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FDA Drug Application 022233 by HELSINN HLTHCARE

Application Number022233
Application Type New Drug Application
Sponsor ApplicantHELSINN HLTHCARE
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
AP08/22/2008N20684000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022233LBL.pdf 8/26/2008
AP08/22/2008N20690000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022233s000ltr.pdf 8/27/2008
AP08/22/2008N25535000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022233_aloxi_toc.cfm 5/12/2010
AP08/22/2008N25536000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022233s000Sumr.pdf 5/12/2010
AP09/18/2014SLR40541005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022233s005lbl.pdf 9/22/2014
AP09/18/2014SLR40562005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022233Orig1s005ltr.pdf 9/23/2014




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