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FDA Drug Application 203756 by EXELIXIS

Application Number203756
Application Type New Drug Application
Sponsor ApplicantEXELIXIS
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
AP011/29/2012N34508000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203756lbl.pdf 11/30/2012
AP011/29/2012N34509000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203756Orig1s000ltr.pdf 11/30/2012
AP011/29/2012N34828000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203756Orig1s000TOC.cfm 1/4/2013
AP011/29/2012N34829000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203756Orig1s000SumR.pdf 1/4/2013
AP02/28/2014SCM       
AP05/20/2016SE846111002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203756s002lbl.pdf 5/23/2016
AP05/20/2016SE846120002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203756Orig1s002ltr.pdf 5/24/2016




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