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FDA Drug Application 201699 by CUBIST PHARMS LLC

Application Number201699
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
AP05/27/2011N28995000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201699s000ltr.pdf 5/31/2011
AP05/27/2011N29011000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201699s000lbl.pdf 5/31/2011
AP05/27/2011N29291000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000TOC.cfm 6/28/2011
AP05/27/2011N29292000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000SumR.pdf 6/28/2011
AP012/19/2012SCM       
AP04/4/2013SLR35643004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201699Orig1s004ltr_corrected.pdf 4/9/2013
AP04/4/2013SLR35648004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf 4/9/2013
AP02/21/2013SCM       
AP06/6/2013SCM       
AP011/18/2013SCM       
AP02/24/2015SE841917009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201699Orig1s009ltr.pdf 2/26/2015




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