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FDA Drug Application 022572 by MOBIUS THERAP

Application Number022572
Application Type New Drug Application
Sponsor ApplicantMOBIUS THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/7/2012N31722000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022572s000lbl.pdf 2/9/2012
AP02/7/2012N31758000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022572s000ltr.pdf 2/14/2012
AP02/7/2012N34813000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022572_mitosol_toc.cfm 1/2/2013
AP02/7/2012N34814000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022572Orig1s000SumR.pdf 1/2/2013
AP09/25/2014SLR40646003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022572Orig1s003ltr.pdf 9/29/2014
AP09/25/2014SLR40653003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022572s003lbl.pdf 9/30/2014
AP01/20/2016SLR44996004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022572Orig1s004ltr.pdf 1/21/2016
AP01/20/2016SLR45027004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022572s004lbl.pdf 1/26/2016




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