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FDA Drug Application 021689 by ASTRAZENECA PHARMS

Application Number021689
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
AP03/31/2005N11347000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021689ltr.pdf 4/6/2005
AP03/31/2005N11353000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021689lbl.pdf 4/6/2005
AP03/31/2005N17501000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021689s000TOC.cfm 8/6/2007
AP03/31/2005N31057000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP01/12/2006SLR13389002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s002lbl.pdf 1/13/2006
AP01/12/2006SLR13458002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s002ltr.pdf 1/20/2006
AP02/16/2006SLR13638003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689S003lbl.pdf 2/22/2006
AP02/16/2006SLR13692003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s003ltr.pdf 3/1/2006
AP09/14/2006SLR14835006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s006lbl.pdf 9/18/2006
AP09/14/2006SLR14913006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s006ltr.pdf 9/20/2006
AP09/26/2006SLR15003007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021689s007lbl.pdf 9/27/2006
AP09/26/2006SLR15042007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021689s007ltr.pdf 10/2/2006
AP04/27/2007SLR16336008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf 5/1/2007
AP04/27/2007SLR16378008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021153s027, 021689s008ltr.pdf 5/1/2007
AP04/27/2007SLR16337011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021153s027s028,021689s008s011lbl.pdf 5/1/2007
AP01/15/2009SLR21647012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf 1/16/2009
AP01/15/2009SLR21665012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021689s012,021689s013ltr.pdf 1/21/2009
AP01/15/2009SLR21666013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021689s012,021689s013ltr.pdf 1/21/2009
AP01/15/2009SLR21648013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021689s012s013lbl.pdf 1/16/2009
AP03/4/2014SE838669014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s014lbl.pdf 3/5/2014
AP03/4/2014SE838675014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s014ltr.pdf 3/6/2014
AP03/4/2010SLR24981015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022101s004,021153s034,021957s007,021689s015lbl.pdf 3/5/2010
AP03/4/2010SLR25003015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021153s034,021689s015,021957s007,022101s004ltr.pdf 3/8/2010
AP06/21/2011SLR29285016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s005,021153s035,021957s008,021689s016ltr.pdf 6/27/2011
AP06/21/2011SLR29331016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s016lbl.pdf 6/29/2011
AP04/29/2011SE528663017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s017lbl.pdf 4/29/2011
AP04/29/2011SE528693017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021689s017ltr.pdf 5/4/2011
AP09/3/2010SLR26431018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021689s018ltr.pdf 9/8/2010
AP09/3/2010SLR26458018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021689s018lbl.pdf 9/10/2010
AP06/30/2011SLR29407020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022101s007,021153s038,021957s010,021689s020ltr.pdf 7/6/2011
AP06/30/2011SLR29435020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021689s020lbl.pdf 7/6/2011
AP01/20/2012SLR31485022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689s022ltr.pdf 1/24/2012
AP01/20/2012SLR31499022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s022lbl.pdf 1/24/2012
AP010/9/2012SLR34046025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689Orig1s025ltr.pdf 10/12/2012
AP010/9/2012SLR34083025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s025lbl.pdf 10/12/2012
AP09/28/2012SLR33890026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021689s026lbl.pdf 10/1/2012
AP09/28/2012SLR33915026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021689Orig1s026ltr.pdf 10/2/2012
AP03/27/2014SLR38943027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s027lbl.pdf 4/1/2014
AP03/27/2014SLR39032027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s027ltr.pdf 4/14/2014
AP02/25/2014SLR38610028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s028ltr.pdf 2/27/2014
AP02/25/2014SLR38672028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s028lbl.pdf 3/5/2014
AP010/20/2014SCM       
AP012/19/2014SLR41365030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021689Orig1s030ltr.pdf 12/23/2014
AP012/19/2014SLR41420030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021689s030lbl.pdf 12/29/2014
AP010/24/2016SLR47448032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021689Orig1s032ltr.pdf 10/26/2016
AP010/24/2016SLR47536032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021689s032lbl.pdf 10/31/2016




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