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FDA Drug Application 022307 by ELI LILLY AND CO

Application Number022307
Application Type New Drug Application
Sponsor ApplicantELI LILLY AND CO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/10/2009N22937000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022307s000_ltr.pdf 7/13/2009
AP07/10/2009N22938000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022307s000lbl.pdf 7/13/2009
AP07/10/2009N22942000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000TOC.cfm 7/13/2009
AP07/10/2009N22943000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022307s000_SumR.pdf 7/13/2009
AP07/10/2009N34548000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM238428.pdf 12/5/2012
AP07/10/2009N41380000   http://www.fda.gov/Drugs/DrugSafety/ucm423079.htm 12/23/2014
AP04/16/2010SCM25331001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s001ltr.pdf 4/22/2010
AP04/16/2010SCM25437001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s001lbl.pdf 5/3/2010
AP012/6/2010SLR27231002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022307s002lbl.pdf 12/6/2010
AP012/6/2010SLR27268002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s002ltr.pdf 12/10/2010
AP09/27/2011SLR30142003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022307s003ltr.pdf 9/29/2011
AP09/27/2011SLR30162003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022307s003MedG.pdf 9/30/2011
AP09/27/2011SLR30163003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022307s003lbl.pdf 9/30/2011
AP03/23/2012SLR32197006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307s006ltr.pdf 3/27/2012
AP011/30/2012SLR34527007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307Orig1s007ltr.pdf 12/4/2012
AP011/30/2012SLR34528007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022307s007lbl.pdf 12/4/2012
AP010/16/2013SE837450008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s008ltr.pdf 10/17/2013
AP010/16/2013SE837469008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s008lbl.pdf 10/18/2013
AP010/16/2013SE845140008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022307Orig1s008TOC.cfm 2/10/2016
AP010/16/2013SE846680008Priority 3 Approval Package  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022307Orig1s008.pdf 7/29/2016
AP011/18/2013SLR37864010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s010ltr.pdf 11/20/2013
AP011/18/2013SLR37892010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022307s010lbl.pdf 11/22/2013
AP07/7/2015SLR43295012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022307s012lbl.pdf 7/9/2015
AP07/7/2015SLR43316012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022307Orig1s012ltr.pdf 7/10/2015
AP01/14/2016SLR44968013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s013ltr.pdf 1/15/2016
AP01/14/2016SLR45243013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s013lbl.pdf 2/23/2016
AP07/12/2016SE846513014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s014ltr.pdf 7/13/2016
AP07/12/2016SE846524014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022307s014lbl.pdf 7/13/2016




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