NDA 21864, held by Wyeth Pharms Inc. Ethinyl Estradiol; Levonorgestrel.
As of Nov 14, 2026, NDA 21864 (Lybrel), held by Wyeth Pharms Inc, was first approved by FDA on May 22, 2007, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2007 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lybrel0.02MG;0.09MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ethinyl Estradiol; Levonorgestrel | DiscontinuedReference drug |
| Jun 16, 2016 | Supplement 7Labeling · Standard review | Approved | |
| Dec 31, 2015 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 15, 2008 | Supplement 2Labeling · Standard review | Approved | |
| May 22, 2007 | Original applicationNew formulation or manufacturer · 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
