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FDA Drug Application 021588 by NOVARTIS

Application Number021588
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/18/2003N5499000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf 4/28/2003
AP04/18/2003N5713000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588ltr.pdf 5/29/2003
AP04/18/2003N7122000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110502.htm 12/9/2003
AP04/18/2003N14246000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021588s000_GleevecTOC.cfm 6/7/2006
AP05/20/2003SE55645001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf 5/20/2003
AP05/20/2003SE55841001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se5-001ltr.pdf 6/8/2003
AP05/20/2003SE59958001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm 8/9/2004
AP012/8/2003SE77061002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s002lbl.pdf 12/8/2003
AP012/8/2003SE77301002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se7-002ltr.pdf 12/22/2003
AP012/8/2003SE711359002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-588s002_Gleevec.cfm 4/8/2005
AP06/23/2004SLR9543003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21588slr003ltr.pdf 6/25/2004
AP06/23/2004SLR9566003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21588slr003_gleevec_lbl.pdf 6/25/2004
AP03/14/2005SE811255005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21588s005ltr.pdf 3/18/2005
AP03/14/2005SE811276005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21588s005lbl.pdf 3/18/2005
AP03/14/2005SE842894005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021588_s005_GLEVAC.pdf 5/26/2015
AP05/19/2005SCS11674006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s006ltr.pdf 5/20/2005
AP05/18/2005SLR11675007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s007ltr.pdf 5/20/2005
AP010/20/2005SE812959008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021588s008lbl.pdf 10/25/2005
AP010/20/2005SE812962008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s008ltr.pdf 10/25/2005
AP010/30/2006SLR15299009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s009lbl.pdf 11/6/2006
AP010/30/2006SLR15315009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s009ltr.pdf 11/6/2006
AP05/31/2006SLR14196010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s010lbl.pdf 6/1/2006
AP05/31/2006SLR14215010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s008, s010LTR.pdf 6/2/2006
AP010/19/2006SE115145011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf 10/23/2006
AP010/19/2006SE115169011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf 10/23/2006
AP010/19/2006SE127035011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s011_gleevec.pdf 10/19/2006
AP010/19/2006SE115146012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf 10/23/2006
AP010/19/2006SE115170012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf 10/23/2006
AP010/19/2006SE127036012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s012_gleevic.pdf 10/19/2006
AP010/19/2006SE115147013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf 10/23/2006
AP010/19/2006SE115171013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf 10/23/2006
AP010/19/2006SE127037013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s013_gleevic.pdf 10/19/2006
AP010/19/2006SE115148014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf 10/23/2006
AP010/19/2006SE115172014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf 10/23/2006
AP010/19/2006SE127038014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s014_gleevec.pdf 10/19/2006
AP09/27/2006SE115024016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf 9/28/2006
AP09/27/2006SE115043016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s016ltr.pdf 10/2/2006
AP010/19/2006SE115149017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf 10/23/2006
AP010/19/2006SE115173017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf 10/23/2006
AP010/19/2006SE127039017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s017_gleevec.pdf 10/19/2006
AP09/13/2007SE817905020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021588s020lbl.pdf 9/19/2007
AP09/13/2007SE817975020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021588s020ltr.pdf 9/25/2007
AP09/26/2008SLR20909021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s021ltr.pdf 10/1/2008
AP09/26/2008SLR20922021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf 9/26/2008
AP09/26/2008SLR20910022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s022ltr.pdf 10/1/2008
AP09/26/2008SLR20923022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf 9/26/2008
AP04/30/2008SCP19765023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s023ltr.pdf 5/5/2008
AP09/26/2008SE720895024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf 9/26/2008
AP09/26/2008SE720911024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s024ltr.pdf 10/1/2008
AP012/19/2008SLR21417025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s025ltr.pdf 12/29/2008
AP05/27/2009SE722672026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf 6/2/2009
AP02/10/2009SLR21817027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s027lbl.pdf 2/12/2009
AP02/10/2009SLR21823027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s027ltr.pdf 2/13/2009
AP05/27/2009SLR22673028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf 6/2/2009
AP05/27/2009SLR22700028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s026s028lbl.pdf 6/5/2009
AP04/1/2011SE728437030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf 4/1/2011
AP04/1/2011SE728467030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf 4/6/2011
AP04/1/2011SLR28438031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf 4/1/2011
AP04/1/2011SLR28468031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf 4/6/2011
AP01/31/2012SE731591035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf 1/31/2012
AP01/31/2012SE731640035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021588s035ltr_cor.pdf 2/3/2012
AP01/25/2013SE135005037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s037ltr.pdf 1/30/2013
AP01/25/2013SE135014037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s037lbl.pdf 1/30/2013
AP02/21/2013SLR35229038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s038ltr.pdf 2/25/2013
AP02/21/2013SLR35259038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s038lbl.pdf 2/26/2013
AP010/30/2013SLR37622039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s039ltr.pdf 10/31/2013
AP010/30/2013SLR37639039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s039lbl.pdf 10/31/2013
AP05/22/2014SLR39342040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021588Orig1s040ltr.pdf 5/22/2014
AP05/22/2014SLR39379040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021588s040lbledt.pdf 5/28/2014
AP01/30/2015SE841755042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021588Orig1s042ltr.pdf 2/2/2015
AP01/30/2015SE841772042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021588s042lbl.pdf 2/3/2015
AP08/25/2016SE846895045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf 8/29/2016
AP08/25/2016SE846906045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf 8/29/2016
AP08/25/2016SLR46896046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf 8/29/2016
AP08/25/2016SLR46907046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf 8/29/2016
AP09/27/2016SLR47212047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s047lbl.pdf 9/29/2016
AP09/27/2016SLR47276047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s047ltr.pdf 10/4/2016




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