Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 73210, held by Taro. Desoximetasone.
As of Nov 15, 2026, ANDA 73210 (Topicort), held by Taro, was first approved by FDA on Nov 30, 1990, with 11 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 30, 1990 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topicort0.05% · cream;topical | Desoximetasone | Rx |
| Jun 19, 2014 | Supplement 31Manufacturing | Approved | None posted |
| Jan 11, 2012 | Supplement 29Labeling | Approved | |
| Dec 30, 2011 | Supplement 27Labeling | Approved | None posted |
| Nov 23, 2004 | Supplement 17Labeling | Approved | None posted |
| Feb 19, 2004 | Supplement 16Labeling | Approved | None posted |
| Dec 19, 2003 | Supplement 15Labeling | Approved | None posted |
| Jun 20, 2001 | Supplement 12Manufacturing | Approved | None posted |
| May 3, 2000 | Supplement 11Manufacturing | Approved | None posted |
| Apr 9, 1999 | Supplement 10Manufacturing | Approved | None posted |
| Sep 17, 1996 | Supplement 9Manufacturing | Approved | None posted |
| May 15, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Nov 30, 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
