FDA.reportPublic FDA data

Application 761045

Type
BLA
Sponsor
SANDOZ INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761045Ziextenzopegfilgrastim-bmez351(k) BiosimilarRx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZIEXTENZOPEGFILGRASTIM-BMEZINJECTABLE;INJECTION6MG/0.6MLNoNo

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
ZIEXTENZOPEGFILGRASTIM-BMEZSandoz Inc7dada041-6528-4acf-809c-62d271538c9a2026-05-14Warnings, Adverse reactionsExact identifier
application number: BLA761045
ndc (product): 61314-866

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61314-866ZIEXTENZOpegfilgrastim-bmezSandoz IncBLACurrent
61314-866ZIEXTENZOpegfilgrastim-bmezSandoz IncBLACurrent
61314-866ZIEXTENZOpegfilgrastim-bmezSandoz IncBLACurrent
61314-866ZIEXTENZOpegfilgrastim-bmezSandoz IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85941SUPPL 2026-05-18
85905SUPPL 2026-05-13
77652SUPPL 2024-02-29
77651SUPPL 2024-02-29
75700SUPPL 2023-10-10
75682SUPPL 2023-10-10
66788SUPPL2021-03-16
66780SUPPL2021-03-15
61459ORIG2019-12-27
60789ORIG2019-12-26
60781ORIG2019-11-05