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FDA ANDA · ANDA040196

WARFARIN SODIUM

Sponsor: CHARTWELL RX

APPLICATION
ANDA040196
TYPE
ANDA
ORIGINAL APPROVAL
1997-09-30
LATEST ACTION
2002-04-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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
WARFARIN SODIUMDiscontinued
WARFARIN SODIUM 6MG · TABLET · ORAL

Approval history

2002-04-15Manufacturing (CMC) · Supplement 8AP
2002-04-15Manufacturing (CMC) · Supplement 10AP
2002-04-15Manufacturing (CMC) · Supplement 9AP
2000-07-26Manufacturing (CMC) · Supplement 6AP
2000-07-26Manufacturing (CMC) · Supplement 4AP
2000-07-26Labeling · Supplement 7AP
2000-07-26Manufacturing (CMC) · Supplement 5AP
2000-02-23Manufacturing (CMC) · Supplement 3AP
2000-01-05Labeling · Supplement 2AP
1998-10-08Manufacturing (CMC) · Supplement 1AP
1997-09-30OriginalAP
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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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