APPLICATION
ANDA040301
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-15
LATEST ACTION
2019-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
WARFARIN SODIUMPrescription
WARFARIN SODIUM 6MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 4MG · TABLET · ORAL
WARFARIN SODIUMPrescription
WARFARIN SODIUM 2.5MG · TABLET · ORAL
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
Approval history
2019-09-27Labeling · Supplement 36 · standardAP
2019-09-27Labeling · Supplement 34 · standardAP
2019-09-27Labeling · Supplement 38 · standardAP
2016-11-14Manufacturing (CMC) · Supplement 33 · unknownAP
2016-06-02Labeling · Supplement 32 · standardAP
2012-12-19Labeling · Supplement 29 · standardAP
2012-03-27Labeling · Supplement 26AP
2010-05-20Labeling · Supplement 24AP
2004-02-13Labeling · Supplement 8AP
2004-01-12Labeling · Supplement 9AP
2002-12-23Labeling · Supplement 5AP
2002-12-23Manufacturing (CMC) · Supplement 3AP
2002-12-23Manufacturing (CMC) · Supplement 6AP
2002-12-23Manufacturing (CMC) · Supplement 4AP
2000-04-25Manufacturing (CMC) · Supplement 1AP
2000-02-01Labeling · Supplement 2AP
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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