Visitor Monitoring Drug History: BARACLUDE
 
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Label and Approval History

Drug Name: BARACLUDE
FDA Application No: (NDA) 021798
Active Ingredient(s): ENTECAVIR
Company: BRISTOL MYERS SQUIBB
 
Label History
 
View the label approved on July 27, 2007 for BARACLUDE, (NDA) 021798


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
7/24/2007 003Labeling Revision Letter
Label 
3/27/2007 002New Dosage Regimen Letter
Label 
2/23/2007 001Efficacy Supplement with Clinical Data to Support Letter
Label 
3/29/2005 000Approval Letter
Label
Review
Patient Information Sheet 
 
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