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FDA Drug Application 021957 by ASTRAZENECA PHARMS

Application Number021957
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA PHARMS
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
AP010/20/2006N15249000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021957s000ltr.pdf 10/26/2006
AP010/20/2006N16103000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021957lbl.pdf 3/27/2007
AP010/20/2006N20743000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021957_nexium_toc.cfm 9/5/2008
AP010/20/2006N31058000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP010/20/2006N33940000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322355.pdf 10/3/2012
AP01/11/2008SLR18911001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021957s001,021153s029ltr.pdf 1/18/2008
AP01/15/2009SLR21650003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf 1/16/2009
AP01/15/2009SLR21662003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s031, 021957s003, 022101s001ltr.pdf 1/21/2009
AP012/15/2011SE831246004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021957s004lbl2.pdf 12/23/2011
AP012/15/2011SE831283004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021957s004ltr.pdf 12/28/2011
AP06/18/2009SE822822005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021957s005lbl.pdf 6/24/2009
AP06/18/2009SE826531005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021957s005ltr.pdf 9/23/2010
AP03/4/2010SLR24984007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf 3/5/2010
AP03/4/2010SLR25004007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf 3/8/2010
AP06/21/2011SLR29284008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf 6/27/2011
AP06/21/2011SLR29328008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf 6/29/2011
AP09/3/2010SLR26437009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,022101s006ltr.pdf 9/9/2010
AP09/3/2010SLR26456009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf 9/10/2010
AP06/30/2011SLR29406010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf 7/6/2011
AP06/30/2011SLR29434010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf 7/6/2011
AP01/20/2012SLR31483011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,021957s011ltr.pdf 1/24/2012
AP01/20/2012SLR31497011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf 1/24/2012
AP010/9/2012SLR34031012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957Orig1s012,022101Orig1s009ltr.pdf 10/11/2012
AP010/9/2012SLR34072012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009mg.pdf 10/12/2012
AP010/9/2012SLR34073012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf 10/12/2012
AP09/28/2012SLR33894013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf 10/1/2012
AP09/28/2012SLR33907013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957Orig1s013,022101Orig1s010ltr.pdf 10/2/2012
AP011/28/2012SLR34506014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s044,021957Orig1s014,022101Orig1s011ltr.pdf 11/29/2012
AP011/28/2012SLR34580014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011mg.pdf 12/10/2012
AP011/28/2012SLR34581014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf 12/10/2012
AP03/27/2014SLR38925015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957Orig1s015,022101Orig1s012ltr.pdf 3/28/2014
AP03/27/2014SLR38945015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf 4/1/2014
AP02/25/2014SLR38614016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957Orig1s016,022101Orig1s013ltr.pdf 2/27/2014
AP02/25/2014SLR38671016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf 3/5/2014
AP012/19/2014SLR41392017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957Orig1s017,022101Orig1s014ltr.pdf 12/24/2014
AP012/19/2014SLR41416017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf 12/29/2014
AP010/24/2016SLR47459019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021153Orig1s052,022101Orig1s016,021957Orig1s019ltr.pdf 10/26/2016
AP010/24/2016SLR47501019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf 10/28/2016




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