Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040415
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Discontinued None No No
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Discontinued None No No
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Discontinued None No No
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Discontinued None No No
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Discontinued None No No
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Discontinued None No No
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Discontinued None No No
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Discontinued None No No
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/27/2004 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2012 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/22/2011 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

02/08/2011 SUPPL-10 Labeling-Container/Carton Labels

Label is not available on this site.

08/04/2010 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

11/16/2009 SUPPL-8 Labeling-Container/Carton Labels

Label is not available on this site.

01/22/2009 SUPPL-6 Labeling

Label is not available on this site.

01/09/2007 SUPPL-3 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040415s003lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/09/2007 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040415s003lbl.pdf

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