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FDA Drug Application 125085 by GENENTECH

Application Number125085
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
AP02/26/2004N7722000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm193900.htm 12/11/2009
AP02/26/2004N7723000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125085lbl.pdf 2/27/2004
AP02/26/2004N7724000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125085ltr.pdf 2/27/2004
AP02/26/2004N11058000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/STN-125085_Avastin.cfm 1/28/2005
AP09/30/2005S128360045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125085s45lbl.pdf 9/30/2005
AP09/30/2005S129190045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125085s0045ltr.pdf 10/20/2005
AP04/18/2006S139690067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s067LTR.pdf 4/21/2006
AP04/18/2006S139760067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s067LBL.pdf 4/21/2006
AP06/20/2006S143460074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/0125085s074lbl.pdf 6/21/2006
AP06/20/2006S143490074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s074LTR.pdf 6/27/2006
AP06/20/2006S270560074   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2006/125085_0074_avastin.pdf 6/20/2006
AP09/21/2006S149620082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s082LTR.pdf 9/25/2006
AP09/21/2006S149660082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s082LBL.pdf 9/25/2006
AP010/11/2006S151580085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125085s085lbl.pdf 10/23/2006
AP010/11/2006S151860085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125085s085ltr.pdf 10/23/2006
AP010/11/2006S270570085   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2006/125085_0085_avastin.pdf 10/11/2006
AP02/22/2008S193090091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125085s091ltr.pdf 2/27/2008
AP02/22/2008S278900091   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125085_s091_avastin.pdf 2/15/2011
AP09/20/2007S180300131   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125085s131lbl.pdf 9/26/2007
AP03/10/2008S195480145   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125085s145lbl.pdf 3/27/2008
AP03/10/2008S195520145   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125085s0145ltr.pdf 3/28/2008
AP07/31/2009S231130168   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0168lbl.pdf 8/4/2009
AP07/31/2009S231400168   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125085s0168ltr.pdf 8/6/2009
AP05/5/2009S224270169   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125085s0169lbl.pdf 5/5/2009
AP05/5/2009S225480169   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125085s0169ltr.pdf 5/13/2009
AP05/3/2012S326280238   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s0238lbl.pdf 5/7/2012
AP05/3/2012S326490238   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085s0238ltr.pdf 5/8/2012
AP012/20/2011S312730241   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s0241ltr.pdf 12/27/2011
AP012/28/2010S27494204   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125085s204ltr.pdf 1/10/2011
AP02/8/2011S27860208   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s208ltr.pdf 2/15/2011
AP09/30/2011S30147225   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125085s225lbl.pdf 9/30/2011
AP09/30/2011S30217225   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125085s225ltr.pdf 10/4/2011
AP010/26/2012SE834188239   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s239lbl.pdf 10/26/2012
AP010/26/2012SE834192239   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085Orig1s239ltr.pdf 10/29/2012
AP01/23/2013SE134973263   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s263lbl.pdf 1/24/2013
AP01/23/2013SE134978263   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s263ltr.pdf 1/25/2013
AP011/20/2012SLR34448265   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125085Orig1s265ltr.pdf 11/23/2012
AP011/20/2012SLR34484265   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125085s265lbl.pdf 11/28/2012
AP03/26/2013SLR35553267   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s267ltr.pdf 3/28/2013
AP03/26/2013SLR35600267   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s267lbl.pdf 4/1/2013
AP012/16/2013SLR38077285   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125085Orig1s285ltr.pdf 12/17/2013
AP012/16/2013SLR38084285   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s285lbl.pdf 12/17/2013
AP08/30/2014SLR40375297   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s297ltr.pdf 9/3/2014
AP08/30/2014SLR40391297   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s297lbl.pdf 9/3/2014
AP08/14/2014SE840241301   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s301lbl.pdf 8/14/2014
AP08/14/2014SE840242301   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s301ltr.pdf 8/15/2014
AP08/14/2014SE840263301   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085Orig1s301SumR.pdf 8/19/2014
AP011/14/2014SE840995305   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s305lbl.pdf 11/14/2014
AP011/14/2014SE840998305   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125085Orig1s305ltr.pdf 11/17/2014
AP05/7/2015SLR42753308   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s308lbl.pdf 5/8/2015
AP05/7/2015SLR42768308   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s308ltr.pdf 5/11/2015
AP15/7/2015SLR42753308   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s308lbl.pdf 5/8/2015
AP15/7/2015SLR42768308   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s308ltr.pdf 5/11/2015
AP09/29/2015SLR44061310   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s310ltr.pdf 10/1/2015
AP09/29/2015SLR44157310   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s310lbl.pdf 10/7/2015
AP012/1/2015SLR44646312   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125085Orig1s312ltr.pdf 12/2/2015
AP012/1/2015SLR44653312   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125085s312lbl.pdf 12/2/2015




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