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FDA Drug Application 021444 by JANSSEN PHARMS

Application Number021444
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
AP04/2/2003N4905000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021444lbl.pdf 4/7/2003
AP04/2/2003N5727000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444ltr.pdf 5/29/2003
AP04/2/2003N6126000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021444_risperdal.cfm 7/15/2003
AP04/2/2003N31050000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/20/2011
AP012/4/2003SE17142002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf 12/11/2003
AP012/4/2003SE17154002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf 12/11/2003
AP012/4/2003SE17143003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf 12/11/2003
AP012/4/2003SE17155003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf 12/11/2003
AP09/10/2003SLR6663004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr021,20272slr033ltr.pdf 9/25/2003
AP09/10/2003SLR19184004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021444_S004_RISPERDAL_TABLETS.pdf 2/19/2008
AP010/29/2003SLR6993005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf 11/28/2003
AP011/21/2003SLR6977007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf 11/25/2003
AP010/6/2006SE115080008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf 10/11/2006
AP010/6/2006SE115109008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf 10/18/2006
AP010/6/2006SE136177008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf 6/3/2013
AP012/23/2004SCF10824012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21444s012ltr.pdf 12/29/2004
AP012/23/2004SCF10841012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21444s012lbl.pdf 12/29/2004
AP010/6/2006SE115081015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf 10/11/2006
AP010/6/2006SE115110015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf 10/18/2006
AP010/6/2006SE136178015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf 6/3/2013
AP08/17/2005SLR12619016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf 8/19/2005
AP08/17/2005SLR12639016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf 8/19/2005
AP08/22/2007SE517677020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf 8/22/2007
AP08/22/2007SE517690020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf 8/23/2007
AP08/22/2007SE530967020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm 12/14/2011
AP08/22/2007SE517678021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf 8/22/2007
AP08/22/2007SE517691021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf 8/23/2007
AP08/22/2007SE530968021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm 12/14/2011
AP08/14/2008SLR20627029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf 8/19/2008
AP08/30/2010SLR26326030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf 8/30/2010
AP08/30/2010SLR26389030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP07/19/2009SLR23007031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf 7/21/2009
AP07/19/2009SLR23127031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf 8/6/2009
AP08/30/2010SLR26325033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf 8/30/2010
AP08/30/2010SLR26390033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP08/24/2011SLR29876034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf 8/25/2011
AP08/24/2011SLR29882034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf 8/26/2011
AP09/24/2011SLR30112035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf 9/28/2011
AP09/24/2011SLR30152035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf 9/30/2011
AP08/30/2010SLR26324036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf 8/30/2010
AP08/30/2010SLR26391036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP08/30/2010SLR26323037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf 8/30/2010
AP08/30/2010SLR26392037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf 9/7/2010
AP012/1/2010SLR27168039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf 12/4/2010
AP012/1/2010SLR27205039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf 12/6/2010
AP06/15/2011SLR29169040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf 6/16/2011
AP06/15/2011SLR29231040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf 6/17/2011
AP08/2/2012SE833354041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf 8/3/2012
AP08/2/2012SE833370041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588Orig1s053,021444Orig1s041ltr.pdf 8/3/2012
AP09/24/2011SLR30113042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf 9/28/2011
AP09/24/2011SLR30153042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf 9/30/2011
AP03/12/2012SLR32102043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf 3/13/2012
AP04/28/2014SLR39169048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf 4/29/2014
AP04/28/2014SLR39260048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf 5/9/2014
AP03/1/2016SLR45342051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf 3/3/2016
AP03/1/2016SLR45348051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf 3/3/2016




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