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FDA Drug Application 021520 by LILLY

Application Number021520
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/2003N7466000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21520ltr.pdf 1/2/2004
AP012/24/2003N7467000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520_symbyax_lbl.pdf 1/2/2004
AP012/24/2003N7571000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520ppi.pdf 1/16/2004
AP012/24/2003N11824000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21520_SymbyaxTOC.cfm 6/16/2005
AP012/24/2003N16539000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 5/9/2007
AP012/24/2003N24192000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089140.pdf 12/4/2009
AP07/3/2006SLR       
AP02/18/2005SLR11139005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21520s005ltr.pdf 2/23/2005
AP07/3/2006SLR       
AP04/9/2007SLR16253008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021520s008, 010ltr.pdf 4/20/2007
AP04/9/2007SLR16279008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf 4/20/2007
AP011/29/2006SLR15419009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021520s009lbl.pdf 12/4/2006
AP011/29/2006SLR15569009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021520s009ltr.pdf 12/28/2006
AP04/9/2007SE216254010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021520s008, 010ltr.pdf 4/20/2007
AP04/9/2007SE216280010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s008s010lbl.pdf 4/20/2007
AP09/20/2006SLR14935011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021520s011lbl.pdf 9/21/2006
AP03/19/2009SE822070012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s012lbl.pdf 3/20/2009
AP03/19/2009SE836030012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021520Orig1s012.pdf 5/10/2013
AP08/2/2007SLR17480013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s013s014lbl.pdf 8/3/2007
AP08/2/2007SLR17582013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf 8/7/2007
AP08/2/2007SLR17481014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021520s013s014lbl.pdf 8/3/2007
AP08/2/2007SLR17583014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf 8/7/2007
AP03/18/2008SLR19484016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s016ltr.pdf 3/19/2008
AP03/18/2008SLR19493016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s016lbl.pdf 3/19/2008
AP03/21/2008SLR19513017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s017lbl.pdf 3/24/2008
AP03/21/2008SLR19528017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s017ltr.pdf 3/24/2008
AP08/14/2008SLR20629020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021520s020ltr.pdf 8/19/2008
AP08/31/2009SLR23438022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s022lbl.pdf 9/22/2009
AP01/27/2010SLR24667023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s023lbl.pdf 1/29/2010
AP01/27/2010SLR24690023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s023ltr.pdf 2/1/2010
AP04/22/2011SLR28604025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s025,s028ltr.pdf 4/25/2011
AP04/22/2011SLR28608025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s025s028lbl.pdf 4/26/2011
AP012/1/2010SLR27180027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s027s029lbl.pdf 12/4/2010
AP012/1/2010SLR27242027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s027,s029ltr.pdf 12/7/2010
AP04/22/2011SLR28605028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s025,028ltr.pdf 4/25/2011
AP04/22/2011SLR28609028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s025s028lbl.pdf 4/26/2011
AP012/1/2010SLR27181029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021520s027s029lbl.pdf 12/4/2010
AP012/1/2010SLR27243029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021520s027,s029ltr.pdf 12/7/2010
AP06/21/2011SLR29274031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s031,s032ltr.pdf 6/27/2011
AP06/21/2011SLR29341031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032lbl.pdf 6/29/2011
AP06/21/2011SLR29342031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032MedG.pdf 6/29/2011
AP06/21/2011SLR29275032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s031,s032ltr.pdf 6/27/2011
AP06/21/2011SLR29340032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032lbl.pdf 6/29/2011
AP06/21/2011SLR29343032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s031s032MedG.pdf 6/29/2011
AP010/4/2011SLR30220033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021520s33lbl.pdf 10/5/2011
AP010/4/2011SLR30224033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021520s033ltr.pdf 10/5/2011
AP012/19/2014SLR41360034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020592Orig1s062,021086Orig1s040,021253Orig1s048,022173s015,021520Origs034ltr.pdf 12/23/2014
AP012/19/2014SLR41580034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s034lbl.pdf 1/9/2015
AP01/3/2013SLR34839035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf 1/7/2013
AP01/3/2013SLR34841035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036mg.pdf 1/7/2013
AP01/3/2013SLR34848035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s035,s036ltr.pdf 1/7/2013
AP01/3/2013SLR34840036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036lbl.pdf 1/7/2013
AP01/3/2013SLR34842036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s035s036mg.pdf 1/7/2013
AP01/3/2013SLR34849036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s035,s036ltr.pdf 1/7/2013
AP07/26/2013SLR36637037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s037s039lbl.pdf 7/30/2013
AP07/26/2013SLR36666037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 7/30/2013
AP08/8/2012SLR33412038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021520s038lbl.pdf 8/8/2012
AP08/8/2012SLR33413038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021520s038mg.pdf 8/8/2012
AP08/8/2012SLR33416038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021520Orig1s038ltr.pdf 8/9/2012
AP07/26/2013S36638039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s037s039lbl.pdf 7/30/2013
AP07/26/2013S36665039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf 7/30/2013
AP08/7/2013SLR36732040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s040ltr.pdf 8/8/2013
AP08/7/2013SLR36762040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021520s040lbl.pdf 8/9/2013
AP010/10/2014SE840773041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s041,018936Origs102ltr.pdf 10/15/2014
AP010/10/2014SE840784041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s041lbl.pdf 10/15/2014
AP010/30/2014SCM       
AP07/18/2014SLR39950045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021520s045lbl.pdf 7/23/2014
AP07/18/2014SLR39989045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf 7/24/2014
AP010/6/2016SLR47350046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020592Orig1s067,021086Orig1s043,021253Orig1s056,022173Orig1s025,021520Orig1s046ltr.pdf 10/14/2016




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