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FDA Drug Application 125291 by GENZYME

Application Number125291
Application Type Biologic License Application
Sponsor ApplicantGENZYME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/24/2010N25618000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125291lbl.pdf 5/26/2010
AP05/24/2010N25629000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125291s000ltrR.pdf 5/27/2010
AP05/24/2010N25961000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000TOC.cfm 7/13/2010
AP05/24/2010N25962000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125291s000SumR.pdf 7/13/2010
AP07/9/2012S331680063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125291Orig1s0063ltr.pdf 7/13/2012
AP07/9/2012S331800063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125291s0063lbl.pdf 7/13/2012
AP07/16/2012SLR332230079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125291Origs0079ltr.pdf 7/18/2012
AP05/22/2014SLR39354133   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s133ltr.pdf 5/27/2014
AP05/22/2014SLR39385133   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s133lbl.pdf 5/28/2014
AP08/1/2014SE840118136   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125291s136lbl.pdf 8/4/2014
AP08/1/2014SE840122136   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125291Orig1s136ltr.pdf 8/4/2014
AP08/1/2014SE846683136   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2014/125291Orig1s136.pdf 7/29/2016




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