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FDA Drug Application 021572 by CUBIST PHARMS LLC

Application Number021572
Application Type New Drug Application
Sponsor ApplicantCUBIST PHARMS LLC
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
AP09/12/2003N6666000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21572ltr.pdf 9/25/2003
AP09/12/2003N6694000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21572_cubicin_lbl.pdf 9/25/2003
AP09/12/2003N7243000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-572_Cubicin.cfm 12/15/2003
AP010/14/2005SLR12889006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021572s006ltr.pdf 10/19/2005
AP010/14/2005SLR12901006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021572s006lbl.pdf 10/19/2005
AP03/8/2006SLR17665007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s007ltr.pdf 8/22/2007
AP03/8/2006SLR17666007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s007lbl.pdf 8/22/2007
AP05/25/2006SE114180008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s008lbl.pdf 5/26/2006
AP05/25/2006SE114183008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s008LTR.pdf 5/26/2006
AP010/24/2006SLR15201009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021572s009lbl.pdf 10/25/2006
AP010/24/2006SLR15319009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021572s009ltr.pdf 11/6/2006
AP02/12/2007SLR15872010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s010lbl.pdf 2/21/2007
AP02/12/2007SLR15880010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s010ltr.pdf 2/23/2007
AP02/20/2007SLR15898011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s011ltr.pdf 2/23/2007
AP02/20/2007SLR15871011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s011lbl.pdf 2/21/2007
AP010/5/2007SLR18192014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021572s014ltr.pdf 10/10/2007
AP010/5/2007SLR18214014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021572s014lbl.pdf 10/10/2007
AP02/10/2009SLR21824021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021572s021ltr.pdf 2/13/2009
AP011/30/2010SLR27129022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf 12/2/2010
AP011/30/2010SLR27210022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf 12/6/2010
AP011/30/2010SE227212023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf 12/6/2010
AP011/30/2010SE227130023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf 12/2/2010
AP011/30/2010SLR27131024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf 12/2/2010
AP011/30/2010SLR27213024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf 12/6/2010
AP011/30/2010SLR27214027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf 12/6/2010
AP011/30/2010SLR27132027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf 12/2/2010
AP011/30/2010SLR27133030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf 12/2/2010
AP011/30/2010SLR27215030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf 12/6/2010
AP012/6/2010SLR27265031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s031ltr.pdf 12/10/2010
AP011/30/2010SLR27216032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021572s022,s023,s024,s027,s030,s032ltr.pdf 12/6/2010
AP011/30/2010SLR27134032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s022s023s024s027s030s032lbl.pdf 12/2/2010
AP08/13/2010SLR26305033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s033lbl.pdf 8/28/2010
AP012/14/2010SCM       
AP05/22/2012SLR32752037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572s037ltr.pdf 5/23/2012
AP05/22/2012SLR32755037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s037lbl.pdf 5/23/2012
AP010/3/2011SLR30208038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021572s038lbl.pdf 10/3/2011
AP010/3/2011SLR30218038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021572s038ltr.pdf 10/4/2011
AP06/14/2012SLR32915039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572s039ltr.pdf 6/15/2012
AP06/14/2012SLR32930039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s039lbl.pdf 6/18/2012
AP010/11/2012SLR34064040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021572s040lbl.pdf 10/12/2012
AP010/11/2012SLR34088040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021572Orig1s040ltr.pdf 10/15/2012
AP03/19/2013SCM       
AP06/26/2013SCM       
AP011/22/2013SLR37941043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021572s043s044lbl.pdf 11/26/2013
AP011/22/2013SLR37928043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021572Orig1s043,021572Orig1s044ltr.pdf 11/26/2013
AP011/22/2013SLR37929044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021572Orig1s043,021572Orig1s044ltr.pdf 11/26/2013
AP011/22/2013SLR37942044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021572s043s044lbl.pdf 11/26/2013
AP09/26/2014SCM       
AP011/26/2014SLR41118046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021572Orig1s046ltr.pdf 11/28/2014
AP011/26/2014SLR41332046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021572s046lbl.pdf 12/19/2014
AP02/16/2015SCM       
AP08/3/2015SLR43564048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572Orig1s048lbledt.pdf 8/4/2015
AP08/3/2015SLR43581048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021572Orig1s048ltr.pdf 8/6/2015
AP07/15/2015SCM       
AP09/17/2015SLR43914050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021572Orig1s050ltr.pdf 9/18/2015
AP09/17/2015SLR44657050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021572s050lbl.pdf 12/3/2015
AP07/6/2016SLR46479052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021572s052lbl.pdf 7/8/2016
AP07/6/2016SLR46495053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021572Orig1s053ltr.pdf 7/12/2016
AP07/6/2016SLR46537053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021572s053lbl.pdf 7/18/2016




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