Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009218
Company: BRISTOL MYERS SQUIBB

• Medication Guide

Products on NDA 9218

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COUMADIN	WARFARIN SODIUM	10MG	TABLET;ORAL	Discontinued	None	Yes	No
COUMADIN	WARFARIN SODIUM	5MG	TABLET;ORAL	Discontinued	None	Yes	No
COUMADIN	WARFARIN SODIUM	75MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
COUMADIN	WARFARIN SODIUM	2MG	TABLET;ORAL	Discontinued	None	Yes	No
COUMADIN	WARFARIN SODIUM	7.5MG	TABLET;ORAL	Discontinued	None	Yes	No
COUMADIN	WARFARIN SODIUM	2.5MG	TABLET;ORAL	Discontinued	None	Yes	No
COUMADIN	WARFARIN SODIUM	50MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
COUMADIN	WARFARIN SODIUM	1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
COUMADIN	WARFARIN SODIUM	4MG	TABLET;ORAL	Discontinued	None	Yes	No
COUMADIN	WARFARIN SODIUM	5MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
COUMADIN	WARFARIN SODIUM	3MG	TABLET;ORAL	Discontinued	None	Yes	No
COUMADIN	WARFARIN SODIUM	6MG	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 009218

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2017	SUPPL-118	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf
08/14/2017	SUPPL-118	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf
05/22/2017	SUPPL-117	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf
05/22/2017	SUPPL-117	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf
09/08/2016	SUPPL-116	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf
10/28/2015	SUPPL-115	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf
10/28/2015	SUPPL-115	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf
10/04/2011	SUPPL-107	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf
01/22/2010	SUPPL-108	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf
08/16/2007	SUPPL-105	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf
10/04/2006	SUPPL-102	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf
09/02/2005	SUPPL-101	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf