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FDA Drug Application 020872 by SANOFI AVENTIS US

Application Number020872
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
AP02/25/2000N456000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20872ltr.pdf 2/25/2000
AP02/25/2000N457000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20872lbl.pdf 2/25/2000
AP02/25/2000N8612000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-872_Allegra.cfm 5/26/2004
AP04/14/2000SCM3462001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf 10/29/2001
AP04/14/2000SCM8613001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf 5/26/2004
AP03/21/2000SCP3463002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf 10/29/2001
AP03/21/2000SCP8614002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf 5/26/2004
AP05/12/2003SE85672003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf 5/29/2003
AP05/12/2003SE85835003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf 6/8/2003
AP05/30/2001SCS3464004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra_Approv.pdf 10/29/2001
AP05/30/2001SCS8615004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf 5/26/2004
AP01/5/2001SCM20457005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020872_s005_ALLEGRA_TABLETS.pdf 8/4/2008
AP07/11/2001SLR3466007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf 7/11/2001
AP02/20/2002SCS20435008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s008_ALLEGRA_TABLETS.pdf 8/1/2008
AP012/10/2002SCM20434009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s009_ALLEGRA_TABLETS.pdf 8/1/2008
AP010/10/2002SCM20433010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s010_ALLEGRA_TABLETS.pdf 8/1/2008
AP05/12/2003SE85670011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf 5/29/2003
AP05/12/2003SE85830011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf 6/8/2003
AP010/13/2005SE212896015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020872s015ltr.pdf 10/19/2005
AP010/13/2005SE212908015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020872s015lbl.pdf 10/19/2005
AP06/25/2008SLR20100018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021963s002, 020872s018ltr.pdf 6/30/2008
AP06/25/2008SLR20105018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020872s018,021963s002lbl.pdf 6/30/2008
AP01/24/2011SE627627023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020872s023ltr.pdf 1/27/2011
AP01/24/2011SE637915023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020872Orig1s023lbl.pdf 11/26/2013
AP02/23/2012SLR31910025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872s025ltr.pdf 2/27/2012
AP02/23/2012SLR32233025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s025lbl.pdf 3/27/2012
AP08/23/2012SLR33556029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020872Orig1s029ltr.pdf 8/27/2012
AP08/23/2012SLR34365029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020872Orig1s029lbl.pdf 11/13/2012
AP04/16/2013SCM       
AP04/16/2014SCM39087031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s031ltr.pdf 4/17/2014
AP04/16/2014SCM40166031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s031bl.pdf 8/6/2014
AP09/12/2014SLR40486032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020872Orig1s032ltr.pdf 9/16/2014
AP09/12/2014SLR40569032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020872Orig1s032lbl.pdf 9/23/2014
AP012/2/2014SCM       
AP09/24/2015SCM       
AP09/18/2015SCM       
AP03/23/2016SCM       
AP05/10/2016SLR46019038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020872Orig1s038ltr.pdf 5/12/2016
AP05/10/2016SLR46020038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020872Orig1s038lbl.pdf 5/12/2016




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