Clotrimazole

ANDA 74165, held by Encube. Clotrimazole.

As of Nov 15, 2026, ANDA 74165 (Clotrimazole), held by Encube, was first approved by FDA on Jul 16, 1993, with 24 approved supplements and 0 published complete response letters.

First approved: Jul 16, 1993
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

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
Jul 16, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clotrimazole1% · cream;vaginal	Clotrimazole	OTC

All 25 submissions, including labeling and manufacturing supplements


Mar 10, 2022	Supplement 43Labeling · Standard review	Approved	None posted
Nov 9, 2015	Supplement 39Manufacturing	Approved	None posted
Apr 14, 2015	Supplement 37Labeling · Standard review	Approved	None posted
Apr 14, 2015	Supplement 33Labeling	Approved	None posted
Jan 5, 2015	Supplement 38Manufacturing	Approved	None posted
Jul 10, 2001	Supplement 20Manufacturing	Approved	None posted
Dec 29, 2000	Supplement 19Manufacturing	Approved	None posted
Nov 15, 1999	Supplement 18Labeling	Approved	None posted
Nov 15, 1999	Supplement 17Manufacturing	Approved	None posted
Nov 15, 1999	Supplement 16Manufacturing	Approved	None posted
May 13, 1999	Supplement 15Manufacturing	Approved	None posted
Apr 1, 1998	Supplement 14Manufacturing	Approved	None posted
Sep 11, 1997	Supplement 12Labeling	Approved	None posted
Jun 28, 1996	Supplement 11Manufacturing	Approved	None posted
May 30, 1996	Supplement 10Manufacturing	Approved	None posted
May 30, 1996	Supplement 9Manufacturing	Approved	None posted
May 30, 1996	Supplement 8Manufacturing	Approved	None posted
May 30, 1996	Supplement 7Manufacturing	Approved	None posted
Apr 24, 1996	Supplement 5Labeling	Approved	None posted
Feb 7, 1996	Supplement 6Manufacturing	Approved	None posted
Oct 19, 1994	Supplement 4Labeling	Approved	None posted
Mar 24, 1994	Supplement 1Labeling	Approved	None posted
Dec 20, 1993	Supplement 2Manufacturing	Approved	None posted
Dec 10, 1993	Supplement 3Manufacturing	Approved	None posted
Jul 16, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74165
Drugs@FDA: Overview at FDA
Company: Encube Ethicals

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