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FDA Drug Application 205435 by CUBIST PHARMS LLC

Application Number205435
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
AP06/20/2014N39618000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205435Orig1s000ltr.pdf 6/23/2014
AP06/20/2014N39619000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205435s000lbl.pdf 6/23/2014
AP06/20/2014N39879000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205435Orig1s000TOC.cfm 7/16/2014
AP06/20/2014N39880000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205435Orig1s000SumR.pdf 7/16/2014
AP03/3/2015SLR42040001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205435Orig1s001,205436Orig1s001ltr.pdf 3/6/2015
AP03/3/2015SLR42058001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/0205435s001,0205436s001lbl.pdf 3/9/2015
AP08/11/2015SCM       
AP010/27/2016SLR47541003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s003,205436Orig1s002ltr.pdf 10/31/2016
AP06/5/2016SLR46265005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s005ltr.pdf 6/7/2016
AP09/16/2016SLR47071006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s006ltr.pdf 9/19/2016
AP09/16/2016SLR47183006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205435s006lbl.pdf 9/28/2016




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