Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Alprazolam ×
Actualizaciones regulatorias
19 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
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.
Actualizaciones regulatorias
27 ago 2026•1 min de lectura
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.