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 15, 2026•1 min read
FDA Approves ANDA077510 for Colestipol Hydrochloride Tablets
The FDA has approved ANDA077510 for Colestipol Hydrochloride 1 g tablets, manufactured by Amneal Pharmaceuticals and sponsored by IMPAX Labs.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves IMPAX Labs' ACARBOSE Oral Tablets (ANDA 078441)
FDA granted approval for IMPAX Labs' ANDA 078441, authorizing prescription oral tablets of ACARBOSE in 25 mg, 50 mg, and 100 mg strengths.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA080807 for Diphenhydramine Capsules – IMPAX Labs
FDA approved ANDA080807 submitted by IMPAX Labs for oral diphenhydramine hydrochloride capsules (25 mg and 50 mg). Both products are listed as discontinued.