Cutivate

NDA 19958, held by Fougera. Fluticasone Propionate.

As of Nov 13, 2026, NDA 19958 (Cutivate), held by Fougera, was first approved by FDA on Dec 18, 1990, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1990
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


Jun 17, 1999	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Apr 25, 1997	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 18, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cutivate0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Fluticasone Propionate	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Sep 3, 2010	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 16, 2002	Supplement 13Labeling · Standard review	Approved	Letter Label
Jun 7, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 17, 1999	Supplement 11Labeling · Standard review	Approved	Letter Label
Jun 17, 1999	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Jan 21, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 8, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 25, 1997	Supplement 9Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 7, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 7, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 7, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 7, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 14, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 14, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 18, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19958
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