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FDA Drug Application 204760 by ASTRAZENECA PHARMS

Application Number204760
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/16/2014N40500000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204760Orig1s000ltr.pdf 9/17/2014
AP09/16/2014N40527000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204760s000lbl.pdf 9/19/2014
AP09/16/2014N40822000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000TOC.cfm 10/17/2014
AP09/16/2014N40823000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000SumR.pdf 10/17/2014
AP07/22/2016SLR46603001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s001lbl.pdf 7/25/2016
AP07/22/2016SLR46605001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s001ltr.pdf 7/26/2016
AP08/22/2016SLR46855002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s002,s003ltr.pdf 8/23/2016
AP08/22/2016SLR46866002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf 8/23/2016
AP08/22/2016SLR46867003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf 8/23/2016
AP08/22/2016SLR46856003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s002,s003ltr.pdf 8/23/2016
AP09/2/2016SCM       




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