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FDA Drug Application 021253 by LILLY

Application Number021253
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
AP03/29/2004N8229000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21253_zyprexa_lbl.pdf 4/5/2004
AP03/29/2004N8300000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21253ltr.pdf 4/7/2004
AP03/29/2004N11981000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21253_Zyprexa.TOC.cfm 7/13/2005
AP03/29/2004N31193000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP02/16/2006SLR13625004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf 2/22/2006
AP02/16/2006SLR13641004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf 2/22/2006
AP08/25/2006SLR14758006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s029_021086s011_021253s006lbl.pdf 8/29/2006
AP08/25/2006SLR14880006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s029, 021086s011, 021253s006ltr.pdf 9/18/2006
AP02/16/2006SLR13626012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s027s032,021086s009s013,021253s004s012lbl.pdf 2/22/2006
AP02/16/2006SLR13642012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s027s032,021086s009s013,021253s004s012ltr.pdf 2/22/2006
AP09/13/2005SLR12782015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020592s034,021086s015,021253s015ltr.pdf 9/15/2005
AP02/23/2006SLR13669016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021253s016,021086s016,020592s035lbl.pdf 2/28/2006
AP02/23/2006SLR13684016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021253s016,021086s016,020592s035ltr.pdf 3/1/2006
AP011/29/2006SLR15416021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020592s038,021086s020,021253s021lbl.pdf 12/4/2006
AP011/29/2006SLR15574021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020592s038, 021086s020, 021253s021ltr.pdf 12/28/2006
AP07/6/2007SLR17257026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020592s042s043_021086s022s023_021253s026_ltr.pdf 7/10/2007
AP07/6/2007SLR17264026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020592s042s043,021086s022s023,021253s026lbl.pdf 7/10/2007
AP08/14/2008SLR20635033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020592s049,021086s028,021253s033ltr.pdf 8/19/2008
AP08/31/2009SLR23381036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020592s051,021086s030,021253s036lbl.pdf 9/17/2009
AP08/31/2009SLR23970036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020592s051,021086s030,021253s036ltr.pdf 11/19/2009
AP01/27/2010SLR24664037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s052,021086s031,021253s037lbl.pdf 1/29/2010
AP01/27/2010SLR24695037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s052,021086s031,021253s037ltr.pdf 2/1/2010
AP05/27/2010SLR25675039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf 6/3/2010
AP05/27/2010SLR25689039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf 6/3/2010
AP05/27/2010SLR25691039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043MedGuide.pdf 6/3/2010
AP05/27/2010SLR25676043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s055,s053,021086s034,s032,021253s043,s039ltr.pdf 6/3/2010
AP05/27/2010SLR25690043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043lbl.pdf 6/3/2010
AP05/27/2010SLR25692043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s053s055,021086s032s034,021253s039s043MedGuide.pdf 6/3/2010
AP09/30/2014SCM       
AP012/1/2010SLR27176045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020592s057,021086s036,021253s045lbl.pdf 12/4/2010
AP012/1/2010SLR27208045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020592s057,021086s036,021253s045ltr.pdf 12/6/2010
AP012/19/2014SLR41358048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf 12/23/2014
AP012/19/2014SLR41579048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020592s062021086s040021253s048lbl.pdf 1/9/2015
AP07/23/2015SLR43485049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020592s064,021086s042,021253s049lbl.pdf 7/24/2015
AP08/11/2014SCM       
AP010/13/2016SCM       
AP010/6/2016SLR47348056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf 10/14/2016




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