Dermatop E Emollient

NDA 20279, held by Valeant Bermuda. Prednicarbate.

As of Nov 14, 2026, NDA 20279 (Dermatop E Emollient), held by Valeant Bermuda, was first approved by FDA on Oct 29, 1993, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1993
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


May 3, 1996	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 29, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dermatop E Emollient0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Prednicarbate	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Dec 6, 2010	Supplement 9Labeling · Standard review	Approved	Letter Label
Sep 15, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
May 3, 1996	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Feb 24, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 29, 1993	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20279
Drugs@FDA: Overview at FDA
Company: Valeant Bermuda

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