NDA 16131, held by Sanofi Aventis US. Clomiphene Citrate.
As of Nov 13, 2026, NDA 16131 (Clomid), held by Sanofi Aventis US, was first approved by FDA on Feb 1, 1967, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 1967 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clomid50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clomiphene Citrate | DiscontinuedReference drug |
| Dec 18, 2017 | Supplement 28Labeling · Standard review | Approved | |
| Oct 22, 2012 | Supplement 26Labeling · Standard review | Approved | |
| Dec 10, 2002 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Oct 25, 1995 | Supplement 24Labeling · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 23Labeling · Standard review | Approved | None posted |
| Feb 22, 1994 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Dec 21, 1993 | Supplement 17Labeling | Approved | None posted |
| Aug 14, 1991 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Apr 27, 1988 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Nov 18, 1981 | Supplement 15Labeling | Approved | None posted |
| Jun 23, 1980 | Supplement 10Labeling | Approved | None posted |
| Jun 23, 1980 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Feb 1, 1967 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
