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FDA Drug Application 020496 by SANOFI AVENTIS US

Application Number020496
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/30/1995N       
AP07/28/1997SCM       
AP02/24/1999SE1746002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf 2/24/1999
AP02/24/1999SE1747002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.cfm 2/24/1999
AP09/16/1998SCP       
AP09/16/1998SCP       
AP09/27/2000SE88707005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20496-S005_Amaryl.pdf 5/27/2004
AP01/6/2000SCM       
AP04/15/2002SLR4376007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf 4/15/2002
AP08/29/2000SCS       
AP012/5/2000SCS       
AP07/21/2001SCM       
AP08/16/2004SLR10050013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf 8/25/2004
AP011/28/2005SE513204015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf 12/5/2005
AP011/28/2005SE513219015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf 12/6/2005
AP09/19/2005SLR12807016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf 9/22/2005
AP09/19/2005SLR12818016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf 9/22/2005
AP02/3/2009SLR21759018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf 2/4/2009
AP02/3/2009SLR21827018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf 2/13/2009
AP02/3/2009SLR21828019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf 2/13/2009
AP02/3/2009SLR21760019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf 2/4/2009
AP06/4/2009SLR22696021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf 6/4/2009
AP06/4/2009SLR22749021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf 6/16/2009
AP02/3/2012SLR31667022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf 2/6/2012
AP02/3/2012SLR31714022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf 2/8/2012
AP03/14/2013SCM       
AP04/19/2013SCM       
AP08/1/2013SLR36687026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf 8/5/2013
AP08/1/2013SLR36757026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf 8/9/2013
AP010/15/2013SLR37457027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf 10/18/2013
AP010/15/2013SLR37514027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf 10/22/2013




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