
Sep 9, 2026•1 min read
Mylan's Chlordiazepoxide Hydrochloride Oral Capsule (ANDA 084887) Discontinued
Mylan's oral capsule product containing 25 mg chlordiazepoxide hydrochloride (product 001) is listed as discontinued. The ANDA includes four manufacturing (CMC) submissions approved on June 10 1981.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA089116 for BROMPHERIL Extended-Release Tablet
FDA approved ANDA089116 for BROMPHERIL, an oral extended-release tablet containing 6 mg dexbrompheniramine maleate and 120 mg pseudoephedrine sulfate, submitted by Copley Pharm; product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Submissions for Sublingual Buprenorphine Hydrochloride Tablets (Products 001 & 002)
FDA records show two discontinued sublingual buprenorphine tablet products with multiple approved labeling and REMS submissions spanning 2010‑2026.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA089479 for Acetaminophen/Codeine Phosphate Tablet (Discontinued)
The FDA granted approval for ANDA089479, submitted by AM THERAP, for an oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate. The product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA 079054 for Alfuzosin Hydrochloride Extended‑Release Tablet
FDA granted labeling approvals for Torrent Pharm's discontinued Alfuzosin Hydrochloride 10 mg extended‑release tablet (ANDA 079054).