APPLICATION
ANDA072011
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-17
LATEST ACTION
2020-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 50MG, TRIAMTERENE 75MG · TABLET · ORAL
Approval history
2020-12-10Labeling · Supplement 39 · standardAP
2012-01-19Labeling · Supplement 32AP
2002-06-05Manufacturing (CMC) · Supplement 18AP
2002-03-25Manufacturing (CMC) · Supplement 19AP
2001-10-22Manufacturing (CMC) · Supplement 16AP
2001-08-08Manufacturing (CMC) · Supplement 17AP
2000-01-24Manufacturing (CMC) · Supplement 15AP
1999-06-24Manufacturing (CMC) · Supplement 12AP
1999-06-24Labeling · Supplement 13AP
1999-05-05Manufacturing (CMC) · Supplement 14AP
1998-12-01Manufacturing (CMC) · Supplement 11AP
1998-12-01Manufacturing (CMC) · Supplement 10AP
1997-10-21Manufacturing (CMC) · Supplement 8AP
1997-09-09Labeling · Supplement 9AP
1995-06-01Manufacturing (CMC) · Supplement 7AP
1993-04-13Labeling · Supplement 6AP
1992-05-15Labeling · Supplement 5AP
1992-04-29Labeling · Supplement 4AP
1992-02-05Labeling · Supplement 3AP
1991-03-28Labeling · Supplement 2AP
1989-05-01Labeling · Supplement 1AP
1989-05-01Labeling · Supplement 41AP
1988-06-17OriginalAP
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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