BLA 761043

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #761043

Documents

• Label: 2017-07-25
• Letter: 2017-07-25
• Letter: 2018-06-27
• Label: 2018-06-29
• Review: 2018-11-27
• Letter: 2019-04-30
• Label: 2019-04-30
• Label: 2019-09-16
• Medication Guide: 2019-09-16
• Letter: 2019-09-17
• Label: 2020-01-22
• Medication Guide: 2020-01-22
• Letter: 2020-01-23
• Label: 2020-12-17
• Letter: 2020-12-21
• Medication Guide: 2020-12-17
• Letter: 2022-07-27
• Label: 2022-07-27
• Medication Guide: 2022-07-27

Application Sponsors

BLA 761043

GLAXOSMITHKLINE LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

0

BENLYSTA

BELIMUMAB

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2017-07-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-06-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-09-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-04-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-01-17	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2020-12-16	UNKNOWN
LABELING; Labeling	SUPPL	21	AP	2022-07-26	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	6
SUPPL	5	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	13	Null	15
SUPPL	21	Null	46

CDER Filings

GLAXOSMITHKLINE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761043
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125370s068,761043s008lbl.pdf#page=33"]
            [products] => [{"drugName":"BENLYSTA","activeIngredients":"BELIMUMAB","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/17\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125370s068,761043s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/13\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125370s067,761043s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125370s064,761043s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125370s062,761043s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125370s062,761043s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125370s062,761043s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761043lbl.pdf\"}]","notes":""}]
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            [supplements] => [{"actionDate":"01\/17\/2020","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125370s068,761043s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"04\/26\/2019","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125370s064,761043s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/13\/2019","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125370s067,761043s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"06\/22\/2018","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125370s062,761043s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [actionDate] => 2020-01-17
        )

)