APPLICATION
ANDA083972
TYPE
ANDA
ORIGINAL APPROVAL
1974-10-03
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 100MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 175 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 174AP
1994-12-23Manufacturing (CMC) · Supplement 173AP
1994-10-11Manufacturing (CMC) · Supplement 172AP
1994-05-24Labeling · Supplement 171AP
1993-02-12Labeling · Supplement 170AP
1992-08-18Labeling · Supplement 169AP
1992-04-03Manufacturing (CMC) · Supplement 168AP
1992-04-03Manufacturing (CMC) · Supplement 166AP
1991-04-02Manufacturing (CMC) · Supplement 163AP
1991-04-02Manufacturing (CMC) · Supplement 162AP
1990-08-06Labeling · Supplement 164AP
1989-12-28Labeling · Supplement 161AP
1986-02-05Manufacturing (CMC) · Supplement 152AP
1986-02-05Manufacturing (CMC) · Supplement 153AP
1985-03-29Manufacturing (CMC) · Supplement 150AP
1985-03-29Manufacturing (CMC) · Supplement 151AP
1984-12-18Manufacturing (CMC) · Supplement 149AP
1984-12-18Manufacturing (CMC) · Supplement 148AP
1982-05-25Manufacturing (CMC) · Supplement 142AP
1982-05-25Manufacturing (CMC) · Supplement 140AP
1982-05-25Manufacturing (CMC) · Supplement 109AP
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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