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FDA Drug Application 022535 by GENENTECH INC

Application Number022535
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/15/2014N40813000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022535s000lbl.pdf 10/16/2014
AP010/15/2014N40852000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022535Orig1s000ltr.pdf 10/22/2014
AP010/15/2014N41170000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022535Orig1s000toc.cfm 12/5/2014
AP010/15/2014N41171000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022535Orig1s000SumR.pdf 12/5/2014
AP09/24/2015SCM44151001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022535s001lbl.pdf 10/7/2015
AP06/8/2016SCM       




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