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FDA Drug Application 125460 by BIOMARIN PHARM

Application Number125460
Application Type Biologic License Application
Sponsor ApplicantBIOMARIN PHARM
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
AP02/14/2014N38534000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125460Orig1s000ltr.pdf 2/19/2014
AP02/14/2014N38539000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125460s000lbl.pdf 2/19/2014
AP02/14/2014N38876000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125460Orig1s000TOC.cfm 3/24/2014
AP02/14/2014N38877000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125460Orig1s000SumR.pdf 3/24/2014




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