FDA.reportPublic FDA data

Application 761371

Type
BLA
Sponsor
GENENTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761371Ocrevus Zunovoocrelizumab and hyaluronidase-ocsq351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCREVUS ZUNOVOOCRELIZUMAB AND HYALURONIDASE-OCSQINJECTABLE;INJECTION40MG;1000UNITS 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
Ocrevus ZunovoOCRELIZUMAB AND HYALURONIDASEGenentech, Inc.b216af61-99d0-42a3-afc2-b5bf86df1ec02026-04-27Warnings, Adverse reactionsExact identifier
application number: BLA761371

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83897ORIG 2025-10-23
83155SUPPL 2025-08-20
83154SUPPL 2025-08-20
83141SUPPL 2025-08-19
79635ORIG 2024-09-16
79583ORIG 2024-09-13