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Drugs@FDA: FDA-Approved Drugs

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