ANDA 201108, held by Amneal Pharms. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 201108 (Levonorgestrel And Ethinyl Estradiol), held by Amneal Pharms, was first approved by FDA on Feb 5, 2014, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol0.02MG;0.1MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Discontinued |
| Apr 29, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 9, 2017 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 5, 2014 | 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
