DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
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0-9
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 Date
Supplement Number
Approval Type
Letters, Reviews, Labels, Patient Package Insert
9/25/2007
008
Labeling Revision
Letter
Label
6/29/2007
005
Labeling Revision
Letter
Label
3/2/2007
004
Labeling Revision
Letter
Label
12/21/2006
003
Labeling Revision
Letter
Label
4/20/2007
002
Efficacy Supplement with Clinical Data to Support
Letter
Label
10/28/2005
000
Approval
Letter
Label
Review
Other Important Information from FDA
There are no Therapeutic Equivalents
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