← FDA DRUG APPROVALS

FDA NDA · NDA021269

CARDURA XL

doxazosin mesylate

Sponsor: VIATRIS

APPLICATION
NDA021269
TYPE
NDA
ORIGINAL APPROVAL
2005-02-22
LATEST ACTION
2021-06-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CARDURA XL · ReferencePrescription
DOXAZOSIN MESYLATE EQ 8MG BASE · TABLET, EXTENDED RELEASE · ORAL
CARDURA XL · ReferencePrescription
DOXAZOSIN MESYLATE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-06-22Labeling · Supplement 21 · standard — Letter ↗AP
2017-02-27Labeling · Supplement 18 · standard — Label ↗AP
2015-06-08Labeling · Supplement 17 · standard — Letter ↗AP
2014-07-28Manufacturing (CMC) · Supplement 16 · standardAP
2012-11-30Manufacturing (CMC) · Supplement 15 · standardAP
2011-07-08Labeling · Supplement 12 · unknown — Label ↗AP
2010-03-16Labeling · Supplement 11 · standard — Letter ↗AP
2006-03-24Labeling · Supplement 1 · standard — Letter ↗AP
2005-02-22Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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