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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 3/10/2004
AP04/30/2003N78750000 3/10/2004
AP04/30/2003N78760000 3/10/2004
AP04/14/2008S198930154 5/28/2008
AP05/20/2009S227260160,125058s0161ltr.pdf 6/10/2009
AP05/20/2009S228440160, 125058s161lbl.pdf 6/29/2009
AP05/20/2009S228450161, 125058s161lbl.pdf 6/29/2009
AP05/20/2009S227270161,125058s0161ltr.pdf 6/10/2009
AP05/14/2010S274160186 1/3/2011
AP04/3/2013SLR35650220 4/9/2013
AP04/3/2013SLR35661220 4/9/2013

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