NDA 18985, held by Janssen Pharms. Ethinyl Estradiol; Norethindrone.
As of Nov 13, 2026, NDA 18985 (Ortho-Novum 7/7/7-21, Ortho-Novum 7/7/7-28), held by Janssen Pharms, was first approved by FDA on Apr 4, 1984, with 42 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 4, 1984 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ortho-Novum 7/7/7-210.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG · tablet;oral-21 | Ethinyl Estradiol; Norethindrone | Discontinued |
| Ortho-Novum 7/7/7-280.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral-28 | Ethinyl Estradiol; Norethindrone | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 9, 2017 | Supplement 64Labeling · Standard review | Approved | |
| Oct 29, 2015 | Supplement 63Labeling · Standard review | Approved | |
| Sep 11, 2014 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Oct 3, 2013 | Supplement 50Labeling · Standard review | Approved | |
| Oct 2, 2013 | Supplement 60Labeling · Standard review | Approved | |
| Oct 2, 2013 | Supplement 56Labeling · Standard review | Approved | |
| Oct 2, 2013 | Supplement 54Labeling · Standard review | Approved | |
| Jun 18, 2012 | Supplement 53Labeling · Standard review | Approved | |
| Jun 3, 2002 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Feb 21, 2002 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jul 9, 2001 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jun 6, 2000 | Supplement 35Labeling · Standard review | Approved | None posted |
| Jan 5, 2000 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1999 | Supplement 33Labeling · Standard review | Approved | None posted |
| Aug 27, 1999 | Supplement 30Labeling · Standard review | Approved | None posted |
| Aug 27, 1999 | Supplement 29Labeling · Standard review | Approved | None posted |
| Apr 28, 1998 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Apr 13, 1998 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Feb 24, 1997 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jan 29, 1997 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| May 10, 1996 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1996 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1995 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1995 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1995 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Mar 7, 1994 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jan 3, 1994 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 4, 1993 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| May 18, 1993 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1991 | Supplement 14Labeling | Approved | None posted |
| Mar 18, 1991 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jan 18, 1990 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Oct 23, 1989 | Supplement 11Labeling | Approved | None posted |
| Jul 19, 1989 | Supplement 10Labeling | Approved | None posted |
| Oct 28, 1988 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1988 | Supplement 7Labeling | Approved | None posted |
| Jun 8, 1988 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Nov 23, 1987 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 2, 1987 | Supplement 6Labeling | Approved | None posted |
| Oct 21, 1985 | Supplement 3Labeling | Approved | None posted |
| Apr 5, 1985 | Supplement 2Labeling | Approved | None posted |
| Jun 21, 1984 | Supplement 1Labeling | Approved | None posted |
| Apr 4, 1984 | 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
