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FDA Drug Application 021372 by HELSINN HLTHCARE

Application Number021372
Application Type New Drug Application
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/25/2003N6403000 8/6/2003
AP07/25/2003N6404000 8/6/2003
AP07/25/2003N7567000 1/15/2004
AP07/5/2005SLR11940002 7/7/2005
AP07/5/2005SLR11956002 7/8/2005
AP08/23/2006SLR14765005 8/29/2006
AP08/23/2006SLR14889005 9/18/2006
AP08/30/2007SE217739006 9/4/2007
AP08/30/2007SE217743006 9/4/2007
AP02/29/2008SE119364008 3/5/2008
AP02/29/2008SE119380008, s010ltr.pdf 3/5/2008
AP02/29/2008SE124285008 12/12/2009
AP02/29/2008SE124287008 12/12/2009
AP02/29/2008SE824288010 12/12/2009
AP02/29/2008SE824286010 12/12/2009
AP02/29/2008SE819381010, s010ltr.pdf 3/5/2008
AP02/29/2008SE819365010 3/5/2008
AP02/6/2014SLR38476017 2/7/2014
AP02/6/2014SLR38492017 2/11/2014
AP05/27/2014SE839411018,s019ltr.pdf 6/2/2014
AP05/27/2014SE839412019,s019ltr.pdf 6/2/2014
AP05/27/2014SE839370019 5/28/2014
AP09/18/2014SLR40534020 9/22/2014
AP09/18/2014SLR40560020 9/23/2014

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