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FDA Drug Application 021436 by OTSUKA

Application Number021436
Application Type New Drug Application
Sponsor ApplicantOTSUKA
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
AP011/15/2002N4217000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify.cfm 3/7/2003
AP011/15/2002N4688000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21436_Abilify_lbl.pdf 11/15/2002
AP011/15/2002N4689000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21436ltr.pdf 11/15/2002
AP011/15/2002N24803000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085804.pdf 2/17/2010
AP011/15/2002N31183000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP08/28/2003SE16603001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21436se1-001_abilify_lbl.pdf 9/9/2003
AP08/28/2003SE16604001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21436se1-001ltr.pdf 9/9/2003
AP08/28/2003SE117930001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021436_S001_ABILIFY_TABLETS.pdf 9/24/2007
AP09/29/2004SE110353002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21436s002ltr.pdf 10/4/2004
AP09/29/2004SE110354002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21436s002lbl.pdf 10/4/2004
AP09/29/2004SE136027002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021436Orig1s002.pdf 5/10/2013
AP012/30/2003S17929004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021436_S004_ABILIFY_TABLETS.pdf 9/24/2007
AP03/1/2005SE111187005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21436s005,008,21713s003ltr.pdf 3/3/2005
AP03/1/2005SE111199005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl.pdf 3/3/2005
AP04/8/2004SLR8356006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21436slr006ltr.pdf 4/20/2004
AP04/8/2004SLR8462006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21436slr006_abilify_lbl.pdf 5/3/2004
AP06/21/2005SLR11866007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021713s004,021436s007ltr.pdf 6/23/2005
AP06/21/2005SLR11880007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021713s004,021436s007lbl.pdf 6/23/2005
AP06/21/2005SLR36717007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021436Orig1s007.pdf 8/6/2013
AP03/1/2005SLR11188008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21436s005,008,21713s003ltr.pdf 3/3/2005
AP03/1/2005SLR11200008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21436s005,008,21713s003lbl.pdf 3/3/2005
AP02/16/2006SLR13633010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s010,021713s006lbl.pdf 2/22/2006
AP02/16/2006SLR13646010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s010,021713s006ltr.pdf 2/22/2006
AP010/20/2006SLR15140013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s013,021713s008,021729s001lbl.pdf 10/23/2006
AP010/20/2006SLR15165013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s013, 021713s008, 021729s001ltr.pdf 10/23/2006
AP09/18/2006SLR14902014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s014, 021713s009ltr.pdf 9/20/2006
AP09/18/2006SLR14919014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s014,021713s009lbl.pdf 9/20/2006
AP09/25/2007SLR18035016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf 9/26/2007
AP09/25/2007SLR18157016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf 10/4/2007
AP010/29/2007SE518312017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf 11/7/2007
AP010/29/2007SE518386017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf 11/8/2007
AP010/29/2007SE532108017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436Orig1s017.pdf 3/14/2012
AP011/16/2007SE118438018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf 11/19/2007
AP011/16/2007SE118480018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf 11/19/2007
AP011/16/2007SE123206018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018TOC.cfm 8/20/2009
AP011/16/2007SE123207018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018_SumR.pdf 8/20/2009
AP05/6/2008SE219808019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf 5/14/2008
AP05/6/2008SE220239019   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf 7/17/2008
AP05/6/2008SE231544019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021436Orig1s019_s020_s022.pdf 1/27/2012
AP05/6/2008SE119806020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf 5/14/2008
AP05/6/2008SE120240020   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf 7/17/2008
AP05/6/2008SE131545020   http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/021436Orig1s019_s020_s022.pdf 1/27/2012
AP02/27/2008SE519316021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf 2/28/2008
AP02/27/2008SE519342021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf 2/29/2008
AP05/6/2008SLR19807022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436se2-019,021436se1-020,021436s022,021713se2-014.pdf 5/14/2008
AP05/6/2008SLR20241022   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021436s19s20s22,21713s14s15s017SUMR.pdf 7/17/2008
AP05/6/2008SLR31546022   http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/021436Orig1s019_s020_s022.pdf 1/27/2012
AP03/6/2008SLR19391023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf 3/7/2008
AP08/14/2008SLR20638026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf 8/19/2008
AP08/14/2008SLR20679026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf 8/26/2008
AP011/19/2009SE124102027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s027lbl.pdf 11/23/2009
AP011/19/2009SE124159027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s027ltr.pdf 11/27/2009
AP011/19/2009SE139540027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021436Orig1s027.pdf 6/16/2014
AP07/19/2009SLR23057028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf 7/23/2009
AP07/19/2009SLR23076028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf 7/24/2009
AP02/16/2011SE827928029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf 2/18/2011
AP02/16/2011SE827954029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf 2/24/2011
AP011/30/2010SLR27141030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf 12/2/2010
AP011/30/2010SLR27157030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pd 12/3/2010
AP012/1/2010SLR27156031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf 12/3/2010
AP012/1/2010SLR27237031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf 12/7/2010
AP03/2/2011SLR28116032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf 3/7/2011
AP03/2/2011SLR28178032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf 3/8/2011
AP02/22/2012SLR31876034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf 2/24/2012
AP02/22/2012SLR31906034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf 2/27/2012
AP03/25/2013SCM       
AP06/9/2014SLR39470036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf 6/10/2014
AP06/9/2014SLR39849036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf 7/11/2014
AP07/30/2013SLR36680037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf 8/5/2013
AP07/30/2013SLR36752037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf 8/9/2013
AP012/12/2014SE841242038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf 12/15/2014
AP012/12/2014SE841254038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf 12/15/2014
AP012/12/2014SE845700038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021436Orig1s038.pdf 4/20/2016
AP012/15/2014SCM       
AP01/15/2016SLR44982040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf 1/20/2016
AP01/15/2016SLR45007040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf 1/22/2016
AP01/15/2016SLR46655040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021436Orig1s040.pdf 7/28/2016
AP08/18/2016SLR46819041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf 8/19/2016
AP08/18/2016SLR46828041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf 8/22/2016




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