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FDA Drug Application 021235 by LILLY

Application Number021235
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
AP02/26/2001N12435000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
AP02/26/2001N1507000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21235ltr.pdf 2/26/2001
AP02/26/2001N1508000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21235LBL.PDF 2/26/2001
AP02/26/2001N10432000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-235_Prozac.cfm 10/18/2004
AP02/26/2001N24821000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088999.pdf 2/19/2010
AP08/19/2004SLR10037002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf 8/25/2004
AP012/1/2005SLR13214003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf 12/6/2005
AP02/18/2005SLR11161004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf 2/23/2005
AP04/11/2006SLR13912006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf 4/13/2006
AP09/20/2006SLR14936007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s76,20101s35,20974s8,21235s7,21520s12,21427s11lbl.pdf 9/21/2006
AP03/15/2007SLR16065008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,020101s036ltr.pdf 3/23/2007
AP08/2/2007SLR17476009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf 8/3/2007
AP08/2/2007SLR17584009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf 8/7/2007
AP03/9/2008SLR19427010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s083, 020101s038, 021235s010ltr.pdf 3/12/2008
AP03/9/2008SLR19445010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf 3/13/2008
AP03/21/2008SLR19508011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf 3/24/2008
AP03/21/2008SLR19526011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s084,020101s039,021235s011ltr.pdf 3/24/2008
AP01/30/2009SLR21709014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s088,020101s042,021235s014ltr.pdf 2/3/2009
AP01/30/2009SLR21751014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf 2/4/2009
AP04/4/2011SLR28460015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021235s015lbl.pdf 4/4/2011
AP04/4/2011SLR29144015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091s093s095,021235s015s016s017MedG.pdf 6/15/2011
AP04/4/2011SLR28530015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf 4/13/2011
AP04/4/2011SLR28531016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf 4/13/2011
AP04/4/2011SLR29145016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091s093s095,021235s015s016s017MedG.pdf 6/15/2011
AP04/4/2011SLR37532016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021235Orig1s016.pdf 10/23/2013
AP04/4/2011SLR28461016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021235s016lbl.pdf 4/4/2011
AP04/4/2011SLR28462017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021235s017lbl.pdf 4/4/2011
AP04/4/2011SLR29146017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091s093s095,021235s015s016s017MedG.pdf 6/15/2011
AP04/4/2011SLR28532017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf 4/13/2011
AP06/15/2011SLR29172018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf 6/16/2011
AP06/15/2011SLR29239018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936Orig1s096,021235Orig1s018ltr.pdf 6/23/2011
AP01/3/2013SLR34831019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf 1/7/2013
AP01/3/2013SLR34833019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020mg.pdf 1/7/2013
AP01/3/2013SLR34845019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf 1/7/2013
AP01/3/2013SLR34846020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf 1/7/2013
AP01/3/2013SLR34834020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020mg.pdf 1/7/2013
AP01/3/2013SLR34832020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf 1/7/2013
AP07/26/2013SLR36641021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf 7/30/2013
AP07/26/2013SLR36671021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 7/30/2013
AP07/18/2014SLR39948024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf 7/23/2014
AP07/18/2014SLR39991024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf 7/24/2014
AP08/4/2015SLR43582025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021235Orig1s025ltr.pdf 8/6/2015
AP08/4/2015SLR43586025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021235s025lbl.pdf 8/6/2015




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