Regulatory UpdatesSep 17, 2026•1 min read

FDA Approves ANDA076367 for Amcinonide Topical Ointment

By the PharmaCountry team

FDA approved ANDA076367 for a 0.1% amcinonide prescription ointment; the product is currently listed as discontinued.

The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) numbered ANDA076367 for a topical ointment containing the corticosteroid amcinonide. The product, marketed under the brand name AMCINONIDE, is a prescription ointment with a 0.1% strength, administered topically. It is manufactured by Sun Pharmaceutical Industries, Inc. and sponsored by TARO PHARM INDS. The FDA’s original submission (ORIG) received an approved status (AP) on March 19, 2003. Current marketing status is listed as Discontinued. Associated National Drug Code (NDC) identifiers include 51672-4054-4, 51672-4054-1, 51672-4054-2, 51672-4054-3, 51672-4060-1, 51672-4060-2, and 51672-4060-3.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#ANDA #topical #Corticosteroid #FDA approval #Sun Pharmaceutical #Amcinonide