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FDA Drug Application 125359 by JAZZ PHARMS INC

Application Number125359
Application Type Biologic License Application
Sponsor ApplicantJAZZ PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/18/2011N30652000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125359lbl.pdf 11/18/2011
AP011/18/2011N30687000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125359s000ltr.pdf 11/21/2011
AP011/18/2011N31284000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125359_erwinaze_toc.cfm 12/28/2011
AP011/18/2011N31285000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125359Orig1s000SumR.pdf 12/28/2011
AP03/7/2014SLR38732070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125359s070lbl.pdf 3/10/2014
AP03/7/2014SLR38743070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125359Orig1s070ltr.pdf 3/11/2014
AP012/19/2014SLR41395085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125359Orig1s085ltr.pdf 12/24/2014
AP012/19/2014SLR42302085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125359s085lbl.pdf 3/27/2015
AP03/29/2016S45554088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125359s088lbl.pdf 3/30/2016
AP03/29/2016S45559088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125359Orig1s088ltr.pdf 3/31/2016




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