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FDA Drug Application 021743 by OSI PHARMS

Application Number021743
Application Type New Drug Application
Sponsor ApplicantOSI PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/18/2004N10625000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021743lbl.pdf 11/18/2004
AP011/18/2004N10666000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21743ltr.pdf 12/2/2004
AP011/18/2004N11291000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-743_Tarceva.cfm 3/28/2005
AP011/2/2005SE113015003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021743s003ltr.pdf 11/3/2005
AP011/2/2005SE113016003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021743s003lbl.pdf 11/3/2005
AP04/27/2007SLR16333007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021743s007lbl.pdf 5/1/2007
AP04/27/2007SLR16429007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021743s007ltr.pdf 5/7/2007
AP09/12/2008SLR20774008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s008, s010ltr.pdf 9/16/2008
AP09/12/2008SLR20775010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s008, s010ltr.pdf 9/16/2008
AP09/12/2008SLR20858010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s010lbl.pdf 9/19/2008
AP09/19/2008SE220874011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021743s011ltr.pdf 9/23/2008
AP09/19/2008SE220883011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021743s011lbl.pdf 9/25/2008
AP04/16/2010SLR25308014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021743s014,s016ltr.pdf 4/20/2010
AP04/16/2010SLR25280014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf 4/19/2010
AP04/27/2009SLR22424015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021743s015ltr.pdf 5/5/2009
AP04/27/2009SLR22563015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021743s015lbl.pdf 5/13/2009
AP04/16/2010SE125309016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021743s014,s016ltr.pdf 4/20/2010
AP04/16/2010SE125283016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743s14s16lbl.pdf 4/19/2010
AP04/17/2012SLR32472017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021743s017ltr.pdf 4/19/2012
AP04/17/2012SLR32483017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021743s017lbl.pdf 4/20/2012
AP05/14/2013SE136069018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021743s018lbl.pdf 5/14/2013
AP05/14/2013SE136076018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021743Orig1s018ltr.pdf 5/16/2013
AP04/14/2014SLR39045019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021743Orig1s019ltr.pdf 4/16/2014
AP04/14/2014SLR39055019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021743s019lbl.pdf 4/16/2014
AP04/27/2015SE842687021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021743Orig2s021ltr.pdf 4/29/2015
AP04/27/2015SE842706021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021743s021lbl.pdf 4/29/2015
AP07/6/2015SCM       
AP05/20/2016SE846110023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s023lbl.pdf 5/23/2016
AP05/20/2016SE846115023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s023ltr.pdf 5/24/2016
AP03/15/2016SCM       
AP010/18/2016SE147383025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf 10/18/2016
AP010/18/2016SE147410025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s025ltr.pdf 10/20/2016
AP09/28/2016SLR47218026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s026lbl.pdf 9/29/2016
AP09/28/2016SLR47239026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s026ltr.pdf 9/30/2016
AP06/1/2016SE846243027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s027lbl.pdf 6/2/2016
AP06/1/2016SE846254027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021743Orig1s027ltr.pdf 6/6/2016




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