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FDA Drug Application 125029 by LILLY

Application Number125029
Application Type Biologic License Application
Sponsor ApplicantLILLY
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
AP011/21/2001N81660000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/droteli112101L.htm 3/30/2004
AP011/21/2001N81670000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/droteli112101LB.pdf 3/30/2004
AP011/21/2001N81680000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093372.htm 3/30/2004
AP012/15/2004S110240053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125029_0053ltr.pdf 1/26/2005
AP012/15/2004S110410053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125029_0053lbl.pdf 1/26/2005
AP06/23/2005S119330065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125029s065lbl.pdf 7/7/2005
AP06/23/2005S126680065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125029s0065ltr.pdf 8/31/2005
AP03/22/2007S161160080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125029s080LTR.pdf 3/31/2007
AP03/22/2007S161310080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125029s080LBL.pdf 3/31/2007




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