APPLICATION
NDA017986
TYPE
NDA
ORIGINAL APPROVAL
1980-06-13
LATEST ACTION
1994-05-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
MINIZIDEDiscontinued
POLYTHIAZIDE 0.5MG, PRAZOSIN HYDROCHLORIDE EQ 2MG BASE · CAPSULE · ORAL
MINIZIDEDiscontinued
POLYTHIAZIDE 0.5MG, PRAZOSIN HYDROCHLORIDE EQ 5MG BASE · CAPSULE · ORAL
MINIZIDEDiscontinued
POLYTHIAZIDE 0.5MG, PRAZOSIN HYDROCHLORIDE EQ 1MG BASE · CAPSULE · ORAL
Approval history
1994-05-10Manufacturing (CMC) · Supplement 12 · standardAP
1992-06-26Manufacturing (CMC) · Supplement 11 · standardAP
1989-05-01Labeling · Supplement 10AP
1985-02-26Labeling · Supplement 9AP
1984-08-22Manufacturing (CMC) · Supplement 5 · standardAP
1984-08-13Labeling · Supplement 8AP
1984-08-01Manufacturing (CMC) · Supplement 6 · standardAP
1984-04-06Manufacturing (CMC) · Supplement 7 · standardAP
1982-07-02Manufacturing (CMC) · Supplement 4 · standardAP
1981-12-01Manufacturing (CMC) · Supplement 2 · standardAP
1981-07-31Manufacturing (CMC) · Supplement 3 · standardAP
1981-02-19Labeling · Supplement 1AP
1980-06-13Type 4 - New Combination · Original · standardAP
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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