APPLICATION
ANDA085054
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-20
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 41 · standardAP
2002-12-23Manufacturing (CMC) · Supplement 26AP
2002-07-17Manufacturing (CMC) · Supplement 25AP
2001-11-02Manufacturing (CMC) · Supplement 24AP
1999-12-13Labeling · Supplement 23AP
1999-08-26Manufacturing (CMC) · Supplement 22AP
1996-01-18Manufacturing (CMC) · Supplement 21AP
1995-08-02Labeling · Supplement 20AP
1993-08-13Labeling · Supplement 19AP
1993-05-07Manufacturing (CMC) · Supplement 16AP
1993-01-28Labeling · Supplement 18AP
1992-06-19Labeling · Supplement 17AP
1991-05-07Labeling · Supplement 15AP
1991-03-26Manufacturing (CMC) · Supplement 14AP
1991-03-26Manufacturing (CMC) · Supplement 12AP
1991-03-26Manufacturing (CMC) · Supplement 13AP
1991-03-26Manufacturing (CMC) · Supplement 11AP
1988-11-14Labeling · Supplement 10AP
1988-05-23Labeling · Supplement 9AP
1986-01-17Manufacturing (CMC) · Supplement 6AP
1982-08-05Manufacturing (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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