APPLICATION
ANDA040616
TYPE
ANDA
ORIGINAL APPROVAL
2006-07-05
LATEST ACTION
2025-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
WARFARIN SODIUMPrescription
WARFARIN SODIUM 1MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 7.5MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 5MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 3MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 2MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 10MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 6MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 4MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 2.5MG · TABLET · ORAL
Approval history
2025-07-02Labeling · Supplement 21 · standardAP
2018-09-05Labeling · Supplement 15 · standardAP
2018-09-05Labeling · Supplement 9 · standardAP
2018-09-05Manufacturing (CMC) · Supplement 16 · unknownAP
2018-09-05Labeling · Supplement 14 · standardAP
2018-09-05Labeling · Supplement 12 · standardAP
2007-07-11Labeling · Supplement 2AP
2006-07-05OriginalAP
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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