Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 73193, held by Taro. Desoximetasone.
As of Nov 15, 2026, ANDA 73193 (Topicort), held by Taro, was first approved by FDA on Nov 29, 1990, with 10 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 |
|---|---|---|---|
| Nov 29, 1990 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topicort0.25% · cream;topical | Desoximetasone | Rx |
| Jan 3, 2012 | Supplement 33Labeling | Approved | |
| Feb 29, 2008 | Supplement 27Labeling | Approved | None posted |
| Nov 23, 2004 | Supplement 22Labeling | Approved | None posted |
| Feb 19, 2004 | Supplement 21Labeling | Approved | None posted |
| Dec 19, 2003 | Supplement 20Labeling | Approved | None posted |
| Jun 20, 2001 | Supplement 15Manufacturing | Approved | None posted |
| May 3, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Apr 9, 1999 | Supplement 13Manufacturing | Approved | None posted |
| Sep 17, 1996 | Supplement 6Manufacturing | Approved | None posted |
| May 15, 1996 | Supplement 5Manufacturing | Approved | None posted |
| Nov 29, 1990 | 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
