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FDA Drug Application 021086 by LILLY

Application Number021086
Application Type New Drug Application
Sponsor ApplicantLILLY
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
AP04/6/2000N1156000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21086ltr.pdf 4/6/2000
AP04/6/2000N1157000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21086lbl.pdf 4/6/2000
AP04/6/2000N2237000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-086_ZyprexaZydis.cfm 4/6/2000
AP04/6/2000N24211000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134700.pdf 12/4/2009
AP04/6/2000N31192000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP010/24/2001SCS       
AP02/16/2006SLR       
AP08/25/2006SLR14760011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf 8/29/2006
AP08/25/2006SLR14881011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s029, 021086s011, 021253s006ltr.pdf 9/18/2006
AP02/16/2006SLR       
AP09/13/2005SLR12783015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,021253s015ltr.pdf 9/15/2005
AP02/23/2006SLR13668016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf 2/28/2006
AP02/23/2006SLR13683016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021253s016,021086s016,020592s035ltr.pdf 3/1/2006
AP011/29/2006SLR15417020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf 12/4/2006
AP011/29/2006SLR15575020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s038, 021086s020, 021253s021ltr.pdf 12/28/2006
AP03/19/2009SE822068021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf 3/20/2009
AP07/6/2007SLR17258022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf 7/10/2007
AP07/6/2007SLR17265022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf 7/10/2007
AP07/6/2007SLR17259023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf 7/10/2007
AP07/6/2007SLR17266023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf 7/10/2007
AP08/14/2008SLR20634028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,021253s033ltr.pdf 8/19/2008
AP08/31/2009SLR23380030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf 9/17/2009
AP08/31/2009SLR23969030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s051,021086s030,021253s036ltr.pdf 11/19/2009
AP01/27/2010SLR24665031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf 1/29/2010
AP01/27/2010SLR24694031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s052,021086s031,021253s037ltr.pdf 2/1/2010
AP05/27/2010SLR25673032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf 6/3/2010
AP05/27/2010SLR25693032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf 6/3/2010
AP05/27/2010SLR25695032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043MedGuide.pdf 6/3/2010
AP05/27/2010SLR25674034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf 6/3/2010
AP05/27/2010SLR25694034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf 6/3/2010
AP05/27/2010SLR25696034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043MedGuide.pdf 6/3/2010
AP012/1/2010SLR27177036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf 12/4/2010
AP012/1/2010SLR27207036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s057,021086s036,021253s045ltr.pdf 12/6/2010
AP06/21/2011SLR29279038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf 6/27/2011
AP06/21/2011SLR29332038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf 6/29/2011
AP06/21/2011SLR29338038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039MedG.pdf 6/29/2011
AP06/21/2011SLR29280039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf 6/27/2011
AP06/21/2011SLR29333039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf 6/29/2011
AP06/21/2011SLR29339039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039MedG.pdf 6/29/2011
AP012/19/2014SLR41357040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf 12/23/2014
AP012/19/2014SLR41578040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf 1/9/2015
AP07/26/2013S36643041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.pdf 7/30/2013
AP07/26/2013S36670041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 7/30/2013
AP07/23/2015SLR43484042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf 7/24/2015
AP010/6/2016SLR47312043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf 10/7/2016
AP010/6/2016SLR47347043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf 10/14/2016




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