In Brief: Hydrocortisone topical ointment 2.5%
Executive Summary
Hydrocortisone topical ointment 2.5%: FDA determines Upjohn's Cortef was not withdrawn for safety or efficacy reasons, and the agency will accept ANDAs for the product, according to a May 21 Federal Register notice. Reed & Carnick submitted a citizen petition in May 1995 requesting an agency determination on Cortef's withdrawal. Upjohn received approval for the product in 1953 and withdrew it from the market in 1991...