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FDA ANDA · ANDA074259

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA074259
TYPE
ANDA
ORIGINAL APPROVAL
1995-03-30
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TRIAMTERENE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 50MG · CAPSULE · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 3AP
2002-03-12Manufacturing (CMC) · Supplement 2AP
2000-01-28Manufacturing (CMC) · Supplement 1AP
1995-03-30OriginalAP
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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