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FDA Drug Application 019810 by ASTRAZENECA PHARMS

Application Number019810
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/14/1989N33942000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322359.pdf 10/3/2012
AP09/14/1989N31060000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP010/26/1989SLR       
AP06/12/1991SE1       
AP02/23/2004SLR7769003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19810se8-058,slr003ltr.pdf 3/2/2004
AP02/23/2004SLR8194003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058,slr003_prilosec_lbl.pdf 4/5/2004
AP02/23/2004SLR17322003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019810_S003_S058_PRILOSEC.pdf 7/20/2007
AP09/14/1992SCM       
AP07/19/1990SLR       
AP01/3/1991SLR       
AP01/27/1992SCM17171008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019810_S008_OMEPRAZOLE_AP.pdf 7/9/2007
AP03/9/1995SLR       
AP03/9/1995SLR       
AP05/26/1993SCM       
AP03/19/1993SCS       
AP010/21/1992SCP       
AP06/15/1993SCM       
AP06/29/1993SCP       
AP011/4/1997SLR       
AP06/22/1995SE1       
AP010/13/1994SCM       
AP012/22/1993SCP       
AP03/9/1995SLR       
AP010/5/1995SCF       
AP06/16/1995SLR       
AP010/19/1995SCP       
AP012/29/1994SCP       
AP01/20/1995SCF       
AP01/27/1995SCS       
AP01/31/1995SCM       
AP03/23/1995SCM       
AP03/23/1995SCS       
AP03/22/1996SE1       
AP011/9/1995SCM       
AP03/9/1995SLR       
AP011/26/1996SE13766036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019810ap.pdf 11/4/1997
AP04/15/1996SE1       
AP01/15/1998SCF143038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm 1/15/1998
AP09/11/1996SCS       
AP08/9/1996SLR       
AP04/18/1997SCM       
AP04/4/1997SCM       
AP02/18/1999SCS       
AP04/15/1997SLR       
AP09/3/1997SCM       
AP01/7/1998SCP3895050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm 1/7/1998
AP06/17/1997SCS       
AP07/30/1998SCM       
AP08/17/1998SCP       
AP012/1/1998SCS       
AP06/30/1998SE8       
AP07/10/1998SCP3896056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm 7/10/1998
AP02/3/1999SLR994057   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19810-S57_Prilosec.pdf 2/3/1999
AP02/23/2004SE87770058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19810se8-058,slr003ltr.pdf 3/2/2004
AP02/23/2004SE88193058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058,slr003_prilosec_lbl.pdf 4/5/2004
AP02/23/2004SE817323058   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019810_S003_S058_PRILOSEC.pdf 7/20/2007
AP03/13/2000SCE       
AP05/18/1999SCS       
AP02/14/2002SE83894061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19810s061ltr.pdf 2/14/2002
AP02/23/2000SLR3893062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19810-S062_Prilosec.pdf 2/23/2000
AP08/8/2000SCM       
AP03/16/2000SCM       
AP011/10/1999SCM       
AP05/16/2001SCP       
AP010/9/2003SLR6806067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_lbl.pdf 10/16/2003
AP010/9/2003SLR6804067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19810slr067,080ltr.pdf 10/16/2003
AP03/13/2000SCS       
AP07/27/2000SCS       
AP07/27/2000SCE       
AP02/4/2002SCP       
AP08/10/2000SCS       
AP010/30/2001SLR       
AP07/12/2002SE53891074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19810se5074ltr.pdf 7/12/2002
AP07/12/2002SE53892074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19810s074lbl.pdf 7/12/2002
AP05/10/2001SCP       
AP012/16/2002SLR3890076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19180slr076ltr.pdf 12/16/2002
AP012/19/2002SCS       
AP010/9/2003SLR6805080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19810slr067,080ltr.pdf 10/16/2003
AP010/9/2003SLR6807080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_lbl.pdf 10/16/2003
AP03/7/2005SLR11225082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19810s082ltr.pdf 3/10/2005
AP03/7/2005SLR11229082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19810s082lbl.pdf 3/10/2005
AP01/26/2006SLR13506083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s083lbl.pdf 1/27/2006
AP01/26/2006SLR13535083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019810s083ltr.pdf 1/30/2006
AP09/25/2006SLR14984084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s084lbl.pdf 9/26/2006
AP09/25/2006SLR15008084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019810s084LTR.pdf 9/27/2006
AP04/27/2007SLR16341085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019810s085lbl.pdf 5/1/2007
AP04/27/2007SLR16380085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019810s085ltr.pdf 5/1/2007
AP012/1/2008SLR21315087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019810s087, 022056s001ltr.pdf 12/4/2008
AP012/1/2008SLR21324087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf 12/4/2008
AP03/3/2010SLR24969088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf 3/5/2010
AP03/3/2010SLR24995088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s088,022056s003ltr.pdf 3/8/2010
AP09/3/2010SLR26417090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005ltr.pdf 9/8/2010
AP09/3/2010SLR26464090   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf 9/10/2010
AP06/30/2011SLR29403091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022056s007,019810s091ltr.pdf 7/6/2011
AP06/30/2011SLR29431091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf 7/6/2011
AP01/20/2011SLR27576092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf 1/24/2011
AP01/20/2011SLR27594092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s092,022056s008ltr.pdf 1/25/2011
AP05/20/2011SLR28939093   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s093,022056s009ltr.pdf 5/25/2011
AP05/20/2011SLR28954093   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf 5/25/2011
AP01/20/2012SLR31479094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010ltr.pdf 1/24/2012
AP01/20/2012SLR31686094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf 2/6/2012
AP010/9/2012SLR34035095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056Orig1s011ltr.pdf 10/11/2012
AP010/9/2012SLR34066095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011mg.pdf 10/12/2012
AP010/9/2012SLR34069095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf 10/12/2012
AP09/28/2012SLR33891096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf 10/1/2012
AP09/28/2012SLR33897096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s096,022056Orig1s012ltr.pdf 10/2/2012
AP05/15/2013SLR36080097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019810Orig1s097,022056Orig1s013ltr.pdf 5/16/2013
AP05/15/2013SLR36110097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf 5/21/2013
AP03/27/2014SLR38942098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf 4/1/2014
AP03/27/2014SLR39033098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s098,022056Orig1s014ltr.pdf 4/14/2014
AP02/25/2014SLR38611099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056Orig1s015ltr.pdf 2/27/2014
AP02/25/2014SLR38626099   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf 2/27/2014
AP012/19/2014SLR41385101   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s101,022056Orig1s017ltr.pdf 12/24/2014
AP012/19/2014SLR41419101   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf 12/29/2014
AP010/24/2016SLR47451103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s103,022056Orig1s020ltr.pdf 10/26/2016
AP010/24/2016SLR47533103   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf 10/31/2016




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