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FDA Drug Application 202067 by LUNDBECK LLC

Application Number202067
Application Type New Drug Application
Sponsor ApplicantLUNDBECK LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/21/2011N30393000 10/24/2011
AP010/21/2011N30403000 10/25/2011
AP010/21/2011N30443000 11/1/2011
AP010/21/2011N30749000 11/22/2011
AP03/1/2013SCM35343001 3/5/2013
AP011/21/2013SLR37885002,203993s002lbl.pdf 11/22/2013
AP011/21/2013SLR37926002,203993Orig1s002ltr.pdf 11/26/2013
AP012/9/2014SLR41212003,203993Orig1s003ltr.pdf 12/11/2014
AP012/9/2014SLR42774003,203993s003lbl.pdf 5/12/2015

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