NDA 20683, held by Cadence Health. Ethinyl Estradiol; Levonorgestrel.
As of Nov 13, 2026, NDA 20683 (Alesse), held by Cadence Health, was first approved by FDA on Mar 27, 1997, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 27, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alesse0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral-21 | Ethinyl Estradiol; Levonorgestrel | DiscontinuedReference drug |
| Alesse0.02MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral-28 | Ethinyl Estradiol; Levonorgestrel | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 16Labeling · Standard review | Approved | |
| Mar 20, 2018 | Supplement 12Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Jan 31, 2008 | Supplement 7Labeling · Standard review | Approved | |
| Jan 31, 2008 | Supplement 6Labeling · Standard review | Approved | |
| Jan 31, 2008 | Supplement 4Labeling · Standard review | Approved | |
| Mar 6, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 27, 1997 | 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
