NDA 16029, held by Gd Searle LLC. Ethynodiol Diacetate; Mestranol.
As of Nov 13, 2026, NDA 16029 (Ovulen, Ovulen-21), held by Gd Searle LLC, was first approved by FDA on Mar 23, 1966, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 1966 | Original applicationNew molecular entity, new combination · Standard review | Approved | None posted |
| Ovulen1MG;0.1MG · tablet;oral-20 | Ethynodiol Diacetate; Mestranol | Discontinued |
| Ovulen-211MG;0.1MG · tablet;oral-21 | Ethynodiol Diacetate; Mestranol | Discontinued |
| Oct 23, 1986 | Supplement 65Labeling | Approved | None posted |
| Jun 10, 1986 | Supplement 64Labeling | Approved | None posted |
| Mar 13, 1986 | Supplement 63Labeling | Approved | None posted |
| Jun 5, 1985 | Supplement 62Labeling | Approved | None posted |
| Apr 5, 1985 | Supplement 61Labeling | Approved | None posted |
| Feb 12, 1985 | Supplement 60Labeling | Approved | None posted |
| Sep 18, 1984 | Supplement 59Labeling | Approved | None posted |
| Mar 6, 1984 | Supplement 57Labeling | Approved | None posted |
| Jun 9, 1983 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1983 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1982 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Mar 3, 1981 | Supplement 35Labeling | Approved | None posted |
| May 16, 1979 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Mar 23, 1966 | Original applicationNew molecular entity, new combination · Standard 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
