Desowen

Relieves inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. NDA 19048, held by Galderma Labs LP. Desonide.

As of Nov 14, 2026, NDA 19048 (Desowen), held by Galderma Labs LP, was first approved by FDA on Dec 14, 1984, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1984
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATION AND USAGE: Desonide Cream and Lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 14, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Desowen0.05% · cream;topical	Desonide	Rx

All 13 submissions, including labeling and manufacturing supplements


Mar 13, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
May 11, 1995	Supplement 12Labeling · Standard review	Approved	None posted
Jan 18, 1994	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 30, 1993	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 3, 1993	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 30, 1991	Supplement 7Labeling	Approved	None posted
Aug 28, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 18, 1989	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 23, 1988	Supplement 4Labeling	Approved	None posted
Oct 25, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 26, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 14, 1985	Supplement 1Labeling	Approved	None posted
Dec 14, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19048
Drugs@FDA: Overview at FDA
Company: Galderma Laboratories

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