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FDA Drug Application 020786 by SANOFI AVENTIS US

Application Number020786
Application Type New Drug Application
Sponsor ApplicantSANOFI AVENTIS US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/1997N25613000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020786_allegra-d_toc.cfm 5/25/2010
AP07/6/1998SCM20537001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s001_ALLEGRA TABS.pdf 8/8/2008
AP012/21/1999SCS20517002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s002_ALLEGRA D.pdf 8/8/2008
AP012/22/1998SLR20536003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s003_ALLEGRA TABS.pdf 8/8/2008
AP01/21/2000SCS20477004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s004_ALLEGRA CAPSULES.pdf 8/4/2008
AP012/1/1999SCS20516005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s005_ALLEGRA D.pdf 8/8/2008
AP01/6/2000SCM20476006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s006_ALLEGRA CAPSULES.pdf 8/4/2008
AP09/26/2000SCP       
AP01/19/2001SCS20459009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020786_s009_ALLEGRA D.pdf 8/4/2008
AP010/29/2002SCM       
AP011/1/2002SLR17516012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020786_S012_ALLEGRA D.pdf 8/6/2007
AP011/1/2002SLR3467012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20786slr012ltr.pdf 11/1/2002
AP010/31/2001SCS       
AP05/12/2003SE85669014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf 5/29/2003
AP05/12/2003SE85829014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf 6/8/2003
AP012/6/2004SLR       
AP04/14/2010SLR25287026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020786s026ltr.pdf 4/19/2010
AP04/14/2010SLR25296026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf 4/19/2010
AP01/24/2011SE627628027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020786s027ltr.pdf 1/27/2011
AP01/24/2011SE632234027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020786Orig1s027lbl.pdf 3/27/2012
AP02/3/2012SCM31756028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010ltr.pdf 2/13/2012
AP08/23/2012SLR33554029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s029ltr(r).pdf 8/27/2012
AP08/23/2012SLR34042029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s029lbl.pdf 10/12/2012
AP012/5/2012SLR34588031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s031ltr.pdf 12/11/2012
AP012/5/2012SLR34854031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf 1/8/2013
AP05/14/2014SCM       
AP06/8/2015SE843032033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020786Orig1s033,021704Orig1s017ltr.pdf 6/10/2015
AP06/8/2015SE843078033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf 6/19/2015
AP07/9/2015SCM       
AP06/2/2016SLR46266035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020786Orig1s035,021704Orig1s018ltr.pdf 6/7/2016
AP06/2/2016SLR46290035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf 6/10/2016




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