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FDA Drug Application 022033 by JAZZ PHARMS

Application Number022033
Application Type New Drug Application
Sponsor ApplicantJAZZ PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/28/2008N19352000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022033s000ltr.pdf 3/4/2008
AP02/28/2008N19375000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022033lbl.pdf 3/5/2008
AP02/28/2008N20576000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022033TOC.cfm 8/11/2008
AP02/28/2008N20577000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022033s000_SumR.pdf 8/11/2008
AP02/28/2008N24010000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088625.pdf 11/19/2009
AP02/28/2008N31752000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113425.htm 2/13/2012
AP02/24/2009SLR21921002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021519s001,022033s002ltr.pdf 2/27/2009
AP02/24/2009SLR22020002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022033s002lbl.pdf 3/17/2009
AP05/9/2011SLR28749003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s003lbl.pdf 5/9/2011
AP05/9/2011SLR28783003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf 5/11/2011
AP05/9/2011SLR28750006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s006lbl.pdf 5/9/2011
AP05/9/2011SLR28784006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf 5/11/2011
AP05/9/2011SLR28752007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s007lbl.pdf 5/9/2011
AP05/9/2011SLR28785007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf 5/11/2011
AP011/30/2012SLR34526009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022033Orig1s009ltr.pdf 12/4/2012
AP011/30/2012SLR34540009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022033s009lbl.pdf 12/4/2012
AP07/18/2014SLR39946010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022033s010lbl.pdf 7/23/2014
AP07/18/2014SLR39984010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022033Orig1s010ltr.pdf 7/24/2014




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