FDA.reportPublic FDA data

Application 761345

Type
BLA
Sponsor
PFIZER INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761345Elrexfioelranatamab-bcmm351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELREXFIOELRANATAMABSOLUTION;INJECTION12MGNoNo

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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElrexfioELRANATAMAB-BCMMU.S. Pharmaceuticalsaa044060-5b4b-4692-bf0f-9a50e140b10e2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761345
ElrexfioELRANATAMAB-BCMMPfizer Laboratories Div Pfizer Incf6fea598-ff58-4a20-b5e8-8a51f37d8beb2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761345

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85545SUPPL 2026-03-27
85160SUPPL 2026-02-25
85159SUPPL 2026-02-25
85101SUPPL 2026-02-23
82817SUPPL 2025-07-11
82788SUPPL 2025-07-11
82765SUPPL 2025-07-09
79577SUPPL 2024-09-12
76821SUPPL 2023-12-14
76363ORIG 2023-11-06
75408ORIG 2023-09-12
75405ORIG 2023-09-12
75077ORIG 2023-09-12