Lotrimin

NDA 18813, held by Schering. Clotrimazole.

As of Nov 13, 2026, NDA 18813 (Lotrimin), held by Schering, was first approved by FDA on Feb 17, 1984, with 22 approved supplements and 0 published complete response letters.

First approved: Feb 17, 1984
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Dec 7, 2007	Supplement 17Efficacy (new indication or use)	Approved	None posted
Dec 7, 2007	Supplement 10Efficacy (new indication or use)	Approved	None posted
Oct 27, 1989	Supplement 7Efficacy (new indication or use)	Approved	None posted
Feb 17, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lotrimin1% · lotion;topical	Clotrimazole	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 18Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 17Efficacy (new indication or use)	Approved	None posted
Dec 7, 2007	Supplement 12Labeling	Approved	None posted
Dec 7, 2007	Supplement 10Efficacy (new indication or use)	Approved	None posted
Jan 10, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 6, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 7, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
May 14, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
May 18, 1998	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 2, 1993	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 12, 1993	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 23, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 25, 1991	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 7, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 27, 1989	Supplement 7Efficacy (new indication or use)	Approved	None posted
Apr 6, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 18, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
May 20, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
May 20, 1985	Supplement 4Labeling	Approved	None posted
Apr 16, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 6, 1984	Supplement 2Labeling	Approved	None posted
Aug 6, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 17, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18813
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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