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FDA Drug Application 020038 by GENZYME CORP

Application Number020038
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
AP04/18/1991N       
AP012/4/1991SCS       
AP012/4/1991SCS       
AP04/2/1992SLR       
AP01/7/1993SCS       
AP01/7/1993SCM       
AP010/28/1992SLR       
AP05/21/1993SCM       
AP09/26/1994SLR       
AP01/29/1996SCS       
AP05/24/1999SLR       
AP09/5/1996SCS       
AP012/3/2001SLR5394019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20038s19lbl.pdf 4/21/2003
AP03/8/2000SCP       
AP07/2/2002SCM       
AP07/2/2002SCS       
AP03/28/2002SCS       
AP05/1/2002SCM       
AP05/1/2002SCS       
AP08/1/2003SE86490028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20038se8-028_fludara_lbl.pdf 8/14/2003
AP08/1/2003SE86495028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20038se8-028ltr.pdf 8/14/2003
AP012/20/2007SLR18674031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020038s031lbl.pdf 12/27/2007
AP012/20/2007SLR18815031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020038s031ltr.pdf 1/9/2008
AP02/10/2009SLR21813032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020038s032lbl.pdf 2/12/2009
AP02/10/2009SLR21830032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020038s032ltr.pdf 2/13/2009
AP07/29/2010SLR26071033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020038s033lbl.pdf 7/31/2010
AP07/29/2010SLR26085033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020038s033ltr.pdf 8/2/2010




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