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FDA Drug Application 206829 by CUBIST PHARMS LLC

Application Number206829
Application Type New Drug Application
Sponsor ApplicantCUBIST PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/19/2014N41353000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206829lbl.pdf 12/22/2014
AP012/19/2014N41375000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206829Orig1s000ltr.pdf 12/23/2014
AP012/19/2014N41692000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206829Orig1s000TOC.cfm 1/27/2015
AP012/19/2014N41693000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206829Orig1s000SumR.pdf 1/27/2015
AP05/20/2015SLR42852001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206829s001lbl.pdf 5/20/2015
AP05/20/2015SLR42880001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206829Orig1s001ltr.pdf 5/22/2015
AP09/6/2016SLR46989002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206829Orig1s002ltr.pdf 9/7/2016
AP09/6/2016SLR46995002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206829s002lbl.pdf 9/8/2016
AP010/26/2016SLR47487003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206829Orig1s003ltr.pdf 10/28/2016




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