NDA 21840, held by Teva Branded Pharm. Ethinyl Estradiol; Levonorgestrel.
As of Nov 14, 2026, NDA 21840 (Seasonique), held by Teva Branded Pharm, was first approved by FDA on May 25, 2006, with 6 approved supplements and 0 published complete response letters.
CAMRESE is indicated for use by females of reproductive potential to prevent pregnancy.
| Jul 29, 2010 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| May 25, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Seasonique0.03MG,0.01MG;0.15MG,N/A · tablet;oral | Ethinyl Estradiol; Levonorgestrel | RxReference drug |
| Jan 27, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Jan 27, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 15Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Sep 22, 2014 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jul 29, 2010 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| May 25, 2006 | 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
