NDA 203667, held by Apil. Ethinyl Estradiol; Norethindrone Acetate.
As of Nov 14, 2026, NDA 203667 (Minastrin 24 Fe), held by Apil, was first approved by FDA on May 8, 2013, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Minastrin 24 Fe0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ethinyl Estradiol; Norethindrone Acetate | DiscontinuedReference drug |
| Jun 26, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 14Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Dec 20, 2016 | Supplement 7Labeling · Standard review | Approved | |
| Aug 1, 2016 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 3, 2015 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 5, 2014 | Supplement 4Labeling · Standard review | Approved | |
| Apr 14, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 19, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 11, 2013 | Supplement 2Labeling · Standard review | Approved | |
| May 8, 2013 | 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
