Visitor Monitoring Drug History: FABRAZYME
 
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Label and Approval History

Drug Name: FABRAZYME
FDA Application No: (BLA) 103979
Active Ingredient(s): AGALSIDASE BETA
Company: GENZYME
 
Label History
 
View the label approved on January 8, 2007 for FABRAZYME, (BLA) 103979


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
10/13/2006 5066Supplement Letter
Label 
10/13/2006 5065Supplement Letter
Label 
10/13/2006 5058Supplement Letter
Label 
4/24/2003 0000Approval Letter
Label
Review
FDA Talk Paper
Other 
 
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