APPLICATION
ANDA085683
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-17
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 58 · standardAP
2000-10-06Manufacturing (CMC) · Supplement 57AP
1996-03-13Labeling · Supplement 54AP
1995-08-02Labeling · Supplement 53AP
1995-03-13Labeling · Supplement 52AP
1993-07-15Labeling · Supplement 50AP
1991-11-13Labeling · Supplement 48AP
1991-07-25Labeling · Supplement 47AP
1990-12-04Labeling · Supplement 46AP
1990-08-03Labeling · Supplement 45AP
1990-01-31Labeling · Supplement 44AP
1989-05-02Manufacturing (CMC) · Supplement 42AP
1989-03-24Labeling · Supplement 43AP
1989-01-23Labeling · Supplement 41AP
1988-03-24Manufacturing (CMC) · Supplement 39AP
1983-06-06Manufacturing (CMC) · Supplement 36AP
1977-08-17OriginalAP
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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