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FDA Drug Application 021321 by BAXTER HLTHCARE

Application Number021321
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/2002N5081000 4/9/2003
AP012/20/2002N5482000 4/25/2003
AP012/20/2002N8977000 6/3/2004
AP012/20/2002N23957000 11/18/2009
AP012/20/2002N28339000REMS 3/25/2011
AP05/24/2005SCP11707008 5/25/2005
AP05/24/2005SLR11708009 5/25/2005
AP012/17/2004SE110849010 12/30/2004
AP012/17/2004SE110887010 12/30/2004
AP02/23/2007SLR15956013 3/6/2007
AP04/7/2009SLR22265017 4/15/2009
AP04/7/2009SLR22275017 4/16/2009
AP01/29/2009SCP21705018 2/3/2009
AP03/9/2011SLR28206020,s021ltr.pdf 3/10/2011
AP03/9/2011SLR28231020 3/11/2011
AP03/9/2011SLR28209021,s021ltr.pdf 3/10/2011
AP03/9/2011SLR28230021 3/11/2011
AP012/9/2014SLR41211028 12/11/2014
AP02/25/2014SLR38603029 2/27/2014
AP010/16/2015SLR44238032 10/21/2015
AP010/16/2015SLR44265032 10/22/2015
AP010/24/2016S47435035 10/25/2016

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