NDA 16709, held by Ortho Mcneil Janssen. Mestranol; Norethindrone.
As of Nov 13, 2026, NDA 16709 (Ortho-Novum 1/50 28), held by Ortho Mcneil Janssen, was first approved by FDA on Aug 21, 1968, with 60 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 1968 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ortho-Novum 1/50 280.05MG;1MG · tablet;oral-28 | Mestranol; Norethindrone | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2002 | Supplement 128Manufacturing · Standard review | Approved | None posted |
| Jun 5, 2000 | Supplement 126Labeling · Standard review | Approved | None posted |
| Jan 5, 2000 | Supplement 125Manufacturing · Standard review | Approved | None posted |
| Jul 10, 1998 | Supplement 123Labeling · Standard review | Approved | None posted |
| Apr 28, 1998 | Supplement 124Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1997 | Supplement 122Labeling · Standard review | Approved | None posted |
| Jan 29, 1997 | Supplement 121Manufacturing · Standard review | Approved | None posted |
| Dec 27, 1996 | Supplement 107Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1996 | Supplement 120Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1995 | Supplement 118Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1995 | Supplement 117Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1994 | Supplement 116Manufacturing · Standard review | Approved | None posted |
| Jul 6, 1994 | Supplement 115Labeling · Standard review | Approved | None posted |
| Mar 7, 1994 | Supplement 112Manufacturing · Standard review | Approved | None posted |
| Nov 4, 1993 | Supplement 114Manufacturing · Standard review | Approved | None posted |
| May 18, 1993 | Supplement 113Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1991 | Supplement 109Labeling | Approved | None posted |
| Mar 18, 1991 | Supplement 110Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1990 | Supplement 108Manufacturing · Standard review | Approved | None posted |
| Oct 23, 1989 | Supplement 106Labeling | Approved | None posted |
| Jul 19, 1989 | Supplement 105Labeling | Approved | None posted |
| Oct 28, 1988 | Supplement 104Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1988 | Supplement 102Labeling | Approved | None posted |
| Jun 8, 1988 | Supplement 103Manufacturing · Standard review | Approved | None posted |
| Nov 23, 1987 | Supplement 100Manufacturing · Standard review | Approved | None posted |
| Feb 26, 1987 | Supplement 101Labeling | Approved | None posted |
| Oct 21, 1985 | Supplement 98Labeling | Approved | None posted |
| Apr 5, 1985 | Supplement 97Labeling | Approved | None posted |
| Jun 21, 1984 | Supplement 96Labeling | Approved | None posted |
| Jan 30, 1984 | Supplement 95Labeling | Approved | None posted |
| Sep 29, 1983 | Supplement 94Labeling | Approved | None posted |
| Nov 8, 1979 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Oct 19, 1979 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Aug 15, 1979 | Supplement 81Labeling | Approved | None posted |
| Apr 10, 1979 | Supplement 49Labeling | Approved | None posted |
| Jul 25, 1978 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1978 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1978 | Supplement 76Labeling | Approved | None posted |
| May 25, 1978 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Apr 17, 1978 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Mar 19, 1978 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1978 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1978 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1978 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1978 | Supplement 54Labeling | Approved | None posted |
| Jan 18, 1978 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1977 | Supplement 52Labeling | Approved | None posted |
| Aug 9, 1976 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Aug 9, 1976 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1975 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1975 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1975 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1975 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1975 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1975 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| May 21, 1975 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| May 21, 1975 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| May 21, 1975 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| May 21, 1975 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1975 | Supplement 21REMS · Standard review | Approved | None posted |
| Aug 21, 1968 | 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
