APPLICATION
NDA011971
TYPE
NDA
ORIGINAL APPROVAL
1959-07-06
LATEST ACTION
1998-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORETICDiscontinued
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
ORETICDiscontinued
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
Approval history
1998-04-16Manufacturing (CMC) · Supplement 27 · standardAP
1991-09-13Labeling · Supplement 21 · standardAP
1985-07-15Manufacturing (CMC) · Supplement 25 · standardAP
1983-12-15Manufacturing (CMC) · Supplement 24 · standardAP
1982-06-11Manufacturing (CMC) · Supplement 22 · standardAP
1982-05-14Manufacturing (CMC) · Supplement 23 · standardAP
1976-06-29Manufacturing (CMC) · Supplement 16 · standardAP
1976-02-03Labeling · Supplement 15 · standardAP
1975-03-03Labeling · Supplement 12 · standardAP
1959-07-06Type 5 - New Formulation or New Manufacturer · 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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