APPLICATION
ANDA084912
TYPE
ANDA
ORIGINAL APPROVAL
1976-12-17
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 71 · standardAP
2020-08-06Labeling · Supplement 70 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 68AP
1998-12-01Manufacturing (CMC) · Supplement 69AP
1998-01-12Manufacturing (CMC) · Supplement 67AP
1995-07-27Labeling · Supplement 66AP
1994-03-30Labeling · Supplement 64AP
1994-01-24Manufacturing (CMC) · Supplement 65AP
1992-08-11Labeling · Supplement 63AP
1990-08-21Manufacturing (CMC) · Supplement 57AP
1990-08-21Manufacturing (CMC) · Supplement 58AP
1989-11-21Labeling · Supplement 61AP
1989-11-09Labeling · Supplement 62AP
1989-08-23Labeling · Supplement 60AP
1988-05-27Labeling · Supplement 59AP
1987-06-03Manufacturing (CMC) · Supplement 55AP
1987-06-03Manufacturing (CMC) · Supplement 53AP
1987-06-03Manufacturing (CMC) · Supplement 56AP
1987-06-03Manufacturing (CMC) · Supplement 54AP
1985-04-23Manufacturing (CMC) · Supplement 49AP
1985-04-12Manufacturing (CMC) · Supplement 50AP
1983-08-17Manufacturing (CMC) · Supplement 45AP
1983-08-17Manufacturing (CMC) · Supplement 46AP
1982-08-09Manufacturing (CMC) · Supplement 43AP
1982-07-08Manufacturing (CMC) · Supplement 39AP
1982-07-08Manufacturing (CMC) · Supplement 37AP
1982-07-08Manufacturing (CMC) · Supplement 41AP
1982-07-08Manufacturing (CMC) · Supplement 36AP
1976-12-17OriginalAP
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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