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FDA ANDA · ANDA071251

TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Sponsor: APOTEX INC

APPLICATION
ANDA071251
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-08
LATEST ACTION
2020-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 37.5MG · TABLET · ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 50MG, TRIAMTERENE 75MG · TABLET · ORAL

Approval history

2020-12-10Labeling · Supplement 48 · standardAP
2012-01-19Labeling · Supplement 41AP
2009-04-29Labeling · Supplement 40AP
2002-03-13Manufacturing (CMC) · Supplement 29AP
2000-06-27Manufacturing (CMC) · Supplement 28AP
1999-12-21Manufacturing (CMC) · Supplement 27AP
1999-05-20Manufacturing (CMC) · Supplement 26AP
1999-03-04Manufacturing (CMC) · Supplement 25AP
1998-12-01Manufacturing (CMC) · Supplement 24AP
1998-10-08Manufacturing (CMC) · Supplement 23AP
1998-05-05Manufacturing (CMC) · Supplement 20AP
1998-05-05Labeling · Supplement 19AP
1998-05-05Manufacturing (CMC) · Supplement 21AP
1998-05-05Manufacturing (CMC) · Supplement 22AP
1997-06-23Labeling · Supplement 18AP
1997-04-07Manufacturing (CMC) · Supplement 17AP
1995-11-02Manufacturing (CMC) · Supplement 16AP
1995-06-23Manufacturing (CMC) · Supplement 15AP
1994-12-23Manufacturing (CMC) · Supplement 14AP
1994-10-11Manufacturing (CMC) · Supplement 13AP
1993-06-09Labeling · Supplement 12AP
1992-10-05Labeling · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 10AP
1992-04-03Manufacturing (CMC) · Supplement 8AP
1991-12-03Labeling · Supplement 4AP
1989-10-26Bioequivalence · Supplement 6AP
1989-10-20Bioequivalence · Supplement 5AP
1988-06-02Manufacturing (CMC) · Supplement 2AP
1988-05-06Manufacturing (CMC) · Supplement 3AP
1988-05-06Manufacturing (CMC) · Supplement 1AP
1987-12-08OriginalAP
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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