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FDA Drug Application 206162 by ASTRAZENECA PHARMS

Application Number206162
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
AP012/19/2014N41339000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf 12/19/2014
AP012/19/2014N41340000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000SumR.pdf 12/19/2014
AP012/19/2014N41342000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000TOC.cfm 12/19/2014
AP012/19/2014N41343000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206162Orig1s000ltr.pdf 12/19/2014
AP01/12/2016SCM       
AP010/19/2016SLR47415002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206162Orig1s002ltr.pdf 10/20/2016
AP010/19/2016SLR47419002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206162s002lbl.pdf 10/20/2016




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