APPLICATION
ANDA084324
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-24
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 70 · standardAP
2011-08-18Labeling · Supplement 65AP
2008-03-06Labeling · Supplement 59AP
2007-08-06Labeling · Supplement 56AP
1989-06-15Manufacturing (CMC) · Supplement 55AP
1989-04-10Bioequivalence · Supplement 54AP
1983-11-22Manufacturing (CMC) · Supplement 52AP
1983-11-22Manufacturing (CMC) · Supplement 53AP
1982-11-23Manufacturing (CMC) · Supplement 50AP
1982-11-23Manufacturing (CMC) · Supplement 51AP
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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