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FDA Drug Application 021456 by EISAI MEDCL RES

Application Number021456
Application Type New Drug Application
Sponsor ApplicantEISAI MEDCL RES
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/8/2002N5478000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm 4/25/2003
AP011/8/2002N8576000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21456,20973se8-013ltr.pdf 5/25/2004
AP011/8/2002N8577000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf 5/25/2004
AP011/8/2002N31078000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011




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