Visitor Monitoring Drug History: XOPENEX HFA
 
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Label and Approval History

Drug Name: XOPENEX HFA
FDA Application No: (NDA) 021730
Active Ingredient(s): LEVALBUTEROL TARTRATE
Company: SEPRACOR
 
Label History
 
View the label approved on March 14, 2005 for XOPENEX HFA, (NDA) 021730


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
4/4/2006 006Labeling Revision Letter 
9/15/2006 003Labeling Revision Letter 
3/11/2005 000Approval Letter
Label
Review 
 
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