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FDA Drug Application 022101 by ASTRAZENECA PHARMS

Application Number022101
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
AP02/27/2008N19320000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022101lbl.pdf 2/28/2008
AP02/27/2008N19346000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022101s000ltr.pdf 2/29/2008
AP02/27/2008N25043000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022101_nexium_toc.cfm 3/17/2010
AP02/27/2008N25044000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022101s000sumr.pdf 3/17/2010
AP02/27/2008N31059000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP02/27/2008N33941000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322355.pdf 10/3/2012
AP01/15/2009SLR21651001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s031,021957s003,022101s001lbl.pdf 1/16/2009
AP01/15/2009SLR21663001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s031, 021957s003, 022101s001ltr.pdf 1/21/2009
AP010/9/2009SLR23579003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021153s033,022101s003lbl.pdf 10/14/2009
AP010/9/2009SLR24143003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021153s033,022101s003ltr.pdf 11/25/2009
AP03/4/2010SLR24987004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf 3/5/2010
AP03/4/2010SLR25005004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf 3/8/2010
AP06/21/2011SLR29282005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf 6/27/2011
AP06/21/2011SLR29330005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s005,021153s035,021957s008lbl.pdf 6/29/2011
AP09/3/2010SLR26438006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s036,021957s009,022101s006ltr.pdf 9/9/2010
AP09/3/2010SLR26455006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021153s036,021957s009,022101s006lbl.pdf 9/10/2010
AP06/30/2011SLR29404007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf 7/6/2011
AP06/30/2011SLR29432007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022101s007,021153s038,021957s010lbl.pdf 7/6/2011
AP01/20/2012SLR31481008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022101s008,021153s040,021957s011ltr.pdf 1/24/2012
AP01/20/2012SLR31496008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s040,021957s011,022101s008lbl.pdf 1/24/2012
AP010/9/2012SLR34032009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s042,021957Orig1s012,022101Orig1s009ltr.pdf 10/11/2012
AP010/9/2012SLR34070009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009lbl.pdf 10/12/2012
AP010/9/2012SLR34071009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s042,021957s012,022101s009mg.pdf 10/12/2012
AP09/28/2012SLR33895010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s043_02195sS013_02210s010lbl.pdf 10/1/2012
AP09/28/2012SLR33908010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s043,021957Orig1s013,022101Orig1s010ltr.pdf 10/2/2012
AP011/28/2012SLR34507011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021153Orig1s044,021957Orig1s014,022101Orig1s011ltr.pdf 11/29/2012
AP011/28/2012SLR34578011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011lbl.pdf 12/10/2012
AP011/28/2012SLR34579011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021153s044,021957s014,022101s011mg.pdf 12/10/2012
AP03/27/2014SLR38926012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s046,021957Orig1s015,022101Orig1s012ltr.pdf 3/28/2014
AP03/27/2014SLR38944012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s046,021957s015,022101s012lbl.pdf 4/1/2014
AP02/25/2014SLR38615013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s049,021957Orig1s016,022101Orig1s013ltr.pdf 2/27/2014
AP02/25/2014SLR38628013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021153s049,021957s016,022101s013lbl.pdf 2/27/2014
AP012/19/2014SLR41393014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021153Orig1s050,021957Orig1s017,022101Orig1s014ltr.pdf 12/24/2014
AP012/19/2014SLR41415014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf 12/29/2014
AP010/24/2016SLR47457016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021153Orig1s052,022101Orig1s016,021957Orig1s019ltr.pdf 10/26/2016
AP010/24/2016SLR47500016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021153s052_22101s016_21957s019lbl.pdf 10/28/2016




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