Clobex

NDA 21835, held by Galderma Labs LP. Clobetasol Propionate.

As of Nov 14, 2026, NDA 21835 (Clobex), held by Galderma Labs LP, was first approved by FDA on Oct 27, 2005, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 27, 2005
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 27, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clobex0.05% · spray;topical	Clobetasol Propionate	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Dec 21, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 15, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
May 21, 2015	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 7, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 7, 2012	Supplement 6Labeling	Approved	Label Letter
Aug 17, 2012	Supplement 7Labeling	Approved	Label Letter
Jan 12, 2011	Supplement 2Manufacturing	Approved	Letter Label
Jan 12, 2011	Supplement 4Labeling · Standard review	Approved	Letter Label
Feb 13, 2007	Supplement 1Manufacturing	Approved	None posted
Oct 27, 2005	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21835
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