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FDA Drug Application 125486 by GENENTECH

Application Number125486
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
AP011/1/2013N37664000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486s000lbl.pdf 11/1/2013
AP011/1/2013N37666000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486Orig1s000SumR.pdf 11/1/2013
AP011/1/2013N37667000Office Director Memo  http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486Orig1s000ODMemo.pdf 11/1/2013
AP011/1/2013N37713000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125486Orig1s000ltr.pdf 11/6/2013
AP011/1/2013N37955000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125486Orig1s000TOC.cfm 11/27/2013
AP06/27/2014SLR39712008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125486Orig1s008ltr.pdf 7/1/2014
AP06/27/2014SLR39723008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125486_s008lbl.pdf 7/1/2014
AP012/24/2014SE841463009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125486Orig1s009ltr.pdf 12/31/2014
AP09/23/2015SLR43990010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125486Orig1s010ltr.pdf 9/25/2015
AP09/23/2015SLR44133010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125486s010lbledt.pdf 10/6/2015
AP02/26/2016SE845284013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125486s013lbl.pdf 2/26/2016
AP02/26/2016SE845295013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125486Orig1s013ltr.pdf 2/29/2016




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