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FDA Drug Application 125409 by GENENTECH

Application Number125409
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
AP06/8/2012N32867000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf 6/11/2012
AP06/8/2012N32890000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125409Orig1s000ltr.pdf 6/11/2012
AP06/8/2012N32903000Summary Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000ODMemo.pdf 6/13/2012
AP06/8/2012N33294000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000TOC.cfm 7/30/2012
AP04/12/2013SE835706032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125409Orig1s032ltr.pdf 4/16/2013
AP04/12/2013SE835719032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s032lbl.pdf 4/16/2013
AP09/30/2013SE137263051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s051lbl.pdf 9/30/2013
AP09/30/2013SE137296051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125409Orig1s051_corrected_ltr.pdf 10/1/2013
AP09/30/2013SE137345051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409Orig1s051SumR.pdf 10/4/2013
AP09/30/2013SE137346051Cross Discipline Team Leader Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409Orig1s051CrossR.pdf 10/4/2013
AP09/30/2013SE137473051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409_perjeta_toc.cfm 10/21/2013
AP03/17/2015SE842192104   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125409Orig1s104ltr.pdf 3/18/2015
AP03/17/2015SE842203104   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s104lbl.pdf 3/19/2015
AP05/29/2015SLR42962105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125409Orig1s105ltr.pdf 6/2/2015
AP05/29/2015SLR42993105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s105lbl.pdf 6/4/2015
AP03/22/2016SLR45490109   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125409s109lbl.pdf 3/23/2016
AP03/22/2016SLR45497109   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125409Orig1s109ltr.pdf 3/24/2016




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