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FDA Drug Application 208065 by ASTRAZENECA PHARMS

Application Number208065
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/13/2015N44466000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf 11/13/2015
AP011/13/2015N44469000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208065Orig1s000Ltr.pdf 11/13/2015
AP011/13/2015N44741000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000SumR.pdf 12/11/2015
AP011/13/2015N44865000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000TOC.cfm 12/23/2015
AP02/10/2016SCM       
AP08/12/2016SLR46789002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s002lbl.pdf 8/17/2016
AP08/12/2016SLR46795002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208065Orig1s002ltr.pdf 8/18/2016
AP09/28/2016SLR47215003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208065s003lbl.pdf 9/29/2016
AP09/28/2016SLR47244003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208065Orig1s003ltr.pdf 9/30/2016
AP09/21/2016SCM       




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