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FDA Drug Application 077312 by PAR PHARM

Application Number077312
Application Type Abbreviated New Drug Application
Sponsor ApplicantPAR PHARM
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
AP010/30/2009N23727000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312MedGuide.pdf 11/4/2009
AP010/30/2009N23728000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/077312lbl.pdf 11/4/2009
AP010/30/2009N23734000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077312s000ltr.pdf 11/5/2009
AP010/30/2009N31643000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 2/3/2012




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