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FDA Drug Application 021773 by ASTRAZENECA AB

Application Number021773
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA AB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/28/2005N11571000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021773ltr.pdf 5/3/2005
AP04/28/2005N11572000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021773lbl.pdf 5/3/2005
AP04/28/2005N12533000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_ByettaTOC.cfm 8/4/2005
AP04/28/2005N23768000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113705.htm 11/2/2009
AP04/28/2005N23937000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191084.pdf 11/18/2009
AP012/22/2006SE115511002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf 12/28/2006
AP012/22/2006SE115611002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002, s006ltr.pdf 1/8/2007
AP010/12/2006SLR15087004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s004lbl.pdf 10/13/2006
AP010/12/2006SLR15114004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s004LTR.pdf 10/18/2006
AP011/1/2006SLR15293005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s005lbl.pdf 11/6/2006
AP011/1/2006SLR15306005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s005ltr.pdf 11/6/2006
AP012/22/2006SLR15512006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf 12/28/2006
AP012/22/2006SLR15612006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002, s006ltr.pdf 1/8/2007
AP02/10/2007SCS15826007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf 2/16/2007
AP02/10/2007SCS15885007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021773s007ltr.pdf 2/23/2007
AP010/30/2009SLR23720009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf 11/4/2009
AP010/30/2009SLR23929009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf 11/18/2009
AP06/17/2008SLR20040010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s010lbl.pdf 6/19/2008
AP06/17/2008SLR20045010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s010ltr.pdf 6/20/2008
AP010/30/2009SLR23721011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf 11/4/2009
AP010/30/2009SLR23930011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf 11/18/2009
AP01/11/2008SLR18875012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s012lbl.pdf 1/15/2008
AP01/11/2008SLR18910012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s012ltr.pdf 1/18/2008
AP010/30/2009SLR23722017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf 11/4/2009
AP010/30/2009SLR23931017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf 11/18/2009
AP010/30/2009SLR23723018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf 11/4/2009
AP010/30/2009SLR23932018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf 11/18/2009
AP010/30/2009SLR23724022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf 11/4/2009
AP010/30/2009SLR23933022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf 11/18/2009
AP010/30/2009SLR23725025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf 11/4/2009
AP010/30/2009SLR23934025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf 11/18/2009
AP08/13/2010SLR26269026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s026ltr.pdf 8/20/2010
AP011/12/2010SLR26965028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021773s028lbl.pdf 11/17/2010
AP011/12/2010SLR26979028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s028ltr.pdf 11/18/2010
AP010/19/2011SE830391029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf 10/24/2011
AP010/19/2011SE830502029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf 11/4/2011
AP010/19/2011SE830392030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf 10/24/2011
AP010/19/2011SE830503030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf 11/4/2011
AP08/5/2011SLR29730031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s031ltr.pdf 8/10/2011
AP01/30/2014SCM       
AP04/23/2014SCM       
AP011/24/2014SE841092036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021773s036lbl.pdf 11/26/2014
AP011/24/2014SE841099036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021773Orig1s036ltr.pdf 11/26/2014
AP06/4/2014SCM       
AP06/4/2014SCM       
AP08/12/2014SCM       
AP02/25/2015SLR41937040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021773Orig1s040ltr.pdf 2/27/2015
AP02/25/2015SLR42004040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf 3/3/2015




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