Urex

Treats frequently recurring urinary tract infections. NDA 16151, held by Quagen. Methenamine Hippurate.

As of Nov 13, 2026, NDA 16151 (Urex), held by Quagen, was first approved by FDA on Jul 5, 1967, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 5, 1967
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Methenamine Hippurate Tablets and other antibacterial drugs, Methenamine Hippurate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 5, 1967	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Urex1GM · tablet;oral	Methenamine Hippurate	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 30, 2015	Supplement 28Manufacturing · Standard review	Approved	None posted
Mar 11, 2008	Supplement 25Labeling · Standard review	Approved	Letter Label
Jul 2, 1993	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 10, 1992	Supplement 20Labeling	Approved	None posted
Mar 6, 1989	Supplement 18Labeling	Approved	None posted
Aug 10, 1988	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 21, 1986	Supplement 19Labeling	Approved	None posted
Jul 24, 1975	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 5, 1967	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 16151
Drugs@FDA: Overview at FDA
Company: Quagen Pharmaceuticals

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