APPLICATION
ANDA083965
TYPE
ANDA
ORIGINAL APPROVAL
1977-03-21
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 97 · standardAP
2000-10-06Manufacturing (CMC) · Supplement 96AP
1996-03-13Labeling · Supplement 93AP
1995-08-02Labeling · Supplement 92AP
1995-03-13Labeling · Supplement 91AP
1993-07-15Labeling · Supplement 89AP
1991-11-13Labeling · Supplement 87AP
1991-07-25Labeling · Supplement 86AP
1990-08-03Labeling · Supplement 85AP
1990-08-03Labeling · Supplement 83AP
1990-08-03Labeling · Supplement 84AP
1990-02-12Labeling · Supplement 82AP
1989-01-18Manufacturing (CMC) · Supplement 80AP
1988-09-01Manufacturing (CMC) · Supplement 78AP
1988-04-04Labeling · Supplement 81AP
1983-08-09Manufacturing (CMC) · Supplement 71AP
1983-03-21Manufacturing (CMC) · Supplement 70AP
1982-05-19Manufacturing (CMC) · Supplement 69AP
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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