NDA 209405, held by Exeltis USA Inc. Ethinyl Estradiol; Levonorgestrel.
As of Nov 14, 2026, NDA 209405 (Tyblume), held by Exeltis USA Inc, was first approved by FDA on Mar 30, 2020, with 2 approved supplements and 0 published complete response letters.
TYBLUME is indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tyblume0.02MG;0.1MG · tablet;oral | Ethinyl Estradiol; Levonorgestrel | RxReference drug |
| Apr 29, 2022 | Supplement 2Labeling · Standard review | Approved | |
| May 29, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Mar 30, 2020 | Original applicationNew dosage form · Standard review | Approved |
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
