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FDA Drug Application 022363 by KOWA CO

Application Number022363
Application Type New Drug Application
Sponsor ApplicantKOWA CO
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
AP08/3/2009N23227000 8/26/2009
AP08/3/2009N23234000 8/26/2009
AP08/3/2009N24109000 11/23/2009
AP06/1/2010SLR25713002 6/8/2010
AP06/16/2011SLR29190005 6/16/2011
AP06/16/2011SLR29264005 6/27/2011
AP08/3/2011SLR29682006 8/5/2011
AP08/3/2011SLR29708006 8/5/2011
AP02/28/2012SLR31942008,s009ltr.pdf 2/28/2012
AP02/28/2012SLR31953008 2/28/2012
AP02/28/2012SLR31955008Tracked Changes Label 2/28/2012
AP02/28/2012SLR32298008 3/30/2012
AP02/28/2012SLR32523009 4/24/2012
AP02/28/2012SLR31956009Tracked Changes Label 2/28/2012
AP02/28/2012SLR31954009 2/28/2012
AP02/28/2012SLR31943009,s009ltr.pdf 2/28/2012
AP010/31/2012SLR34276010 11/6/2012
AP010/31/2012SLR34316010 11/6/2012
AP010/16/2013SLR37451012 10/18/2013
AP010/16/2013SLR37463012 10/18/2013

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