Desonide

NDA 17010, held by Padagis US. Desonide.

As of Nov 13, 2026, NDA 17010 (Desonide), held by Padagis US, was first approved by FDA on Jan 4, 1972, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 4, 1972
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Jan 4, 1972	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Desonide0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Desonide	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 2, 2016	Supplement 23Manufacturing · Standard review	Approved	None posted
May 15, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 31, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 17, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 9, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 12, 1995	Supplement 14Labeling · Standard review	Approved	None posted
Mar 8, 1991	Supplement 13Labeling	Approved	None posted
Jan 5, 1983	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 6, 1982	Supplement 9Labeling	Approved	None posted
Sep 16, 1982	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 16, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
May 1, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 19, 1979	Supplement 6Labeling	Approved	None posted
Apr 17, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 12, 1976	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 10, 1974	Supplement 2	Approved	None posted
Jan 4, 1972	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 17010
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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