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FDA Drug Application 021632 by VICURON

Application Number021632
Application Type New Drug Application
Sponsor ApplicantVICURON
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
AP02/17/2006N13671000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s000,021948s000lbl.pdf 2/28/2006
AP02/17/2006N13688000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021948s000,021632s000ltr.pdf 3/1/2006
AP02/17/2006N13933000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021632_021948_EraxisTOC.cfm 4/14/2006
AP08/7/2006SCS14639002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s002lbl.pdf 8/9/2006
AP08/7/2006SCS14652002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021632s002LTR.pdf 8/9/2006
AP011/15/2006SCS15366003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021632s003lbl.pdf 11/16/2006
AP011/15/2006SCS15388003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021632s003ltr.pdf 11/22/2006
AP02/2/2007SLR15805004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021632s004ltr.pdf 2/12/2007
AP02/2/2007SLR15873004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s004.pdf 2/21/2007
AP011/9/2007SLR18407006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021632s006lbl.pdf 11/13/2007
AP011/9/2007SLR18448006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021632s006ltr.pdf 11/19/2007
AP06/5/2009SCF22734010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021632s010lbl.pdf 6/10/2009
AP06/5/2009SCF22752010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021632s010ltr.pdf 6/16/2009
AP07/20/2012SLR33260011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021632s011lbl.pdf 7/23/2012
AP07/20/2012SLR33262011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021632Orig1s011ltr.pdf 7/24/2012
AP011/4/2010SLR26908013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021632s013ltr.pdf 11/9/2010
AP03/28/2014SCM       
AP06/9/2014SCM       
AP012/2/2015SCM       




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