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FDA Drug Application 022311 by GENZYME

Application Number022311
Application Type New Drug Application
Sponsor ApplicantGENZYME
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
AP012/15/2008N21384000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022311s000ltr.pdf 12/19/2008
AP012/15/2008N21472000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022311lbl.pdf 1/2/2009
AP012/15/2008N22098000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000TOC.cfm 3/24/2009
AP012/15/2008N22099000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000_SumR.pdf 3/24/2009
AP06/14/2010SLR25742001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022311s001lbl.pdf 6/15/2010
AP06/14/2010SLR25751001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022311s001ltr.pdf 6/16/2010
AP02/26/2013SCM       
AP06/4/2013SLR36231013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022311Orig1s013ltr.pdf 6/6/2013
AP06/4/2013SLR36274013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022311s013lbl.pdf 6/11/2013
AP011/12/2013SCM       
AP012/4/2014SLR41167015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022311Orig1s015ltr.pdf 12/5/2014
AP012/4/2014SLR41197015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022311s015lbl.pdf 12/10/2014
AP08/4/2015SLR43580016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022311Orig1s016ltr.pdf 8/6/2015
AP08/4/2015SLR43585016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022311s016lbl.pdf 8/6/2015
AP05/12/2016SCM       




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