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FDA Drug Application 205692 by ELI LILLY AND CO

Application Number205692
Application Type New Drug Application
Sponsor ApplicantELI LILLY AND CO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA08/18/2014TA40264000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.pdf 8/19/2014
AP112/16/2015N40264000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.pdf 8/19/2014
TA08/18/2014TA41736000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.pdf 1/30/2015
AP112/16/2015N41736000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205692Orig1s000TAltr.pdf 1/30/2015
TA08/18/2014TA44809000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf 12/17/2015
AP112/16/2015N44809000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205692lbl.pdf 12/17/2015
TA08/18/2014TA44829000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205692Orig1s000ltr.pdf 12/18/2015
AP112/16/2015N44829000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205692Orig1s000ltr.pdf 12/18/2015
TA08/18/2014TA45752000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000TOC.cfm 4/26/2016
AP112/16/2015N45752000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000TOC.cfm 4/26/2016
TA08/18/2014TA45753000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000SumR.pdf 4/26/2016
AP112/16/2015N45753000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205692Orig1s000SumR.pdf 4/26/2016
AP06/17/2016SLR46371001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205692Orig1s001ltr.pdf 6/21/2016
AP06/17/2016SLR46388001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205692s001lbl.pdf 6/21/2016
AP06/17/2016SCM       
AP07/15/2016SCM       
AP06/1/2016SLR46244005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205692s005lbl.pdf 6/2/2016
AP06/1/2016SLR46249005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205692Orig1s005ltr.pdf 6/6/2016
AP09/23/2016SCM       




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