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FDA ANDA · ANDA074970

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA074970
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-06
LATEST ACTION
2001-12-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TRIAMTERENE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 37.5MG · CAPSULE · ORAL

Approval history

2001-12-12Labeling · Supplement 7AP
2000-04-21Manufacturing (CMC) · Supplement 6AP
1999-12-21Manufacturing (CMC) · Supplement 5AP
1999-05-20Manufacturing (CMC) · Supplement 3AP
1998-12-01Manufacturing (CMC) · Supplement 2AP
1998-12-01Manufacturing (CMC) · Supplement 1AP
1998-01-06Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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