APPLICATION
ANDA075580
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-18
LATEST ACTION
2024-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
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
DOXAZOSIN MESYLATEPrescription
DOXAZOSIN MESYLATE EQ 8MG BASE · TABLET · ORAL
Approval history
2024-09-27Labeling · Supplement 24 · standardAP
2024-09-27Labeling · Supplement 25 · standardAP
2017-02-21Labeling · Supplement 21 · standardAP
2014-09-21Labeling · Supplement 20 · standardAP
2014-09-21Labeling · Supplement 19AP
2006-06-07Labeling · Supplement 14AP
2006-01-31Labeling · Supplement 13AP
2005-03-18Labeling · Supplement 11AP
2002-08-28Labeling · Supplement 4AP
2002-01-24Manufacturing (CMC) · Supplement 3AP
2001-09-21Manufacturing (CMC) · Supplement 2AP
2001-01-19Labeling · Supplement 1AP
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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