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FDA Drug Application 022405 by GENZYME CORP

Application Number022405
Application Type New Drug Application
Sponsor ApplicantGENZYME CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/6/2011N29463000REMS 7/8/2011
AP04/6/2011N28483000 4/7/2011
AP04/6/2011N28511000 4/11/2011
AP04/6/2011N28549000 4/15/2011
AP04/6/2011N28684000 5/3/2011
AP04/6/2011N28685000 5/3/2011
AP06/22/2011SLR29350001 6/29/2011
AP06/22/2011SLR29361001 6/29/2011
AP010/9/2012SLR34033003 10/11/2012
AP010/9/2012SLR34084003 10/12/2012
AP07/3/2013SLR36470004 7/5/2013
AP07/3/2013SLR36495004 7/8/2013
AP011/27/2013SLR37965005 12/5/2013
AP03/31/2014SLR38932007 4/1/2014
AP03/31/2014SLR38959007 4/2/2014
AP07/28/2016SLR46689010 8/1/2016
AP07/28/2016SLR46701010 8/2/2016

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