ANDA 206201, held by Mayne Pharma Inc. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 206201 (Ethinyl Estradiol; Levonorgestrel), held by Mayne Pharma Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2017 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ethinyl Estradiol; Levonorgestrel0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A ยท tablet;oral | Ethinyl Estradiol; Levonorgestrel | None (tentative approval) |
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
