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FDA Drug Application 203993 by LUNDBECK LLC

Application Number203993
Application Type New Drug Application
Sponsor ApplicantLUNDBECK LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/14/2012N34693000 12/18/2012
AP012/14/2012N34711000 12/20/2012
AP012/14/2012N35368000 3/8/2013
AP012/14/2012N36478000 7/8/2013
AP012/14/2012N36479000 7/8/2013
AP011/21/2013SLR37884002,203993s002lbl.pdf 11/22/2013
AP011/21/2013SLR37927002,203993Orig1s002ltr.pdf 11/26/2013
AP012/9/2014SLR41213003,203993Orig1s003ltr.pdf 12/11/2014
AP012/9/2014SLR42775003,203993s003lbl.pdf 5/12/2015

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