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FDA Drug Application 022562 by ORPHAN EUROPE

Application Number022562
Application Type New Drug Application
Sponsor ApplicantORPHAN EUROPE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/18/2010N25071000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022562lbl.pdf 3/18/2010
AP03/18/2010N25082000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022562s000ltr.pdf 3/22/2010
AP03/18/2010N25310000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022562s000TOC.cfm 4/20/2010
AP07/22/2013SCM       
AP08/5/2013SLR36704002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022562s002lbl.pdf 8/5/2013
AP08/5/2013SLR36715002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022562Orig1s002ltr.pdf 8/6/2013
AP01/23/2014SCM       
AP011/5/2015SCM       




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