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FDA Drug Application 021754 by FUJISAWA HLTHCARE

Application Number021754
Application Type New Drug Application
Sponsor ApplicantFUJISAWA HLTHCARE
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
AP03/16/2005N11257000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21506,21754ltr.pdf 3/18/2005
AP03/16/2005N11273000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl.pdf 3/18/2005
AP03/16/2005N11274000Package Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21506,21754lbl_2.pdf 3/18/2005
AP03/16/2005N18621000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021754s000_mycamine_TOC.cfm 12/6/2007




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