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FDA ANDA · ANDA075509

DOXAZOSIN

doxazosin mesylate

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA075509
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-19
LATEST ACTION
2017-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2017-02-21Labeling · Supplement 18 · standardAP
2015-02-24Manufacturing (CMC) · Supplement 16AP
2014-09-22Labeling · Supplement 17 · standardAP
2011-07-08Labeling · Supplement 15AP
2007-10-01Labeling · Supplement 8AP
2004-01-21Labeling · Supplement 3AP
2002-03-25Labeling · Supplement 1AP
2000-10-19OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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