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FDA Drug Application 078185 by ROXANE

Application Number078185
Application Type Abbreviated New Drug Application
Sponsor ApplicantROXANE
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
TA07/13/2007TA21710000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078185s000ltr.pdf 2/3/2009
TA07/13/2007TA21911000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078185s000lbl.pdf 2/24/2009
AP11/30/2009N21710000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078185s000ltr.pdf 2/3/2009
AP11/30/2009N21911000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078185s000lbl.pdf 2/24/2009




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