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FDA Drug Application 204384 by JANSSEN THERAP

Application Number204384
Application Type New Drug Application
Sponsor ApplicantJANSSEN THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/28/2012N34807000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf 12/31/2012
AP012/28/2012N34809000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204384Orig1s000ltr.pdf 1/2/2013
AP012/28/2012N34819000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM333729.pdf 1/3/2013
AP012/28/2012N35159000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000TOC.cfm 2/13/2013
AP012/28/2012N35160000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/204384Orig1s000SumR.pdf 2/13/2013
AP03/19/2014SCM       
AP08/28/2013SLR36916002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204384s002lbl.pdf 8/29/2013
AP08/28/2013SLR36923002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204384Orig1s002ltr.pdf 8/29/2013
AP08/4/2014SCM       
AP010/17/2014SLR40843004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204384s004lbl.pdf 10/21/2014
AP010/17/2014SLR40853004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204384Orig1s004ltr.pdf 10/22/2014
AP05/14/2015SLR42833005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204384Orig1s005ltr.pdf 5/19/2015
AP05/14/2015SLR42874005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s005lbl.pdf 5/21/2015
AP012/9/2015SLR44730006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204384Orig1s006ltr.pdf 12/10/2015
AP012/9/2015SLR44781006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204384s006lbl.pdf 12/15/2015
AP02/10/2016SCM       
AP08/22/2016SCM       




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