ANDA 75862, held by Barr. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 75862 (Levonorgestrel And Ethinyl Estradiol), held by Barr, was first approved by FDA on Apr 29, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2003 | Original application | Approved | None posted |
| Levonorgestrel And Ethinyl Estradiol0.02MG;0.1MG · tablet;oral-21 | Ethinyl Estradiol; Levonorgestrel | Discontinued |
| Levonorgestrel And Ethinyl Estradiol0.02MG;0.1MG · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | Discontinued |
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