CORTEF

FDA-2026-P-3242

Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Hydrocortisone Tablets USP in 2.5 mg and 7.5 mg strengths, which differ from the currently approved Referen

FDA-2026-P-1308

The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client seeking FDA approval under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act to declare that Hydrocortisone Tablets in 2.5 mg, 7.5 mg, and 15 mg strengths are suitable for submission in a

FDA-2007-P-0053

West-Ward Pharmaceutical Corp. filed this petition under 21 CFR 10.25(a) and 10.30 to request that the FDA determine whether Hydrocortisone Tablets USP, 10 mg (CORTEF, NDA 008697), which was voluntarily withdrawn from distribution by Pharmacia and Upjohn, was shortened for safety or effectiveness re