Actualités réglementaires30 août 2026•1 min de lecture

FDA Discontinues Alprazolam Extended‑Release Tablets (ANDA077777)

Par l'équipe PharmaCountry

FDA records show Sandoz's alprazolam extended‑release tablets (product numbers 001‑004) are discontinued, with multiple labeling supplement approvals.

The FDA’s database for application ANDA077777 lists alprazolam extended‑release tablets marketed by Sandoz Inc. All four product numbers (001, 002, 003, 004) are marked as discontinued. These oral tablets are available in strengths of 0.5 mg, 1 mg, 2 mg, and 3 mg. The submission history includes an original ANDA (submission 1) approved on 30 June 2006, and several labeling supplement submissions (numbers 4, 6, and 7) approved on 22 November 2011 and 30 June 2023. No reference drug status or reference standard is indicated for these products.

Compilé par l'équipe PharmaCountry · Source : FDA.gov

Sujets :#Alprazolam #ANDA #Sandoz #discontinued #labeling #FDA