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FDA Drug Application 207946 by JANSSEN PHARMS

Application Number207946
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/18/2015N42847000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207946s000lbl.pdf 5/20/2015
AP05/18/2015N42855000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207946Orig1s000ltr.pdf 5/21/2015
AP05/18/2015N45126000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207946Orig1s000TOC.cfm 2/8/2016
AP05/18/2015N45127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207946Orig1s000SumR.pdf 2/8/2016
AP03/1/2016SLR45340001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf 3/3/2016
AP03/1/2016SLR45354001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207946s001lbl.pdf 3/3/2016




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