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FDA Drug Application 206192 by GENENTECH INC

Application Number206192
Application Type New Drug Application
Sponsor ApplicantGENENTECH INC
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
AP011/10/2015N44434000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf 11/10/2015
AP011/10/2015N44435000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206192Orig1s000Ltr.pdf 11/10/2015
AP011/10/2015N44690000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000TOC.cfm 12/8/2015
AP011/10/2015N44691000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000SumR.pdf 12/8/2015
AP05/31/2016SLR46204001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206192Orig1s001ltr.pdf 6/1/2016
AP05/31/2016SLR46232001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf 6/1/2016




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