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FDA Drug Application 021713 by OTSUKA

Application Number021713
Application Type New Drug Application
Sponsor ApplicantOTSUKA
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
AP012/10/2004N10795000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021713lbl.pdf 12/10/2004
AP012/10/2004N10796000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021713ltr.pdf 12/10/2004
AP012/10/2004N15006000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021713s000_AbilifyTOC2.cfm 9/27/2006
AP012/10/2004N24804000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085804.pdf 2/17/2010
AP012/10/2004N31184000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP03/1/2005SLR11189003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21436s005,008,21713s003ltr.pdf 3/3/2005
AP03/1/2005SLR11201003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl.pdf 3/3/2005
AP06/21/2005SLR11865004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021713s004,021436s007ltr.pdf 6/23/2005
AP06/21/2005SLR11881004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021713s004,021436s007lbl.pdf 6/23/2005
AP02/16/2006SLR13632006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s010,021713s006lbl.pdf 2/22/2006
AP02/16/2006SLR13645006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s010,021713s006ltr.pdf 2/22/2006
AP010/20/2006SLR15139008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s013,021713s008,021729s001lbl.pdf 10/23/2006
AP010/20/2006SLR15164008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s013, 021713s008, 021729s001ltr.pdf 10/23/2006
AP09/18/2006SLR14901009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s014, 021713s009ltr.pdf 9/20/2006
AP09/18/2006SLR14918009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s014,021713s009lbl.pdf 9/20/2006
AP09/25/2007SLR18036010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf 9/26/2007
AP09/25/2007SLR18156010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf 10/4/2007
AP010/29/2007SE518313012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf 11/7/2007
AP010/29/2007SE518387012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf 11/8/2007
AP011/16/2007SE118437013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf 11/19/2007
AP011/16/2007SE118477013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf 11/19/2007
AP05/6/2008SE231547014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf 1/27/2012
AP05/6/2008SE219809014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf 5/14/2008
AP05/6/2008SE220236014   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf 7/17/2008
AP05/6/2008SE120237015   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf 7/17/2008
AP05/6/2008SE119810015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf 5/14/2008
AP05/6/2008SE131548015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf 1/27/2012
AP02/27/2008SE519315016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf 2/28/2008
AP02/27/2008SE519343016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf 2/29/2008
AP05/6/2008SLR31549017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021713Orig1s014_s015_s017.pdf 1/27/2012
AP05/6/2008SLR19811017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf 5/14/2008
AP05/6/2008SLR20238017   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf 7/17/2008
AP03/6/2008SLR19392018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf 3/7/2008
AP08/14/2008SLR20639019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf 8/19/2008
AP08/14/2008SLR20677019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf 8/26/2008
AP07/19/2009SLR23056020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf 7/23/2009
AP07/19/2009SLR23077020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf 7/24/2009
AP02/16/2011SE827930021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf 2/18/2011
AP02/16/2011SE827950021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf 2/24/2011
AP011/30/2010SLR27159022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pdf 12/3/2010
AP011/30/2010SLR27136022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf 12/2/2010
AP012/1/2010SLR27154023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf 12/3/2010
AP012/1/2010SLR27239023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf 12/7/2010
AP03/2/2011SLR28114024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf 3/7/2011
AP03/2/2011SLR28180024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf 3/8/2011
AP02/22/2012SLR31877025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf 2/24/2012
AP02/22/2012SLR31908025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf 2/27/2012
AP06/9/2014SLR39467028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf 6/10/2014
AP06/9/2014SLR39850028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf 7/11/2014
AP07/30/2013SLR36681029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf 8/5/2013
AP07/30/2013SLR36751029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf 8/9/2013
AP012/12/2014SE841243030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf 12/15/2014
AP012/12/2014SE841253030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf 12/15/2014
AP01/15/2016SLR44983031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf 1/20/2016
AP01/15/2016SLR45008031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf 1/22/2016
AP08/18/2016SLR46820032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf 8/19/2016
AP08/18/2016SLR46849032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf 8/23/2016




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