FDA NDA · NDA021287

UROXATRAL

alfuzosin hcl

Sponsor: ADVANZ PHARMA

APPLICATION

NDA021287

TYPE

NDA

ORIGINAL APPROVAL

2003-06-12

LATEST ACTION

2020-05-22

ROUTE

ORAL

DOSAGE FORM

TABLET, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

UROXATRAL · ReferencePrescription

ALFUZOSIN HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL

2020-05-22Labeling · Supplement 24 · standard — Label ↗AP

2018-05-14Labeling · Supplement 21 · standard — Letter ↗AP

2016-03-23Manufacturing (CMC) · Supplement 19 · standardAP

2014-04-21Labeling · Supplement 18 · standard — Label ↗AP

2013-05-30Labeling · Supplement 17 · standard — Label ↗AP

2010-12-15Efficacy · Supplement 16 · priority — Letter ↗AP

2010-04-09Labeling · Supplement 14 · unknown — Label ↗AP

2009-05-20Labeling · Supplement 13 · standard — Label ↗AP

2008-09-18Labeling · Supplement 11 · standard — Label ↗AP

2008-05-06Labeling · Supplement 9 · standard — Letter ↗AP

2007-03-29Labeling · Supplement 8 · standard — Letter ↗AP

2006-11-16Labeling · Supplement 7 · standard — Label ↗AP

2006-03-17Labeling · Supplement 5 · standard — Letter ↗AP

2003-07-15Labeling · Supplement 1 · standard — Review ↗AP

2003-06-12Type 1 - New Molecular Entity · Original · standard — Review ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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