NDA 20611, held by Leo Pharm. Calcipotriene.
As of Nov 14, 2026, NDA 20611 (Dovonex), held by Leo Pharm, was first approved by FDA on Mar 3, 1997, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dovonex0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;topical | Calcipotriene | DiscontinuedReference drug |
| Sep 26, 2007 | Supplement 7Labeling · Standard review | Approved | |
| Apr 28, 2005 | Supplement 6Labeling · Standard review | Approved | |
| Jan 11, 2000 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 3, 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
