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FDA Drug Application 021229 by ASTRAZENECA PHARMS

Application Number021229
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; New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/20/2003N11366000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-229_Prilosec.cfm 4/8/2005
AP06/20/2003N6006000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21229ltr_Prilosec.pdf 6/24/2003
AP06/20/2003N6009000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21229lbl_Part2.pdf 6/20/2003
AP06/20/2003N6010000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 6/20/2003
AP012/20/2004SLR10850002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21229s002ltr.pdf 12/30/2004
AP012/20/2004SLR10888002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21229s002lbl.pdf 12/30/2004
AP010/2/2006SLR15046005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021229s005LTR.pdf 10/5/2006
AP010/2/2006SLR15061005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021229s005lbl.pdf 10/5/2006
AP03/19/2007SLR16079006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021229s006ltr.pdf 3/23/2007
AP03/19/2007SLR16088006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021229s006lbl.pdf 3/23/2007
AP01/18/2008SLR18940008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s008ltr.pdf 1/24/2008
AP02/29/2008SCP19347009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s009ltr.pdf 3/4/2008
AP06/18/2008SCP20044010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s010ltr.pdf 6/20/2008
AP09/9/2009SLR23789013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021229s013ltr.pdf 11/10/2009
AP07/6/2010SLR25942014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021229s014ltr.pdf 7/8/2010
AP012/20/2010SLR27352017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021229s017ltr.pdf 12/22/2010
AP02/25/2011SLR28004019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s019ltr.pdf 3/2/2011
AP06/20/2011SLR29356020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s020ltr.pdf 6/29/2011
AP07/22/2011SLR29586021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s021ltr.pdf 7/25/2011
AP06/16/2011SCM       
AP08/29/2011SLR29935023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s023ltr.pdf 8/31/2011
AP08/29/2011SLR32236023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021229Orig1s023lbl.pdf 3/27/2012
AP09/13/2012SLR33750024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021229Orig1s024ltr.pdf 9/14/2012
AP09/6/2013SLR37037025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021229Orig1s025ltr.pdf 9/10/2013
AP09/6/2013SLR37161025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021229Orig1s025lbl.pdf 9/19/2013
AP06/22/2015SLR43108026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021229Orig1s026ltr.pdf 6/24/2015
AP06/22/2015SLR43223026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021229Orig1s026lbl.pdf 7/2/2015
AP05/15/2014SCM       
AP010/12/2016SLR47360029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021229Orig1s029ltr.pdf 10/14/2016
AP010/12/2016SLR47403029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021229Orig1s029lbl.pdf 10/20/2016




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