APPLICATION
ANDA084325
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-24
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 49 · standardAP
2011-08-18Labeling · Supplement 44AP
2008-03-06Labeling · Supplement 38AP
2007-08-06Labeling · Supplement 35AP
1989-03-08Bioequivalence · Supplement 34AP
1983-11-22Manufacturing (CMC) · Supplement 30AP
1983-11-22Manufacturing (CMC) · Supplement 29AP
1982-11-23Manufacturing (CMC) · Supplement 27AP
1982-11-23Manufacturing (CMC) · Supplement 28AP
1976-06-24OriginalAP
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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