FDA.reportPublic FDA data

Application 125156

Type
BLA
Sponsor
GENENTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125156Lucentisranibizumab351(a)Disc*2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUCENTISRANIBIZUMABINJECTABLE; INJECTION10MG/MLNoNo
002LUCENTISRANIBIZUMABInjectable; Injection6MG/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
LUCENTISRANIBIZUMABGenentech, Inc.de4e66cc-ca05-4dc9-8262-e00e9b41c36d2025-11-21Warnings, Adverse reactionsExact identifier
application number: BLA125156
ndc (product): 50242-082
ndc (product): 50242-080

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77582SUPPL 2024-02-20
77549SUPPL 2024-02-16
67700SUPPL2021-06-04
58922SUPPL2019-06-03
57210SUPPL2019-01-14
57209SUPPL2019-01-14
57208SUPPL2019-01-14
54462SUPPL2018-06-05
53493SUPPL2018-03-28
48056SUPPL2017-04-18
48052SUPPL2017-04-18
46838SUPPL2017-01-13
46725SUPPL2017-01-06
45980SUPPL2016-12-01
45958SUPPL2016-11-25
45634SUPPL2016-10-17
45614SUPPL2016-10-17
9631SUPPL2015-02-10
18811SUPPL2015-02-09
9630SUPPL2014-11-28
18810SUPPL2014-11-26
39863SUPPL2014-03-04
31853SUPPL2014-03-04
43306SUPPL2014-01-17
9629SUPPL2013-03-12
31852SUPPL2013-02-08
18809SUPPL2013-02-08
18808SUPPL2012-08-15
18807SUPPL2012-08-15
31851SUPPL2012-08-13
31850SUPPL2012-08-13
18806SUPPL2010-07-06
31849SUPPL2010-07-02
22790ORIG2006-09-26
18805ORIG2006-07-13
9628ORIG2006-07-13