Visitor Monitoring Drug History: KALETRA
 
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Label and Approval History

Drug Name: KALETRA
FDA Application No: (NDA) 021906
Active Ingredient(s): LOPINAVIR; RITONAVIR
Company: ABBOTT
 
Label History
 
View the label approved on September 26, 2007 for KALETRA, (NDA) 021906


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
9/25/2007 008Labeling Revision Letter
Label 
6/29/2007 005Labeling Revision Letter
Label 
3/2/2007 004Labeling Revision Letter
Label 
12/21/2006 003Labeling Revision Letter
Label 
4/20/2007 002Efficacy Supplement with Clinical Data to Support Letter
Label 
10/28/2005 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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