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FDA Drug Application 021427 by LILLY

Application Number021427
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
AP08/3/2004N9978000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21427ltr.pdf 8/10/2004
AP08/3/2004N9986000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21427lbl.pdf 8/10/2004
AP08/3/2004N10371000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021427_s000_Cymbalta.cfm 10/8/2004
AP08/3/2004N12364000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114966.htm 7/29/2005
AP08/3/2004N23920000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088579.pdf 11/16/2009
AP02/18/2005SLR11140002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21427s002ltr.pdf 2/23/2005
AP06/6/2006SLR14308007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021427s007LTR.pdf 6/14/2006
AP02/23/2007S15913009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf 2/26/2007
AP02/23/2007S15958009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf 3/6/2007
AP02/23/2007SE115914011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf 2/26/2007
AP02/23/2007SE115959011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf 3/6/2007
AP09/20/2006SLR14934012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021427s012lbl.pdf 9/21/2006
AP02/23/2007SLR15915013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf 2/26/2007
AP02/23/2007SLR15957013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf 3/6/2007
AP011/28/2007SE118598015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s015, s017ltr.pdf 12/3/2007
AP011/28/2007SE118608015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf 12/3/2007
AP011/28/2007SE130807015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021427Orig1s015_s017.pdf 10/10/2011
AP011/28/2007SE118599017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s015, s017ltr.pdf 12/3/2007
AP011/28/2007SE118609017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf 12/3/2007
AP011/28/2007SE130808017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021427Orig1s015_s017.pdf 10/10/2011
AP08/2/2007SLR17475018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s018lbl.pdf 8/3/2007
AP08/2/2007SLR17588018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf 8/7/2007
AP03/18/2009SLR22065021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf 3/20/2009
AP03/18/2009SLR22091021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf 3/24/2009
AP03/18/2009SLR22066027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf 3/20/2009
AP03/18/2009SLR22092027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf 3/24/2009
AP03/18/2009SLR22067028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf 3/20/2009
AP03/18/2009SLR22093028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf 3/24/2009
AP01/30/2009SLR21721029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s029ltr.pdf 2/3/2009
AP01/30/2009SLR21776029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s029lbl.pdf 2/4/2009
AP011/19/2009SE124100030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s030lbl.pdf 11/23/2009
AP011/19/2009SE124101030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s030MedGuide.pdf 11/23/2009
AP011/19/2009SE124158030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s030ltr.pdf 11/27/2009
AP03/4/2011SLR28153031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s031lbl.pdf 3/7/2011
AP03/4/2011SLR28173031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s031ltr.pdf 3/8/2011
AP08/24/2012SLR33565032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s032,s038ltr.pdf 8/28/2012
AP08/24/2012SLR33595032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf 8/30/2012
AP04/12/2011SLR28546036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s036ltr.pdf 4/15/2011
AP04/12/2011SLR28555036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s036lbl.pdf 4/15/2011
AP011/25/2014SLR41106037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s037,s042ltr.pdf 11/28/2014
AP011/25/2014SLR41138037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf 12/3/2014
AP08/24/2012SLR33566038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s032,s038ltr.pdf 8/28/2012
AP08/24/2012SLR33577038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038mg.pdf 8/28/2012
AP08/24/2012SLR33596038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf 8/30/2012
AP09/2/2011SLR29955039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s039lbl.pdf 9/7/2011
AP09/2/2011SLR29956039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s039ltr.pdf 9/7/2011
AP09/2/2011SLR32658039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021427Orig1s039.pdf 5/9/2012
AP010/18/2012SLR34132040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s040,s041ltr.pdf 10/22/2012
AP010/18/2012SLR34147040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf 10/22/2012
AP010/18/2012SLR34149040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041mg.pdf 10/22/2012
AP010/18/2012SE534133041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s040,s041ltr.pdf 10/22/2012
AP010/18/2012SE534148041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf 10/22/2012
AP010/18/2012SE534150041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041mg.pdf 10/22/2012
AP011/25/2014SLR41105042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s037,s042ltr.pdf 11/28/2014
AP011/25/2014SLR41139042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf 12/3/2014
AP010/16/2014SE840833043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s043,s044ltr.pdf 10/21/2014
AP010/16/2014SE840848043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf 10/21/2014
AP010/16/2014SE840834044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s043,s044ltr.pdf 10/21/2014
AP010/16/2014SE840849044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf 10/21/2014
AP07/17/2014SLR39898045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s045ltr.pdf 7/21/2014
AP07/17/2014SLR40006045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427Orig1s045lbl.pdf 7/28/2014
AP06/18/2015SLR43081046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021427s046lbl.pdf 6/19/2015
AP06/18/2015SLR43089046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021427Orig1s046ltr.pdf 6/22/2015
AP07/12/2016SCM       
AP09/2/2016SLR46973048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021427Orig1s048ltr.pdf 9/6/2016
AP09/2/2016SLR46977048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021427s048lbl.pdf 9/6/2016




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