NDA 22262, held by Teva Branded Pharm. Ethinyl Estradiol; Levonorgestrel.
As of Nov 14, 2026, NDA 22262 (Loseasonique), held by Teva Branded Pharm, was first approved by FDA on Oct 24, 2008, with 5 approved supplements and 0 published complete response letters.
CAMRESE LO is indicated for use by females of reproductive potential to prevent pregnancy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loseasonique0.02MG,0.1MG;0.01MG,N/A · tablet;oral | Ethinyl Estradiol; Levonorgestrel | Rx |
| Jan 27, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Jan 27, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 6Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Apr 7, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 24, 2008 | 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
