Topicort

NDA 18594, held by Taro. Desoximetasone.

As of Nov 13, 2026, NDA 18594 (Topicort), held by Taro, was first approved by FDA on Jan 17, 1985, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1985
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jan 17, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Topicort0.05% · ointment;topical	Desoximetasone	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Nov 6, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 26, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 26, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
May 12, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 7, 2012	Supplement 8Manufacturing · Standard review	Approved	Label Letter
May 14, 2010	Supplement 7Labeling · Standard review	Approved	Label Letter
Jul 26, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 13, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 8, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 19, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 17, 1985	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18594
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