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FDA Drug Application 125058 by BIOMARIN

Application Number125058
Application Type Biologic License Application
Sponsor ApplicantBIOMARIN
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
AP04/30/2003N78740000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080438.htm 3/10/2004
AP04/30/2003N78750000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/larobio043003L.htm 3/10/2004
AP04/30/2003N78760000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/larobio043003LB.pdf 3/10/2004
AP04/14/2008S198930154   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125058s154ltr.pdf 5/28/2008
AP07/16/2009S       
AP05/20/2009S227260160   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s0161ltr.pdf 6/10/2009
AP05/20/2009S228440160   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf 6/29/2009
AP05/20/2009S228450161   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125058s160, 125058s161lbl.pdf 6/29/2009
AP05/20/2009S227270161   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125058s0160,125058s0161ltr.pdf 6/10/2009
AP05/14/2010S274160186   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125058s0186lbl.pdf 1/3/2011
AP04/3/2013SLR35650220   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125058s220lbl.pdf 4/9/2013
AP04/3/2013SLR35661220   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125058Orig1s220ltr.pdf 4/9/2013




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