Vagistat-1

NDA 20676, held by Combe. Tioconazole.

As of Nov 13, 2026, NDA 20676 (Vagistat-1), held by Combe, was first approved by FDA on Feb 11, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 11, 1997
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Feb 11, 1997	Original applicationTYPE 8 · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vagistat-16.5% · ointment;vaginal	Tioconazole	OTCReference drug

All 8 submissions, including labeling and manufacturing supplements


Apr 21, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 15, 2009	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 12, 2001	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 9, 2001	Supplement 4Labeling · Standard review	Approved	Label
Apr 24, 2001	Supplement 1Labeling · Standard review	Approved	None posted
Apr 24, 2001	Supplement 3Labeling · Standard review	Approved	None posted
Sep 23, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 11, 1997	Original applicationTYPE 8 · Standard review	Approved	Review

Identifiers

Application: NDA 20676
Drugs@FDA: Overview at FDA
Company: Combe Incorporated

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