FDA.reportPublic FDA data

Application 761158

Type
BLA
Sponsor
GLAXOSMITHKLINE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761158Blenrepbelantamab mafodotin-blmf351(a)Disc2026-10-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BLENREPBELANTAMAB MAFODOTIN-BLMFINJECTABLE;INTRAVENOUS2.5MG/KGNoNo

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 ยท 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0896BlenrepBelantamabGlaxoSmithKline LLCBLACurrent
0173-0896BlenrepBelantamabGlaxoSmithKline LLCBLACurrent
0173-0896BlenrepBelantamabGlaxoSmithKline LLCBLACurrent
0173-0896BlenrepBelantamabGlaxoSmithKline LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70339SUPPL2022-03-01
70338SUPPL2022-03-01
70314SUPPL2022-03-01
69513SUPPL2021-12-08
65310SUPPL2020-11-25
64469ORIG2020-09-01
64241ORIG2020-08-10
64208ORIG2020-08-06
64207ORIG2020-08-06