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FDA Drug Application 022264 by JANSSEN PHARMS

Application Number022264
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
AP07/31/2009N23199000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022264s000ltr.pdf 8/17/2009
AP07/31/2009N23519000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022264lbl.pdf 10/1/2009
AP07/31/2009N25543000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264_invega_sustenna_toc.cfm 5/13/2010
AP07/31/2009N25544000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264s000sumr.pdf 5/13/2010
AP07/31/2009N31197000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP05/13/2010SLR25563001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s001lbl.pdf 5/17/2010
AP05/13/2010SLR25580001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022264s001ltr.pdf 5/18/2010
AP06/15/2011SLR29200002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s002lbl.pdf 6/16/2011
AP06/15/2011SLR29256002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s002ltr.pdf 6/24/2011
AP012/1/2010SLR27174004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022264s004lbl.pdf 12/4/2010
AP012/1/2010SLR27248004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022264s004ltr.pdf 12/7/2010
AP08/29/2012SE833598005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022264Orig1s005ltr.pdf 8/30/2012
AP08/29/2012SE833609005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022264s005lbl.pdf 8/31/2012
AP09/24/2011SLR30118006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s006ltr.pdf 9/28/2011
AP09/24/2011SLR30160006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022264s006lbl.pdf 9/30/2011
AP04/29/2014SLR39185010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf 5/1/2014
AP04/29/2014SLR39206010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s010lbl.pdf 5/2/2014
AP08/26/2013SCM       
AP08/25/2014SCM       
AP011/12/2014SES40987013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf 11/14/2014
AP011/12/2014SES41346013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf 12/20/2014
AP011/12/2014SES41347014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022264s013s014lbl.pdf 12/20/2014
AP011/12/2014SES40986014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf 11/14/2014
AP06/16/2015SCM       
AP06/9/2015SLR43034018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022264Orig1s018ltr.pdf 6/10/2015
AP06/9/2015SLR43043018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022264s018lbl.pdf 6/11/2015
AP03/1/2016SLR45338019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf 3/3/2016
AP03/1/2016SLR45353019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022264s019lbl.pdf 3/3/2016
AP08/29/2016SCM       




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