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FDA Drug Application 205065 by BIOMARIN PHARM

Application Number205065
Application Type New Drug Application
Sponsor ApplicantBIOMARIN PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/19/2013N38124000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205065Orig1s000ltr.pdf 12/20/2013
AP012/19/2013N38147000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf 12/23/2013
AP012/19/2013N38688000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000TOC.cfm 3/6/2014
AP012/19/2013N38689000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000SumR.pdf 3/6/2014
AP010/28/2015SCM45622001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf 4/8/2016
AP08/9/2016SLR46763002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205065Orig1s002ltr.pdf 8/10/2016
AP08/9/2016SLR46768002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205065s002lbl.pdf 8/10/2016




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