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FDA Drug Application 020272 by JANSSEN PHARMS

Application Number020272
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1993N27867000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020272_safety_review.pdf 2/15/2011
AP012/29/1993N31047000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/20/2011
AP08/24/1994SLR       
AP012/22/1994SCM       
AP04/12/1995SLR       
AP02/28/1996SLR17324004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020272_S004_RISPERDAL TABLETS.pdf 7/20/2007
AP03/7/1996SCM17325005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020272_S004_RISPERDAL TABLETS.pdf 7/20/2007
AP04/2/1998SLR       
AP010/17/1997SE24340007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588.pdf 10/17/1997
AP010/17/1997SE210528007Clinical Pharmacology & Biopharmaceutics Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588s002_20272s007_Risperdal.htm 11/3/2004
AP03/3/2002SE83214008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272s8ltr.pdf 3/3/2002
AP03/3/2002SE821621008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020272_s008_RISPERDALE TABLETS.pdf 1/12/2009
AP07/2/1999SLR9390009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20588s05ltr.pdf 6/16/2004
AP07/2/1999SLR9391009   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf 6/16/2004
AP05/13/1998SCS       
AP010/26/1998SCM       
AP01/27/1999SCM       
AP05/10/1999SCM       
AP010/27/1999SCS       
AP07/20/2001SCM       
AP010/22/2001SCS       
AP09/28/2001SCM       
AP07/9/2002SCE       
AP011/19/2002SLR3212024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272slr024,20588slr015ltr.pdf 11/19/2002
AP010/29/2003SLR6991025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf 11/28/2003
AP012/4/2003SE17138026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf 12/11/2003
AP012/4/2003SE17150026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf 12/11/2003
AP012/4/2003SE123337026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_s026&s027_Risperdal_MEDR_.pdf 9/16/2009
AP012/4/2003SE123338027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_s026&s027_Risperdal_MEDR_.pdf 9/16/2009
AP012/4/2003SE17151027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf 12/11/2003
AP012/4/2003SE17139027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf 12/11/2003
AP09/10/2003SLR9389033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr021,20272slr033ltr.pdf 6/16/2004
AP09/10/2003SLR19186033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020272_S033_RISPERDAL_TABLETS.pdf 2/19/2008
AP011/21/2003SLR6973035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf 11/25/2003
AP010/6/2006SE115075036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf 10/11/2006
AP010/6/2006SE115104036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf 10/18/2006
AP010/6/2006SE136173036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf 6/3/2013
AP010/6/2006SE136174041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf 6/3/2013
AP010/6/2006SE115105041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf 10/18/2006
AP010/6/2006SE115076041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf 10/11/2006
AP08/17/2005SLR12621042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf 8/19/2005
AP08/17/2005SLR12641042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf 8/19/2005
AP08/22/2007SE517692046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf 8/23/2007
AP08/22/2007SE517675046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf 8/22/2007
AP08/22/2007SE530960046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm 12/14/2011
AP08/22/2007SE530964047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm 12/14/2011
AP08/22/2007SE517676047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf 8/22/2007
AP08/22/2007SE517693047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf 8/23/2007
AP08/14/2008SLR20624054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf 8/19/2008
AP08/30/2010SLR26343055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf 8/30/2010
AP08/30/2010SLR26381055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP07/19/2009SLR23128056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf 8/6/2009
AP07/19/2009SLR23131056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf 8/6/2009
AP08/30/2010SLR26382058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP08/30/2010SLR26342058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf 8/30/2010
AP08/24/2011SLR29874059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf 8/25/2011
AP08/24/2011SLR29880059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf 8/26/2011
AP09/24/2011SLR30114060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf 9/28/2011
AP09/24/2011SLR30156060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf 9/30/2011
AP08/30/2010SLR26341061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf 8/30/2010
AP08/30/2010SLR26383061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP08/30/2010SLR26384062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP08/30/2010SLR26340062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf 8/30/2010
AP012/1/2010SLR27171063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf 12/4/2010
AP012/1/2010SLR27202063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf 12/6/2010
AP06/15/2011SLR29167064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf 6/16/2011
AP06/15/2011SLR29229064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf 6/17/2011
AP08/2/2012SE833356065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf 8/3/2012
AP08/2/2012SE833368065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588Orig1s053,021444Orig1s041ltr.pdf 8/3/2012
AP09/24/2011SLR30157066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf 9/30/2011
AP09/24/2011SLR30115066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf 9/28/2011
AP03/12/2012SLR32098067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf 3/13/2012
AP02/8/2013SCM       
AP06/13/2013SCM       
AP04/28/2014SLR39171073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf 4/29/2014
AP04/28/2014SLR39258073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf 5/9/2014
AP02/9/2016SCM       
AP03/1/2016SLR45341077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf 3/3/2016
AP03/1/2016SLR45351077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf 3/3/2016




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