Desonate

NDA 21844, held by Leo Pharma As. Desonide.

As of Nov 15, 2026, NDA 21844 (Desonate), held by Leo Pharma As, was first approved by FDA on Oct 20, 2006, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 20, 2006
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

Date	Submission	Status	Documents
Oct 20, 2006	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Desonate0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;topical	Desonide	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Mar 14, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 12, 2015	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 22, 2014	Supplement 8Labeling · Standard review	Approved	Letter Label
Dec 29, 2009	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 20, 2006	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21844
Drugs@FDA: Overview at FDA
Company: LEO Pharma

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