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FDA Drug Application 205879 by JANSSEN PHARMS

Application Number205879
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/20/2016N47140000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205879s000lbl.pdf 9/21/2016
AP09/20/2016N47150000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205879Orig1s000ltr.pdf 9/22/2016
AP09/20/2016N47320000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524689.pdf 10/12/2016




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