Regulatory UpdatesAug 30, 2026•1 min read

FDA Grants ANDA Approval for Amcinonide Topical Lotion (ANDA076329)

By the PharmaCountry team

Solubiomix received FDA approval for ANDA 076329 for a prescription topical lotion containing 0.1% amcinonide.

The U.S. Food and Drug Administration has granted approval for ANDA 076329 submitted by Solubiomix. The approved product is a prescription topical lotion containing 0.1% amcinonide, listed under the brand name Amcinonide (product number 001). It is not a reference drug but is designated as a reference standard. The submission was an original filing (submission number 1) and received an "AP" (Approved) status on November 6, 2002.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#ANDA #topical #Amcinonide #prescription #FDA approval #dermatology