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FDA Drug Application 022173 by ELI LILLY CO

Application Number022173
Application Type New Drug Application
Sponsor ApplicantELI LILLY CO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/11/2009N24290000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022173lbl.pdf 12/15/2009
AP012/11/2009N24350000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022173s000ltr.pdf 12/29/2009
AP012/11/2009N24875000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=74 3/1/2010
AP012/11/2009N24876000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM194579.pdf 3/1/2010
AP012/11/2009N26017000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022173_zyprexa_relprevv_toc.cfm 7/27/2010
AP012/11/2009N26018000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022173s000SumR.pdf 7/27/2010
AP012/11/2009N31194000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP04/27/2010SLR25448002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s002ltr.pdf 5/3/2010
AP04/27/2010SLR25504002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s002lbl.pdf 5/7/2010
AP05/27/2010SLR25665003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s003,s006ltr.pdf 6/2/2010
AP05/27/2010SLR25725003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf 6/11/2010
AP07/8/2010S25948004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s004ltr.pdf 7/12/2010
AP05/27/2010SLR25666006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s003,s006ltr.pdf 6/2/2010
AP05/27/2010SLR25687006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006lbl.pdf 6/3/2010
AP05/27/2010SLR25688006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s003s006MedGuide.pdf 6/3/2010
AP08/3/2012SLR33391008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf 8/6/2012
AP08/3/2012SLR33394008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014mg.pdf 8/6/2012
AP08/3/2012SLR33399008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173Orig1s008,s010,s014_r_ltr.pdf 8/7/2012
AP012/1/2010SLR27179009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022173s009lbl.pdf 12/4/2010
AP012/1/2010SLR27194009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022173s009ltr.pdf 12/6/2010
AP08/3/2012SLR33392010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf 8/6/2012
AP08/3/2012SLR33400010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173orig1s008,s010,s014ltr.pdf 8/7/2012
AP08/3/2012SLR33395010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014mg.pdf 8/6/2012
AP08/3/2012SLR33396014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014mg.pdf 8/6/2012
AP08/3/2012SLR33401014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022173orig1s008,s010,s014ltr.pdf 8/7/2012
AP08/3/2012SLR33393014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022173s008s010s014lbl.pdf 8/6/2012
AP012/19/2014SLR41359015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf 12/23/2014
AP012/19/2014SLR41581015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s015lbl.pdf 1/9/2015
AP07/23/2015SLR43482017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022173s017lbl.pdf 7/24/2015
AP03/27/2013SLR35567018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022173Orig1s018ltr.pdf 3/29/2013
AP03/27/2013SLR35607018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022173s018lbl.pdf 4/1/2013
AP012/23/2015SCM       
AP02/18/2014SCM       
AP010/30/2014S40918023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022173Orig1s023ltr.pdf 11/3/2014
AP010/30/2014S40940023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022173s023lbl.pdf 11/4/2014
AP09/17/2015SLR43916024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022173Orig1s024ltr.pdf 9/18/2015
AP010/6/2016SLR47313025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022173s025lbl.pdf 10/7/2016
AP010/6/2016SLR47349025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf 10/14/2016




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