Aclovate

NDA 18702, held by Fougera. Alclometasone Dipropionate.

As of Nov 13, 2026, NDA 18702 (Aclovate), held by Fougera, was first approved by FDA on Dec 14, 1982, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 14, 1982
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
Dec 14, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aclovate0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Alclometasone Dipropionate	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 5, 2011	Supplement 11Labeling	Approved	Letter Label
Apr 2, 2003	Supplement 7Labeling · Standard review	Approved	Label Letter
Jul 26, 2002	Supplement 8Manufacturing · Standard review	Approved	Letter Label
Apr 26, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Jun 22, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 7, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 16, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
May 20, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 7, 1983	Supplement 1Labeling	Approved	None posted
Dec 14, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18702
Drugs@FDA: Overview at FDA
Company: Fougera

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