APPLICATION
ANDA040145
TYPE
ANDA
ORIGINAL APPROVAL
1997-03-26
LATEST ACTION
2020-01-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 6MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 10MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 5MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 2.5MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 1MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 3MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 7.5MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 4MG · TABLET · ORAL
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 2MG · TABLET · ORAL
Approval history
2020-01-02Labeling · Supplement 65 · standardAP
2020-01-02Labeling · Supplement 61 · standardAP
2020-01-02Labeling · Supplement 64 · standardAP
2020-01-02Labeling · Supplement 60 · standardAP
2012-03-27Labeling · Supplement 56AP
2010-06-16Labeling · Supplement 54AP
2010-05-20Labeling · Supplement 55AP
2009-07-15Labeling · Supplement 53AP
2008-07-28Labeling · Supplement 52AP
2007-01-08Labeling · Supplement 49AP
2003-07-14Labeling · Supplement 44AP
2001-11-02Manufacturing (CMC) · Supplement 42AP
2001-04-06Manufacturing (CMC) · Supplement 41AP
2001-01-22Manufacturing (CMC) · Supplement 40AP
2000-09-18Manufacturing (CMC) · Supplement 37AP
2000-09-18Manufacturing (CMC) · Supplement 31AP
2000-09-18Manufacturing (CMC) · Supplement 38AP
2000-05-11Labeling · Supplement 39AP
2000-03-07Manufacturing (CMC) · Supplement 35AP
2000-03-07Manufacturing (CMC) · Supplement 33AP
2000-03-07Manufacturing (CMC) · Supplement 32AP
1999-12-28Manufacturing (CMC) · Supplement 30AP
1999-12-28Manufacturing (CMC) · Supplement 29AP
1999-12-21Manufacturing (CMC) · Supplement 34AP
1999-10-22Labeling · Supplement 36AP
1999-06-24Manufacturing (CMC) · Supplement 22AP
1999-06-24Manufacturing (CMC) · Supplement 20AP
1999-06-15Manufacturing (CMC) · Supplement 25AP
1999-06-15Manufacturing (CMC) · Supplement 28AP
1999-06-15Labeling · Supplement 26AP
1999-06-15Manufacturing (CMC) · Supplement 24AP
1999-05-20Manufacturing (CMC) · Supplement 23AP
1998-12-01Manufacturing (CMC) · Supplement 14AP
1998-11-05Manufacturing (CMC) · Supplement 16AP
1998-11-05Labeling · Supplement 19AP
1998-11-05Manufacturing (CMC) · Supplement 17AP
1998-11-05Manufacturing (CMC) · Supplement 15AP
1998-11-05Manufacturing (CMC) · Supplement 18AP
1998-10-08Manufacturing (CMC) · Supplement 13AP
1998-09-28Labeling · Supplement 21AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.