APPLICATION
ANDA085208
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-20
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 39 · standardAP
2002-12-23Manufacturing (CMC) · Supplement 25AP
2002-07-17Manufacturing (CMC) · Supplement 24AP
2001-11-02Manufacturing (CMC) · Supplement 23AP
2001-02-21Manufacturing (CMC) · Supplement 22AP
1999-12-13Labeling · Supplement 21AP
1996-01-18Manufacturing (CMC) · Supplement 20AP
1995-08-02Labeling · Supplement 19AP
1993-08-13Labeling · Supplement 18AP
1993-01-28Labeling · Supplement 17AP
1992-06-19Labeling · Supplement 16AP
1991-08-12Manufacturing (CMC) · Supplement 15AP
1990-12-04Labeling · Supplement 14AP
1988-11-14Labeling · Supplement 12AP
1988-06-17Manufacturing (CMC) · Supplement 10AP
1988-05-23Labeling · Supplement 11AP
1987-05-21Manufacturing (CMC) · Supplement 9AP
1985-12-13Manufacturing (CMC) · Supplement 6AP
1982-05-24Manufacturing (CMC) · Supplement 2AP
1981-08-20OriginalAP
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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