Temovate

NDA 19322, held by Fougera. Clobetasol Propionate.

As of Nov 13, 2026, NDA 19322 (Temovate), held by Fougera, was first approved by FDA on Dec 27, 1985, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 27, 1985
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Dec 27, 1985	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Temovate0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Clobetasol Propionate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Apr 2, 2003	Supplement 18Labeling · Standard review	Approved	Letter Label
Aug 8, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 15, 1996	Supplement 15Manufacturing · Standard review	Approved	Review
Aug 30, 1995	Supplement 10Labeling	Approved	None posted
Jun 29, 1994	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 7, 1994	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 23, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 5, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 17, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 7, 1989	Supplement 5Labeling	Approved	None posted
Dec 7, 1989	Supplement 6Labeling	Approved	None posted
Sep 15, 1989	Supplement 7Labeling	Approved	None posted
Jul 10, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 9, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 3, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 27, 1985	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 19322
Drugs@FDA: Overview at FDA
Company: Fougera

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