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FDA Drug Application 022065 by R-PHARM US LLC

Application Number022065
Application Type New Drug Application
Sponsor ApplicantR-PHARM US LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/16/2007N18244000 10/17/2007
AP010/16/2007N18270000 10/22/2007
AP010/16/2007N19522000 3/24/2008
AP03/13/2009SCS22007001 3/17/2009
AP03/13/2009SCS22195001 4/3/2009
AP010/2/2009SE823552002 10/7/2009
AP010/2/2009SE823556002,s003ltr.pdf 10/13/2009
AP010/2/2009SLR23557003,s003ltr.pdf 10/13/2009
AP010/2/2009SLR23553003 10/7/2009
AP05/12/2010SLR25552004,s005ltr.pdf 5/17/2010
AP05/12/2010SLR25564004 5/17/2010
AP05/12/2010SLR25565005 5/17/2010
AP05/12/2010SLR25553005,s005ltr.pdf 5/17/2010
AP010/18/2011SE530354006 10/20/2011
AP010/18/2011SE530380006 10/20/2011

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