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FDA Drug Application 020592 by LILLY

Application Number020592
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/30/1996N18537000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020592_Original_Approval_Pkg .pdf 11/19/2007
AP09/30/1996N24210000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM134700.pdf 12/4/2009
AP09/30/1996N31191000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP02/19/1997SCM       
AP04/18/1997SCM       
AP09/9/1997SCM       
AP012/4/1997SCS       
AP03/17/2000SE127475006Approval Package  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020592_s006_zyprexa oral tablets.pdf 1/7/2011
AP03/17/2000SE116218006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020592_S006_ZUPREXA_ORAL_TABS_AP.pdf 4/11/2007
AP03/23/1998SCM       
AP01/11/1999SLR       
AP011/9/2000SE18351011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-592S011_review.pdf 4/15/2004
AP03/13/2001SCS       
AP01/22/2002SCP       
AP07/10/2003SE16120018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20592s18lbl_Zyprexa.pdf 7/10/2003
AP07/10/2003SE16155018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20592se1-018ltr.pdf 7/28/2003
AP07/10/2003SE117043018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020592_S018_ZYPREXA_AP.pdf 7/6/2007
AP01/14/2004SE123362019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020592_s019_Zyprexa.pdf 9/16/2009
AP01/14/2004SE17589019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20592se1-019ltr.pdf 1/22/2004
AP01/14/2004SE17613019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20592se1-019_zyprexa_lbl.pdf 1/22/2004
AP06/29/2005SLR11912020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s020ltr.pdf 6/29/2005
AP08/3/2005SLR12547026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s026ltr.pdf 8/8/2005
AP02/16/2006SLR13643027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf 2/22/2006
AP02/16/2006SLR13627027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf 2/22/2006
AP08/25/2006SLR14759029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf 8/29/2006
AP08/25/2006SLR14882029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s029, 021086s011, 021253s006ltr.pdf 9/18/2006
AP02/16/2006SLR13644032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf 2/22/2006
AP02/16/2006SLR13628032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf 2/22/2006
AP09/13/2005SLR23363034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020592_s034_Zyprexa Tabs.pdf 9/16/2009
AP09/13/2005SLR12784034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,021253s015ltr.pdf 9/15/2005
AP02/23/2006SLR13667035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf 2/28/2006
AP02/23/2006SLR13682035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021253s016,021086s016,020592s035ltr.pdf 3/1/2006
AP02/23/2006SLR32124035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020592Orig1s035.pdf 3/16/2012
AP011/29/2006SLR15418038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf 12/4/2006
AP011/29/2006SLR15576038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s038, 021086s020, 021253s021ltr.pdf 12/28/2006
AP03/19/2009SE832125039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020592Orig1s039.pdf 3/16/2012
AP03/19/2009SE822069039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s039,021086s021lbl.pdf 3/20/2009
AP012/4/2009SE529376040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020592_s40s41_zyprexa_toc.cfm 6/30/2011
AP012/4/2009SE524632040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s040s041ltr.pdf 1/26/2010
AP012/4/2009SE524243040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf 12/10/2009
AP012/4/2009SE524244041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s040s041lbl.pdf 12/10/2009
AP012/4/2009SE524633041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s040s041ltr.pdf 1/26/2010
AP012/4/2009SE529377041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020592_s40s41_zyprexa_toc.cfm 6/30/2011
AP07/6/2007SLR17267042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf 7/10/2007
AP07/6/2007SLR17260042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf 7/10/2007
AP07/6/2007SLR17261043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf 7/10/2007
AP07/6/2007SLR17268043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf 7/10/2007
AP08/14/2008SLR20633049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,021253s033ltr.pdf 8/19/2008
AP08/14/2008SLR31537049   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020592Orig1s049.pdf 1/27/2012
AP08/31/2009SLR23379051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf 9/17/2009
AP08/31/2009SLR23968051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s051,021086s030,021253s036ltr.pdf 11/19/2009
AP01/27/2010SLR24666052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf 1/29/2010
AP01/27/2010SLR24693052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s052,021086s031,021253s037ltr.pdf 2/1/2010
AP05/27/2010SLR25671053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf 6/3/2010
AP05/27/2010SLR25699053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043MedGuide.pdf 6/3/2010
AP05/27/2010SLR25697053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf 6/3/2010
AP05/27/2010SLR32126053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020592Orig1s053.pdf 3/16/2012
AP05/27/2010SLR32127055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/020592Orig1s055.pdf 3/16/2012
AP05/27/2010SLR25698055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf 6/3/2010
AP05/27/2010SLR25700055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043MedGuide.pdf 6/3/2010
AP05/27/2010SLR25672055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf 6/3/2010
AP012/1/2010SLR27178057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf 12/4/2010
AP012/1/2010SLR27206057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s057,021086s036,021253s045ltr.pdf 12/6/2010
AP06/21/2011SLR29277060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf 6/27/2011
AP06/21/2011SLR29334060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf 6/29/2011
AP06/21/2011SLR29336060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039MedG.pdf 6/29/2011
AP06/21/2011SLR29337061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039MedG.pdf 6/29/2011
AP06/21/2011SLR29335061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020592s060s061,021086s038s039lbl.pdf 6/29/2011
AP06/21/2011SLR29278061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020592s060,s061,021086s038,s039ltr.pdf 6/27/2011
AP012/19/2014SLR41356062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf 12/23/2014
AP012/19/2014SLR41577062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf 1/9/2015
AP07/26/2013S36642063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020592s063,021086s041lbl.pdf 7/30/2013
AP07/26/2013S36669063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 7/30/2013
AP07/23/2015SLR43483064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf 7/24/2015
AP010/21/2013SCM       
AP010/25/2013SCM       
AP010/6/2016SLR47311067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020592s067,021086s043,021253s056lbl.pdf 10/7/2016
AP010/6/2016SLR47346067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf 10/14/2016




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