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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   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203993s000lbl.pdf 12/18/2012
AP012/14/2012N34711000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203993Orig1s000ltr.pdf 12/20/2012
AP012/14/2012N35368000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277791.pdf 3/8/2013
AP012/14/2012N36478000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203993_onfi_toc.cfm 7/8/2013
AP012/14/2012N36479000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203993Orig1s000SumR.pdf 7/8/2013
AP01/16/2014SCM       
AP011/21/2013SLR37884002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202067s002,203993s002lbl.pdf 11/22/2013
AP011/21/2013SLR37927002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202067Orig1s002,203993Orig1s002ltr.pdf 11/26/2013
AP012/9/2014SLR41213003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202067Orig1s003,203993Orig1s003ltr.pdf 12/11/2014
AP012/9/2014SLR42775003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202067s003,203993s003lbl.pdf 5/12/2015
AP06/16/2016SCM       




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