Visitor Monitoring Drug History: LANTUS
 
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Label and Approval History

Drug Name: LANTUS
FDA Application No: (NDA) 021081
Active Ingredient(s): INSULIN GLARGINE RECOMBINANT
Company: SANOFI AVENTIS US
 
Label History
 
View the label approved on May 1, 2007 for LANTUS, (NDA) 021081


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
4/25/2007 024Package Change Letter
Label 
3/15/2005 017Formulation Revision Letter
Label 
2/11/2005 014Package Change Letter
Label 
8/10/2004 011Package Change Letter
Label 
5/1/2003 005New Dosage Regimen Letter
Label 
8/15/2002 004Control Supplement  
1/31/2001 003Control Supplement  
3/7/2001 002Manufacturing Change or Addition  
11/17/2000 001Control Supplement  
4/20/2000 000Approval Letter
Label
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