FDA.reportPublic FDA data

Application 761028

Type
BLA
Sponsor
AMGEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761028Mvasibevacizumab-awwb351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MVASIBEVACIZUMAB-AWWBINJECTABLE; INJECTION100MG/4ML (25MG/ML)NoNo
002MVASIBEVACIZUMAB-AWWBINJECTABLE; INJECTION400MG/16ML (25MG/ML)NoNo

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
MVASIBEVACIZUMAB-AWWBAmgen, Inc0a562b4e-67ce-4bab-852c-d9ee71e55fb82026-06-23Warnings, Adverse reactionsExact identifier
application number: BLA761028
ndc (product): 55513-207
ndc (product): 55513-206

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73576SUPPL 2023-02-21
69325SUPPL2021-11-16
69316SUPPL2021-11-16
67136SUPPL2021-04-22
67125SUPPL2021-04-20
59180SUPPL2019-06-27
59168SUPPL2019-06-25
55957ORIG2018-10-16
49732ORIG2017-09-14
49729ORIG2017-09-14