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FDA Drug Application 125164 by HOFFMAN-LA ROCHE

Application Number125164
Application Type Biologic License Application
Sponsor ApplicantHOFFMAN-LA ROCHE
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
AP011/14/2007N184170000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125164lbl.pdf 11/15/2007
AP011/14/2007N194660000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/125164TOC.cfm 3/17/2008
AP011/14/2007N240170000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088644.pdf 11/19/2009
AP010/1/2014SLR40707062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125164Orig1s062ltr.pdf 10/3/2014
AP010/1/2014SLR40717062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125164s062lbledt.pdf 10/3/2014
AP010/1/2014SLR40828062   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088644.pdf 10/21/2014
AP08/21/2015SLR43702070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125164Orig1s070ltr.pdf 8/24/2015
AP08/21/2015SLR43709070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125164s070lbl.pdf 8/25/2015
AP04/28/2016SLR45804071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf 4/29/2016
AP04/28/2016SLR45827071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf 5/2/2016
AP04/28/2016SLR45828072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf 5/2/2016
AP04/28/2016SLR45805072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf 4/29/2016
AP04/28/2016SLR45806073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125164s071s072s073lbl.pdf 4/29/2016
AP04/28/2016SLR45829073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125164Orig1s071,s072,s073ltr.pdf 5/2/2016




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