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FDA Drug Application 208398 by JANSSEN PHARMS

Application Number208398
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
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/19/2016N47417000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208398s000lbl.pdf 10/20/2016
AP010/19/2016N47424000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208398Orig1s000ltr.pdf 10/21/2016




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