Trivagizole 3

NDA 21143, held by Sun Pharma Canada. Clotrimazole.

As of Nov 14, 2026, NDA 21143 (Trivagizole 3), held by Sun Pharma Canada, was first approved by FDA on Apr 12, 2000, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 12, 2000
Review: Standard
Supplements approved: 7
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 8 submissions below

Date	Submission	Status	Documents
Apr 12, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trivagizole 32% · cream;vaginal	Clotrimazole	OTC

All 8 submissions, including labeling and manufacturing supplements


Aug 25, 2016	Supplement 12Labeling · Standard review	Approved	Letter Label
May 15, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 10, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 8, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 17, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 10, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 18, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21143
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