Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021588
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLEEVEC IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription AB Yes No
GLEEVEC IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/18/2003 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021588s000_GleevecTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2017 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021588orig1s051ltr.pdf
04/24/2017 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021588Orig1s049ltr.pdf
09/27/2016 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s047ltr.pdf
08/25/2016 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf
08/25/2016 SUPPL-45 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf
01/30/2015 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021588s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021588Orig1s042ltr.pdf
05/22/2014 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021588s040lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021588Orig1s040ltr.pdf
10/30/2013 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s039ltr.pdf
02/21/2013 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s038ltr.pdf
01/25/2013 SUPPL-37 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s037ltr.pdf
01/31/2012 SUPPL-35 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021588s035ltr_cor.pdf
04/01/2011 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf
04/01/2011 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf
05/27/2009 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf
02/10/2009 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s027ltr.pdf
05/27/2009 SUPPL-26 Efficacy-Accelerated Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf
12/19/2008 SUPPL-25 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s025ltr.pdf
09/26/2008 SUPPL-24 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s024ltr.pdf
04/30/2008 SUPPL-23 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s023ltr.pdf
09/26/2008 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s022ltr.pdf
09/26/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s021ltr.pdf
09/13/2007 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021588s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021588s020ltr.pdf
10/19/2006 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s017_gleevec.pdf
09/27/2006 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s016ltr.pdf
10/19/2006 SUPPL-14 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s014_gleevec.pdf
10/19/2006 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s013_gleevic.pdf
10/19/2006 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s012_gleevic.pdf
10/19/2006 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s011_gleevec.pdf
05/31/2006 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s008, s010LTR.pdf
10/30/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s009ltr.pdf
10/20/2005 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021588s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s008ltr.pdf
05/18/2005 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s007ltr.pdf
05/19/2005 SUPPL-6 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s006ltr.pdf
03/14/2005 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21588s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21588s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021588_s005_GLEVAC.pdf
06/23/2004 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21588slr003_gleevec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21588slr003ltr.pdf
12/08/2003 SUPPL-2 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se7-002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-588s002_Gleevec.cfm
05/20/2003 SUPPL-1 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se5-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/06/2017 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s051lbl.pdf
04/24/2017 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s049lbl.pdf
09/27/2016 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s047lbl.pdf
08/25/2016 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf
08/25/2016 SUPPL-45 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf
01/30/2015 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021588s042lbl.pdf
05/22/2014 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021588s040lbledt.pdf
10/30/2013 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s039lbl.pdf
02/21/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s038lbl.pdf
01/25/2013 SUPPL-37 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s037lbl.pdf
01/31/2012 SUPPL-35 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf
04/01/2011 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf
04/01/2011 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf
05/27/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s026s028lbl.pdf
02/10/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s027lbl.pdf
09/26/2008 SUPPL-24 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf
09/26/2008 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf
09/26/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf
09/13/2007 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021588s020lbl.pdf
10/30/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s009lbl.pdf
10/19/2006 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
10/19/2006 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
10/19/2006 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
10/19/2006 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
10/19/2006 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
09/27/2006 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf
05/31/2006 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s010lbl.pdf
10/20/2005 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021588s008lbl.pdf
03/14/2005 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21588s005lbl.pdf
06/23/2004 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21588slr003_gleevec_lbl.pdf
12/08/2003 SUPPL-2 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s002lbl.pdf
05/20/2003 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf
04/18/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf

GLEEVEC

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLEEVEC IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription Yes AB 021588 NOVARTIS
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 079179 APOTEX INC
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 204644 MYLAN PHARMS INC
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 078340 SUN PHARMA GLOBAL
IMATINIB MESYLATE IMATINIB MESYLATE EQ 100MG BASE TABLET;ORAL Prescription No AB 204285 TEVA PHARMS USA

TABLET;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLEEVEC IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription Yes AB 021588 NOVARTIS
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 079179 APOTEX INC
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 204644 MYLAN PHARMS INC
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 078340 SUN PHARMA GLOBAL
IMATINIB MESYLATE IMATINIB MESYLATE EQ 400MG BASE TABLET;ORAL Prescription No AB 204285 TEVA PHARMS USA

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