Back to FDA Applications sponsored by CPPI CV

FDA Drug Application 021938 by CPPI CV

Application Number021938
Application Type New Drug Application
Sponsor ApplicantCPPI CV
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
AP01/26/2006N13496000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf 1/26/2006
AP01/26/2006N13559000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021938s000ltr.pdf 1/30/2006
AP01/26/2006N13870000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021938s000_021968s000_Stutent.cfm 4/6/2006
AP01/26/2006N25973000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM219111.pdf 7/16/2010
AP02/2/2007SLR15764002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf 2/5/2007
AP02/2/2007SLR15806002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf 2/12/2007
AP02/2/2007SLR27040002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s002_sutent.pdf 2/2/2007
AP02/2/2007SE815765003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf 2/2/2007
AP02/2/2007SE815807003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf 2/12/2007
AP02/2/2007SE827041003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s003_sutent.pdf 2/2/2007
AP02/2/2007SE815767004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf 2/5/2007
AP02/2/2007SE815808004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf 2/12/2007
AP02/2/2007SE827042004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s004_sutent.pdf 2/2/2007
AP02/2/2007SE815768005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021938s002s003s004s005lbl.pdf 2/5/2007
AP02/2/2007SE815809005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf 2/12/2007
AP02/2/2007SE827043005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021938_s005_sutent.pdf 2/2/2007
AP011/7/2008SLR26524006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf 9/22/2010
AP011/7/2008SLR26525006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf 9/22/2010
AP011/7/2008SLR26526007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf 9/22/2010
AP011/7/2008SLR26528007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf 9/22/2010
AP010/24/2008SLR26527008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021938s006,%20021938s007,%20021938s008ltr.pdf 9/22/2010
AP010/24/2008SLR26529008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021938s006s007s008-2lbl.pdf 9/22/2010
AP03/31/2009SCS22200009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021938s009lbl.pdf 4/3/2009
AP03/31/2009SCS22207009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021938s009ltr.pdf 4/3/2009
AP07/1/2010SE825912010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf 7/6/2010
AP07/1/2010SE825927010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf 7/6/2010
AP07/1/2010SLR25913011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf 7/6/2010
AP07/1/2010SLR25928011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf 7/6/2010
AP05/20/2011SE128874013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf 5/20/2011
AP05/20/2011SE128877013   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256237.htm 5/20/2011
AP05/20/2011SE128926013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf 5/25/2011
AP07/1/2010SLR25914014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf 7/6/2010
AP07/1/2010SLR25929014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf 7/6/2010
AP07/1/2010SLR25915015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021938s010,s011,s014,s015ltr.pdf 7/6/2010
AP07/1/2010SLR25930015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021938s010s011s014s015lbl.pdf 7/6/2010
AP05/20/2011SLR28875017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf 5/20/2011
AP05/20/2011SLR28927017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf 5/25/2011
AP05/20/2011SLR28876018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021938s13s17s18lbl.pdf 5/20/2011
AP05/20/2011SLR28928018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021938s013,s017,s018ltr.pdf 5/25/2011
AP04/20/2012SLR32515019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020mg.pdf 4/24/2012
AP04/20/2012SLR32517019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf 4/24/2012
AP04/20/2012SLR32526019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938s019,s020ltr.pdf 4/24/2012
AP04/20/2012SLR32516020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020mg.pdf 4/24/2012
AP04/20/2012SLR32518020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s019s020lbl.pdf 4/24/2012
AP04/20/2012SLR32527020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938s019,s020ltr.pdf 4/24/2012
AP011/16/2012SLR34423021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf 11/19/2012
AP011/16/2012SLR34432021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf 11/19/2012
AP011/16/2012SLR34424022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf 11/19/2012
AP011/16/2012SLR34433022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf 11/19/2012
AP011/16/2012SLR34425023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021938Orig1s021,s022,s023ltr.pdf 11/19/2012
AP011/16/2012SLR34434023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021938s021s022s023lbl.pdf 11/19/2012
AP08/30/2013SLR36942024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021938Orig1s024,s025ltr.pdf 9/4/2013
AP08/30/2013SLR37022024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf 9/9/2013
AP08/30/2013SLR36941025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021938Orig1s024,s025ltr.pdf 9/4/2013
AP08/30/2013SLR37023025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021938s024s025lbl.pdf 9/9/2013
AP06/11/2014SLR39532026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021938Orig1s026ltr.pdf 6/12/2014
AP012/19/2014SLR41361027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021938Orig1s027ltr.pdf 12/23/2014
AP012/19/2014SLR41377027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021938s027lbl.pdf 12/23/2014
AP04/24/2015SLR42660028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s028,s029ltr.pdf 4/27/2015
AP04/24/2015SLR42674028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf 4/28/2015
AP04/24/2015SLR42661029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s028,s029ltr.pdf 4/27/2015
AP04/24/2015SLR42675029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s028s029lbl.pdf 4/28/2015
AP010/8/2015SCM       
AP011/16/2015SLR44491031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021938Orig1s031ltr.pdf 11/17/2015
AP011/16/2015SLR44536031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021938s031lbl.pdf 11/19/2015




Back to FDA Applications sponsored by CPPI CV