Visitor Monitoring Drug History: KALETRA
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: KALETRA
FDA Application No: (NDA) 021251
Active Ingredient(s): LOPINAVIR; RITONAVIR
Company: ABBOTT
 
Label History
 
View the label approved on September 26, 2007 for KALETRA, (NDA) 021251


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 019Labeling Revision Letter
Label 
6/29/2007 016Labeling Revision Letter
Label 
3/2/2007 014Labeling Revision Letter
Label 
12/21/2006 013Labeling Revision Letter
Label 
4/20/2007 012Efficacy Supplement with Clinical Data to Support Letter
Label 
3/28/2005 011Labeling Revision Letter
Label 
10/19/2004 010Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
12/3/2003 009Labeling Revision Letter
Label 
12/24/2002 006Control Supplement  
11/27/2002 005Accelerated Approval Label
Review 
1/18/2002 004Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
1/18/2002 003Efficacy Supplement with Clinical Data to Support  
3/13/2001 002Labeling Revision Letter
Label
Review 
1/30/2001 001Labeling Revision  
9/15/2000 000Approval Letter
Label
Review
Patient Package Insert
Consumer Information Sheet 
 
There are no Therapeutic Equivalents
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