Terazol 7

NDA 19579, held by Janssen Pharms. Terconazole.

As of Nov 13, 2026, NDA 19579 (Terazol 7), held by Janssen Pharms, was first approved by FDA on Dec 31, 1987, with 26 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1987
Review: Standard
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Dec 31, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Terazol 70.4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;vaginal	Terconazole	DiscontinuedReference drug

All 27 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 23, 2014	Supplement 37Labeling · Standard review	Approved	Letter Label
Sep 26, 2013	Supplement 35Labeling · Standard review	Approved	Letter Label
Jul 23, 2013	Supplement 36Manufacturing · Standard review	Approved	None posted
Jun 30, 2004	Supplement 26Labeling · Standard review	Approved	Label Letter
Sep 24, 2003	Supplement 25Labeling · Standard review	Approved	Letter
Mar 11, 2003	Supplement 20Labeling · Standard review	Approved	Letter Label
Mar 11, 2003	Supplement 16Labeling · Standard review	Approved	Letter Label
Oct 4, 2002	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 10, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 21, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 13, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 22, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 1, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 8, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 8, 1999	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 7, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 28, 1997	Supplement 10Labeling · Standard review	Approved	None posted
Oct 17, 1994	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 9, 1993	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 24, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Aug 21, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 21, 1990	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 6, 1989	Supplement 3Labeling	Approved	None posted
Dec 6, 1989	Supplement 1Labeling	Approved	None posted
Jul 28, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 3, 1989	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 31, 1987	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19579
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