NDA 20544, held by Population Council. Levonorgestrel.
As of Nov 13, 2026, NDA 20544 (Jadelle), held by Population Council, was first approved by FDA on Nov 1, 1996, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 22, 2002 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Nov 1, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Jadelle75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · implant;implantation | Levonorgestrel | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2016 | Supplement 10Labeling · Standard review | Approved | |
| Nov 22, 2002 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jan 5, 2000 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
