ANDA 206053, held by Xiromed. Ethinyl Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 206053 (Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol), held by Xiromed, was first approved by FDA on Oct 2, 2017, with 2 approved supplements and 0 published complete response letters.
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive age to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel And Ethinyl Estradiol And Ethinyl Estradiol0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A · tablet;oral | Ethinyl Estradiol; Levonorgestrel | Rx |
| Feb 28, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 28, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 2, 2017 | 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
