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FDA Drug Application 202293 by ASTRAZENECA AB

Application Number202293
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
AP01/8/2014N38242000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s000ltr.pdf 1/10/2014
AP01/8/2014N38247000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf 1/10/2014
AP01/8/2014N38502000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000TOC.cfm 2/11/2014
AP01/8/2014N38503000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf 2/11/2014
AP07/31/2014SCM       
AP03/11/2015SE842113002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s002ltr.pdf 3/12/2015
AP03/11/2015SE842172002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf 3/17/2015
AP08/8/2014SLR40198003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s003ltr.pdf 8/11/2014
AP08/8/2014SLR40206003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf 8/12/2014
AP01/12/2016SCM       
AP01/6/2016SCM45169007   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM439564.pdf 2/16/2016
AP012/4/2015SLR44677008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s008ltr.pdf 12/8/2015
AP012/4/2015SLR44707008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf 12/8/2015
AP06/14/2016SLR46342009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s009ltr.pdf 6/16/2016
AP06/14/2016SLR46356009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf 6/17/2016
AP08/17/2016SLR46806010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s010ltr.pdf 8/18/2016
AP08/17/2016SLR46836010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf 8/22/2016




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