Treats plaque psoriasis. NDA 204141, held by Sun Pharma Canada. Desoximetasone.
As of Nov 13, 2026, NDA 204141 (Topicort), held by Sun Pharma Canada, was first approved by FDA on Apr 11, 2013, with 5 approved supplements and 0 published complete response letters.
Desoximetasone Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.
| Oct 7, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Apr 11, 2013 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topicort0.25% · spray;topical | Desoximetasone | RxReference drug |
| Oct 7, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Dec 16, 2015 | Supplement 4Labeling · Standard review | Approved | |
| Sep 23, 2015 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 10, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 18, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 11, 2013 | 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
