Uroxatral

Treats benign prostatic hyperplasia. NDA 21287, held by Advanz Pharma. Alfuzosin Hydrochloride.

As of Nov 14, 2026, NDA 21287 (Uroxatral), held by Advanz Pharma, was first approved by FDA on Jun 12, 2003, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 12, 2003
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Dec 15, 2010	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 1 Pediatric Written Request
Jun 12, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Uroxatral10MG · tablet, extended release;oral	Alfuzosin Hydrochloride	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


May 22, 2020	Supplement 24Labeling · Standard review	Approved	Letter Label
May 14, 2018	Supplement 21Labeling · Standard review	Approved	Label Letter
Mar 23, 2016	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 21, 2014	Supplement 18Labeling · Standard review	Approved	Letter Label
May 30, 2013	Supplement 17Labeling · Standard review	Approved	Label Letter
Dec 15, 2010	Supplement 16Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Amendment 1 Pediatric Written Request
Apr 9, 2010	Supplement 14Labeling	Approved	Label Letter
May 20, 2009	Supplement 13Labeling · Standard review	Approved	Letter Label
Sep 18, 2008	Supplement 11Labeling · Standard review	Approved	Letter Label
May 6, 2008	Supplement 9Labeling · Standard review	Approved	Letter
Mar 29, 2007	Supplement 8Labeling · Standard review	Approved	Letter Label
Nov 16, 2006	Supplement 7Labeling · Standard review	Approved	Label Letter
Mar 17, 2006	Supplement 5Labeling · Standard review	Approved	Letter Label
Jul 15, 2003	Supplement 1Labeling · Standard review	Approved	Review Letter
Jun 12, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21287
Drugs@FDA: Overview at FDA
Company: ADVANZ PHARMA

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