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FDA Drug Application 050717 by ZAMBON SPA

Application Number050717
Application Type New Drug Application
Sponsor ApplicantZAMBON SPA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/19/1996N       
AP04/22/1998SCM       
AP05/28/1998SCS       
AP05/13/1999SCS       
AP012/18/2002SLR3635004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50717slr004ltr.pdf 12/18/2002
AP012/18/2002SLR4967004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50717SLR004_Monurol_lbl.pdf 4/7/2003
AP03/11/2008SLR19435005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050717s005lbl.pdf 3/13/2008
AP03/11/2008SLR19457005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050717s005ltr.pdf 3/13/2008
AP04/11/2011SLR28525007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050717s007lbl.pdf 4/11/2011
AP04/11/2011SLR28540007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050717s007ltr.pdf 4/13/2011




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