APPLICATION
ANDA078508
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-18
LATEST ACTION
2025-02-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRANDOLAPRILPrescription
TRANDOLAPRIL 4MG · TABLET · ORAL
TRANDOLAPRILPrescription
TRANDOLAPRIL 1MG · TABLET · ORAL
TRANDOLAPRILPrescription
TRANDOLAPRIL 2MG · TABLET · ORAL
Approval history
2025-02-19Labeling · Supplement 6 · standardAP
2025-02-19Labeling · Supplement 5 · standardAP
2015-05-04Labeling · Supplement 4 · standardAP
2015-05-04Labeling · Supplement 3 · standardAP
2014-09-04Manufacturing (CMC) · Supplement 2AP
2008-06-18OriginalAP
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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