NDA 22573, held by Teva Branded Pharm. Ethinyl Estradiol; Norethindrone.
As of Nov 14, 2026, NDA 22573 (Norethindrone And Ethinyl Estradiol And Ferrous Fumarate), held by Teva Branded Pharm, was first approved by FDA on Dec 22, 2010, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2010 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Norethindrone And Ethinyl Estradiol And Ferrous Fumarate0.025MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, chewable;oral | Ethinyl Estradiol; Norethindrone | DiscontinuedReference drug |
| Jun 26, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 14Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 8Labeling · Standard review | Approved | |
| Dec 11, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 12, 2013 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 12, 2013 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 13, 2013 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 22, 2010 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
