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FDA Drug Application 020367 by GENZYME

Application Number020367
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
AP05/23/1994N       
AP04/7/1995SCS       
AP06/19/1995SCM       
AP02/7/1995SCM       
AP05/8/1995SCF       
AP05/3/1995SCS       
AP012/7/1997SLR       
AP07/24/1995SCS       
AP04/18/1996SCM       
AP012/6/1995SCS       
AP05/31/1996SCS       
AP02/23/1996SCS       
AP04/8/1996SCS       
AP06/5/1996SCM       
AP09/20/1996SCM       
AP010/22/1996SCM       
AP012/12/1996SCS       
AP09/23/1996SCS       
AP03/3/1997SCS       
AP012/20/1996SCS       
AP07/16/1997SCS       
AP07/31/1997SCM       
AP08/8/1997SCS       
AP01/30/1998SCS       
AP02/11/1999SLR       
AP03/23/1998SCS       
AP06/12/1998SCS       
AP06/12/1998SCS       
AP06/17/1998SCS       
AP011/18/1998SCS       
AP01/4/1999SCS       
AP09/22/1999SCF       
AP07/26/1999SCP       
AP07/28/1999SCS       
AP010/5/1999SCS       
AP010/22/1999SCS       
AP09/7/1999SCS       
AP012/8/1999SCM       
AP08/13/2001SLR       
AP08/13/2001SLR       
AP04/10/2000SCM       
AP07/10/2000SCS       
AP09/11/2000SCS       
AP08/31/2000SCS       
AP010/27/2000SCS       
AP011/14/2000SCS       
AP08/13/2001SLR       
AP05/7/2001SCS       
AP05/8/2001SCM       
AP06/14/2002SLR2379053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20367s053ltr.pdf 6/14/2002
AP06/14/2002SLR2380053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367s53lbl.pdf 6/14/2002
AP011/13/2002SLR6298055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20367slr055ltr.pdf 7/31/2003
AP011/13/2002SLR2378055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367slr055_Cerezyme_lbl.pdf 11/13/2002
AP010/9/2002SCM       
AP03/3/2005SCM11223066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20367s066ltr.pdf 3/10/2005
AP03/3/2005SCM11230066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20367s066lbl.pdf 3/10/2005
AP07/31/2013SCM       
AP010/30/2013SCM       
AP02/27/2014SCM       
AP09/5/2014SCM       
AP03/9/2015SCM       
AP08/10/2015SCM       
AP010/30/2015SCM       
AP03/3/2016SCM       
AP04/21/2016SCM       
AP06/8/2016SCM       
AP07/7/2016SCM       
AP09/14/2016SCM       
AP07/22/2016SCM       
AP09/30/2016SCM       




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