FDA.reportPublic FDA data

Application 761235

Type
BLA
Sponsor
GENENTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761235Vabysmofaricimab-svoa351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FARICIMABVABYSMOINJECTABLE; INTRAVITREAL120MG/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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VABYSMOFARICIMABGenentech, Inc.04cc9ef7-c02a-4e92-a655-0062674e84872026-04-15Warnings, Adverse reactionsExact identifier
application number: BLA761235
ndc (product): 50242-096

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-096VABYSMOFaricimabGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85678SUPPL 2026-04-14
85670SUPPL 2026-04-10
79109SUPPL 2024-07-17
79054SUPPL 2024-07-12
75979SUPPL 2023-10-27
75962SUPPL 2023-10-27
73327SUPPL2023-01-30
73315SUPPL2023-01-30
70274ORIG2022-02-28
70038ORIG2022-02-01
70002ORIG2022-01-31