Dermatop

NDA 19568, held by Valeant Pharms North. Prednicarbate.

As of Nov 13, 2026, NDA 19568 (Dermatop), held by Valeant Pharms North, was first approved by FDA on Sep 23, 1991, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 23, 1991
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 23, 1991	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dermatop0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Prednicarbate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Dec 6, 2010	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 2, 2004	Supplement 8Manufacturing · Standard review	Approved	Label Letter
Sep 15, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 15, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 7, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 23, 1991	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 19568
Drugs@FDA: Overview at FDA
Company: Valeant Pharmaceuticals North America

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