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.
🏛 Food and Drug Administration (FDA)FDA-2026-P-3444
Documents
0
Total comments
0
all analyzed
Comment status
Closed
Last activity
—
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
No documents mirrored for this docket yet.