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FDA Drug Application 021346 by JANSSEN PHARMS

Application Number021346
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
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/29/2003N6999000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21346ltr.pdf 11/28/2003
AP010/29/2003N11825000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21346_RisperdalTOC.cfm 6/16/2005
AP010/29/2003N31049000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/20/2011
AP010/20/2006SLR15162009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s009ltr.pdf 10/23/2006
AP08/17/2005SLR12618010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf 8/19/2005
AP08/17/2005SLR12638010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf 8/19/2005
AP07/31/2006SLR14600011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s011LTR.pdf 8/4/2006
AP09/20/2006SLR14941013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021346s013lbl.pdf 9/21/2006
AP09/20/2006SLR14954013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s013ltr.pdf 9/25/2006
AP04/12/2007SE216238015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021346s015ltr.pdf 4/20/2007
AP04/12/2007SE216277015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s015lbl.pdf 4/20/2007
AP03/9/2007SLR16022020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021346s020ltr.pdf 3/15/2007
AP03/9/2007SLR16040020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s020lbl.pdf 3/15/2007
AP010/8/2008SLR21017021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf 10/14/2008
AP010/8/2008SLR21169021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf 11/7/2008
AP010/8/2008SLR21170022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf 11/7/2008
AP010/8/2008SLR21018022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf 10/14/2008
AP010/8/2008SLR21019023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf 10/14/2008
AP010/8/2008SLR21171023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf 11/7/2008
AP05/15/2009SE122705025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf 6/7/2009
AP05/15/2009SE122595025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf 5/20/2009
AP010/8/2008SLR21172026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf 11/7/2008
AP010/8/2008SLR21020026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf 10/14/2008
AP08/14/2008SLR20626027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf 8/19/2008
AP05/15/2009SE122596028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf 5/20/2009
AP05/15/2009SE122706028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf 6/7/2009
AP08/30/2010SLR26318031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf 8/30/2010
AP08/30/2010SLR26328031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf 9/1/2010
AP012/7/2011SLR30938032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf 12/13/2011
AP012/7/2011SLR30932032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s032,s041ltr.pdf 12/13/2011
AP07/19/2009SLR23130033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf 8/6/2009
AP07/19/2009SLR23133033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf 8/6/2009
AP08/30/2010SLR26317035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf 8/30/2010
AP08/30/2010SLR26329035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf 9/1/2010
AP08/24/2011SLR29883036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf 8/26/2011
AP08/24/2011SLR29944036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s036lbl.pdf 9/2/2011
AP09/24/2011SLR30116037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s037,s043ltr.pdf 9/28/2011
AP09/24/2011SLR30158037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf 9/30/2011
AP08/30/2010SLR26330038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf 9/1/2010
AP08/30/2010SLR26319038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf 8/30/2010
AP08/30/2010SLR26320039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf 8/30/2010
AP08/30/2010SLR26331039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf 9/1/2010
AP012/1/2010SLR27169040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf 12/4/2010
AP012/1/2010SLR27204040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf 12/6/2010
AP012/7/2011SLR30933041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s032,s041ltr.pdf 12/13/2011
AP012/7/2011SLR30937041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf 12/13/2011
AP06/15/2011SLR29170042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s042lbl.pdf 6/16/2011
AP06/15/2011SLR29232042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf 6/17/2011
AP09/24/2011SLR30159043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf 9/30/2011
AP09/24/2011SLR30117043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s037,s043ltr.pdf 9/28/2011
AP03/12/2012SLR32103044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf 3/13/2012
AP010/10/2013SCM       
AP02/26/2013SCM       
AP07/18/2013SCM       
AP010/22/2013SCM       
AP04/28/2014SLR39172051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s051lbl.pdf 4/29/2014
AP04/28/2014SLR39261051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf 5/9/2014
AP06/5/2014SCM39491052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s052lbl.pdf 6/10/2014
AP03/1/2016SLR45337055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf 3/3/2016
AP03/1/2016SLR45349055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf 3/3/2016




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