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FDA Drug Application 021782 by TAKEDA PHARMS USA

Application Number021782
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
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
AP07/22/2005N12272000 7/26/2005
AP07/22/2005N12286000 7/26/2005
AP07/22/2005N12666000 8/30/2005
AP07/22/2005N12949000 10/20/2005
AP07/22/2005N24074000 11/20/2009
AP08/18/2005SLR12652001 8/23/2005
AP08/18/2005SLR12657001 8/23/2005
AP03/1/2012SLR32023006,s012,s014ltr.pdf 3/5/2012
AP010/20/2008SE821069008, s009, s010ltr.pdf 10/23/2008
AP010/20/2008SE821182008 11/7/2008
AP010/20/2008SE821183009 11/7/2008
AP010/20/2008SE821070009, s009, s010ltr.pdf 10/23/2008
AP010/20/2008SE821071010, s009, s010ltr.pdf 10/23/2008
AP010/20/2008SE821184010 11/7/2008
AP011/9/2010SLR26942011 11/12/2010
AP011/9/2010SLR26943011 11/12/2010
AP011/9/2010SLR26952011 11/15/2010
AP02/21/2012SLR32024012,s012,s014ltr.pdf 3/5/2012
AP03/1/2012SLR32025014,s012,s014ltr.pdf 3/5/2012
AP08/4/2011SLR29697015 8/5/2011

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