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)Rx2026-06-01

Application Products#

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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