FDA-2026-P-3444

Requests that the FDA declare that an ANDA may be submitted for, Clomiphene Citrate Tablets USP 25 mg and 100 mg, two strengths that differ from the currently approved RLD, CLOMID (Clomiphene Citrate) tablets from SANOFI AVENTIS US LLC, which FDA approved in 50 mg strength prior to Jan 1, 1982 under NDA #N016131.