ANDA 70686, held by Dr Reddys Labs SA. Ethinyl Estradiol; Norethindrone.
As of Nov 15, 2026, ANDA 70686 (Norethindrone And Ethinyl Estradiol), held by Dr Reddys Labs SA, was first approved by FDA on Jan 29, 1987, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 29, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norethindrone And Ethinyl Estradiol0.035MG;0.5MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone | Discontinued |
| Apr 29, 2022 | Supplement 38Labeling · Standard review | Approved | None posted |
| Apr 22, 2022 | Supplement 37Labeling · Standard review | Approved | None posted |
| Jun 26, 2002 | Supplement 16Manufacturing | Approved | None posted |
| May 21, 2002 | Supplement 14Manufacturing | Approved | None posted |
| May 8, 2002 | Supplement 10Labeling | Approved | None posted |
| Oct 31, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Aug 27, 2001 | Supplement 12Manufacturing | Approved | None posted |
| May 1, 1997 | Supplement 9Labeling | Approved | None posted |
| Nov 4, 1993 | Supplement 8Labeling | Approved | None posted |
| Aug 10, 1993 | Supplement 7Manufacturing | Approved | None posted |
| Mar 15, 1990 | Supplement 6Labeling | Approved | None posted |
| Jul 28, 1989 | Supplement 5Labeling | Approved | None posted |
| Nov 19, 1987 | Supplement 4Labeling | Approved | None posted |
| Sep 28, 1987 | Supplement 3Labeling | Approved | None posted |
| Feb 25, 1987 | Supplement 1Labeling | Approved | None posted |
| Jan 29, 1987 | Original application | 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
