Visitor Monitoring Drug History: NAGLAZYME
 
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Label and Approval History

Drug Name: NAGLAZYME
FDA Application No: (BLA) 125117
Active Ingredient(s): GALSULFASE
Company: BIOMARIN
 
Label History
 
View the label approved on June 7, 2005 for NAGLAZYME, (BLA) 125117


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
5/31/2005 000Approval Letter
Label
Review 
 
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