Regulatory UpdatesSep 8, 2026•1 min read

FDA Approves ANDA076589 for FLUMAZENIL Injectable Products

By the PharmaCountry team

FDA approved ANDA076589 submitted by Dr Reddys, covering two injectable FLUMAZENIL products, both listed with discontinued marketing status.

The U.S. Food and Drug Administration has granted approval for application ANDA076589, submitted by Dr Reddys. The submission, classified as an original (ORIG) application, received an approved status on October 12, 2004. The approved ANDA includes two injectable FLUMAZENIL products (product numbers 001 and 002). Both are listed as discontinued in marketing status. Product 001 is formulated as 1 MG/10 ML (0.1 MG/ML) and product 002 as 0.5 MG/5 ML (0.1 MG/ML). Neither product is designated as a reference drug or reference standard.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #FLUMAZENIL #Injectable #Dr Reddys #approval