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FDA Drug Application 022187 by JANSSEN R AND D

Application Number022187
Application Type New Drug Application
Sponsor ApplicantJANSSEN R AND D
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/18/2008N18925000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022187lbl.pdf 1/23/2008
AP01/18/2008N18935000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022187s000ltr.pdf 1/23/2008
AP01/18/2008N19465000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022187TOC.cfm 3/17/2008
AP01/18/2008N20263000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022187s000_SumR.pdf 7/22/2008
AP011/24/2009SE724169001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s001lbl.pdf 12/2/2009
AP09/15/2009SLR23538002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022187s002lbl.pdf 10/6/2009
AP09/15/2009SLR23774002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022187s002ltr.pdf 11/10/2009
AP02/23/2010SLR24911003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s003ltr.pdf 3/3/2010
AP02/23/2010SLR24929003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s003lbl.pdf 3/3/2010
AP012/17/2010SLR27330006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s006ltr.pdf 12/22/2010
AP012/17/2010SLR27385006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s006lbl.pdf 12/26/2010
AP012/22/2010SCM27400007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022187s007ltr.pdf 12/28/2010
AP012/22/2010SCM27343007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022187s007lbl.pdf 12/22/2010
AP010/7/2011SLR30248008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022187s008ltr.pdf 10/12/2011
AP010/7/2011SLR30287008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022187s008lbl.pdf 10/12/2011
AP03/26/2012S32199009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s009lbl.pdf 3/26/2012
AP03/26/2012S32240009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187s009ltr.pdf 3/28/2012
AP08/10/2012SLR33442010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022187Orig1s010ltr.pdf 8/15/2012
AP08/10/2012SLR33472010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022187s010lbl.pdf 8/15/2012
AP02/27/2013SLR35291011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf 3/1/2013
AP02/27/2013SLR35304011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf 3/1/2013
AP02/27/2013SLR35305012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf 3/1/2013
AP02/27/2013SLR35292012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf 3/1/2013
AP04/30/2013SCM       
AP02/27/2013SLR35306014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022187s011s012s014lbl.pdf 3/1/2013
AP02/27/2013SLR35293014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022187Orig1s011,s012,s014ltr.pdf 3/1/2013
AP07/8/2013SCM       
AP08/20/2014SLR40298016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022187Orig1s016ltr.pdf 8/21/2014
AP08/20/2014SLR40309016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022187s016lbl.pdf 8/22/2014
AP05/6/2015SCM       
AP03/10/2016SCM       
AP05/20/2016SCM       




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