APPLICATION
ANDA073449
TYPE
ANDA
ORIGINAL APPROVAL
1993-09-23
LATEST ACTION
2022-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIAMTERENE AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 37.5MG · TABLET · ORAL
Approval history
2022-02-25Labeling · Supplement 25 · standardAP
2012-06-11Labeling · Supplement 23 · standardAP
2002-12-24Manufacturing (CMC) · Supplement 9AP
2002-12-24Manufacturing (CMC) · Supplement 7AP
2002-11-07Manufacturing (CMC) · Supplement 8AP
2001-09-05Manufacturing (CMC) · Supplement 6AP
1999-11-15Manufacturing (CMC) · Supplement 4AP
1999-11-10Manufacturing (CMC) · Supplement 5AP
1999-03-11Labeling · Supplement 3AP
1997-08-12Labeling · Supplement 2AP
1997-08-12Manufacturing (CMC) · Supplement 1AP
1993-09-23OriginalAP
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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