Visitor Monitoring Drug History: XOLAIR
 
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Label and Approval History

Drug Name: XOLAIR
FDA Application No: (BLA) 103976
Active Ingredient(s): OMALIZUMAB
Company: GENENTECH
 
Label History
 
View the label approved on July 2, 2007 for XOLAIR, (BLA) 103976


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
7/2/2007 5102Supplement Label
Medication Guide 
4/7/2006 5087Supplement Letter
Label 
6/20/2003 0000Approval Letter
Label
Review
Other Important Information from FDA 
 
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