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FDA Drug Application 203388 by GENENTECH

Application Number203388
Application Type New Drug Application
Sponsor ApplicantGENENTECH
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
AP01/30/2012N31578000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203388lbl.pdf 1/30/2012
AP01/30/2012N31598000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203388s000ltr.pdf 1/31/2012
AP01/30/2012N31626000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM289871.pdf 2/1/2012
AP01/30/2012N31999000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203388Orig1s000TOC.cfm 3/2/2012
AP05/8/2013SCM       
AP06/3/2013SCM       
AP012/19/2013SCM       
AP010/15/2014SCM       
AP05/21/2015SLR42906005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf 5/27/2015
AP05/21/2015SLR42885005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf 5/22/2015
AP05/21/2015SLR42886006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf 5/22/2015
AP05/21/2015SLR42907006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf 5/27/2015
AP05/21/2015SLR42908007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf 5/27/2015
AP05/21/2015SLR42887007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf 5/22/2015
AP05/21/2015SLR42888008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203388Orig1s005,s006,s007,s008ltr.pdf 5/22/2015
AP05/21/2015SLR42909008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203388s005s006s007s008lbl.pdf 5/27/2015
AP010/3/2016SCM       




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