FDA.reportPublic FDA data

Application 125370

Type
BLA
Sponsor
HUMAN GENOME SCIENCES INC.

Application Products#

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

NDC Listings For This Application#

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

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