Temovate

NDA 19966, held by Fougera. Clobetasol Propionate.

As of Nov 13, 2026, NDA 19966 (Temovate), held by Fougera, was first approved by FDA on Feb 22, 1990, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 22, 1990
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
Feb 22, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

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Temovate0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;topical	Clobetasol Propionate	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Apr 3, 2003	Supplement 8Labeling · Standard review	Approved	Letter Label
Aug 8, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 15, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 29, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 7, 1994	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 23, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 17, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19966
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