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FDA Drug Application 125557 by AMGEN

Application Number125557
Application Type Biologic License Application
Sponsor ApplicantAMGEN
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
AP012/3/2014N41131000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf 12/3/2014
AP012/3/2014N41153000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125557Orig1s000ltr.pdf 12/4/2014
AP012/3/2014N41161000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=341 12/5/2014
AP012/3/2014N41206000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM426510.pdf 12/11/2014
AP012/3/2014N41618000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125557Orig1s000TOC.cfm 1/12/2015
AP08/30/2016S46939005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf 9/2/2016
AP08/30/2016S46965005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf 9/2/2016
AP08/30/2016S46966006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf 9/2/2016
AP08/30/2016S46940006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf 9/2/2016




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