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FDA ANDA · ANDA073191

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA073191
TYPE
ANDA
ORIGINAL APPROVAL
1991-07-31
LATEST ACTION
2012-04-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2012-04-18Labeling · Supplement 32AP
2008-08-13Labeling · Supplement 27AP
2004-01-05Labeling · Supplement 20AP
2002-04-19Manufacturing (CMC) · Supplement 19AP
2001-11-06Manufacturing (CMC) · Supplement 18AP
2001-07-27Manufacturing (CMC) · Supplement 16AP
2001-05-09Manufacturing (CMC) · Supplement 17AP
1999-11-19Manufacturing (CMC) · Supplement 15AP
1999-04-14Manufacturing (CMC) · Supplement 10AP
1999-04-14Labeling · Supplement 11AP
1998-12-01Manufacturing (CMC) · Supplement 13AP
1998-12-01Manufacturing (CMC) · Supplement 14AP
1998-12-01Manufacturing (CMC) · Supplement 12AP
1996-05-13Manufacturing (CMC) · Supplement 5AP
1996-05-13Manufacturing (CMC) · Supplement 6AP
1995-02-06Manufacturing (CMC) · Supplement 3AP
1994-01-24Manufacturing (CMC) · Supplement 7AP
1991-07-31OriginalAP
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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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