BLA 125085

GENENTECH

FDA Drug Application

Application #125085

Documents

• Letter: 2005-10-20
• Letter: 2006-09-25
• Letter: 2008-02-27
• Letter: 2011-02-15
• Letter: 2011-10-04
• Letter: 2012-05-08
• Letter: 2012-10-29
• Letter: 2011-12-27
• Letter: 2012-11-23
• Letter: 2014-11-17
• Letter: 2015-10-01
• Letter: 2015-12-02
• Label: 2004-02-27
• Label: 2006-04-21
• Label: 2006-06-21
• Label: 2009-05-05
• Label: 2011-09-30
• Label: 2012-05-07
• Label: 2012-11-28
• Label: 2013-04-01
• Label: 2013-12-17
• Label: 2014-08-14
• Label: 2014-11-14
• Label: 2015-12-02
• Review: 2005-01-28
• Review: 2006-10-11
• Review: 2011-02-15
• Letter: 2004-02-27
• Letter: 2006-04-21
• Letter: 2006-06-27
• Letter: 2006-10-23
• Letter: 2008-03-28
• Letter: 2009-08-06
• Letter: 2009-05-13
• Letter: 2011-01-10
• Letter: 2013-01-25
• Letter: 2013-03-28
• Letter: 2013-12-17
• Letter: 2014-09-03
• Letter: 2014-08-15
• Letter: 2015-05-11
• Label: 2005-09-30
• Label: 2006-09-25
• Label: 2006-10-23
• Label: 2007-09-26
• Label: 2008-03-27
• Label: 2009-08-04
• Label: 2012-10-26
• Label: 2013-01-24
• Label: 2014-09-03
• Label: 2015-05-08
• Label: 2015-10-07
• Review: 2006-06-20
• Other Important Information from FDA: 2009-12-11
• Summary Review: 2014-08-19
• Label: 2016-12-08
• Letter: 2016-12-08
• Letter: 2017-12-07
• Label: 2017-12-07
• Label: 2018-05-02
• Letter: 2018-05-03
• Label: 2018-06-13
• Letter: 2018-06-14
• Letter: 2019-05-13
• Label: 2019-06-21
• Letter: 2019-06-21
• Label: 2020-05-29
• Letter: 2020-06-02
• Letter: 2020-10-01
• Label: 2020-10-02
• Letter: 2020-10-14
• Label: 2020-10-14
• Label: 2020-12-09
• Letter: 2020-12-17
• Review: 2021-12-07
• Review: 2022-06-28
• Letter: 2022-09-19
• Label: 2022-09-20

Application Sponsors

BLA 125085

GENENTECH

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	VIAL; INTRAVENOUS	100MG	0	AVASTIN	BEVACIZUMAB
002	VIAL; INTRAVENOUS	400MG	0	AVASTIN	BEVACIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2004-02-26	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2004-12-22	STANDARD
EFFICACY; Efficacy	SUPPL	45	AP	2005-09-29	STANDARD
LABELING; Labeling	SUPPL	67	AP	2006-04-18	STANDARD
EFFICACY; Efficacy	SUPPL	74	AP	2006-06-20	PRIORITY
LABELING; Labeling	SUPPL	82	AP	2006-09-21	STANDARD
EFFICACY; Efficacy	SUPPL	85	AP	2006-10-11	PRIORITY
EFFICACY; Efficacy	SUPPL	91	AP	2008-02-22	PRIORITY
LABELING; Labeling	SUPPL	131	AP	2007-09-20	STANDARD
LABELING; Labeling	SUPPL	145	AP	2008-03-10	STANDARD
LABELING; Labeling	SUPPL	163	AP	2008-11-04	STANDARD
EFFICACY; Efficacy	SUPPL	168	AP	2009-07-31	STANDARD
EFFICACY; Efficacy	SUPPL	169	AP	2009-05-05	PRIORITY
LABELING; Labeling	SUPPL	204	AP	2010-12-28	STANDARD
LABELING; Labeling	SUPPL	208	AP	2011-02-08	STANDARD
LABELING; Labeling	SUPPL	225	AP	2011-09-30	STANDARD
LABELING; Labeling	SUPPL	229	AP	2011-12-21	STANDARD
LABELING; Labeling	SUPPL	235	AP	2011-12-21	STANDARD
LABELING; Labeling	SUPPL	238	AP	2012-05-03	STANDARD
EFFICACY; Efficacy	SUPPL	239	AP	2012-10-26	STANDARD
LABELING; Labeling	SUPPL	241	AP	2011-12-20	STANDARD
EFFICACY; Efficacy	SUPPL	263	AP	2013-01-23	PRIORITY
LABELING; Labeling	SUPPL	265	AP	2012-11-20	STANDARD
LABELING; Labeling	SUPPL	267	AP	2013-03-26	STANDARD
LABELING; Labeling	SUPPL	285	AP	2013-12-16	STANDARD
LABELING; Labeling	SUPPL	297	AP	2014-08-30	STANDARD
EFFICACY; Efficacy	SUPPL	301	AP	2014-08-14	PRIORITY
EFFICACY; Efficacy	SUPPL	305	AP	2014-11-14	PRIORITY
LABELING; Labeling	SUPPL	308	AP	2015-05-07	STANDARD
LABELING; Labeling	SUPPL	310	AP	2015-09-29	STANDARD
LABELING; Labeling	SUPPL	312	AP	2015-12-01	STANDARD
EFFICACY; Efficacy	SUPPL	317	AP	2016-12-06	PRIORITY
EFFICACY; Efficacy	SUPPL	319	AP	2017-12-05	STANDARD
EFFICACY; Efficacy	SUPPL	323	AP	2018-06-13	STANDARD
EFFICACY; Efficacy	SUPPL	324	AP	2018-04-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	329	AP	2019-04-03	N/A
LABELING; Labeling	SUPPL	331	AP	2019-06-20	STANDARD
EFFICACY; Efficacy	SUPPL	332	AP	2020-05-29	UNKNOWN
LABELING; Labeling	SUPPL	334	AP	2020-09-30	STANDARD
LABELING; Labeling	SUPPL	336	AP	2020-10-09	STANDARD
LABELING; Labeling	SUPPL	337	AP	2020-12-09	STANDARD
LABELING; Labeling	SUPPL	340	AP	2022-09-18	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	91	Null	27
SUPPL	168	Orphan	5
SUPPL	169	Orphan	5
SUPPL	297	Null	15
SUPPL	301	Null	15
SUPPL	305	Null	7
SUPPL	308	Null	15
SUPPL	310	Null	7
SUPPL	312	Null	7
SUPPL	317	Null	7
SUPPL	319	Null	7
SUPPL	323	Null	7
SUPPL	324	Null	15
SUPPL	329	Null	15
SUPPL	331	Null	6
SUPPL	332	Null	6
SUPPL	334	Null	6
SUPPL	336	Null	15
SUPPL	337	Null	6
SUPPL	340	Null	15

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125085
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"AVASTIN","activeIngredients":"BEVACIZUMAB","strength":"100MG","dosageForm":"VIAL; INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"AVASTIN","activeIngredients":"BEVACIZUMAB","strength":"400MG","dosageForm":"VIAL; INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-332","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125085s332lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2019","submission":"SUPPL-331","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125085s331lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2019","submission":"SUPPL-331","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125085s331lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2018","submission":"SUPPL-323","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125085s323lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2018","submission":"SUPPL-324","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125085s324lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2017","submission":"SUPPL-319","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125085s319lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2016","submission":"SUPPL-317","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125085s308lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2014","submission":"SUPPL-305","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125085s305lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2014","submission":"SUPPL-297","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125085s297lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2014","submission":"SUPPL-301","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125085s301lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2013","submission":"SUPPL-285","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125085s285lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2013","submission":"SUPPL-267","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125085s267lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2013","submission":"SUPPL-263","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125085s263lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2012","submission":"SUPPL-265","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125085s265lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2012","submission":"SUPPL-239","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125085s239lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2012","submission":"SUPPL-238","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125085s0238lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2011","submission":"SUPPL-225","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125085s225lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"SUPPL-168","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125085s0168lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2009","submission":"SUPPL-169","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125085s0169lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2008","submission":"SUPPL-145","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125085s145lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2007","submission":"SUPPL-131","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125085s131lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2006","submission":"SUPPL-85","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125085s085lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2006","submission":"SUPPL-82","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125085s082LBL.pdf\"}]","notes":""},{"actionDate":"06\/20\/2006","submission":"SUPPL-74","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/0125085s074lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2006","submission":"SUPPL-67","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125085s067LBL.pdf\"}]","notes":""},{"actionDate":"09\/29\/2005","submission":"SUPPL-45","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125085s45lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/125085lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/26\/2004","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/125085lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/125085ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2004\\\/STN-125085_Avastin.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-332","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125085s332lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125085Orig1s332ltr.pdf\"}]","notes":">"},{"actionDate":"06\/20\/2019","submission":"SUPPL-331","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125085s331lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125085Orig1s331ltr.pdf\"}]","notes":">"},{"actionDate":"04\/03\/2019","submission":"SUPPL-329","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125085Orig1s297ltr.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2013","submission":"SUPPL-285","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125085s285lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125085Orig1s285ltr.pdf\"}]","notes":">"},{"actionDate":"03\/26\/2013","submission":"SUPPL-267","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125085s267lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125085Orig1s267ltr.pdf\"}]","notes":">"},{"actionDate":"11\/20\/2012","submission":"SUPPL-265","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125085s265lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125085Orig1s265ltr.pdf\"}]","notes":">"},{"actionDate":"01\/23\/2013","submission":"SUPPL-263","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125085s263lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125085Orig1s263ltr.pdf\"}]","notes":">"},{"actionDate":"12\/20\/2011","submission":"SUPPL-241","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125085s0241ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/26\/2012","submission":"SUPPL-239","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125085s239lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125085Orig1s239ltr.pdf\"}]","notes":">"},{"actionDate":"05\/03\/2012","submission":"SUPPL-238","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125085s0238lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125085s0238ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2011","submission":"SUPPL-235","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2011","submission":"SUPPL-229","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/30\/2011","submission":"SUPPL-225","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125085s225lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125085s225ltr.pdf\"}]","notes":">"},{"actionDate":"02\/08\/2011","submission":"SUPPL-208","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125085s208ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/28\/2010","submission":"SUPPL-204","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125085s204ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/05\/2009","submission":"SUPPL-169","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125085s0169lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/125085s0169ltr.pdf\"}]","notes":">"},{"actionDate":"07\/31\/2009","submission":"SUPPL-168","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125085s0168lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/125085s0168ltr.pdf\"}]","notes":">"},{"actionDate":"11\/04\/2008","submission":"SUPPL-163","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/10\/2008","submission":"SUPPL-145","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125085s145lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125085s0145ltr.pdf\"}]","notes":">"},{"actionDate":"09\/20\/2007","submission":"SUPPL-131","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125085s131lbl.pdf\"}]","notes":">"},{"actionDate":"02\/22\/2008","submission":"SUPPL-91","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125085s091ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2008\\\/125085_s091_avastin.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/11\/2006","submission":"SUPPL-85","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125085s085lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2006\\\/125085s085ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2006\\\/125085_0085_avastin.pdf\"}]","notes":">"},{"actionDate":"09\/21\/2006","submission":"SUPPL-82","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125085s082LBL.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2006\\\/125085s082LTR.pdf\"}]","notes":">"},{"actionDate":"06\/20\/2006","submission":"SUPPL-74","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/0125085s074lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2006\\\/125085s074LTR.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2006\\\/125085_0074_avastin.pdf\"}]","notes":">"},{"actionDate":"04\/18\/2006","submission":"SUPPL-67","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125085s067LBL.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2006\\\/125085s067LTR.pdf\"}]","notes":">"},{"actionDate":"09\/29\/2005","submission":"SUPPL-45","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125085s45lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/125085s0045ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2004","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-29
        )

)