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FDA Drug Application 021153 by ASTRAZENECA PHARMS

Application Number021153
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/20/2001N4828000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium_Approv.pdf 2/20/2001
AP02/20/2001N4829000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21153lbl.pdf 2/20/2001
AP02/20/2001N2950000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21154_Nexium.cfm 2/20/2001
AP02/20/2001N31056000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP02/20/2001N33939000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322355.pdf 10/3/2012
AP05/16/2001SCM       
AP05/16/2001SCM       
AP03/14/2002SCM       
AP02/27/2003SLR4231004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21153slr004ltr.pdf 3/10/2003
AP09/20/2002SLR8338005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-153S005_review.pdf 4/14/2004
AP09/20/2002SLR2949005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21153slr005ltr.pdf 9/20/2002
AP010/1/2002SCE       
AP01/9/2004SLR34053008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021153Orig1s008.pdf 10/12/2012
AP01/9/2004SLR7526008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr008ltr.pdf 1/14/2004
AP01/9/2004SLR7562008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr008_nexium_lbl.pdf 1/15/2004
AP04/23/2004SLR8422015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153slr015ltr.pdf 4/29/2004
AP04/23/2004SLR8493015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153slr015_nexium_lbl.pdf 5/4/2004
AP04/23/2004SLR19197015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021153_S015_NEXIUM_DELAYED_RELEASE.pdf 2/19/2008
AP011/24/2004SE110677019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21153s019ltr.pdf 12/2/2004
AP011/24/2004SE110716019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21153s019lbl.pdf 12/3/2004
AP06/6/2005SLR11777020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021153s020ltr.pdf 6/8/2005
AP06/6/2005SLR11778020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021153s020lbl.pdf 6/8/2005
AP02/16/2006SLR13631021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s021lbl.pdf 2/22/2006
AP02/16/2006SLR13696021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s021ltr.pdf 3/1/2006
AP04/28/2006SE514043022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s022LTR.pdf 5/2/2006
AP04/28/2006SE514047022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf 5/2/2006
AP010/11/2006SE115086023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s023lbl.pdf 10/13/2006
AP010/11/2006SE115113023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s023LTR.pdf 10/18/2006
AP09/15/2006SLR14836024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s024lbl.pdf 9/18/2006
AP09/15/2006SLR14903024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s024ltr.pdf 9/20/2006
AP09/26/2006SLR15002025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s025lbl.pdf 9/27/2006
AP09/26/2006SLR15044025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021153s025ltr.pdf 10/2/2006
AP04/27/2007SLR16338027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf 5/1/2007
AP04/27/2007SLR16379027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021153s027, 021689s008ltr.pdf 5/1/2007
AP04/27/2007SLR16339028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf 5/1/2007
AP01/11/2008SLR18912029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021957s001,021153s029ltr.pdf 1/18/2008
AP01/15/2009SLR21649031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf 1/16/2009
AP01/15/2009SLR21661031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s031, 021957s003, 022101s001ltr.pdf 1/21/2009
AP010/9/2009SLR23580033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf 10/14/2009
AP010/9/2009SLR24142033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s033,022101s003ltr.pdf 11/25/2009
AP03/4/2010SLR24986034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf 3/5/2010
AP03/4/2010SLR25002034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf 3/8/2010
AP06/21/2011SLR29283035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf 6/27/2011
AP06/21/2011SLR29329035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf 6/29/2011
AP09/3/2010SLR26436036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,022101s006ltr.pdf 9/9/2010
AP09/3/2010SLR26457036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf 9/10/2010
AP06/30/2011SLR29405038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf 7/6/2011
AP06/30/2011SLR29433038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf 7/6/2011
AP01/20/2012SLR31482040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,021957s011ltr.pdf 1/24/2012
AP01/20/2012SLR31498040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf 1/24/2012
AP010/9/2012SLR34030042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957Orig1s012,022101Orig1s009ltr.pdf 10/11/2012
AP010/9/2012SLR34074042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf 10/12/2012
AP010/9/2012SLR34075042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009mg.pdf 10/12/2012
AP09/28/2012SLR33893043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf 10/1/2012
AP09/28/2012SLR33906043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957Orig1s013,022101Orig1s010ltr.pdf 10/2/2012
AP011/28/2012SLR34505044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s044,021957Orig1s014,022101Orig1s011ltr.pdf 11/29/2012
AP011/28/2012SLR34582044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf 12/10/2012
AP011/28/2012SLR34583044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011mg.pdf 12/10/2012
AP06/17/2013SCM40130045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s045.pdf 8/5/2014
AP03/27/2014SLR38924046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957Orig1s015,022101Orig1s012ltr.pdf 3/28/2014
AP03/27/2014SLR38946046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf 4/1/2014
AP010/4/2013SCM40131047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021153Orig1s047.pdf 8/5/2014
AP02/14/2014SCM40132048   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021153Orig1s048.pdf 8/5/2014
AP02/25/2014SLR38613049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957Orig1s016,022101Orig1s013ltr.pdf 2/27/2014
AP02/25/2014SLR38670049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf 3/5/2014
AP012/19/2014SLR41391050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957Orig1s017,022101Orig1s014ltr.pdf 12/24/2014
AP012/19/2014SLR41417050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf 12/29/2014
AP010/24/2016SLR47456052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021153Orig1s052,022101Orig1s016,021957Orig1s019ltr.pdf 10/26/2016
AP010/24/2016SLR47499052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf 10/28/2016




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