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FDA Drug Application 020588 by JANSSEN PHARMS

Application Number020588
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP06/10/1996N31048000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/20/2011
AP04/2/1998SLR       
AP010/17/1997SE24339002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588.pdf 10/17/1997
AP010/17/1997SE210527002Clinical Pharmacology & Biopharmaceutics Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588s002_20272s007_Risperdal.htm 11/2/2004
AP04/15/1997SCM       
AP03/3/2002SE83213004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272s8ltr.pdf 3/3/2002
AP03/3/2002SE823360004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020588_s004_RISPERDAL TABLETS.pdf 9/16/2009
AP07/2/1999SLR404005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20588s05ltr.pdf 7/2/1999
AP07/2/1999SLR405005   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf 7/2/1999
AP05/19/1998SCP       
AP06/3/1998SCP       
AP010/8/1998SCS       
AP010/22/2001SCS       
AP011/19/2002SLR3211015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272slr024,20588slr015ltr.pdf 11/19/2002
AP010/29/2003SLR6992016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf 11/28/2003
AP012/4/2003SE17140017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf 12/11/2003
AP012/4/2003SE17152017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf 12/11/2003
AP012/4/2003SE17153018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf 12/11/2003
AP012/4/2003SE17141018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf 12/11/2003
AP09/10/2003SLR6664021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr021,20272slr033ltr.pdf 9/25/2003
AP09/10/2003SLR19185021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020588_S021_RISPERDAL_TABLETS.pdf 2/19/2008
AP011/21/2003SLR6974023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf 11/25/2003
AP010/6/2006SE115077024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf 10/11/2006
AP010/6/2006SE115106024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf 10/18/2006
AP010/6/2006SE136175024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf 6/3/2013
AP010/6/2006SE136176028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020588s028.pdf020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf 6/3/2013
AP010/6/2006SE115107028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf 10/18/2006
AP010/6/2006SE115078028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf 10/11/2006
AP010/6/2006SE115079029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf 10/11/2006
AP010/6/2006SE115108029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf 10/18/2006
AP08/17/2005SLR12620030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf 8/19/2005
AP08/17/2005SLR12640030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf 8/19/2005
AP08/22/2007SE517673036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf 8/22/2007
AP08/22/2007SE517694036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf 8/23/2007
AP08/22/2007SE530965036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm 12/14/2011
AP08/22/2007SE530966037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm 12/14/2011
AP08/22/2007SE517695037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf 8/23/2007
AP08/22/2007SE517674037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf 8/22/2007
AP08/14/2008SLR20625042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf 8/19/2008
AP08/30/2010SLR26339043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf 8/30/2010
AP08/30/2010SLR26385043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP07/19/2009SLR23129044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf 8/6/2009
AP07/19/2009SLR23132044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf 8/6/2009
AP08/30/2010SLR26386046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP08/30/2010SLR26338046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf 8/30/2010
AP08/24/2011SLR29875047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf 8/25/2011
AP08/24/2011SLR29881047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf 8/26/2011
AP09/24/2011SLR30111048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf 9/28/2011
AP09/24/2011SLR30154048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf 9/30/2011
AP08/30/2010SLR26337049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf 8/30/2010
AP08/30/2010SLR26387049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP08/30/2010SLR26388050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP08/30/2010SLR26327050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf 8/30/2010
AP012/1/2010SLR27170051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf 12/4/2010
AP012/1/2010SLR27203051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf 12/6/2010
AP06/15/2011SLR29168052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf 6/16/2011
AP06/15/2011SLR29230052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf 6/17/2011
AP08/2/2012SE833355053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf 8/3/2012
AP08/2/2012SE833369053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588Orig1s053,021444Orig1s041ltr.pdf 8/3/2012
AP09/24/2011SLR30110054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf 9/28/2011
AP09/24/2011SLR30155054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf 9/30/2011
AP03/12/2012SLR32100055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf 3/13/2012
AP04/28/2014SLR39170062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf 4/29/2014
AP04/28/2014SLR39259062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf 5/9/2014
AP03/1/2016SLR45343065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf 3/3/2016
AP03/1/2016SLR45350065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf 3/3/2016




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