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FDA Drug Application 022056 by ASTRAZENECA PHARMS

Application Number022056
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
AP03/20/2008N25041000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056_prilosec_toc.cfm 3/16/2010
AP03/20/2008N25042000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022056s000SumR.pdf 3/16/2010
AP03/20/2008N19514000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056lbl.pdf 3/24/2008
AP03/20/2008N19520000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022056s000ltr.pdf 3/24/2008
AP03/20/2008N31061000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP03/20/2008N33943000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322359.pdf 10/3/2012
AP012/1/2008SLR21316001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019810s087, 022056s001ltr.pdf 12/4/2008
AP012/1/2008SLR21325001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf 12/4/2008
AP03/3/2010SLR24971003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf 3/5/2010
AP03/3/2010SLR24996003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s088,022056s003ltr.pdf 3/8/2010
AP09/3/2010SLR26418005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005ltr.pdf 9/8/2010
AP09/3/2010SLR26463005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf 9/10/2010
AP06/30/2011SLR29402007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022056s007,019810s091ltr.pdf 7/6/2011
AP06/30/2011SLR29430007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf 7/6/2011
AP01/20/2011SLR27575008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf 1/24/2011
AP01/20/2011SLR27595008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s092,022056s008ltr.pdf 1/25/2011
AP05/20/2011SLR28940009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s093,022056s009ltr.pdf 5/25/2011
AP05/20/2011SLR28953009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf 5/25/2011
AP01/20/2012SLR31480010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010ltr.pdf 1/24/2012
AP01/20/2012SLR31685010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf 2/6/2012
AP010/9/2012SLR34036011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056Orig1s011ltr.pdf 10/11/2012
AP010/9/2012SLR34067011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011mg.pdf 10/12/2012
AP010/9/2012SLR34068011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf 10/12/2012
AP09/28/2012SLR33892012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf 10/1/2012
AP09/28/2012SLR33898012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s096,022056Orig1s012ltr.pdf 10/2/2012
AP05/13/2013SLR36081013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019810Orig1s097,022056Orig1s013ltr.pdf 5/16/2013
AP05/13/2013SLR36109013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf 5/21/2013
AP03/27/2014SLR38941014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf 4/1/2014
AP03/27/2014SLR39034014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s098,022056Orig1s014ltr.pdf 4/14/2014
AP02/25/2014SLR38612015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056Orig1s015ltr.pdf 2/27/2014
AP02/25/2014SLR38627015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf 2/27/2014
AP012/19/2014SLR41386017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s101,022056Orig1s017ltr.pdf 12/24/2014
AP012/19/2014SLR41418017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf 12/29/2014
AP02/3/2016SLR45118018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022056Orig1s018ltr.pdf 2/4/2016
AP02/3/2016SLR45155018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022056s018lbl.pdf 2/11/2016
AP010/24/2016SLR47452020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s103,022056Orig1s020ltr.pdf 10/26/2016
AP010/24/2016SLR47532020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf 10/31/2016




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