APPLICATION
ANDA073281
TYPE
ANDA
ORIGINAL APPROVAL
1992-04-30
LATEST ACTION
2020-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 37.5MG · TABLET · ORAL
Approval history
2020-12-10Labeling · Supplement 35 · standardAP
2012-01-19Labeling · Supplement 27AP
2002-12-16Manufacturing (CMC) · Supplement 15AP
2002-04-19Manufacturing (CMC) · Supplement 13AP
2002-03-25Manufacturing (CMC) · Supplement 14AP
2002-01-08Manufacturing (CMC) · Supplement 11AP
2001-10-25Manufacturing (CMC) · Supplement 12AP
2000-01-24Manufacturing (CMC) · Supplement 10AP
1998-12-01Manufacturing (CMC) · Supplement 8AP
1998-12-01Manufacturing (CMC) · Supplement 9AP
1998-01-20Manufacturing (CMC) · Supplement 5AP
1997-09-09Labeling · Supplement 6AP
1996-12-12Manufacturing (CMC) · Supplement 4AP
1996-12-12Manufacturing (CMC) · Supplement 3AP
1994-01-24Manufacturing (CMC) · Supplement 2AP
1993-04-13Labeling · Supplement 1AP
1992-04-30OriginalAP
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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