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FDA Drug Application 125496 by JANSSEN BIOTECH

Application Number125496
Application Type Biologic License Application
Sponsor ApplicantJANSSEN BIOTECH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/23/2014N39125000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125496s000lbl.pdf 4/23/2014
AP04/23/2014N39129000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125496s000ltr.pdf 4/24/2014
AP04/23/2014N39364000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125496Orig1s000SumR.pdf 5/27/2014
AP04/23/2014N44010000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125496Orig1s000TOC.cfm 9/28/2015




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