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FDA Drug Application 125469 by ELI LILLY AND CO

Application Number125469
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
AP09/18/2014N40514000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s000ltr.pdf 9/19/2014
AP09/18/2014N40702000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=322 10/3/2014
AP09/18/2014N40885000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000TOC.cfm 10/27/2014
AP09/18/2014N40886000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000SumR.pdf 10/27/2014
AP09/18/2014N42356000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf 4/1/2015
AP03/9/2015S42083001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s001ltr.pdf 3/11/2015
AP012/19/2014S41397002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s002ltr.pdf 12/24/2014
AP07/27/2015S43509004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s004ltr.pdf 7/28/2015




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