Actualités réglementaires
19 sept. 2026•1 min de lecture
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.
Actualités réglementaires
9 sept. 2026•1 min de lecture
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.
Actualités réglementaires
30 août 2026•1 min de lecture
FDA Discontinues Alprazolam Extended‑Release Tablets (ANDA077777)
FDA records show Sandoz's alprazolam extended‑release tablets (product numbers 001‑004) are discontinued, with multiple labeling supplement approvals.
Actualités réglementaires
27 août 2026•1 min de lecture
FDA Announces Discontinued Alprazolam Extended‑Release Tablets (ANDA 077198)
The FDA’s ANDA 077198 for alprazolam extended‑release tablets submitted by Actavis Labs FL Inc shows all listed products as discontinued.