Elocon

NDA 19796, held by Organon. Mometasone Furoate.

As of Nov 13, 2026, NDA 19796 (Elocon), held by Organon, was first approved by FDA on Mar 30, 1989, with 17 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1989
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

Date	Submission	Status	Documents
Jul 17, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 30, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Elocon0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · lotion;topical	Mometasone Furoate	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 6, 2026	Supplement 30Labeling · Standard review	Approved	Label Letter
May 21, 2018	Supplement 29Labeling · Standard review	Approved	Letter Label
Mar 28, 2013	Supplement 26Labeling	Approved	Letter Label
Sep 9, 2005	Supplement 20Labeling · Standard review	Approved	Letter Label
Jul 17, 2002	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 17, 2002	Supplement 8Labeling · Standard review	Approved	Letter Label
Jul 13, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 7, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
May 14, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 28, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 2, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 5, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 16, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 25, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 11, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 25, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 13, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 30, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19796
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