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FDA Drug Application 125427 by GENENTECH

Application Number125427
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
AP02/22/2013N35222000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf 2/22/2013
AP02/22/2013N35223000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000SumR.pdf 2/22/2013
AP02/22/2013N35224000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000Approv.pdf 2/22/2013
AP02/22/2013N35277000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000TOC.cfm 2/28/2013
AP02/22/2013N38471000   http://www.fda.gov/drugs/drugsafety/ucm350733.htm 2/7/2014
AP08/19/2013SLR36862012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427s012lbl.pdf 8/21/2013
AP08/19/2013SLR36867012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s012ltr.pdf 8/22/2013
AP08/29/2013SLR36924014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427Orig1s014Lbl.pdf 8/30/2013
AP08/29/2013SLR36936014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s014ltr.pdf 9/3/2013
AP07/11/2014SLR39858033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125427s033lbl.pdf 7/15/2014
AP07/11/2014SLR39865033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125427Orig1s033ltr.pdf 7/15/2014
AP05/29/2015SLR42963087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125427Orig1s087ltr.pdf 6/2/2015
AP05/29/2015SLR42994087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125427s087lbl.pdf 6/4/2015
AP04/28/2016SLR45807094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s094lbledt.pdf 4/29/2016
AP04/28/2016SLR45826094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125427Orig1s094ltr.pdf 5/2/2016
AP07/25/2016SLR46610096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125427Orig1s096ltr.pdf 7/26/2016
AP07/25/2016SLR46652096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s096lbl.pdf 7/27/2016




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