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FDA Drug Application 125196 by SCHERING

Application Number125196
Application Type Biologic License Application
Sponsor ApplicantSCHERING
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/13/2008N200570000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125196s000ltr.pdf 6/24/2008
AP06/13/2008N201950000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125196s000lbl.pdf 7/14/2008
AP06/13/2008N202600000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125196_PEGINTRONTOC.cfm 7/18/2008
AP06/13/2008N202870000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125196_PEGINTRON_SUMMARYR.pdf 7/24/2008
AP06/13/2008N240520000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm110876.pdf 11/20/2009




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