APPLICATION
ANDA040416
TYPE
ANDA
ORIGINAL APPROVAL
2003-10-02
LATEST ACTION
2019-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
JANTOVENPrescription
WARFARIN SODIUM 2.5MG · TABLET · ORAL
JANTOVENPrescription
WARFARIN SODIUM 1MG · TABLET · ORAL
JANTOVENPrescription
WARFARIN SODIUM 7.5MG · TABLET · ORAL
JANTOVENPrescription
WARFARIN SODIUM 5MG · TABLET · ORAL
JANTOVENPrescription
WARFARIN SODIUM 3MG · TABLET · ORAL
JANTOVENPrescription
WARFARIN SODIUM 2MG · TABLET · ORAL
JANTOVENPrescription
WARFARIN SODIUM 10MG · TABLET · ORAL
JANTOVENPrescription
WARFARIN SODIUM 6MG · TABLET · ORAL
JANTOVENPrescription
WARFARIN SODIUM 4MG · TABLET · ORAL
Approval history
2019-09-20Labeling · Supplement 33 · standardAP
2019-09-20Labeling · Supplement 31 · standardAP
2015-06-30Labeling · Supplement 28 · standardAP
2012-03-27Labeling · Supplement 26AP
2010-05-20Labeling · Supplement 22AP
2008-03-28Labeling · Supplement 16AP
2007-07-11Labeling · Supplement 14AP
2007-01-12Labeling · Supplement 11AP
2006-05-05Labeling · Supplement 6AP
2004-11-29Labeling · Supplement 5AP
2003-10-02OriginalAP
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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