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FDA Drug Application 203441 by NPS PHARMS INC

Application Number203441
Application Type New Drug Application
Sponsor ApplicantNPS PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/21/2012N34768000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203441Orig1s000ltr_replacement.pdf 12/27/2012
AP012/21/2012N34769000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203441Orig1s000lbl.pdf 12/27/2012
AP012/21/2012N34772000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=21 12/27/2012
AP012/21/2012N34817000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333533.pdf 1/3/2013
AP012/21/2012N34983000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203441Orig1s000TOC.cfm 1/25/2013
AP012/21/2012N34984000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203441Orig1s000SumR.pdf 1/25/2013
AP06/26/2014SE839676002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203441Orig1s002ltr.pdf 6/27/2014
AP06/26/2014SE839692002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203441s002lbl.pdf 6/30/2014
AP06/26/2014SE845111002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203441Orig1s002.pdf 2/3/2016
AP01/5/2015SCM       
AP05/18/2015SCM       
AP010/5/2015SCM       
AP03/30/2016SCM       
AP05/27/2016S46196008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203441Orig1s008ltr.pdf 5/31/2016




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