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FDA Drug Application 022318 by GENZYME

Application Number022318
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
AP08/12/2009N23197000 8/17/2009
AP08/12/2009N23518000 10/1/2009
AP08/12/2009N24575000 2/3/2011
AP08/12/2009N24576000 2/3/2011
AP06/16/2011SLR29202003,022127s008lbl.pdf 6/16/2011
AP06/16/2011SLR29252003,022127s008,022318s003ltr.pdf 6/24/2011
AP011/26/2014SLR41112005,022318Orig1s005ltr.pdf 11/28/2014
AP011/26/2014SLR41281005 12/17/2014
AP03/9/2016SLR45417006,022318Orig1s006ltr.pdf 3/11/2016
AP03/9/2016SLR45437006,022318s006lbl.pdf 3/14/2016

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