Clotrimazole

Treats candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. ANDA 72640, held by Sun Pharma Canada. Clotrimazole.

As of Nov 15, 2026, ANDA 72640 (Clotrimazole), held by Sun Pharma Canada, was first approved by FDA on Aug 31, 1993, with 24 approved supplements and 0 published complete response letters.

First approved: Aug 31, 1993
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Aug 31, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clotrimazole1% · cream;topical	Clotrimazole	Rx

All 25 submissions, including labeling and manufacturing supplements


Aug 20, 2009	Supplement 31Labeling	Approved	None posted
Nov 4, 2002	Supplement 26Manufacturing	Approved	None posted
Oct 15, 2001	Supplement 25Manufacturing	Approved	None posted
Oct 15, 2001	Supplement 24Manufacturing	Approved	None posted
Jan 24, 2001	Supplement 23Manufacturing	Approved	None posted
Jan 24, 2001	Supplement 22Manufacturing	Approved	None posted
Jan 24, 2001	Supplement 21Manufacturing	Approved	None posted
Jan 24, 2001	Supplement 20Manufacturing	Approved	None posted
Nov 20, 2000	Supplement 19Manufacturing	Approved	None posted
Mar 14, 2000	Supplement 18Manufacturing	Approved	None posted
Aug 24, 1999	Supplement 17Labeling	Approved	None posted
Jun 23, 1999	Supplement 16Labeling	Approved	None posted
Jun 23, 1999	Supplement 15Manufacturing	Approved	None posted
Jun 23, 1999	Supplement 14Manufacturing	Approved	None posted
Jan 29, 1998	Supplement 13Manufacturing	Approved	None posted
Dec 8, 1997	Supplement 12Manufacturing	Approved	None posted
Jan 9, 1997	Supplement 7Manufacturing	Approved	None posted
Jan 7, 1997	Supplement 9Manufacturing	Approved	None posted
Sep 17, 1996	Supplement 8Manufacturing	Approved	None posted
Jun 24, 1996	Supplement 6Manufacturing	Approved	None posted
Aug 1, 1995	Supplement 5Manufacturing	Approved	None posted
Apr 28, 1995	Supplement 4Manufacturing	Approved	None posted
Jul 14, 1994	Supplement 2Manufacturing	Approved	None posted
Jun 15, 1994	Supplement 1Manufacturing	Approved	None posted
Aug 31, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 72640
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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