Visitor Monitoring Drug History: KALETRA
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9
Label and Approval History

Drug Name: KALETRA
FDA Application No: (NDA) 021226
Active Ingredient(s): LOPINAVIR; RITONAVIR
Company: ABBOTT
 
Label History
 
View the label approved on September 26, 2007 for KALETRA, (NDA) 021226


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
9/26/2007 022Labeling Revision Letter
Label 
7/9/2007 020Labeling Revision Letter
Label 
12/21/2006 019Labeling Revision Letter
Label 
4/20/2007 018Efficacy Supplement with Clinical Data to Support Letter
Label 
3/28/2005 017Labeling Revision Letter
Label
Review 
4/29/2005 016New Dosage Regimen Letter
Label 
10/19/2004 014Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
12/3/2003 012Labeling Revision Letter
Label 
12/24/2002 007Control Supplement  
11/27/2002 006Accelerated Approval Label
Review 
2/13/2002 005Control Supplement  
1/18/2002 004Efficacy Supplement with Clinical Data to Support  
1/18/2002 003Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
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
©2019 Drugs That Causes a False Positive on a Drug Test