FDA.reportPublic FDA data

Application 761197

Type
BLA
Sponsor
GENENTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761197Susvimoranibizumab351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUSVIMORANOBIZUMABINJECTABLE;INJECTION100MG/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
SusvimoRANIBIZUMABGenentech, Inc.9c6d9e2a-9a77-4d11-b692-de87cfde34442025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761197
ndc (product): 50242-078

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-078SusvimoRanibizumabGenentech, Inc.BLACurrent
50242-078SusvimoRanibizumabGenentech, Inc.BLACurrent
50242-078SusvimoRanibizumabGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83312SUPPL 2025-09-09
83311SUPPL 2025-09-09
83305SUPPL 2025-09-08
82452SUPPL 2025-06-03
82304SUPPL 2025-05-23
81171SUPPL 2025-02-07
81075SUPPL 2025-02-06
72128ORIG2022-09-21
70795SUPPL2022-04-20
70789SUPPL2022-04-19
69107ORIG2021-10-25
69106ORIG2021-10-25