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FDA Drug Application 020165 by SANOFI AVENTIS US

Application Number020165
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
AP011/7/1991N       
AP07/22/1992SCM       
AP07/22/1992SCM       
AP08/12/1992SCM       
AP07/19/1993SCS       
AP07/19/1993SCS       
AP01/23/1996SCP       
AP08/2/1996SE6       
AP09/11/1997SCP       
AP08/21/1997SCM       
AP08/21/1997SCM       
AP09/14/1999SCS       
AP02/16/2000SLR       
AP02/16/2000SCF       
AP09/21/2000SCM       
AP06/8/2001SLR       
AP08/13/2002SLR2951020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20165slr020ltr.pdf 8/13/2002
AP08/13/2002SLR18553020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020165_S020_NICODERM CQ.pdf 11/19/2007
AP09/15/2006SLR14838023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020165s023lbl.pdf 9/18/2006
AP09/15/2006SLR14911023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020165s023ltr.pdf 9/20/2006
AP04/13/2007SLR16229024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020165s024lbl.pdf 4/19/2007
AP04/13/2007SLR16245024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020165s024ltr.pdf 4/20/2007
AP02/20/2014SCM       
AP09/20/2012SLR33825028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020165Orig1s028ltr.pdf 9/24/2012
AP04/30/2014SLR39190029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020165Orig1s029ltr.pdf 5/1/2014
AP04/30/2014SLR39238029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020165Orig1s029lbl.pdf 5/6/2014
AP010/31/2013SLR37702031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020165Orig1s031ltr.pdf 11/6/2013
AP010/31/2013SLR37859031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020165Orig1s031lbl.pdf 11/19/2013
AP02/3/2015SLR41781034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s034ltr.pdf 2/5/2015
AP02/3/2015SLR41861034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s034lbl.pdf 2/17/2015
AP08/6/2015SLR43604035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s035ltr.pdf 8/10/2015
AP08/6/2015SLR43611035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s035lbl.pdf 8/10/2015
AP010/7/2015SLR44188036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020165Orig1s036ltr.pdf 10/13/2015
AP010/7/2015SLR44601036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s036lbl.pdf 11/25/2015
AP010/26/2015SCM       
AP05/4/2016SLR45881038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020165Orig1s038ltr.pdf 5/6/2016
AP05/4/2016SLR45884038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20165Orig1s038lbl.pdf 5/6/2016




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