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FDA Drug Application 020468 by SANOFI AVENTIS US

Application Number020468
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/20/1996N       
AP08/23/1996SCS20568001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020468_s001_NASACORT AQ.pdf 8/11/2008
AP09/26/1997SE1       
AP010/15/1996SCS       
AP08/17/2000SCS       
AP03/12/2002SCM       
AP05/6/2002SCP       
AP012/17/2003SLR7296011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20468slr011ltr.pdf 12/22/2003
AP012/17/2003SLR7442011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr011_nasacort_lbl.pdf 12/29/2003
AP012/23/2003SLR7488012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20468slr012ltr.pdf 1/9/2004
AP012/23/2003SLR7549012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr012_nasacort_lbl.pdf 1/15/2004
AP03/8/2004SLR7858013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20468slr013ltr.pdf 3/10/2004
AP03/8/2004SLR8256013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20468slr013_nasacort_lbl.pdf 4/5/2004
AP012/7/2013SCM       
AP09/19/2008SE520872024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020468s024ltr.pdf 9/23/2008
AP09/19/2008SE520885024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020468s024lbl.pdf 9/25/2008
AP07/2/2013SE836438033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s033,s034ltr.pdf 7/3/2013
AP07/2/2013SE836445033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf 7/3/2013
AP07/2/2013SE836439034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s033,s034ltr.pdf 7/3/2013
AP07/2/2013SE836446034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf 7/3/2013
AP010/11/2013SE637415035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s035ltr.pdf 10/11/2013
AP010/11/2013SE637417035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468Orig1s035lbl.pdf 10/15/2013
AP05/24/2013SCM       
AP012/7/2013SCM       
AP06/12/2014SCM       
AP09/19/2014SLR40550039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020468Orig1s039lbl.pdf 9/23/2014
AP09/19/2014SLR40576039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020468Orig1s039ltr.pdf 9/23/2014
AP06/18/2015SLR43090040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020468Orig1s040ltr.pdf 6/22/2015
AP06/18/2015SLR43098040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020468Orig1s040lbl.pdf 6/22/2015
AP03/22/2016SCM       
AP09/22/2016SLR47315042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020468Orig1s042lbl.pdf 10/11/2016
AP09/22/2016SLR47344042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020468Orig1s042ltr.pdf 10/12/2016




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