Terazol 3

NDA 19964, held by Janssen Pharms. Terconazole.

As of Nov 13, 2026, NDA 19964 (Terazol 3), held by Janssen Pharms, was first approved by FDA on Feb 21, 1991, with 21 approved supplements and 0 published complete response letters.

First approved: Feb 21, 1991
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Feb 21, 1991	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Terazol 30.8% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;vaginal	Terconazole	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 23, 2014	Supplement 32Labeling · Standard review	Approved	Letter Label
Sep 26, 2013	Supplement 30Labeling · Standard review	Approved	Letter Label
Jul 23, 2013	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 30, 2004	Supplement 21Labeling · Standard review	Approved	Label Letter
Sep 24, 2003	Supplement 20Labeling · Standard review	Approved	Letter
Mar 11, 2003	Supplement 14Labeling · Standard review	Approved	Letter Label
Mar 11, 2003	Supplement 11Labeling · Standard review	Approved	Letter Label
Oct 4, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 16, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 10, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 21, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 13, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 28, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 8, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 8, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 7, 1998	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 28, 1997	Supplement 6Labeling · Standard review	Approved	None posted
Oct 17, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 9, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 25, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 11, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 21, 1991	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19964
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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