Visitor Monitoring Drug History: ELOXATIN
 
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Label and Approval History

Drug Name: ELOXATIN
FDA Application No: (NDA) 021492
Active Ingredient(s): OXALIPLATIN
Company: SANOFI AVENTIS US
 
Label History
 
View the label approved on January 16, 2007 for ELOXATIN, (NDA) 021492


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/10/2007 008Efficacy Supplement with Clinical Data to Support Letter
Label 
3/9/2006 006Labeling Revision Letter
Label 
11/4/2004 005New or Modified Indication Letter
Label 
11/4/2004 004New or Modified Indication Letter
Label 
1/9/2004 002New or Modified Indication Letter
Label
Review 
1/14/2003 001Labeling Revision Letter 
8/9/2002 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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