Application 761125

Type
BLA
Sponsor
NOVARTIS PHARMS CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761125Beovubrolucizumab-dbll351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BEOVUbrolucizumab-dbllINJECTABLE; INTRAVITREAL6MG/0.05MLNoNo

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
BEOVUBROLUCIZUMABNovartis Pharmaceuticals Corporation5d1dc1fa-a2d3-46ed-9e9a-c1a036590d3d2025-11-03Warnings, Adverse reactionsExact identifier
application number: BLA761125
ndc (product): 0078-0827

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent
0078-0827BEOVUbrolucizumabNovartis Pharmaceuticals CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79254SUPPL 2024-07-30
79250SUPPL 2024-07-30
75619SUPPL 2023-09-29
75609SUPPL 2023-09-29
72982SUPPL2022-12-21
72963SUPPL2022-12-21
71178SUPPL2022-05-31
71173SUPPL2022-05-31
70208SUPPL2022-02-22
70207SUPPL2022-02-22
70206SUPPL2022-02-22
70201SUPPL2022-02-22
70200SUPPL2022-02-22
70199SUPPL2022-02-22
64843SUPPL2020-10-06
63532SUPPL2020-06-12
63474SUPPL2020-06-10
60777ORIG2019-11-04
60409ORIG2019-10-09
60338ORIG2019-10-08