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FDA Drug Application 021196 by JAZZ PHARMS

Application Number021196
Application Type New Drug Application
Sponsor ApplicantJAZZ PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/17/2002N2017000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21196ltr.pdf 7/17/2002
AP07/17/2002N2018000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21196lbl.pdf 7/17/2002
AP07/17/2002N2019000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-196_Xyrem.cfm 7/17/2002
AP07/17/2002N22663000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089830.pdf 5/30/2009
AP07/17/2002N34672000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm332408.htm 12/17/2012
AP07/17/2002N43266000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=345 7/7/2015
AP011/4/2003SLR6939001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21196slr001ltr.pdf 11/25/2003
AP011/18/2005SE113125005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021196s005lbl.pdf 11/22/2005
AP011/18/2005SE113134005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021196s005ltr.pdf 11/22/2005
AP09/16/2005SLR12814007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021196s007ltr.pdf 9/22/2005
AP06/30/2006SLR14401009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021196s009ltr.pdf 7/3/2006
AP011/13/2006SLR15361012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021196s012LTR.pdf 11/16/2006
AP012/17/2012SLR34674013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021196s013lbl.pdf 12/17/2012
AP012/17/2012SLR34712013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021196Orig1s013ltr.pdf 12/20/2012
AP02/27/2015SLR41973015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021196Orig1s015ltr.pdf 3/2/2015
AP02/27/2015SLR42026015   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089830.pdf 3/5/2015
AP012/20/2013SCM       
AP04/11/2014SE839036019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021196Orig1s019ltr.pdf 4/14/2014
AP04/11/2014SE839039019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021196Orig1s019lbl.pdf 4/14/2014
AP02/23/2015SCM       
AP08/17/2015SCM       
AP07/15/2015SLR43383023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021196Orig1s023ltr.pdf 7/16/2015
AP07/15/2015SLR45259023   http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=345 2/24/2016
AP06/23/2016SCM       




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