APPLICATION
ANDA074821
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-05
LATEST ACTION
2024-07-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 37.5MG · CAPSULE · ORAL
Approval history
2024-07-15Labeling · Supplement 42 · standardAP
2012-04-18Labeling · Supplement 31AP
2007-11-01Labeling · Supplement 23AP
2002-12-06Manufacturing (CMC) · Supplement 17AP
2002-06-27Manufacturing (CMC) · Supplement 15AP
2002-06-27Manufacturing (CMC) · Supplement 16AP
2002-06-27Manufacturing (CMC) · Supplement 14AP
2002-04-19Manufacturing (CMC) · Supplement 13AP
2001-11-06Manufacturing (CMC) · Supplement 11AP
2001-07-23Labeling · Supplement 12AP
2001-06-14Manufacturing (CMC) · Supplement 2AP
2001-06-14Manufacturing (CMC) · Supplement 3AP
2001-05-09Manufacturing (CMC) · Supplement 10AP
2000-09-12Manufacturing (CMC) · Supplement 6AP
2000-02-22Manufacturing (CMC) · Supplement 9AP
1999-08-25Manufacturing (CMC) · Supplement 7AP
1998-12-01Manufacturing (CMC) · Supplement 4AP
1998-02-20Manufacturing (CMC) · Supplement 1AP
1997-06-05OriginalAP
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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