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FDA Drug Application 017430 by SANOFI AVENTIS US

Application Number017430
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/17/1973N       
AP03/13/1975SCS       
AP02/28/1975SCS       
AP04/8/1976SCS       
AP09/23/1976SCF       
AP02/23/1977SLR       
AP07/1/1977SCS       
AP02/23/1981SLR       
AP06/30/1980SLR       
AP08/18/1981SCP       
AP06/2/1983SCS       
AP02/6/1984SCS       
AP08/21/1987SLR       
AP04/21/1986SLR       
AP03/14/1988SCS       
AP02/7/1995SLR       
AP07/13/1990SCS       
AP07/30/1990SCP       
AP05/13/1991SCS       
AP06/24/1991SCS       
AP08/3/1993SCS       
AP010/31/1994SCS       
AP011/23/1999SLR9968026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm 8/10/2004
AP011/23/1999SLR9969027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm 8/10/2004
AP09/7/2004SLR10167028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf 9/10/2004
AP09/7/2004SLR10175028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf 9/10/2004
AP09/7/2004SLR10176029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf 9/10/2004
AP09/7/2004SLR10168029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf 9/10/2004
AP09/7/2004SLR10169030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17430s028,029,030ltr.pdf 9/10/2004
AP09/7/2004SLR10177030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17430s028,029,030lbl.pdf 9/10/2004
AP08/3/2007SLR17505032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017430s032lbl.pdf 8/6/2007
AP08/3/2007SLR17566032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017430s032ltr.pdf 8/7/2007




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