Gynazole-1

Treats vulvovaginal candidiasis (infections caused by Candida ). ANDA 200923, held by Padagis Israel. Butoconazole Nitrate.

As of Nov 15, 2026, ANDA 200923 (Gynazole-1), held by Padagis Israel, was first approved by FDA on May 18, 2012, with 1 approved supplement and 0 published complete response letters.

First approved: May 18, 2012
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE GYNAZOLE

1 Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida ). The diagnosis should be confirmed by KOH smears and/or cultures (see CLINICAL STUDIES ). Note: GYNAZOLE
1 Butoconazole Nitrate Vaginal Cream USP, 2% is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established (see PRECAUTIONS - Pregnancy ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 18, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gynazole-12% · cream;vaginal	Butoconazole Nitrate	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 17, 2015	Supplement 4Labeling · Standard review	Approved	None posted
May 18, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 200923
Drugs@FDA: Overview at FDA
Company: Padagis Israel

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