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FDA Drug Application 014214 by SANOFI AVENTIS US

Application Number014214
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
AP03/6/1964N       
AP02/26/1975S       
AP02/23/1977S       
AP07/18/1975SCS       
AP09/8/1975SCS       
AP04/8/1976SCS       
AP03/31/1976SLR       
AP06/29/1977SCS       
AP05/3/1978SLR       
AP02/23/1981SLR       
AP07/11/1978SCM       
AP02/13/1979SCS       
AP04/9/1980SCP       
AP012/12/1980SLR       
AP08/18/1981SCP       
AP06/4/1981SCP       
AP06/4/1981SCP       
AP08/18/1981SCP       
AP08/17/1983SCS       
AP04/28/1986SLR       
AP03/21/1986SCP       
AP02/7/1995SLR       
AP07/20/1990SCS       
AP010/5/1990SCM       
AP09/17/1990SCM       
AP06/24/1991SCS       
AP010/3/1995SCS       
AP011/23/1999SLR9970050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm 8/10/2004
AP011/23/1999SLR9971051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/17-430s026s027_14-214s050s051_Negram.cfm 8/10/2004
AP09/20/2002SCM       
AP09/7/2004SLR10164053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf 9/10/2004
AP09/7/2004SLR10172053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf 9/10/2004
AP09/7/2004SLR10165055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf 9/10/2004
AP09/7/2004SLR10173055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf 9/10/2004
AP09/7/2004SLR10166056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14214s053,055,056ltr.pdf 9/10/2004
AP09/7/2004SLR10174056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14214s053,055,056lbl.pdf 9/10/2004
AP05/24/2007SLR16594057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014214s057ltr.pdf 5/29/2007
AP05/24/2007SLR16635057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014214s057lbl.pdf 5/29/2007
AP03/28/2009SLR22138058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014214s058ltr.pdf 4/1/2009
AP03/28/2009SLR22179058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014214s058lbl.pdf 4/3/2009
AP04/29/2011SLR28668059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014214s059lbl.pdf 5/2/2011
AP04/29/2011SLR28683059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014214s059ltr.pdf 5/3/2011
AP011/28/2012SLR34497060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014214Orig1s060ltr.pdf 11/29/2012
AP011/28/2012SLR34584060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014214s060lbl.pdf 12/10/2012




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