Actualités réglementaires27 sept. 2026•1 min de lecture

FDA Approves ANDA077076 for Lorazepam Injectable Products

Par l'équipe PharmaCountry

FDA approved ANDA077076 submitted by Bedford for Lorazepam injectable products (2 mg/mL and 4 mg/mL), both listed as discontinued.

The U.S. Food and Drug Administration has approved application ANDA077076, submitted by Bedford, for Lorazepam injectable products. The approval covers two injectable dosage strengths: 2 mg/mL (product number 001) and 4 mg/mL (product number 002). Both products are currently marked as discontinued in the FDA’s records. The original submission (submission number 1) received approval on July 13, 2005.

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

Sujets :#Lorazepam #Injectable #ANDA #FDA approval #Bedford