Visitor Monitoring Drug History: LEVITRA
 
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Label and Approval History

Drug Name: LEVITRA
FDA Application No: (NDA) 021400
Active Ingredient(s): VARDENAFIL HYDROCHLORIDE
Company: BAYER PHARMS
 
Label History
 
View the label approved on October 18, 2007 for LEVITRA, (NDA) 021400


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
10/18/2007 010Labeling Revision Letter
Label 
4/6/2007 008Labeling Revision Letter
Label 
7/8/2005 004Labeling Revision Letter
Label 
5/13/2005 002Labeling Revision Letter
Label 
8/19/2003 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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