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FDA Drug Application 125477 by ELI LILLY AND CO

Application Number125477
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
AP04/21/2014N39110000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477lbl.pdf 4/21/2014
AP04/21/2014N39112000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s000ltr.pdf 4/22/2014
AP04/21/2014N39315000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000TOC.cfm 5/16/2014
AP04/21/2014N39316000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000SumR.pdf 5/16/2014
AP011/5/2014SE840950002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s002lbl.pdf 11/5/2014
AP011/5/2014SE840954002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s002ltr.pdf 11/6/2014
AP012/12/2014SE141238007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125477s007lbl.pdf 12/12/2014
AP012/12/2014SE141239007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125477Orig1s007ltr.pdf 12/15/2014
AP04/24/2015SE842648011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf 4/24/2015
AP04/24/2015SE842658011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125477Orig1s011ltr.pdf 4/27/2015




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