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FDA Drug Application 017557 by SANOFI AVENTIS US

Application Number017557
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/21/1976N       
AP09/27/1976SLR       
AP03/23/1978SCF       
AP03/14/1978SLR       
AP05/31/1978SCM       
AP09/2/1980SES       
AP010/25/1979SCS       
AP05/18/1981SES       
AP03/31/1980SCP       
AP06/3/1980SCM       
AP05/29/1980SCP       
AP011/3/1980SLR       
AP011/1/1982SLR       
AP01/22/1982SCS       
AP08/9/1984SLR       
AP08/9/1984SLR       
AP08/9/1984SLR       
AP01/29/1985SLR       
AP03/24/1986SLR       
AP05/2/1988SCS       
AP07/5/1990SLR       
AP03/1/1993SLR       
AP08/2/1995SCP       
AP01/28/1994SLR       
AP05/2/1994SLR       
AP012/20/2011SLR31215033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf 12/22/2011
AP012/20/2011SLR31234033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf 12/23/2011
AP012/19/1996SCS       
AP012/20/2011SLR31216039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf 12/22/2011
AP012/20/2011SLR31235039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf 12/23/2011
AP012/20/2011SLR31217040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf 12/22/2011
AP012/20/2011SLR31236040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf 12/23/2011
AP012/20/2011SLR31218041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf 12/22/2011
AP012/20/2011SLR31237041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf 12/23/2011
AP012/20/2011SLR31219042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017557s033,s039,s040,s041,s042ltr.pdf 12/22/2011
AP012/20/2011SLR31238042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017557s033s039s040s041s042lbl.pdf 12/23/2011




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