NDA 20860, held by Bayer Hlthcare. Ethinyl Estradiol; Levonorgestrel.
As of Nov 13, 2026, NDA 20860 (Levlite), held by Bayer Hlthcare, was first approved by FDA on Jul 13, 1998, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Levlite0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral-21 | Ethinyl Estradiol; Levonorgestrel | DiscontinuedReference drug |
| Levlite0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | DiscontinuedReference drug |
| Dec 17, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Dec 17, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 13, 1998 | 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
