FDA Approves ANDA080693 for Hydrocortisone 1% Topical Cream

The U.S. Food and Drug Administration has approved application ANDA080693 for a hydrocortisone 1% topical cream. The product, marketed under the brand name HYDROCORTISONE, is a prescription human drug manufactured by E. Fougera & Co., a division of Fougera Pharmaceuticals, LLC, and sponsored by FOUGERA PHARMS INC. The submission history includes an original submission on April 30, 1976 and several manufacturing (CMC) supplements approved between 1982 and 1996, indicating ongoing compliance updates. The cream is intended for topical use and contains hydrocortisone as the active ingredient at a strength of 1%.