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FDA ANDA · ANDA075052

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA075052
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-18
LATEST ACTION
2002-12-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2002-12-23Manufacturing (CMC) · Supplement 10AP
2002-06-19Manufacturing (CMC) · Supplement 9AP
2002-04-30Manufacturing (CMC) · Supplement 7AP
2002-04-30Manufacturing (CMC) · Supplement 6AP
2002-03-21Labeling · Supplement 8AP
2001-07-20Manufacturing (CMC) · Supplement 5AP
2000-11-30Labeling · Supplement 3AP
2000-11-30Manufacturing (CMC) · Supplement 4AP
2000-11-30Manufacturing (CMC) · Supplement 2AP
2000-03-14Manufacturing (CMC) · Supplement 1AP
1999-06-18Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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