FDA.reportPublic FDA data

Application 761099

Type
BLA
Sponsor
PFIZER INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761099Zirabevbevacizumab-bvzr351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIRABEVBEVACIZUMAB-BVZRINJECTABLE;INJECTION100MG/4MLNoNo
002ZIRABEVBEVACIZUMAB-BVZRINJECTABLE;INJECTION400MG/16MLNoNo

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
ZirabevBEVACIZUMAB-BVZRPfizer Laboratories Div Pfizer Incaa27acbd-d117-4350-aeee-17bc2e2c0ca42026-07-21Warnings, Adverse reactionsExact identifier
application number: BLA761099
ndc (product): 0069-0315
ndc (product): 0069-0342

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
0069-0315Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0315Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0315Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0315Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0315Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0342Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0342Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0342Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0342Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent
0069-0342Zirabevbevacizumab-bvzrPfizer Laboratories Div Pfizer IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79506SUPPL 2024-08-29
79505SUPPL 2024-08-29
73586SUPPL 2023-02-22
73553SUPPL 2023-02-17
66222SUPPL2021-02-16
66221SUPPL2021-02-16
66172SUPPL2021-02-10
59703ORIG2019-08-14
59196ORIG2019-06-28
59190ORIG2019-06-28