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FDA Drug Application 020057 by GENZYME

Application Number020057
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
AP04/5/1991N       
AP011/27/1991SCM       
AP09/24/1991SCE       
AP05/8/1992SCP       
AP06/30/1993SCS       
AP06/19/1995SLR       
AP06/9/1993SCS       
AP06/30/1993SCM       
AP05/28/1993SCE       
AP06/16/1993SCS       
AP05/17/1994SCM       
AP01/7/1994SCM       
AP010/1/1993SCS       
AP02/28/1996SLR       
AP05/17/1994SCS       
AP01/7/1994SCF       
AP08/3/1994SCS       
AP012/6/1994SCS       
AP010/26/1995SCS       
AP012/14/1994SLR       
AP06/19/1995SCM       
AP06/8/1995SLR       
AP010/16/1995SCS       
AP011/9/1995SCS       
AP012/21/1995SCS       
AP03/26/1996SCS       
AP05/21/1996SCS       
AP07/3/1996SCS       
AP09/11/1996SLR       
AP07/23/1996SCM       
AP011/27/1996SCS       
AP02/9/2006SLR13622034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020057s034lbl.pdf 2/22/2006
AP02/9/2006SLR13653034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020057s034ltr.pdf 2/22/2006
AP04/30/1999SCE       
AP09/24/2001SCS       
AP01/30/2002SCS       




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