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FDA Drug Application 205649 by ASTRAZENECA AB

Application Number205649
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA AB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/29/2014N40907000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205649Orig1s000ltr.pdf 10/31/2014
AP010/29/2014N40947000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205649s000lbl.pdf 11/4/2014
AP010/29/2014N42436000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000TOC.cfm 4/6/2015
AP010/29/2014N42437000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000SumR.pdf 4/6/2015
AP09/1/2015SCM       
AP01/12/2016SCM       
AP012/4/2015SLR44667003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205649Orig1s003ltr.pdf 12/7/2015
AP012/4/2015SLR44708003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205649s003lbl.pdf 12/8/2015
AP06/14/2016SLR46340004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s004ltr.pdf 6/16/2016
AP06/14/2016SLR46354004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s004lbl.pdf 6/17/2016
AP08/17/2016SLR46804005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s005ltr.pdf 8/18/2016
AP08/17/2016SLR46838005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf 8/22/2016
AP08/17/2016SLR47324005   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524805.pdf 10/12/2016




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