BLA 103792

GENENTECH

FDA Drug Application

Application #103792

Documents

• Letter: 2004-03-15
• Letter: 2008-01-23
• Letter: 2014-01-02
• Letter: 2014-01-02
• Letter: 2014-03-11
• Letter: 2014-07-01
• Letter: 2015-04-24
• Letter: 2016-03-18
• Label: 2006-11-17
• Label: 2010-11-01
• Label: 2013-11-22
• Label: 2016-03-22
• Review: 2004-03-15
• Review: 2015-11-18
• Review: 2014-03-18
• Letter: 2004-03-15
• Letter: 2004-03-15
• Letter: 2004-03-15
• Letter: 2003-11-06
• Letter: 2006-12-04
• Letter: 2008-05-29
• Letter: 2008-05-29
• Letter: 2010-10-26
• Letter: 2010-12-03
• Letter: 2014-07-01
• Label: 2004-03-15
• Label: 2004-03-15
• Label: 2004-03-15
• Label: 2004-03-15
• Label: 2008-01-23
• Label: 2010-10-19
• Label: 2014-03-07
• Label: 2015-04-24
• Review: 2012-05-10
• Review: 2012-05-23
• Other: 2014-03-10
• Label: 2017-04-28
• Letter: 2017-05-02
• Review: 2017-06-28
• Letter: 2018-10-01
• Label: 2018-10-17
• Label: 2018-10-18
• Letter: 2018-12-20
• Label: 2018-11-30
• Review: 2008-01-18
• Letter: 2020-08-06

Application Sponsors

BLA 103792

GENENTECH

Marketing Status

• Prescription: 001

Application Products

001

VIAL; INTRAVENOUS

21MG/ML

0

HERCEPTIN

TRASTUZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-09-25	PRIORITY
S; Supplement	SUPPL	1005	AP	2000-02-09
EFFICACY; Efficacy	SUPPL	5004	AP	2001-12-11	STANDARD
EFFICACY; Efficacy	SUPPL	5008	AP	2002-08-28	STANDARD
S; Supplement	SUPPL	5046	AP	2003-10-16
EFFICACY; Efficacy	SUPPL	5150	AP	2006-11-16	PRIORITY
EFFICACY; Efficacy	SUPPL	5175	AP	2008-01-18	STANDARD
EFFICACY; Efficacy	SUPPL	5187	AP	2008-05-22	STANDARD
EFFICACY; Efficacy	SUPPL	5189	AP	2008-05-22	STANDARD
LABELING; Labeling	SUPPL	5213	AP	2009-04-08	STANDARD
EFFICACY; Efficacy	SUPPL	5250	AP	2010-10-20	PRIORITY
LABELING; Labeling	SUPPL	5256	AP	2010-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5275	AP	2012-02-23
LABELING; Labeling	SUPPL	5305	AP	2013-11-20	STANDARD
EFFICACY; Efficacy	SUPPL	5311	AP	2014-03-07	PRIORITY
LABELING; Labeling	SUPPL	5313	AP	2014-06-30	STANDARD
LABELING; Labeling	SUPPL	5318	AP	2014-06-30	STANDARD
LABELING; Labeling	SUPPL	5327	AP	2015-04-23	STANDARD
LABELING; Labeling	SUPPL	5330	AP	2016-03-17	STANDARD
LABELING; Labeling	SUPPL	5337	AP	2017-04-27	STANDARD
LABELING; Labeling	SUPPL	5339	AP	2017-03-27	N/A
LABELING; Labeling	SUPPL	5344	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	5345	AP	2018-11-29	STANDARD
LABELING; Labeling	SUPPL	5347	AP	2018-10-17	STANDARD
LABELING; Labeling	SUPPL	5349	TA	2020-04-01	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	1005	Null	0
SUPPL	5046	Null	0
SUPPL	5250	Orphan	5
SUPPL	5275	Null	0
SUPPL	5327	Null	6
SUPPL	5330	Null	7
SUPPL	5337	Null	15
SUPPL	5339	Null	15
SUPPL	5344	Null	6
SUPPL	5345	Null	6
SUPPL	5347	Null	7
SUPPL	5349	Null	15

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103792
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"HERCEPTIN","activeIngredients":"TRASTUZUMAB","strength":"21MG\/ML","dosageForm":"VIAL; INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/29\/2018","submission":"SUPPL-5345","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103792s5345lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2018","submission":"SUPPL-5347","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103792s5347lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2018","submission":"SUPPL-5344","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103792s5344lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2017","submission":"SUPPL-5337","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103792s5337lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2017","submission":"SUPPL-5337","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103792s5337lbl.pdf\"}]","notes":""},{"actionDate":"03\/17\/2016","submission":"SUPPL-5330","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103792s5330lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2015","submission":"SUPPL-5327","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103792s5327lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2014","submission":"SUPPL-5311","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103792s5311lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2013","submission":"SUPPL-5305","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103792s5300s5305lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2010","submission":"SUPPL-5256","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103792s5256lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2010","submission":"SUPPL-5250","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103792s5250lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2008","submission":"SUPPL-5175","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103792s5175lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2006","submission":"SUPPL-5150","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103792s5150lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2002","submission":"SUPPL-5008","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/trasgen082802LB.pdf\"}]","notes":""},{"actionDate":"12\/11\/2001","submission":"SUPPL-5004","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/trasgen121101LB.pdf\"}]","notes":""},{"actionDate":"02\/09\/2000","submission":"SUPPL-1005","supplementCategories":"Supplement","inserts":"[{\"name\":\"\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/trasgen020900LB.htm\"}]","notes":""},{"actionDate":"09\/25\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/trasgen092598lb.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/25\/1998","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/trasgen092598lb.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1998\\\/trasgen092598L.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170128163102\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080591.htm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/05\/2020","submission":"SUPPL-5349","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103792Orig1s5349ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/17\/2018","submission":"SUPPL-5347","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103792s5347lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103792Orig1s5345ltr.pdf\"}]","notes":">"},{"actionDate":"11\/29\/2018","submission":"SUPPL-5345","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103792s5345lbl.pdf\"}]","notes":">"},{"actionDate":"09\/20\/2018","submission":"SUPPL-5344","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103792s5344lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2017","submission":"SUPPL-5339","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/27\/2017","submission":"SUPPL-5337","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/103792s5337lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/103792Orig1s5337ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/103792Orig1s5337.pdf\"}]","notes":">"},{"actionDate":"03\/17\/2016","submission":"SUPPL-5330","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103792s5330lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/103792Orig1s5330ltr.pdf\"}]","notes":">"},{"actionDate":"04\/23\/2015","submission":"SUPPL-5327","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103792s5327lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103792Orig1s5327ltr.pdf\"}]","notes":">"},{"actionDate":"06\/30\/2014","submission":"SUPPL-5318","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103792Orig1s5313,s5318ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2014","submission":"SUPPL-5313","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103792Orig1s5313,s5318ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/07\/2014","submission":"SUPPL-5311","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103792s5311lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103792Orig1s5311ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/103792Orig1s5311TOC.cfm\"}]","notes":">"},{"actionDate":"11\/20\/2013","submission":"SUPPL-5305","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103792s5300s5305lbl.pdf\"}]","notes":">"},{"actionDate":"02\/23\/2012","submission":"SUPPL-5275","supplementCategories":"Supplement","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2012\\\/103792Orig1s5275.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/29\/2010","submission":"SUPPL-5256","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103792s5256lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103792s5256ltr.pdf\"}]","notes":">"},{"actionDate":"10\/20\/2010","submission":"SUPPL-5250","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103792s5250lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/103792s5250ltr.pdf\"}]","notes":">"},{"actionDate":"04\/08\/2009","submission":"SUPPL-5213","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/22\/2008","submission":"SUPPL-5189","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103792Orig1s5187,s5189ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/103792s5187,s5189ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2008\\\/103792s5187-5189_Herceptin_toc.cfm\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/22\/2008","submission":"SUPPL-5187","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103792Orig1s5187,s5189ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/103792s5187,s5189ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2008\\\/103792s5187-5189_Herceptin_toc.cfm\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/18\/2008","submission":"SUPPL-5175","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103792s5175lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/103792s5175ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2008\\\/103792Orig1s5175.pdf\"}]","notes":">"},{"actionDate":"11\/16\/2006","submission":"SUPPL-5150","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103792s5150lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"10\/16\/2003","submission":"SUPPL-5046","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/103792-5046ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/28\/2002","submission":"SUPPL-5008","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/trasgen082802LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/trasgen082802L.htm\"}]","notes":">"},{"actionDate":"12\/11\/2001","submission":"SUPPL-5004","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/trasgen121101LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2001\\\/trasgen121101L.htm\"}]","notes":">"},{"actionDate":"02\/09\/2000","submission":"SUPPL-1005","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/trasgen020900LB.htm\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2000\\\/trasgen020900L.htm\"}]","notes":">"}]
            [actionDate] => 2020-08-05
        )

)