FDA Approves ANDA076850 for Terconazole Vaginal Suppository

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.