Back to FDA Applications sponsored by ROXANE

FDA Drug Application 078485 by ROXANE

Application Number078485
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
TA06/28/2007TA25869000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078485s000ltr.pdf 6/30/2010
AP16/28/2010N25869000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078485s000ltr.pdf 6/30/2010




Back to FDA Applications sponsored by ROXANE