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FDA Drug Application 022110 by THERAVANCE BIOPHARMA

Application Number022110
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
AP09/11/2009N29651000REMS 8/2/2011
AP09/11/2009N23318000 9/16/2009
AP09/11/2009N23405000 9/18/2009
AP09/11/2009N23454000 9/25/2009
AP09/11/2009N24155000 11/25/2009
AP09/11/2009N24156000 11/25/2009
AP07/27/2011SLR29619002 7/27/2011
AP06/21/2013S36380003,022110s003lbl.pdf 6/25/2013
AP06/21/2013S36389003,022110Orig1s003ltr.pdf 6/26/2013
AP02/7/2014SLR38480007 2/10/2014
AP03/13/2014SCM38848009 3/19/2014
AP011/12/2014S40985010 11/14/2014
AP012/3/2014SLR41152011 12/4/2014
AP012/3/2014SLR41196011 12/10/2014
AP05/6/2016SE845887012 5/9/2016
AP05/6/2016SE845891012 5/9/2016
AP03/23/2016S45503013 3/25/2016
AP03/23/2016S45520013REMS 3/29/2016

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