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FDA Drug Application 205436 by CUBIST PHARMS LLC

Application Number205436
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
AP06/20/2014N39620000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205436Orig1s000ltr.pdf 6/23/2014
AP06/20/2014N39621000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205436s000lbl.pdf 6/23/2014
AP06/20/2014N40754000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205436Orig1s000TOC.cfm 10/10/2014
AP06/20/2014N40756000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205436Orig1s000SumR.pdf 10/10/2014
AP03/3/2015SLR42041001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205435Orig1s001,205436Orig1s001ltr.pdf 3/6/2015
AP03/3/2015SLR42057001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/0205435s001,0205436s001lbl.pdf 3/9/2015
AP010/28/2016SLR47540002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205435Orig1s003,205436Orig1s002ltr.pdf 10/31/2016




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