Lotrisone

NDA 18827, held by Organon. Betamethasone Dipropionate; Clotrimazole.

As of Nov 14, 2026, NDA 18827 (Lotrisone), held by Organon, was first approved by FDA on Jul 10, 1984, with 28 approved supplements and 0 published complete response letters.

First approved: Jul 10, 1984
Review: Standard
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below


Oct 3, 2001	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 10, 1984	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
LotrisoneEQ 0.05% BASE;1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Betamethasone Dipropionate; Clotrimazole	DiscontinuedReference drug

All 29 submissions, including labeling and manufacturing supplements


Jun 14, 2019	Supplement 50Labeling · Standard review	Approved	Letter Label
May 21, 2018	Supplement 49Labeling · Standard review	Approved	Letter Label
Apr 21, 2014	Supplement 46Labeling · Standard review	Approved	Letter Label
May 11, 2009	Supplement 42Labeling · Standard review	Approved	Label Letter
Jan 25, 2008	Supplement 38Labeling · Standard review	Approved	Label Letter
Mar 27, 2003	Supplement 25Labeling · Standard review	Approved	Letter Label
Jan 10, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 3, 2001	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 3, 2001	Supplement 20Labeling · Standard review	Approved	None posted
Oct 3, 2001	Supplement 9Labeling	Approved	None posted
Oct 3, 2001	Supplement 7Labeling	Approved	Label
Feb 28, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 2, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
May 14, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 10, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 31, 1998	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 15, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
May 18, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 30, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 30, 1995	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 6, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 1, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 29, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 12, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
May 20, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 23, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 22, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 10, 1984	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18827
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