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FDA Drug Application 125522 by AMGEN INC

Application Number125522
Application Type Biologic License Application
Sponsor ApplicantAMGEN 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
AP08/27/2015N43744000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125522s000lbl.pdf 8/28/2015
AP08/27/2015N43757000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125522Orig1s000ltr.pdf 9/1/2015
AP08/27/2015N44072000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125522Orig1s000TOC.cfm 10/1/2015
AP08/27/2015N44073000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125522Orig1s000SumR.pdf 10/1/2015
AP07/8/2016SE846491001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125522Orig1s001,s004ltr.pdf 7/12/2016
AP07/8/2016SLR46492004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125522Orig1s001,s004ltr.pdf 7/12/2016




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