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FDA Drug Application 021859 by HALOZYME THERAP

Application Number021859
Application Type New Drug Application
Sponsor ApplicantHALOZYME THERAP
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
AP012/2/2005N13240000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021859lbl.pdf 12/13/2005
AP012/2/2005N13247000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021859ltr.pdf 12/13/2005
AP012/2/2005N13314000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021859_s000_HylenexTOC.cfm 1/3/2006
AP06/9/2006SLR14288002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021859s002LTR.pdf 6/12/2006
AP010/1/2008SCP20957005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021859s005ltr.pdf 10/6/2008
AP010/1/2008SCP21006005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021859s005lbl.pdf 10/9/2008
AP012/11/2009SLR24289006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021859s006lbl.pdf 12/15/2009
AP012/11/2009SLR24615006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021859s006ltr.pdf 1/25/2010
AP03/1/2012SLR32014009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021859s009ltr.pdf 3/5/2012
AP03/1/2012SLR32162009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s009lbl.pdf 3/20/2012
AP03/20/2012SLR32171015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021859s015ltr.pdf 3/23/2012
AP03/20/2012SLR32179015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s015lbl.pdf 3/23/2012
AP07/23/2013SCM       
AP010/16/2014SCM       
AP05/6/2014SCM       
AP04/17/2015SCM       
AP07/27/2015SCM       
AP01/21/2016SLR45013023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021859Orig1s023ltr.pdf 1/25/2016
AP01/21/2016SLR45022023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021859s023lbl.pdf 1/26/2016
AP07/28/2016SCM       
AP06/21/2016SCM       
AP09/15/2016SCM       




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