Regulatory UpdatesSep 23, 2026•1 min read

FDA Approves ANDA087315 for Hydrocortisone 1% Topical Lotion

By the PharmaCountry team

The FDA has approved ANDA087315 submitted by Alpharma US Pharms for a 1% hydrocortisone topical lotion, currently listed as discontinued.

The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) number 087315 submitted by Alpharma US Pharms. The application covers a topical lotion formulation containing 1% hydrocortisone. The product, identified as Hydrocortisone lotion (product number 001), is classified with a discontinued marketing status. The original submission (submission number 1) received an approval status on June 7, 1982.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#hydrocortisone #topical #Lotion #ANDA #FDA approval #discontinued