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FDA Drug Application 017532 by SANOFI AVENTIS US

Application Number017532
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/1/1984N       
AP03/27/1985SLR       
AP03/27/1985SCF       
AP01/4/1985SCP       
AP07/1/1986SLR       
AP010/20/1987SCS       
AP010/20/1987SCS       
AP08/27/1987SLR       
AP04/27/1988SCM       
AP04/27/1988SLR       
AP03/26/1993SCS       
AP06/19/1992SLR       
AP08/6/1992SLR       
AP03/26/1993SCP       
AP01/21/1993SLR       
AP07/27/1993SLR       
AP05/20/1994SCP       
AP08/11/1994SLR       
AP02/1/1995SCS       
AP011/22/1996SCS       
AP03/29/1996SCP       
AP02/20/1997SCS       
AP010/8/1997SCM       
AP012/29/1999SLR       
AP03/5/2009SLR21968027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s027,s028ltr.pdf 3/10/2009
AP03/5/2009SLR22024027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf 3/17/2009
AP03/5/2009SLR22025028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf 3/17/2009
AP03/5/2009SLR21969028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s027,s028ltr.pdf 3/10/2009
AP07/9/2009SLR22973030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s030ltr.pdf 7/15/2009
AP07/9/2009SLR23038030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf 7/23/2009
AP010/15/2013SLR37429034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017532Orig1s034ltr.pdf 10/16/2013
AP010/15/2013SLR37486034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017532Orig1s034lbl.pdf 10/21/2013
AP08/16/2013SCM       
AP08/25/2014SCM       




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