FDA-2026-P-3242

Requests that the FDA declare that an ANDA may be submitted for, Hydrocortisone Tablets USP 2.5 and 7.5, two strengths that differ from the currently approved RLD, CORTEF (Hydrocortisone) tablets from PHARMACAIA AND UPJOHN CO, which FDA approved in 5 mg, 10 mg, and 20 mg strength prior to Jan 1, 1982 under NDA #N008697