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FDA Drug Application 050420 by SANOFI AVENTIS US

Application Number050420
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/21/1971N       
AP010/5/1982SCM       
AP010/26/1982SCS       
AP011/15/1982SCS       
AP011/15/1982SCS       
AP011/17/1982SCS       
AP05/25/1977SCS       
AP02/12/1990SLR       
AP09/2/1983SLR       
AP02/12/1990SCS       
AP02/8/1984SCP       
AP02/18/1986SCM       
AP09/12/1984SLR       
AP05/18/1989SCS       
AP011/16/1987SCS       
AP08/9/1971SLR       
AP012/6/1971SCS       
AP01/26/1972SLR       
AP03/22/1982SLR       
AP06/16/1972SCM       
AP08/31/1972SCF       
AP09/25/1972SLR       
AP010/5/1972SCP       
AP01/19/1973SLR       
AP05/9/1973SCS       
AP011/20/1973SLR       
AP010/11/1973SLR       
AP01/24/1974SLR       
AP03/28/1974SLR       
AP03/28/1974SCM       
AP05/29/1974SLR       
AP05/21/1974SLR       
AP011/26/1974SLR       
AP01/30/1975SLR       
AP09/16/1975SLR       
AP010/15/1975SCP       
AP08/28/1975SCP       
AP03/29/1976SLR       
AP01/19/1976SLR       
AP01/28/1976SLR       
AP02/18/1976SLR       
AP03/1/1976SCS       
AP08/3/1976SCS       
AP08/9/1976SCP       
AP012/21/1976SLR       
AP06/29/1977SLR       
AP02/10/1978SLR       
AP05/30/1978SLR       
AP06/29/1978SLR       
AP06/26/1979SLR       
AP03/23/1979SLR       
AP04/16/1979SCF       
AP04/16/1979SLR       
AP05/1/1979SLR       
AP07/25/1979SLR       
AP010/25/1979SCP       
AP010/29/1979SCM       
AP07/25/1980SCS       
AP012/31/1980SCS       
AP09/11/1982SCM       
AP010/20/1981SLR       
AP010/20/1981SCM       
AP06/18/1993SLR       
AP01/5/1996SCS       
AP07/12/1994SCM       
AP09/17/1996SLR       
AP09/5/1995SCM       
AP04/12/2000SLR       
AP04/12/2000SLR       
AP08/20/2004SLR10028072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50420s072,50627s008ltr.pdf 8/25/2004
AP08/20/2004SLR10081072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50420s072,50627s008lbl.pdf 8/25/2004
AP011/10/2010SLR26947073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050420s073,050627s012lbl.pdf 11/12/2010
AP011/10/2010SLR26996073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050420s073,050627s012ltr.pdf 11/22/2010
AP02/27/2013SLR35289075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050420Orig1s075,050627Orig1s014ltr.pdf 3/1/2013
AP02/27/2013SLR35303075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050420s075,050627s014lbl.pdf 3/1/2013




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