NDA 20946, held by Teva Branded Pharm. Ethinyl Estradiol; Levonorgestrel.
As of Nov 13, 2026, NDA 20946 (Preven Emergency Contraceptive Kit), held by Teva Branded Pharm, was first approved by FDA on Sep 1, 1998, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 1, 1998 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Preven Emergency Contraceptive Kit0.05MG;0.25MG · tablet;oral | Ethinyl Estradiol; Levonorgestrel | Discontinued |
| Nov 19, 2002 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Nov 13, 2002 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Feb 21, 2002 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Feb 21, 2002 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jul 17, 2001 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Aug 2, 2000 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| May 23, 2000 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Apr 3, 2000 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 2, 2000 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jun 7, 1999 | Supplement 1Labeling · Standard review | Approved | |
| Sep 1, 1998 | Original applicationNew dosage form · Priority 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
