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FDA Drug Application 125511 by NPS PHARMS INC

Application Number125511
Application Type Biologic License Application
Sponsor ApplicantNPS PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/23/2015N41688000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125511Orig1s000ltr.pdf 1/26/2015
AP01/23/2015N41706000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=343 1/28/2015
AP01/23/2015N41723000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125511s000lbl.pdf 1/29/2015
AP01/23/2015N41866000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125511Orig1s000TOC.cfm 2/19/2015
AP01/23/2015N41867000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125511Orig1s000SumR.pdf 2/19/2015
AP09/29/2016S47261002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125511Orig1s002ltr.pdf 10/3/2016
AP06/15/2016SLR46358004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125511s004lbl.pdf 6/17/2016
AP06/15/2016SLR46367004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125511Orig1s004ltr.pdf 6/21/2016




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