NDA 17565, held by Allergan. Ethinyl Estradiol; Norethindrone.
As of Nov 13, 2026, NDA 17565 (Norinyl 1+35 21-Day, Norinyl 1+35 28-Day), held by Allergan, was first approved by FDA on Dec 27, 1974, with 48 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 1974 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norinyl 1+35 21-Day0.035MG;1MG · tablet;oral-21 | Ethinyl Estradiol; Norethindrone | Discontinued |
| Norinyl 1+35 28-Day0.035MG;1MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2022 | Supplement 86Labeling · Standard review | Approved | |
| Oct 10, 2017 | Supplement 85Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 84Labeling · Standard review | Approved | |
| Aug 15, 2001 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Jan 24, 2000 | Supplement 70Labeling · Standard review | Approved | None posted |
| Feb 4, 1999 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Nov 16, 1998 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1997 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1995 | Supplement 64Labeling · Standard review | Approved | None posted |
| Dec 13, 1994 | Supplement 66Labeling · Standard review | Approved | None posted |
| Dec 13, 1994 | Supplement 65Labeling · Standard review | Approved | None posted |
| Feb 4, 1994 | Supplement 62Labeling | Approved | None posted |
| Jul 31, 1992 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Nov 2, 1990 | Supplement 58Labeling | Approved | None posted |
| Sep 19, 1990 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1989 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1989 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1986 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1986 | Supplement 55Labeling | Approved | None posted |
| Oct 25, 1985 | Supplement 54Labeling | Approved | None posted |
| Apr 16, 1985 | Supplement 53Labeling | Approved | None posted |
| Nov 13, 1984 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Sep 27, 1984 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1984 | Supplement 50Labeling | Approved | None posted |
| Jun 12, 1984 | Supplement 49Labeling | Approved | None posted |
| May 16, 1984 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| May 7, 1984 | Supplement 46Labeling | Approved | None posted |
| Mar 6, 1984 | Supplement 44Labeling | Approved | None posted |
| Jul 26, 1983 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1983 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jul 29, 1982 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1982 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1980 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1980 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Oct 14, 1980 | Supplement 8Labeling | Approved | None posted |
| Aug 26, 1980 | Supplement 28Labeling | Approved | None posted |
| Jul 31, 1980 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1979 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1979 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1978 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1978 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| May 26, 1978 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1977 | Supplement 9Labeling | Approved | None posted |
| Jul 1, 1977 | Supplement 10Labeling | Approved | None posted |
| May 16, 1976 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 16, 1975 | Supplement 1Labeling | Approved | None posted |
| May 16, 1975 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 16, 1975 | Supplement 6Labeling | Approved | None posted |
| Dec 27, 1974 | Original applicationNew formulation or manufacturer · 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
