Regulatory UpdatesSep 27, 2026•1 min read

FDA Approves ANDA077076 for Lorazepam Injectable Products

By the PharmaCountry team

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.

Compiled by the PharmaCountry team · Source: FDA.gov

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