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FDA Drug Application 021027 by GENZYME CORP

Application Number021027
Application Type New Drug Application
Sponsor ApplicantGENZYME CORP
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
AP04/6/2000N966000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21027ltr.pdf 4/6/2000
AP04/6/2000N967000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21027_Hectorol.cfm 4/6/2000
AP04/6/2000N968000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21027lbl.pdf 4/6/2000
AP06/26/2001SCM       
AP06/3/2002SCM       
AP07/24/2002SCM       
AP011/19/2002SCM       
AP011/26/2003SCM7048007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21027scm007ltr.pdf 12/4/2003
AP06/22/2005SLR11870012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021027s012ltr.pdf 6/23/2005
AP06/22/2005SLR11877012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021027s012lbl.pdf 6/23/2005
AP07/20/2006SLR14480013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf 7/21/2006
AP07/20/2006SLR14486013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021027s013,020862s019ltr.pdf 7/21/2006
AP012/5/2008SCF21338015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021027s015ltr.pdf 12/11/2008
AP012/5/2008SCF21482015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021027s015lbl.pdf 1/2/2009
AP012/5/2008SCF32657015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021027Orig1s015.pdf 5/9/2012
AP06/1/2016SLR46242026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021027s026lbl.pdf 6/2/2016
AP06/1/2016SLR46253026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021027Orig1s026ltr.pdf 6/6/2016
AP09/23/2013SCM       
AP012/24/2013SCM       
AP07/31/2014SCM       
AP09/11/2014SCM       
AP012/15/2015SCM       
AP08/15/2016SCM       




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