NDA 17743, held by Allergan. Ethinyl Estradiol; Norethindrone.
As of Nov 13, 2026, NDA 17743 (Brevicon 28-Day), held by Allergan, was first approved by FDA on Mar 29, 1976, with 45 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 1976 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brevicon 28-Day0.035MG;0.5MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone | Discontinued |
| Oct 10, 2017 | Supplement 89Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 88Labeling · Standard review | Approved | |
| Aug 15, 2001 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Feb 14, 2000 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Jan 24, 2000 | Supplement 74Labeling · Standard review | Approved | None posted |
| Feb 4, 1999 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1997 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1995 | Supplement 69Labeling · Standard review | Approved | None posted |
| Dec 13, 1994 | Supplement 70Labeling · Standard review | Approved | None posted |
| Feb 4, 1994 | Supplement 67Labeling | Approved | None posted |
| Jul 31, 1992 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Nov 2, 1990 | Supplement 63Labeling | Approved | None posted |
| Sep 19, 1990 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1989 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1989 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1987 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1986 | Supplement 61Labeling | Approved | None posted |
| Oct 25, 1985 | Supplement 60Labeling | Approved | None posted |
| Apr 16, 1985 | Supplement 59Labeling | Approved | None posted |
| Nov 13, 1984 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Sep 27, 1984 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1984 | Supplement 56Labeling | Approved | None posted |
| Jun 12, 1984 | Supplement 55Labeling | Approved | None posted |
| May 16, 1984 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| May 7, 1984 | Supplement 52Labeling | Approved | None posted |
| Mar 6, 1984 | Supplement 48Labeling | Approved | None posted |
| Jul 26, 1983 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1983 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jul 19, 1983 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Jul 19, 1983 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1983 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jul 29, 1982 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1982 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1980 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1980 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 14, 1980 | Supplement 3Labeling | Approved | None posted |
| Jun 23, 1980 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1979 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1979 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1978 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1978 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| May 26, 1978 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1977 | Supplement 4Labeling | Approved | None posted |
| Jun 14, 1977 | Supplement 8Labeling | Approved | None posted |
| Jun 14, 1977 | Supplement 7Labeling | Approved | None posted |
| Mar 29, 1976 | Original applicationNew dosage form · 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
