Regulatory UpdatesSep 22, 2026•1 min read

FDA Approves ANDA076850 for Terconazole Vaginal Suppository

By the PharmaCountry team

FDA granted approval (ANDA076850) for Fougera Pharms' terconazole 80 mg vaginal suppository, now listed as discontinued.

The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) numbered ANDA076850 for a terconazole vaginal suppository. The product, marketed by Fougera Pharms, is a 80 mg terconazole suppository intended for vaginal administration. The submission was an original (ORIG) filing and received approval on July 12, 2006. FDA records indicate the product’s marketing status is listed as discontinued.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#ANDA #Terconazole #Vaginal Suppository #FDA #Regulatory Approval #discontinued