APPLICATION
ANDA072575
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-28
LATEST ACTION
2015-11-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PRAZOSIN HYDROCHLORIDEPrescription
PRAZOSIN HYDROCHLORIDE EQ 1MG BASE · CAPSULE · ORAL
PRAZOSIN HYDROCHLORIDEPrescription
PRAZOSIN HYDROCHLORIDE EQ 5MG BASE · CAPSULE · ORAL
PRAZOSIN HYDROCHLORIDEPrescription
PRAZOSIN HYDROCHLORIDE EQ 2MG BASE · CAPSULE · ORAL
Approval history
2015-11-17Labeling · Supplement 17 · standardAP
2015-11-17Labeling · Supplement 18 · standardAP
2011-03-31Labeling · Supplement 13AP
2002-06-03Labeling · Supplement 8AP
2000-08-01Manufacturing (CMC) · Supplement 7AP
1998-02-25Manufacturing (CMC) · Supplement 6AP
1998-02-05Manufacturing (CMC) · Supplement 5AP
1993-10-15Manufacturing (CMC) · Supplement 4AP
1990-10-04Labeling · Supplement 2AP
1990-01-31Manufacturing (CMC) · Supplement 1AP
1989-02-28OriginalAP
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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