Topicort

NDA 18586, held by Taro. Desoximetasone.

As of Nov 13, 2026, NDA 18586 (Topicort), held by Taro, was first approved by FDA on Mar 29, 1982, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 29, 1982
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 29, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Topicort0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;topical	Desoximetasone	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 27, 2004	Supplement 4Labeling	Approved	Label Letter
Sep 15, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
May 22, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 25, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 26, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 13, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 25, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 16, 1989	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 30, 1983	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 29, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18586
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals

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