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FDA Drug Application 020862 by GENZYME CORP

Application Number020862
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/9/1999N423000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20862ltr.pdf 6/9/1999
AP06/9/1999N424000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020862_Hectorol.cfm 6/9/1999
AP06/9/1999N425000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20862lbl.pdf 6/9/1999
AP06/25/2001SLR       
AP05/30/2001SCE       
AP06/26/2001SCM       
AP04/23/2004SE18450006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20862se1-006ltr.pdf 4/29/2004
AP04/23/2004SE18487006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20862se1-006_hectorol_lbl.pdf 5/4/2004
AP06/3/2002SCM       
AP06/17/2002SCE       
AP07/24/2002SCM       
AP011/19/2002SCM       
AP012/17/2004SLR10855016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20862s016ltr.pdf 12/30/2004
AP06/24/2005SLR11916018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020862s018ltr.pdf 6/29/2005
AP06/24/2005SLR11920018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020862s018lbl.pdf 6/29/2005
AP07/20/2006SLR14479019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020862s019,021027s013lbl.pdf 7/21/2006
AP07/20/2006SLR14487019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020862s019ltr.pdf 7/21/2006
AP07/10/2008SCS20189023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020862s023lbl.pdf 7/14/2008
AP07/10/2008SCS20200023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020862s023ltr.pdf 7/14/2008
AP07/13/2009SCS22985024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020862s024ltr.pdf 7/17/2009
AP07/13/2009SCS23046024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020862s024lbl.pdf 7/23/2009
AP02/11/2011SLR27845030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020862s030ltr.pdf 2/15/2011
AP02/11/2011SLR28029030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020862s030lbl.pdf 3/4/2011
AP01/2/2014SCM       




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