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FDA Drug Application 022047 by ASTRAZENECA

Application Number022047
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/17/2007N24872000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM194582.pdf 2/26/2010
AP05/17/2007N30097000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022047s000TOC.cfm 9/27/2011
AP05/17/2007N30100000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022047Orig1s000ltr.pdf 9/28/2011
AP05/17/2007N31198000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP03/13/2008SCM19470002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s002ltr.pdf 3/17/2008
AP03/13/2008SCM19477002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s002lbl.pdf 3/17/2008
AP010/8/2008SE120984006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf 10/9/2008
AP010/8/2008SE121191006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf 11/7/2008
AP010/8/2008SE147055006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022047Orig1s006s007s008TOC.cfm 9/15/2016
AP010/8/2008SE147056007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022047Orig1s006s007s008TOC.cfm 9/15/2016
AP010/8/2008SE121192007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf 11/7/2008
AP010/8/2008SE120985007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf 10/9/2008
AP010/8/2008SE120983008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf 10/9/2008
AP010/8/2008SE121193008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf 11/7/2008
AP010/8/2008SE147057008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022047Orig1s006s007s008TOC.cfm 9/15/2016
AP05/21/2008SLR19886009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s009ltr.pdf 5/28/2008
AP012/2/2009SE124255011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf 12/11/2009
AP012/2/2009SE124260011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022MedGuide.pdf 12/11/2009
AP012/2/2009SE124360011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf 12/30/2009
AP012/2/2009SE140103011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022047Orig1s011.pdf 8/1/2014
AP08/11/2008SCM20607013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s013ltr.pdf 8/13/2008
AP08/11/2008SCM20712013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s013lbl.pdf 8/29/2008
AP012/2/2009SLR24256016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf 12/11/2009
AP012/2/2009SLR24361016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf 12/30/2009
AP012/2/2009SLR24261016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022MedGuide.pdf 12/11/2009
AP012/2/2009SLR24262017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022MedGuide.pdf 12/11/2009
AP012/2/2009SLR24362017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf 12/30/2009
AP012/2/2009SLR24257017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf 12/11/2009
AP08/14/2008SLR20632018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s018ltr.pdf 8/19/2008
AP012/2/2009SLR24258019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf 12/11/2009
AP012/2/2009SLR24363019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf 12/30/2009
AP012/2/2009SLR24263019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022MedGuide.pdf 12/11/2009
AP012/2/2009SLR24364022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf 12/30/2009
AP012/2/2009SLR24259022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf 12/11/2009
AP07/8/2011SLR29484023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s023,s027ltr.pdf 7/12/2011
AP07/8/2011SLR29495023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf 7/12/2011
AP05/17/2011SLR28861024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s024ltr.pdf 5/19/2011
AP05/17/2011SLR28903024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s024lbl.pdf 5/23/2011
AP012/1/2010SLR27184025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022047s025lbl.pdf 12/4/2010
AP012/1/2010SLR27245025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022047s025ltr.pdf 12/7/2010
AP04/30/2013SLR35929026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf 5/2/2013
AP04/30/2013SLR35907026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf 5/1/2013
AP07/8/2011SLR29496027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf 7/12/2011
AP07/8/2011SLR29485027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s023,s027ltr.pdf 7/12/2011
AP011/9/2011SLR30555028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s028MG.pdf 11/10/2011
AP011/9/2011SLR30567028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s028ltr.pdf 11/14/2011
AP04/30/2013SE835908029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf 5/1/2013
AP04/30/2013SE835930029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf 5/2/2013
AP04/30/2013SLR35931030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf 5/2/2013
AP04/30/2013SLR35909030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf 5/1/2013
AP04/30/2013SLR35910031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf 5/1/2013
AP04/30/2013SLR35932031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf 5/2/2013
AP010/29/2013SLR37616034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s061,022047Orig1s034ltr.pdf 10/30/2013
AP010/29/2013SLR37644034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s034lbl.pdf 10/31/2013
AP01/26/2015SCM46131036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022047s036lbl.pdf 5/25/2016
AP06/17/2016SLR46361038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020639Orig1s064,022047Orig1s038ltr.pdf 6/21/2016
AP06/17/2016SLR46383038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022047s038lbl.pdf 6/21/2016




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