Regulatory Updates
Sep 9, 2026•1 min read
FDA Discontinues Oral Prednisone 5mg Tablet (ANDA080300)
The FDA has listed the oral prednisone 5 mg tablet (product 001) from sponsor HALSEY as discontinued under application ANDA080300.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA085790 for Isoniazid 100 mg Tablet by Watson Labs
The FDA has approved ANDA085790 for an oral 100 mg Isoniazid tablet submitted by Watson Labs. The product is currently listed as 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 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
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 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 ANDA078442 for Alprazolam Extended-Release Tablets (Discontinued)
The FDA approved the original ANDA for Alprazolam extended‑release tablets (product numbers 001‑004) on Oct 15 2007, with a labeling supplement approved on Nov 29 2011. All four strengths (0.5 mg, 1 mg, 2 mg, 3 mg) are now listed as discontinued by sponsor PH Health.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077248 for Pilocarpine Hydrochloride Oral Tablets
The FDA has granted approval for ANDA077248, an oral tablet formulation of pilocarpine hydrochloride (5 mg and 7.5 mg) manufactured by Impax Labs and Amneal Pharmaceuticals.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA 076392 for Mefloquine Hydrochloride
The FDA has approved ANDA 076392 for Mefloquine Hydrochloride oral tablets (250 mg) manufactured by Teva Pharmaceuticals, sponsor BARR.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA086088 for Hydralazine Hydrochloride Oral Tablet (Discontinued)
The FDA has listed ANDA086088 for Hydralazine Hydrochloride 25 mg oral tablets submitted by Vitarine, noting the product is discontinued.