ANDA 78323, held by Watson Labs. Ethinyl Estradiol; Norethindrone.
As of Nov 15, 2026, ANDA 78323 (Norethindrone And Ethinyl Estradiol), held by Watson Labs, was first approved by FDA on Feb 4, 2010, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norethindrone And Ethinyl Estradiol0.035MG;0.4MG · tablet;oral-28 | Ethinyl Estradiol; Norethindrone | Rx |
| Apr 29, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 4, 2010 | 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
