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FDA Drug Application 021673 by GENZYME

Application Number021673
Application Type New Drug Application
Sponsor ApplicantGENZYME
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
AP012/28/2004N10804000 12/29/2004
AP012/28/2004N10805000 12/29/2004
AP012/28/2004N11342000 4/5/2005
AP010/17/2008SE821055005,s007ltr.pdf 10/23/2008
AP010/17/2008SLR21054007,s007ltr.pdf 10/23/2008
AP06/10/2011SLR29120010 6/14/2011
AP06/10/2011SLR29143010 6/15/2011
AP01/10/2013SLR34877022 1/11/2013
AP01/10/2013SLR34880022 1/14/2013
AP09/15/2014SLR40508023 9/17/2014
AP09/15/2014SLR40521023 9/19/2014
AP012/16/2015SLR44810024 12/17/2015
AP012/16/2015SLR44824024 12/18/2015
AP010/27/2016SLR47539025 10/31/2016

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