NDA 5292, held by Schering. Ethinyl Estradiol.
As of Nov 13, 2026, NDA 5292 (Estinyl), held by Schering, was first approved by FDA on Jun 25, 1943, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 1943 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Estinyl0.02MG · tablet;oral | Ethinyl Estradiol | Discontinued |
| Estinyl0.05MG · tablet;oral | Ethinyl Estradiol | Discontinued |
| Estinyl0.5MG · tablet;oral | Ethinyl Estradiol | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 31, 2001 | Supplement 25Manufacturing | Approved | None posted |
| Mar 23, 2001 | Supplement 24Manufacturing | Approved | None posted |
| Mar 9, 2001 | Supplement 22Manufacturing | Approved | None posted |
| Dec 4, 2000 | Supplement 21Manufacturing | Approved | None posted |
| Nov 1, 2000 | Supplement 20Manufacturing | Approved | None posted |
| Aug 18, 2000 | Supplement 19Manufacturing | Approved | None posted |
| Apr 23, 1999 | Supplement 18Manufacturing | Approved | None posted |
| Nov 6, 1998 | Supplement 17Manufacturing | Approved | None posted |
| Dec 17, 1987 | Supplement 16Manufacturing | Approved | None posted |
| Jun 26, 1986 | Supplement 15Labeling | Approved | None posted |
| Mar 27, 1986 | Supplement 14Labeling | Approved | None posted |
| Jun 11, 1980 | Supplement 12Manufacturing | Approved | None posted |
| Jan 14, 1980 | Supplement 11Labeling | Approved | None posted |
| Jan 31, 1979 | Supplement 9Manufacturing | Approved | None posted |
| Oct 20, 1978 | Supplement 7Labeling | Approved | None posted |
| Jun 25, 1943 | Original application | 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
