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FDA Drug Application 021590 by JAZZ PHARMS III

Application Number021590
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
AP02/9/2004N12840000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021590s000_FazacloTOC.cfm 10/6/2005
AP02/9/2004N7749000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590ltr.pdf 2/27/2004
AP02/9/2004N7823000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21590_fazaclo_lbl.pdf 3/3/2004
AP02/9/2004N43877000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351 9/16/2015
AP06/17/2004SLR9493001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590slr001ltr.pdf 6/23/2004
AP08/27/2004SLR10134002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590s002ltr.pdf 9/7/2004
AP08/12/2005SLR12610003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s003ltr.pdf 8/15/2005
AP06/8/2005SLR11786007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s007ltr.pdf 6/10/2005
AP06/8/2005SLR11789007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s007lbl.pdf 6/10/2005
AP08/12/2005SLR12605008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s008lbl.pdf 8/15/2005
AP08/12/2005SLR12614008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s008ltr.pdf 8/16/2005
AP02/16/2006SLR13637009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021590s009lbl.pdf 2/22/2006
AP02/16/2006SLR13640009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021590s009ltr.pdf 2/22/2006
AP05/30/2007SCM16669010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021590s010ltr.pdf 6/4/2007
AP05/30/2007SCM16693010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021590s010lbl.pdf 6/4/2007
AP07/15/2008SLR20225011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021590s011ltr.pdf 7/17/2008
AP08/14/2008SLR20630013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021590s013ltr.pdf 8/19/2008
AP09/15/2015S43887014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s014,s027ltr.pdf 9/16/2015
AP09/15/2015S43895014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s014s027lbl.pdf 9/16/2015
AP07/9/2010SLR25958015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s015s016lbl.pdf 7/12/2010
AP07/9/2010SLR25964015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s015,s016ltr.pdf 7/14/2010
AP07/9/2010SCM25965016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s015,s016ltr.pdf 7/14/2010
AP07/9/2010SCM25959016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s015s016lbl.pdf 7/12/2010
AP09/8/2010SLR26449017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s017lbl.pdf 9/10/2010
AP09/8/2010SLR26477017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s017ltr.pdf 9/13/2010
AP012/1/2010SLR27173018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s018lbl.pdf 12/4/2010
AP012/1/2010SLR27220018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s018ltr.pdf 12/6/2010
AP07/19/2013SLR36582021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021590Orig1s021ltr.pdf 7/22/2013
AP07/19/2013SLR36588021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021590s021lbl.pdf 7/23/2013
AP01/9/2012SLR31373024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021590s024lbl.pdf 1/9/2012
AP01/9/2012SLR31379024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021590s024ltr.pdf 1/12/2012
AP011/7/2012SCM       
AP09/15/2015SLR43888027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s014,s027ltr.pdf 9/16/2015
AP09/15/2015SLR43896027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s014s027lbl.pdf 9/16/2015
AP09/30/2015SLR44098028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479Orig1s009ltr.pdf 10/2/2015
AP09/30/2015SLR44252028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028lbl.pdf 10/22/2015
AP04/25/2016SCM       




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