ANDA 214640, held by Xiromed. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 214640 (Levonorgestrel And Ethinyl Estradiol And Ferrous Fumarate), held by Xiromed, was first approved by FDA on Aug 16, 2023, with 0 approved supplements and 0 published complete response letters.
Joyeaux is indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 16, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol And Ferrous Fumarate0.02MG;0.1MG · tablet;oral | Ethinyl Estradiol; Levonorgestrel | Rx |
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
