Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 74286, held by Taro. Desoximetasone.
As of Nov 15, 2026, ANDA 74286 (Topicort), held by Taro, was first approved by FDA on Jun 7, 1996, with 14 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Desoximetasone ointment USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topicort0.25% · ointment;topical | Desoximetasone | Discontinued |
| Apr 15, 2015 | Supplement 15Labeling | Approved | None posted |
| Mar 20, 2013 | Supplement 17Labeling | Approved | |
| Mar 15, 2010 | Supplement 16Manufacturing | Approved | |
| Jul 25, 2008 | Supplement 13Manufacturing | Approved | |
| Jul 25, 2008 | Supplement 12Manufacturing | Approved | |
| Sep 15, 2005 | Supplement 10Manufacturing | Approved | |
| Nov 23, 2004 | Supplement 9Labeling | Approved | |
| Apr 26, 2004 | Supplement 8Labeling | Approved | |
| Apr 26, 2004 | Supplement 7Manufacturing | Approved | |
| Dec 19, 2003 | Supplement 6Labeling | Approved | |
| May 16, 2000 | Supplement 4Manufacturing | Approved | |
| Apr 9, 1999 | Supplement 3Manufacturing | Approved | |
| Jul 18, 1997 | Supplement 2Manufacturing | Approved | |
| Sep 17, 1996 | Supplement 1Manufacturing | Approved | |
| Jun 7, 1996 | Original application | 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
