Back to FDA Applications sponsored by ROXANE

FDA Drug Application 077043 by ROXANE

Application Number077043
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
AP012/13/2004N10790000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/077043ltr.pdf 12/13/2004
AP012/13/2004N12404000   http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053339.htm 7/29/2005
AP07/17/2014SLR40427010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077043s010lbl.pdf 9/5/2014




Back to FDA Applications sponsored by ROXANE