Application 761232

Type
BLA
Sponsor
BEIGENE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761232Tevimbratislelizumab-jsgr351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEVIMBRATISLELIZUMAB-JSGRINJECTION;SOLUTION100MG/10MLNoNo

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 reactionsExact identifier
application number: BLA761232

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84442SUPPL 2025-12-18
84440SUPPL 2025-12-18
84379SUPPL 2025-12-10
84378SUPPL 2025-12-10
84377SUPPL 2025-12-10
82135SUPPL 2025-05-05
82265SUPPL 2025-05-01
82264SUPPL 2025-05-01
82090SUPPL 2025-05-01
82089SUPPL 2025-05-01
82088SUPPL 2025-05-01
82087SUPPL 2025-05-01
82086SUPPL 2025-05-01
82085SUPPL 2025-05-01
82084SUPPL 2025-05-01
81975SUPPL 2025-04-24
81974SUPPL 2025-04-24
81973SUPPL 2025-04-24
81972SUPPL 2025-04-24
81971SUPPL 2025-04-24
81970SUPPL 2025-04-24
78106ORIG 2024-04-10
77851ORIG 2024-03-18
77850ORIG 2024-03-18
77831ORIG 2024-03-14