APPLICATION
ANDA085672
TYPE
ANDA
ORIGINAL APPROVAL
1977-06-02
LATEST ACTION
1996-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
Approval history
1996-03-13Labeling · Supplement 54AP
1995-08-02Labeling · Supplement 53AP
1995-03-13Labeling · Supplement 52AP
1993-07-15Labeling · Supplement 49AP
1991-11-13Labeling · Supplement 47AP
1991-07-25Labeling · Supplement 46AP
1990-08-03Labeling · Supplement 45AP
1990-08-03Labeling · Supplement 44AP
1990-01-31Labeling · Supplement 43AP
1988-10-31Labeling · Supplement 42AP
1988-03-24Manufacturing (CMC) · Supplement 40AP
1983-06-06Manufacturing (CMC) · Supplement 36AP
1983-02-24Manufacturing (CMC) · Supplement 35AP
1977-06-02OriginalAP
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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