Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 74904, held by Taro. Desoximetasone.
As of Nov 15, 2026, ANDA 74904 (Topicort), held by Taro, was first approved by FDA on Jul 14, 1998, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Desoximetasone cream USP, 0.05%, desoximetasone cream USP, 0.25%, and desoximetasone gel USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topicort0.05% · gel;topical | Desoximetasone | Rx |
| Jan 5, 2012 | Supplement 15Labeling | Approved | |
| Nov 23, 2004 | Supplement 8Labeling | Approved | None posted |
| Dec 19, 2003 | Supplement 7Labeling | Approved | None posted |
| Jul 24, 2003 | Supplement 5Labeling | Approved | None posted |
| Nov 4, 1999 | Supplement 3Manufacturing | Approved | None posted |
| Apr 9, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Apr 7, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Jul 14, 1998 | Original application | 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
