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FDA Drug Application 125472 by GENENTECH

Application Number125472
Application Type Biologic License Application
Sponsor ApplicantGENENTECH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/21/2013N37544000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125472Orig1s000ltr.pdf 10/24/2013
AP010/21/2013N37550000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM197463.pdf 10/24/2013
AP010/21/2013N37589000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125472s000lbl.pdf 10/25/2013
AP010/21/2013N39890000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000TOC.cfm 7/17/2014
AP010/21/2013N39891000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000SumR.pdf 7/17/2014
AP08/18/2015SE843695014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125276s106,125472s014ltr.pdf 8/21/2015
AP09/23/2016SE847169018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125276Orig1s107,125472Orig1s018ltr.pdf 9/26/2016
AP09/23/2016SE847177018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf 9/27/2016




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