Topicort

NDA 18763, held by Taro. Desoximetasone.

As of Nov 14, 2026, NDA 18763 (Topicort), held by Taro, was first approved by FDA on Oct 3, 1983, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 3, 1983
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 3, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Topicort0.25% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Desoximetasone	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Apr 27, 2004	Supplement 3Labeling	Approved	Label Letter
Feb 18, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 25, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 19, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 26, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 13, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 18, 1988	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 3, 1983	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18763
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