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FDA Drug Application 021999 by JANSSEN PHARMS

Application Number021999
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/19/2006N15518000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021999lbl.pdf 12/28/2006
AP012/19/2006N15528000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021999s000_ltr.pdf 12/28/2006
AP012/19/2006N16110000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021999s000_TOC.cfm 3/30/2007
AP012/19/2006N31195000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP012/21/2007SE818722001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021999s001lbl.pdf 1/8/2008
AP012/21/2007SE818767001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021999s001,s002ltr.pdf 1/9/2008
AP012/21/2007S18768002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021999s001,s002ltr.pdf 1/9/2008
AP012/22/2009SCM40148004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021999Orig1s004.pdf 8/5/2014
AP08/26/2008SCM20693005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s005, s008ltr.pdf 8/28/2008
AP08/26/2008SCM20704005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf 8/29/2008
AP09/4/2008SLR20752006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s006ltr.pdf 9/5/2008
AP09/4/2008SLR20753006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s006lbl.pdf 9/5/2008
AP05/16/2008SLR19862007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s007ltr.pdf 5/21/2008
AP08/26/2008SCM20694008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s005, s008ltr.pdf 8/28/2008
AP08/26/2008SCM20705008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s005s008lbl.pdf 8/29/2008
AP08/14/2008SLR20631010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021999s010ltr.pdf 8/19/2008
AP08/14/2008SLR20683010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021999s010lbl.pdf 8/26/2008
AP010/30/2009SLR23726011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s011lbl.pdf 11/4/2009
AP07/31/2009SLR23116013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf 8/4/2009
AP07/31/2009SLR23141013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s013,s014ltr.pdf 8/6/2009
AP07/31/2009SLR23117014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s013s014lbl.pdf 8/4/2009
AP07/31/2009SLR23142014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s013,s014ltr.pdf 8/6/2009
AP07/19/2009SLR23031015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021999s015ltr.pdf 7/23/2009
AP07/19/2009SLR23058015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021999s015lbl.pdf 7/23/2009
AP02/16/2011SLR27922017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s017ltr.pdf 2/18/2011
AP02/16/2011SLR27945017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s017lbl.pdf 2/24/2011
AP03/3/2010SLR24966018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s018lbl.pdf 3/5/2010
AP03/3/2010SLR25029018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021999s018ltr.pdf 3/11/2010
AP04/6/2011SLR28484020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf 4/7/2011
AP04/6/2011SLR28494020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s020,s024ltr.pdf 4/11/2011
AP012/1/2010SLR27175023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021999s023lbl.pdf 12/4/2010
AP012/1/2010SLR27244023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021999s023ltr.pdf 12/7/2010
AP04/6/2011SE828485024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021999s020s024lbl.pdf 4/7/2011
AP04/6/2011SE828495024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021999s020,s024ltr.pdf 4/11/2011
AP06/17/2013SCM       
AP04/29/2014SLR39184029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf 5/1/2014
AP04/29/2014SLR39205029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021999s029lbl.pdf 5/2/2014
AP03/1/2016SLR45339030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf 3/3/2016
AP03/1/2016SLR45352030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021999s030lbl.pdf 3/3/2016




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