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FDA Drug Application 125117 by BIOMARIN

Application Number125117
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
AP05/31/2005N11759000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125117_0000_ltr.pdf 6/7/2005
AP05/31/2005N11760000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf 6/7/2005
AP05/31/2005N12761000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125117s000_NaglazyneTOC.cfm 9/13/2005
AP04/28/2011S286580086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf 4/29/2011
AP04/28/2011S286990086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf 5/5/2011
AP04/28/2011S287000088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf 5/5/2011
AP04/28/2011S286590088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf 4/29/2011
AP04/28/2011S286600090   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf 4/29/2011
AP04/28/2011S287010090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf 5/5/2011
AP03/26/2013SLR35562111   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125117Orig1s111ltr.pdf 3/29/2013
AP03/26/2013SLR35599111   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125117s111lbl.pdf 4/1/2013




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