FDA.reportPublic FDA data

Application 761347

Type
BLA
Sponsor
GENENTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761347Tecentriq Hybrezaatezolizumab and hyaluronidase-tqjs351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECENTRIQ HYBREZAATEZOLIZUMAB AND HYALURONIDASE-TQJSINJECTABLE;INJECTION125MG;2000UNITS PER MLNoNo

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
Tecentriq HybrezaATEZOLIZUMAB AND HYALURONIDASE-TQJSGenentech, Inc.a617b089-ce66-464b-987b-b45d029b4d6f2026-05-20Warnings, Adverse reactionsExact identifier
application number: BLA761347

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85981SUPPL 2026-05-19
85947SUPPL 2026-05-18
85908SUPPL 2026-05-13
84306SUPPL 2025-11-25
84301SUPPL 2025-11-25
84300SUPPL 2025-11-25
84192SUPPL 2025-11-18
83651SUPPL 2025-10-03
83142SUPPL 2025-08-20
83140SUPPL 2025-08-19
81921ORIG 2025-04-10
79623ORIG 2024-09-16
79595ORIG 2024-09-16