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FDA Drug Application 021081 by SANOFI AVENTIS US

Application Number021081
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
AP04/20/2000N1137000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21081ltr.pdf 4/20/2000
AP04/20/2000N1138000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21081lbl.pdf 4/20/2000
AP04/20/2000N2665000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21081_Lantus.cfm 3/18/2002
AP04/20/2000N30539000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm239389.htm 11/9/2011
AP011/17/2000SCS       
AP03/7/2001SCM       
AP01/31/2001SCS       
AP08/15/2002SCS       
AP05/1/2003SE25582005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021081s025lbl.pdf 5/6/2003
AP05/1/2003SE25753005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21081se2-005ltr.pdf 5/30/2003
AP08/10/2004SCP9995011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21081s011ltr.pdf 8/11/2004
AP08/10/2004SCP9997011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21081s011lbl.pdf 8/11/2004
AP02/11/2005SCP11124014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21081s014ltr.pdf 2/17/2005
AP02/11/2005SCP11133014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s014lbl.pdf 2/17/2005
AP03/15/2005SCF11258017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21081s017ltr.pdf 3/18/2005
AP03/15/2005SCF11271017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21081s017lbl.pdf 3/18/2005
AP03/15/2005SCF23450017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021081_s017_Lantus.pdf 9/17/2009
AP04/25/2007SCP16351024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021081s024lbl.pdf 5/1/2007
AP04/25/2007SCP16392024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021081s024ltr.pdf 5/1/2007
AP04/25/2007SCP34976024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021081Orig1s024.pdf 1/24/2013
AP09/9/2009SE823401034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021081s034lbl.pdf 9/18/2009
AP09/9/2009SE823755034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021081s034ltr.pdf 11/9/2009
AP09/9/2009SE834352034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021081Orig1s034.pdf 11/9/2012
AP08/14/2013SCM       
AP05/16/2013SLR36088055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021081Orig1s055ltr.pdf 5/17/2013
AP05/16/2013SLR36103055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021081s055lbl.pdf 5/21/2013
AP03/27/2013SCM       
AP010/18/2013SE837491057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021081Orig1s057ltr.pdf 10/22/2013
AP010/18/2013SE837521057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021081s057lbl.pdf 10/22/2013
AP07/18/2013SCM       
AP06/5/2013SCM       
AP09/5/2014SCM       
AP02/25/2015SLR41929062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021081Orig1s062ltr.pdf 2/27/2015
AP02/25/2015SLR42007062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s062lbl.pdf 3/3/2015
AP07/17/2015SE843410063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021081Orig1s063ltr.pdf 7/20/2015
AP07/17/2015SE843444063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021081s063lbl.pdf 7/22/2015
AP06/16/2015SCM       
AP04/13/2016SCM       




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