FDA.reportPublic FDA data

Application 761328

Type
BLA
Sponsor
ASTRAZENECA AB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761328Beyfortusnirsevimab-alip351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BEYFORTUSNIRSEVIMAB-ALIPINJECTABLE;INJECTION50MGNoNo
002BEYFORTUSNIRSEVIMAB-ALIPINJECTABLE;INJECTION100MGNoNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BEYFORTUSNIRSEVIMABSanofi Vaccines US Inc.2f08fa60-f674-432d-801b-1f9514bd9b392026-06-26Warnings, Adverse reactionsExact identifier
application number: BLA761328

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85669SUPPL 2026-04-10
85658SUPPL 2026-04-09
83848SUPPL 2025-10-21
83847SUPPL 2025-10-21
79466SUPPL 2024-08-26
79465SUPPL 2024-08-23
77626SUPPL 2024-02-26
77612SUPPL 2024-02-26
75093ORIG 2023-08-15
75092ORIG 2023-07-18
75091ORIG 2023-07-18