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FDA Drug Application 103948 by GENZYME

Application Number103948
Application Type Biologic License Application
Sponsor ApplicantGENZYME
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
AP05/7/2001N127600000 9/13/2005
AP05/7/2001N131830000 11/30/2005
AP05/7/2001N79180000 3/12/2004
AP05/7/2001N79190000 3/12/2004
AP05/7/2001N432060000REMS 7/2/2015
AP05/19/2004S91905035 5/19/2004
AP05/19/2004S91945036 5/19/2004
AP05/19/2004S91895036 5/19/2004
AP012/19/2006S156285065 1/8/2007
AP012/19/2006S156365065 1/8/2007
AP09/19/2007S180075070 9/25/2007
AP09/19/2007S180095070 9/26/2007
AP09/19/2007S315645070 1/27/2012
AP011/14/2014SLR409975139 11/17/2014
AP011/14/2014SLR410005139 11/17/2014
AP011/14/2014SLR412075139 12/11/2014
AP09/5/2014SLR404595150 9/9/2014
AP09/5/2014SLR404755150,s5143ltr.pdf 9/10/2014
AP09/18/2015S439385151 9/22/2015
AP04/5/2016S456315153 4/11/2016

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