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FDA Drug Application 022350 by ASTRAZENECA AB

Application Number022350
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
AP07/31/2009N23136000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022350s000ltr.pdf 8/6/2009
AP07/31/2009N23193000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022350lbl.pdf 8/14/2009
AP07/31/2009N23466000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000TOC.cfm 9/29/2009
AP07/31/2009N23467000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000_SumR.pdf 9/29/2009
AP07/31/2009N36276000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280356.pdf 6/12/2013
AP02/18/2011SE827955001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf 2/24/2011
AP02/18/2011SE827969001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf 2/24/2011
AP02/18/2011SE827956002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf 2/24/2011
AP02/18/2011SE827970002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf 2/24/2011
AP012/16/2011SE831214004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s004ltr.pdf 12/22/2011
AP012/16/2011SE831241004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s004mg.pdf 12/23/2011
AP012/16/2011SE831242004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s004lbl.pdf 12/23/2011
AP011/15/2011SLR30605007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s007lbl.pdf 11/16/2011
AP011/15/2011SLR30606007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s007MG.pdf 11/16/2011
AP011/15/2011SLR30650007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s007ltr.pdf 11/17/2011
AP03/13/2012SLR32114009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022350s009ltr.pdf 3/15/2012
AP05/24/2013SE836153011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022350Orig1s011ltr.pdf 5/29/2013
AP05/24/2013SE836223011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022350s011lbl.pdf 6/4/2013
AP01/23/2014SCM       
AP04/5/2016SE845593014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf 4/7/2016
AP04/5/2016SE845614014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022350s014lbl.pdf 4/7/2016
AP08/28/2015SLR43762016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf 9/1/2015
AP08/28/2015SLR43801016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022350s016lbl.pdf 9/4/2015
AP011/25/2015SCM       




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