Clotrimazole

As of Nov 15, 2026, ANDA 73306 (Clotrimazole), held by Teva, was first approved by FDA on Feb 28, 1995, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 28, 1995
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 28, 1995	Original application	Approved	None posted

Products

1 strengths and forms

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

All 10 submissions, including labeling and manufacturing supplements


Dec 20, 2002	Supplement 10Manufacturing	Approved	None posted
May 29, 2002	Supplement 9Manufacturing	Approved	None posted
Aug 30, 2001	Supplement 8Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 6Manufacturing	Approved	None posted
Feb 4, 2000	Supplement 4Manufacturing	Approved	None posted
Feb 4, 2000	Supplement 5Manufacturing	Approved	None posted
Jan 28, 1998	Supplement 3Manufacturing	Approved	None posted
Jun 23, 1997	Supplement 2Manufacturing	Approved	None posted
Oct 18, 1996	Supplement 1Manufacturing	Approved	None posted
Feb 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 73306
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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