Visitor Monitoring Drug History: XYREM
 
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Label and Approval History

Drug Name: XYREM
FDA Application No: (NDA) 021196
Active Ingredient(s): SODIUM OXYBATE
Company: JAZZ
 
Label History
 
View the label approved on July 3, 2006 for XYREM, (NDA) 021196


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
11/13/2006 012Labeling Revision Letter 
6/30/2006 009Labeling Revision Letter
Label 
9/16/2005 007Labeling Revision Letter 
11/18/2005 005New or Modified Indication Letter
Label 
11/4/2003 001Labeling Revision Letter 
7/17/2002 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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