← FDA DRUG APPROVALS

FDA NDA · NDA017442

PRAZOSIN HYDROCHLORIDE

Sponsor: PFIZER

APPLICATION
NDA017442
TYPE
NDA
ORIGINAL APPROVAL
1976-06-23
LATEST ACTION
2016-01-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MINIPRESS · ReferencePrescription
PRAZOSIN HYDROCHLORIDE EQ 2MG BASE · CAPSULE · ORAL
MINIPRESS · ReferencePrescription
PRAZOSIN HYDROCHLORIDE EQ 5MG BASE · CAPSULE · ORAL
MINIPRESS · ReferencePrescription
PRAZOSIN HYDROCHLORIDE EQ 1MG BASE · CAPSULE · ORAL

Approval history

2016-01-08Manufacturing (CMC) · Supplement 44 · priorityAP
2015-02-27Labeling · Supplement 43 · standard — Label ↗AP
2014-07-28Manufacturing (CMC) · Supplement 42 · priorityAP
2013-11-04Labeling · Supplement 41 · standard — Label ↗AP
2009-07-10Labeling · Supplement 35 · standard — Label ↗AP
2009-04-06Labeling · Supplement 33 · standard — Letter ↗AP
2001-06-12Labeling · Supplement 29 · standard — Letter ↗AP
1994-05-10Manufacturing (CMC) · Supplement 28 · priorityAP
1989-08-21Manufacturing (CMC) · Supplement 26 · priorityAP
1989-05-01Labeling · Supplement 27AP
1988-10-14Manufacturing (CMC) · Supplement 25 · priorityAP
1988-08-29Manufacturing (CMC) · Supplement 24 · priorityAP
1988-06-06Manufacturing (CMC) · Supplement 22 · priorityAP
1987-07-14Manufacturing (CMC) · Supplement 23 · priorityAP
1986-04-25Labeling · Supplement 13AP
1986-04-25Labeling · Supplement 20AP
1985-09-27Manufacturing (CMC) · Supplement 21 · priorityAP
1985-02-26Labeling · Supplement 19AP
1984-09-13Manufacturing (CMC) · Supplement 17 · priorityAP
1984-08-13Labeling · Supplement 18AP
1984-08-03Manufacturing (CMC) · Supplement 16 · priorityAP
1984-08-01Manufacturing (CMC) · Supplement 15 · priorityAP
1983-11-29Manufacturing (CMC) · Supplement 14 · priorityAP
1982-08-06Manufacturing (CMC) · Supplement 4 · priorityAP
1982-02-19Manufacturing (CMC) · Supplement 11 · priorityAP
1982-02-19Labeling · Supplement 12AP
1981-11-17Manufacturing (CMC) · Supplement 10 · priorityAP
1981-09-25Manufacturing (CMC) · Supplement 9 · priorityAP
1981-07-30Manufacturing (CMC) · Supplement 8 · priorityAP
1981-01-14Labeling · Supplement 7AP
1979-01-10Labeling · Supplement 5AP
1978-11-27Manufacturing (CMC) · Supplement 3 · priorityAP
1977-07-13Manufacturing (CMC) · Supplement 1 · priorityAP
1977-06-14Labeling · Supplement 2AP
1976-06-23Type 1 - New Molecular Entity · Original · priorityAP
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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