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FDA Drug Application 090120 by ROXANE

Application Number090120
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
TA09/6/2011TA32246000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf 3/28/2012
AP13/27/2012N32246000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf 3/28/2012
TA09/6/2011TA32296000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090120s000ltr.pdf 3/30/2012
AP13/27/2012N32296000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090120s000ltr.pdf 3/30/2012
TA09/6/2011TA44401000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf 11/6/2015
AP13/27/2012N44401000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/090120ltr.pdf 11/6/2015




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