FDA.reportPublic FDA data

Application 125370

Type
BLA
Sponsor
HUMAN GENOME SCIENCES INC.

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125370Benlystabelimumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENLYSTABELIMUMABINJECTABLE; INJECTION120MGNoNo
002BENLYSTABELIMUMABINJECTABLE; INJECTION400MGNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENLYSTABELIMUMABGlaxoSmithKline LLC2fa3c528-1777-4628-8a55-a69dae2381a32026-08-21Warnings, Adverse reactionsExact identifier
application number: BLA125370
ndc (product): 49401-101
ndc (product): 49401-102

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49401-101BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-101BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent
49401-101BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-101BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-101BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-101BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-101BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-101BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-101BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-101BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent
49401-101BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent
49401-102BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-102BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent
49401-102BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-102BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-102BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-102BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-102BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-102BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-102BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-102BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent
49401-102BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82637SUPPL 2025-06-24
82631SUPPL 2025-06-23
82630SUPPL 2025-06-23
78502SUPPL 2024-05-20
78496SUPPL 2024-05-20
78495SUPPL 2024-05-20
77476SUPPL 2024-02-12
77467SUPPL 2024-02-12
73541SUPPL 2023-02-17
73530SUPPL 2023-02-16
71639SUPPL2022-07-27
65643SUPPL2020-12-21
65615SUPPL2020-12-17
65611SUPPL2020-12-17
64711SUPPL2020-09-29
64675SUPPL2020-09-25
61626SUPPL2020-01-23
61620SUPPL2020-01-22
61619SUPPL2020-01-22
60018SUPPL2019-09-17
60008SUPPL2019-09-16
60007SUPPL2019-09-16
58490SUPPL2019-04-30
58475SUPPL2019-04-30
54728SUPPL2018-06-29
54706SUPPL2018-06-27
46934SUPPL2017-01-24
46917SUPPL2017-01-18
46046SUPPL2016-12-06
46021SUPPL2016-12-02
31944SUPPL2014-04-04
18890SUPPL2014-04-04
39939SUPPL2013-12-17
31943SUPPL2013-12-17
18889SUPPL2012-04-02
9723SUPPL2012-04-02
44805ORIG2011-04-22
43324ORIG2011-04-22
31942ORIG2011-03-16
18888ORIG2011-03-11
63279SUPPL1900-01-01