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FDA Drug Application 021411 by LILLY

Application Number021411
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
AP011/26/2002N3316000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21411ltr.pdf 11/26/2002
AP011/26/2002N3317000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21411_strattera_lbl.pdf 11/26/2002
AP011/26/2002N4218000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-411_Strattera.cfm 3/7/2003
AP011/26/2002N12822000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107912.htm 9/30/2005
AP011/26/2002N24189000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089138.pdf 12/4/2009
AP01/17/2003SLR4184001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21411slr001ltr.pdf 1/17/2003
AP01/17/2003SLR4185001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21411slr001_strattera_lbl.pdf 1/17/2003
AP01/17/2003SLR16998001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021411_S001_STRATTERA_CAPSULES_AP.pdf 7/6/2007
AP02/1/2005SLR11069002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s002,011ltr.pdf 2/3/2005
AP04/25/2007SLR16357004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf 5/1/2007
AP04/25/2007SLR16385004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf 5/1/2007
AP05/7/2008SE119799005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411se1-005ltr.pdf 5/9/2008
AP05/7/2008SE120229005   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021411se1-005_SUMR.pdf 7/17/2008
AP05/26/2005SE811734008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021411s008ltr.pdf 5/27/2005
AP02/14/2005SCS11121010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s010ltr.pdf 2/17/2005
AP02/1/2005SLR11070011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s002,011ltr.pdf 2/3/2005
AP04/25/2007SLR16358012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf 5/1/2007
AP04/25/2007SLR16386012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf 5/1/2007
AP04/25/2007SLR16359013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf 5/1/2007
AP04/25/2007SLR16387013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf 5/1/2007
AP011/8/2005SLR13093014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021411s014ltr.pdf 11/18/2005
AP04/25/2007SLR16360015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf 5/1/2007
AP04/25/2007SLR16388015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf 5/1/2007
AP010/19/2006SLR15153018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021411s018lbl.pdf 10/23/2006
AP010/19/2006SLR15175018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021411s018ltr.pdf 10/23/2006
AP09/28/2007SE818132019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s019ltr.pdf 10/4/2007
AP09/28/2007SE818166019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s019lbl.pdf 10/4/2007
AP04/25/2007SLR16361021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf 5/1/2007
AP04/25/2007SLR16389021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf 5/1/2007
AP07/23/2008SE820295024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf 7/25/2008
AP07/23/2008SE820315024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf 7/29/2008
AP07/23/2008SLR20296025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf 7/25/2008
AP07/23/2008SLR20316025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf 7/29/2008
AP07/23/2008SLR20297026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf 7/25/2008
AP07/23/2008SLR20317026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf 7/29/2008
AP06/3/2009SLR22694029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf 6/4/2009
AP06/3/2009SLR22750029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021411s029,s030ltr.pdf 6/16/2009
AP06/3/2009SLR22695030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf 6/4/2009
AP06/3/2009SLR22751030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021411s029,s030ltr.pdf 6/16/2009
AP07/29/2010SLR26040032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021411s032ltr.pdf 7/30/2010
AP07/29/2010SLR26074032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021411s032lbl.pdf 7/31/2010
AP07/5/2012SLR33092034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411s034ltr.pdf 7/9/2012
AP07/5/2012SLR33113034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s034lbl.pdf 7/10/2012
AP03/7/2011SLR28186035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf 3/7/2011
AP03/7/2011SLR28187035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021411s035ltr.pdf 3/10/2011
AP08/16/2012SLR33508036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s036mg.pdf 8/17/2012
AP08/16/2012SLR33517036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411Orig1s036ltr.pdf 8/20/2012
AP08/16/2012SLR33730036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s036lbl.pdf 9/12/2012
AP06/14/2012SLR32918039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411s039ltr.pdf 6/18/2012
AP06/14/2012SLR32927039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s039lbl.pdf 6/18/2012
AP08/5/2013SLR36701040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s040lbl.pdf 8/5/2013
AP08/5/2013SLR36712040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s040,s042ltr.pdf 8/6/2013
AP05/20/2013SCM       
AP08/5/2013SLR36700042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s042lbl.pdf 8/5/2013
AP08/5/2013SLR36713042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s040,s042ltr.pdf 8/6/2013
AP02/21/2014SCM       
AP02/20/2014SLR38550044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021411s044lbl.pdf 2/21/2014
AP02/20/2014SLR38557044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021411Orig1s044ltr.pdf 2/21/2014
AP012/4/2013SLR37972045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s045lbl.pdf 12/5/2013
AP012/4/2013SLR37984045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s045ltr.pdf 12/9/2013
AP05/26/2015SLR42926046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021411Orig1s046ltr.pdf 5/28/2015
AP05/26/2015SLR42945046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s046lbl.pdf 5/29/2015
AP04/17/2015SLR42576047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021411Orig1s047ltr.pdf 4/20/2015
AP04/17/2015SLR42609047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s047lbl.pdf 4/21/2015




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