Visitor Monitoring Drug History: GLEEVEC
 
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Label and Approval History

Drug Name: GLEEVEC
FDA Application No: (NDA) 021588
Active Ingredient(s): IMATINIB MESYLATE
Company: NOVARTIS
 
Label History
 
View the label approved on September 19, 2007 for GLEEVEC, (NDA) 021588


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
9/13/2007 020Efficacy Supplement with Clinical Data to Support Letter
Label 
10/19/2006 017New or Modified Indication Letter
Label 
9/27/2006 016New or Modified Indication Letter
Label 
10/19/2006 014New or Modified Indication Letter
Label 
10/19/2006 013New or Modified Indication Letter
Label 
10/19/2006 012New or Modified Indication Letter
Label 
10/19/2006 011New or Modified Indication Letter
Label 
5/31/2006 010Labeling Revision Letter
Label 
10/30/2006 009Labeling Revision Letter
Label 
10/20/2005 008Efficacy Supplement with Clinical Data to Support Letter
Label 
5/18/2005 007Labeling Revision Letter 
5/19/2005 006Control Supplement Letter 
3/14/2005 005Efficacy Supplement with Clinical Data to Support Letter
Label 
6/23/2004 003Labeling Revision Letter
Label 
12/8/2003 002Accelerated Approval Letter
Label
Review 
5/20/2003 001Patient Population Altered Letter
Label
Review 
4/18/2003 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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