ANDA 205329, held by Xiromed. Levonorgestrel.
As of Nov 13, 2026, ANDA 205329 (Levonorgestrel), held by Xiromed, was first approved by FDA on Sep 18, 2018, with 0 approved supplements and 0 published complete response letters.
Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levonorgestrel1.5MG · tablet;oral | Levonorgestrel | OTC |
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
