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FDA Drug Application 021060 by JAZZ PHARMS INTL

Application Number021060
Application Type New Drug Application
Sponsor ApplicantJAZZ PHARMS INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/28/2004N10802000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021060ltr.pdf 12/29/2004
AP012/28/2004N10803000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021060lbl.pdf 12/29/2004
AP012/28/2004N11458000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-060_Prialt.cfm 4/27/2005
AP05/26/2005SLR11732001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021060s001ltr.pdf 5/27/2005
AP05/26/2005SLR17312001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021060_S001_PRIALT.pdf 7/20/2007
AP04/18/2007SLR16260003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021060s003lbl.pdf 4/20/2007
AP04/18/2007SLR16311003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021060s003_LTR.pdf 4/25/2007
AP09/1/2011SLR29942006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021060s006lbl.pdf 9/2/2011
AP09/1/2011SLR29951006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021060s006ltr.pdf 9/6/2011
AP012/19/2012SCM       




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