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FDA Drug Application 203479 by JAZZ PHARMS III

Application Number203479
Application Type New Drug Application
Sponsor ApplicantJAZZ PHARMS III
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
AP02/6/2013N35100000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351 2/8/2013
AP02/6/2013N35107000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s000lbl.pdf 2/8/2013
AP02/6/2013N35108000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s000ltr.pdf 2/8/2013
AP02/6/2013N37181000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479_versacloz_toc.cfm 9/20/2013
AP02/6/2013N37182000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479Orig1s000SumR.pdf 9/20/2013
AP012/5/2013SLR37988001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s001ltr.pdf 12/9/2013
AP012/5/2013SLR38258001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf 1/13/2014
AP08/22/2013SLR36881002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s002ltr.pdf 8/23/2013
AP08/22/2013SLR36888002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s002lbl.pdf 8/27/2013
AP03/25/2014SCM       
AP09/29/2014SCM       
AP02/18/2016SCM       
AP09/15/2015SLR43893007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf 9/16/2015
AP09/15/2015SLR43902007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf 9/17/2015
AP09/15/2015S43894008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf 9/16/2015
AP09/15/2015S43903008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf 9/17/2015
AP09/30/2015SLR44099009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479Orig1s009ltr.pdf 10/2/2015
AP09/30/2015SLR44735009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028,203479s009lbl.pdf 12/10/2015




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