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FDA Drug Application 022368 by PHARMAXIS LTD

Application Number022368
Application Type New Drug Application
Sponsor ApplicantPHARMAXIS LTD
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
AP010/5/2010N26639000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022368s000ltr.pdf 10/12/2010
AP010/5/2010N26643000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022368S000lbl.pdf 10/13/2010
AP010/5/2010N28870000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022368_aridol_toc.cfm 5/19/2011
AP010/5/2010N28871000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022368Orig1s000SumR.pdf 5/19/2011




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