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FDA Drug Application 021775 by CUBIST PHARMS

Application Number021775
Application Type New Drug Application
Sponsor ApplicantCUBIST PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/20/2008N19877000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021775s000ltr.pdf 5/28/2008
AP05/20/2008N19879000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021775lbl.pdf 5/28/2008
AP05/20/2008N19894000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=15 5/28/2008
AP05/20/2008N20242000   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021775s000_SUMR.pdf 7/17/2008
AP05/20/2008N20257000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021775_ENTEREGTOC.cfm 7/18/2008
AP02/5/2009SLR21870001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021775s001ltr.pdf 2/19/2009
AP011/6/2009SLR24026004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021775s004lbl.pdf 11/19/2009
AP011/6/2009SLR24571004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021775s004ltr.pdf 1/21/2010
AP09/25/2012SLR33916007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021775Orig1s007ltr.pdf 10/2/2012
AP010/21/2012SLR34141008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021775s008lbl.pdf 10/22/2012
AP010/21/2012SLR34166008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021775Orig1s008ltr.pdf 10/23/2012
AP010/18/2013SE137487010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021775Orig1s010ltr.pdf 10/21/2013
AP010/18/2013SE137517010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021775s010lbl.pdf 10/22/2013
AP05/29/2014SCM       
AP05/18/2016S46077013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021775Orig1s013ltr.pdf 5/20/2016




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