Elocon

NDA 19543, held by Organon. Mometasone Furoate.

As of Nov 14, 2026, NDA 19543 (Elocon), held by Organon, was first approved by FDA on Apr 30, 1987, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1987
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


Jul 17, 2002	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 3, 1995	Supplement 3Efficacy (new indication or use)	Approved	None posted
Apr 30, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Elocon0.1% · ointment;topical	Mometasone Furoate	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Jul 6, 2026	Supplement 29Labeling · Standard review	Approved	Label Letter
May 21, 2018	Supplement 28Labeling · Standard review	Approved	Letter Label
Aug 5, 2016	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 28, 2013	Supplement 24Labeling	Approved	Letter Label
Dec 15, 2002	Supplement 14Labeling · Standard review	Approved	Letter Label
Jul 17, 2002	Supplement 11Labeling · Standard review	Approved	Letter Label
Jul 17, 2002	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 27, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 20, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 28, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 10, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 9, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 7, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 16, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 3, 1995	Supplement 3Efficacy (new indication or use)	Approved	None posted
Sep 25, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 29, 1987	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 30, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19543
Drugs@FDA: Overview at FDA
Company: Organon

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