Cardura

NDA 19668, held by Viatris. Doxazosin Mesylate.

As of Nov 13, 2026, NDA 19668 (Cardura), held by Viatris, was first approved by FDA on Nov 2, 1990, with 23 approved supplements and 0 published complete response letters.

First approved: Nov 2, 1990
Review: Standard
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Doxazosin is an alpha 1 adrenergic antagonist indicated for:

Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablet is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Nov 2, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
CarduraEQ 1MG BASE · tablet;oral	Doxazosin Mesylate	RxReference drug
CarduraEQ 2MG BASE · tablet;oral	Doxazosin Mesylate	RxReference drug
CarduraEQ 4MG BASE · tablet;oral	Doxazosin Mesylate	RxReference drug
CarduraEQ 8MG BASE · tablet;oral	Doxazosin Mesylate	RxReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 23, 2021	Supplement 32Labeling · Standard review	Approved	Label Letter
Jun 9, 2016	Supplement 28Labeling · Standard review	Approved	Label Letter
Jul 28, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 6, 2013	Supplement 26Labeling · Standard review	Approved	Label Letter
Jan 14, 2010	Supplement 22Labeling	Approved	Label Letter
Jul 10, 2009	Supplement 21Labeling · Standard review	Approved	Label Letter
Feb 28, 2006	Supplement 17Labeling · Standard review	Approved	Letter
Jun 13, 2003	Supplement 12Labeling · Standard review	Approved	Letter
Sep 13, 2002	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 23, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Oct 10, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Apr 7, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 21, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 21, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 29, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Sep 13, 1996	Supplement 8Labeling · Standard review	Approved	None posted
Feb 6, 1995	Supplement 7Labeling · Standard review	Approved	None posted
Jul 18, 1994	Supplement 6Labeling · Standard review	Approved	None posted
Oct 5, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 29, 1993	Supplement 4Labeling · Standard review	Approved	None posted
Nov 2, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 6, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
May 14, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 2, 1990	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 19668
Drugs@FDA: Overview at FDA
Company: Viatris

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