FDA.reportPublic FDA data

Application 761043

Type
BLA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENLYSTABELIMUMABINJECTABLE;INJECTION200MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49401-088BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-088BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent
49401-088BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-088BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-088BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-088BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-088BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-088BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-088BENLYSTAbelimumabHuman Genome Sciences, Inc.BLACurrent
49401-088BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent
49401-088BENLYSTAbelimumabGlaxoSmithKline LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82639SUPPL 2025-06-24
82628SUPPL 2025-06-23
78504SUPPL 2024-05-20
78494SUPPL 2024-05-20
78493SUPPL 2024-05-20
77477SUPPL 2024-02-12
77469SUPPL 2024-02-12
73542SUPPL 2023-02-17
73531SUPPL 2023-02-16
71648SUPPL2022-07-27
71647SUPPL2022-07-27
71643SUPPL2022-07-27
65609SUPPL2020-12-21
65610SUPPL2020-12-17
65608SUPPL2020-12-17
61627SUPPL2020-01-23
61622SUPPL2020-01-22
61621SUPPL2020-01-22
60019SUPPL2019-09-17
60010SUPPL2019-09-16
60009SUPPL2019-09-16
58491SUPPL2019-04-30
58476SUPPL2019-04-30
56575ORIG2018-11-27
54729SUPPL2018-06-29
54705SUPPL2018-06-27
49066ORIG2017-07-25
49044ORIG2017-07-25