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FDA ANDA · ANDA085219

HYDROCHLOROTHIAZIDE

Sponsor: AUROLIFE PHARMA LLC

APPLICATION
ANDA085219
TYPE
ANDA
ORIGINAL APPROVAL
1979-03-12
LATEST ACTION
1995-03-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL

Approval history

1995-03-28Manufacturing (CMC) · Supplement 16AP
1993-08-17Labeling · Supplement 19AP
1993-03-29Labeling · Supplement 18AP
1992-10-19Labeling · Supplement 17AP
1989-11-02Labeling · Supplement 14AP
1987-04-06Manufacturing (CMC) · Supplement 12AP
1987-04-06Manufacturing (CMC) · Supplement 9AP
1982-09-30Manufacturing (CMC) · Supplement 7AP
1979-03-12OriginalAP
VIEW ON DRUGS@FDA ↗

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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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