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FDA Drug Application 020588 by JANSSEN PHARMS

Application Number	020588
Application Type	New Drug Application
Sponsor Applicant	JANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document Title	Document URL	Document Date
AP	6/10/1996	N	31048	000		http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm	12/20/2011
AP	4/2/1998	SLR
AP	10/17/1997	SE2	4339	002		http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588.pdf	10/17/1997
AP	10/17/1997	SE2	10527	002	Clinical Pharmacology & Biopharmaceutics Review	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20588s002_20272s007_Risperdal.htm	11/2/2004
AP	4/15/1997	SCM
AP	3/3/2002	SE8	3213	004		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272s8ltr.pdf	3/3/2002
AP	3/3/2002	SE8	23360	004		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020588_s004_RISPERDAL TABLETS.pdf	9/16/2009
AP	7/2/1999	SLR	404	005		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20588s05ltr.pdf	7/2/1999
AP	7/2/1999	SLR	405	005		http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf	7/2/1999
AP	5/19/1998	SCP
AP	6/3/1998	SCP
AP	10/8/1998	SCS
AP	10/22/2001	SCS
AP	11/19/2002	SLR	3211	015		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20272slr024,20588slr015ltr.pdf	11/19/2002
AP	10/29/2003	SLR	6992	016		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr025,20588slr016,21444slr005ltr.pdf	11/28/2003
AP	12/4/2003	SE1	7140	017		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf	12/11/2003
AP	12/4/2003	SE1	7152	017		http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf	12/11/2003
AP	12/4/2003	SE1	7141	018		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272se1-26,27,20588se1-017,018,21444se1-002,003ltr.pdf	12/11/2003
AP	12/4/2003	SE1	7153	018		http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf	12/11/2003
AP	9/10/2003	SLR	6664	021		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21444slr004,20588slr021,20272slr033ltr.pdf	9/25/2003
AP	9/10/2003	SLR	19185	021		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020588_S021_RISPERDAL_TABLETS.pdf	2/19/2008
AP	11/21/2003	SLR	6974	023		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20272slr035,20588slr023,21444slr007ltr.pdf	11/25/2003
AP	10/6/2006	SE1	15077	024		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf	10/11/2006
AP	10/6/2006	SE1	15106	024		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf	10/18/2006
AP	10/6/2006	SE1	36175	024		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf	6/3/2013
AP	10/6/2006	SE1	15078	028		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf	10/11/2006
AP	10/6/2006	SE1	15107	028		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf	10/18/2006
AP	10/6/2006	SE1	36176	028		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020588s028.pdf020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf	6/3/2013
AP	10/6/2006	SE1	15079	029		http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf	10/11/2006
AP	10/6/2006	SE1	15108	029		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020272s36,s41,20588s24,s28,s29,21444s8,s15LTR.pdf	10/18/2006
AP	8/17/2005	SLR	12620	030		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf	8/19/2005
AP	8/17/2005	SLR	12640	030		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf	8/19/2005
AP	8/22/2007	SE5	17673	036		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf	8/22/2007
AP	8/22/2007	SE5	17694	036		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf	8/23/2007
AP	8/22/2007	SE5	30965	036		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm	12/14/2011
AP	8/22/2007	SE5	17674	037		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020272s46s47,20588s36s37,21444s20s21ltr.pdf	8/22/2007
AP	8/22/2007	SE5	17695	037		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf	8/23/2007
AP	8/22/2007	SE5	30966	037		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm	12/14/2011
AP	8/14/2008	SLR	20625	042		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf	8/19/2008
AP	8/30/2010	SLR	26339	043		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf	8/30/2010
AP	8/30/2010	SLR	26385	043		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf	9/7/2010
AP	7/19/2009	SLR	23129	044		http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf	8/6/2009
AP	7/19/2009	SLR	23132	044		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf	8/6/2009
AP	8/30/2010	SLR	26338	046		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf	8/30/2010
AP	8/30/2010	SLR	26386	046		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf	9/7/2010
AP	8/24/2011	SLR	29875	047		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf	8/25/2011
AP	8/24/2011	SLR	29881	047		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf	8/26/2011
AP	9/24/2011	SLR	30111	048		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf	9/28/2011
AP	9/24/2011	SLR	30154	048		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf	9/30/2011
AP	8/30/2010	SLR	26337	049		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf	8/30/2010
AP	8/30/2010	SLR	26387	049		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf	9/7/2010
AP	8/30/2010	SLR	26327	050		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf	8/30/2010
AP	8/30/2010	SLR	26388	050		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s055s058s061s062,020588s043s046s049s050,021444s030s033s036s037ltr.pdf	9/7/2010
AP	12/1/2010	SLR	27170	051		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf	12/4/2010
AP	12/1/2010	SLR	27203	051		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf	12/6/2010
AP	6/15/2011	SLR	29168	052		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf	6/16/2011
AP	6/15/2011	SLR	29230	052		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf	6/17/2011
AP	8/2/2012	SE8	33355	053		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf	8/3/2012
AP	8/2/2012	SE8	33369	053		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272Orig1s065,020588Orig1s053,021444Orig1s041ltr.pdf	8/3/2012
AP	9/24/2011	SLR	30110	054		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s066,s060,021444s042,s035,020588s054,s048ltr.pdf	9/28/2011
AP	9/24/2011	SLR	30155	054		http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf	9/30/2011
AP	3/12/2012	SLR	32100	055		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf	3/13/2012
AP	4/28/2014	SLR	39170	062		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf	4/29/2014
AP	4/28/2014	SLR	39259	062		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf	5/9/2014
AP	3/1/2016	SLR	45343	065		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf	3/3/2016
AP	3/1/2016	SLR	45350	065		http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf	3/3/2016

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