← FDA DRUG APPROVALS

FDA NDA · NDA009218

COUMADIN

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION

NDA009218

TYPE

NDA

ORIGINAL APPROVAL

1954-06-08

LATEST ACTION

2017-08-14

ROUTE

ORAL, INJECTION

DOSAGE FORM

TABLET, INJECTABLE

MARKETING STATUS

Discontinued

Products

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 3MG · TABLET · ORAL

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 4MG · TABLET · ORAL

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 5MG · TABLET · ORAL

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 2MG · TABLET · ORAL

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 10MG · TABLET · ORAL

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 6MG · TABLET · ORAL

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 2.5MG · TABLET · ORAL

COUMADINDiscontinued

WARFARIN SODIUM 5MG/VIAL · INJECTABLE · INJECTION

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 7.5MG · TABLET · ORAL

COUMADIN · ReferenceDiscontinued

WARFARIN SODIUM 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

COUMADINDiscontinued

WARFARIN SODIUM 50MG/VIAL · INJECTABLE · INJECTION

COUMADINDiscontinued

WARFARIN SODIUM 75MG/VIAL · INJECTABLE · INJECTION

Approval history

2017-08-14Labeling · Supplement 118 · standard — Label ↗AP

2017-05-22Labeling · Supplement 117 · standard — Label ↗AP

2016-09-08Labeling · Supplement 116 · standard — Label ↗AP

2015-10-28Labeling · Supplement 115 · standard — Label ↗AP

2014-12-02Manufacturing (CMC) · Supplement 114 · standardAP

2013-03-25Manufacturing (CMC) · Supplement 113 · standardAP

2011-10-04Labeling · Supplement 107 · standard — Letter ↗AP

2010-01-22Labeling · Supplement 108 · unknown — Label ↗AP

2007-08-16Labeling · Supplement 105 · standard — Letter ↗AP

2006-10-04Labeling · Supplement 102 · standard — Label ↗AP

2005-09-02Labeling · Supplement 101 · standard — Review ↗AP

2002-05-03Labeling · Supplement 99 · standard — Letter ↗AP

2002-05-03Labeling · Supplement 98 · standard — Letter ↗AP

2000-02-17Labeling · Supplement 97 · standard — Review ↗AP

1999-12-02Manufacturing (CMC) · Supplement 95 · standardAP

1999-07-09Labeling · Supplement 96 · standardAP

1999-03-31Manufacturing (CMC) · Supplement 94 · standardAP

1998-12-23Manufacturing (CMC) · Supplement 93 · standardAP

1998-11-23Manufacturing (CMC) · Supplement 87 · standardAP

1998-06-01Labeling · Supplement 91 · standard — Review ↗AP

1998-06-01Labeling · Supplement 86 · standard — Review ↗AP

1998-06-01Labeling · Supplement 90 · standard — Review ↗AP

1998-04-16Manufacturing (CMC) · Supplement 89 · standardAP

1997-10-29Manufacturing (CMC) · Supplement 88 · standardAP

1996-11-18Manufacturing (CMC) · Supplement 83 · standardAP

1996-11-08Manufacturing (CMC) · Supplement 84 · standardAP

1996-09-05Labeling · Supplement 85 · standardAP

1995-09-07Labeling · Supplement 80 · standardAP

1995-04-28Efficacy · Supplement 76 · standardAP

1995-03-08Manufacturing (CMC) · Supplement 79 · standardAP

1995-02-07Manufacturing (CMC) · Supplement 77 · standardAP

1995-02-07Manufacturing (CMC) · Supplement 78 · standardAP

1994-03-31Efficacy · Supplement 74 · priorityAP

1993-12-15Manufacturing (CMC) · Supplement 69 · standardAP

1993-08-24Manufacturing (CMC) · Supplement 70 · standardAP

1993-08-06Labeling · Supplement 75 · standardAP

1993-06-08Labeling · Supplement 73 · standardAP

1993-02-01Labeling · Supplement 72 · standardAP

1992-08-20Labeling · Supplement 71AP

1991-05-10Manufacturing (CMC) · Supplement 66 · standardAP

VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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