APPLICATION
NDA019668
TYPE
NDA
ORIGINAL APPROVAL
1990-11-02
LATEST ACTION
2021-06-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARDURA · ReferencePrescription
DOXAZOSIN MESYLATE EQ 4MG BASE · TABLET · ORAL
CARDURA · ReferencePrescription
DOXAZOSIN MESYLATE EQ 1MG BASE · TABLET · ORAL
CARDURA · ReferencePrescription
DOXAZOSIN MESYLATE EQ 8MG BASE · TABLET · ORAL
CARDURA · ReferencePrescription
DOXAZOSIN MESYLATE EQ 2MG BASE · TABLET · ORAL
Approval history
2014-07-28Manufacturing (CMC) · Supplement 27 · standardAP
2002-09-13Manufacturing (CMC) · Supplement 16 · standardAP
2000-10-10Labeling · Supplement 14 · standardAP
2000-04-07Manufacturing (CMC) · Supplement 13 · standardAP
1998-07-21Manufacturing (CMC) · Supplement 11 · standardAP
1998-07-21Manufacturing (CMC) · Supplement 10 · standardAP
1997-07-29Labeling · Supplement 9 · standardAP
1996-09-13Labeling · Supplement 8 · standardAP
1995-02-06Labeling · Supplement 7 · standardAP
1994-07-18Labeling · Supplement 6 · standardAP
1993-10-05Manufacturing (CMC) · Supplement 5 · standardAP
1993-04-29Labeling · Supplement 4 · standardAP
1992-11-02Manufacturing (CMC) · Supplement 3 · standardAP
1991-07-06Manufacturing (CMC) · Supplement 2 · standardAP
1991-05-14Manufacturing (CMC) · Supplement 1 · standardAP
1990-11-02Type 1 - New Molecular Entity · Original · standardAP
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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