Application 761417

Type
BLA
Sponsor
BEIGENE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEVIMBRATISLELIZUMAB-JSGRINJECTABLE;INTRAVENOUS100MG/10ML(10MG/ML)NoNo

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
TEVIMBRATISLELIZUMAB-JSGRBeOne Medicines USA, Inc.08ef1e3e-496f-4b0b-94ee-fbba3cc1985a2026-05-22Warnings, Adverse reactionsName fallback
brand name: TEVIMBRA
generic name: TISLELIZUMAB-JSGR

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83584ORIG 2025-09-29
83319ORIG 2025-09-11
80758ORIG 2025-09-11
80759ORIG 2025-09-10