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FDA Drug Application 022405 by GENZYME CORP

Application Number022405
Application Type New Drug Application
Sponsor ApplicantGENZYME CORP
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
AP04/6/2011N28483000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM250399.pdf 4/7/2011
AP04/6/2011N28511000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s000ltr.pdf 4/11/2011
AP04/6/2011N28549000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s000lbl.pdf 4/15/2011
AP04/6/2011N28684000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000TOC.cfm 5/3/2011
AP04/6/2011N28685000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022405Orig1s000SumR.pdf 5/3/2011
AP04/6/2011N29463000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=11 7/8/2011
AP06/22/2011SLR29350001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s001lbl.pdf 6/29/2011
AP06/22/2011SLR29361001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s001ltr.pdf 6/29/2011
AP010/9/2012SLR34033003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022405Orig1s003ltr.pdf 10/11/2012
AP010/9/2012SLR34084003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf 10/12/2012
AP07/3/2013SLR36470004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022405s004lbl.pdf 7/5/2013
AP07/3/2013SLR36495004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s004ltr.pdf 7/8/2013
AP011/27/2013SLR37965005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s005ltr.pdf 12/5/2013
AP03/31/2014SLR38932007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022405s007lbl.pdf 4/1/2014
AP03/31/2014SLR38959007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022405Orig1s007ltr.pdf 4/2/2014
AP07/28/2016SLR46689010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022405Orig1s010ltr.pdf 8/1/2016
AP07/28/2016SLR46701010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022405s010lbl.pdf 8/2/2016




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