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FDA Drug Application 125521 by ELI LILLY AND CO

Application Number125521
Application Type Biologic License Application
Sponsor ApplicantELI LILLY AND CO
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
AP03/22/2016N45489000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf 3/23/2016
AP03/22/2016N45496000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125521Orig1s000ltr.pdf 3/24/2016
AP03/22/2016N45550000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM493178.pdf 3/30/2016
AP03/22/2016N45831000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125521Orig1s000TOC.cfm 5/3/2016
AP03/22/2016N45832000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125521Orig1s000SumR.pdf 5/3/2016




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