Topicort LP

NDA 18309, held by Taro. Desoximetasone.

As of Nov 13, 2026, NDA 18309 (Topicort LP), held by Taro, was first approved by FDA on Mar 28, 1980, with 14 approved supplements and 0 published complete response letters.

First approved: Mar 28, 1980
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Mar 28, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Topicort LP0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Desoximetasone	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Apr 27, 2004	Supplement 13Labeling	Approved	Label Letter
Sep 15, 1998	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 25, 1996	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 26, 1994	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 13, 1993	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 8, 1988	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 19, 1988	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 23, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 1, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 7, 1983	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 6, 1982	Supplement 2Labeling	Approved	None posted
Jun 8, 1982	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 20, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 6, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 28, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18309
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