← FDA DRUG APPROVALS

FDA ANDA · ANDA075536

DOXAZOSIN

doxazosin mesylate

Sponsor: TEVA

APPLICATION
ANDA075536
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-18
LATEST ACTION
2017-09-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DOXAZOSIN MESYLATEPrescription
DOXAZOSIN MESYLATE EQ 8MG BASE · TABLET · ORAL
DOXAZOSIN MESYLATEPrescription
DOXAZOSIN MESYLATE EQ 2MG BASE · TABLET · ORAL
DOXAZOSIN MESYLATEPrescription
DOXAZOSIN MESYLATE EQ 4MG BASE · TABLET · ORAL
DOXAZOSIN MESYLATEPrescription
DOXAZOSIN MESYLATE EQ 1MG BASE · TABLET · ORAL

Approval history

2017-09-29Labeling · Supplement 18 · standardAP
2017-02-21Labeling · Supplement 19 · standardAP
2013-04-26Labeling · Supplement 10AP
2010-06-15Labeling · Supplement 9AP
2006-12-15Labeling · Supplement 7AP
2004-03-26Labeling · Supplement 6AP
2003-07-14Labeling · Supplement 5AP
2002-06-17Manufacturing (CMC) · Supplement 3AP
2001-12-26Manufacturing (CMC) · Supplement 2AP
2001-04-25Labeling · Supplement 1AP
2000-10-18Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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