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FDA Drug Application 022127 by GENZYME

Application Number022127
Application Type New Drug Application
Sponsor ApplicantGENZYME
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
AP010/19/2007N18256000 10/22/2007
AP010/19/2007N18263000 10/22/2007
AP010/19/2007N20716000 8/29/2008
AP010/19/2007N20717000 8/29/2008
AP06/16/2011SLR29203008,022127s008lbl.pdf 6/16/2011
AP06/16/2011SLR29251008,022127s008,022318s003ltr.pdf 6/24/2011
AP011/26/2014SLR41111011,022318Orig1s005ltr.pdf 11/28/2014
AP011/26/2014SLR41282011 12/17/2014
AP03/9/2016SLR45416013,022318Orig1s006ltr.pdf 3/11/2016
AP03/9/2016SLR45438013,022318s006lbl.pdf 3/14/2016

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