FDA.reportPublic FDA data

Application 125553

Type
BLA
Sponsor
SANDOZ INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125553Zarxiofilgrastim-sndz351(k) BiosimilarRx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZARXIOFILGRASTIM-SNDZINJECTABLE;INJECTION300 mcg/0.5 mLNoNo
002ZARXIOFILGRASTIM-SNDZINJECTABLE;INJECTION480 mcg/0.8 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
ZARXIOFILGRASTIM-SNDZSandoz Inc.c0d1c22b-566b-4776-bdbf-00f96dad0cae2025-08-29Warnings, Adverse reactionsExact identifier
application number: BLA125553
ndc (product): 61314-318
ndc (product): 61314-326

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61314-304ZARXIOfilgrastim-sndzSandoz IncBLACurrent
61314-304ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-304ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-312ZARXIOfilgrastim-sndzSandoz IncBLACurrent
61314-312ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-312ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-318ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-318ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-318ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-318ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-326ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-326ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-326ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent
61314-326ZARXIOfilgrastim-sndzSandoz Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85716SUPPL 2026-04-20
85713SUPPL 2026-04-20
83204SUPPL 2025-08-26
83172SUPPL 2025-08-22
79968SUPPL 2024-10-23
79962SUPPL 2024-10-23
79372SUPPL 2024-08-12
79368SUPPL 2024-08-12
77250SUPPL 2024-02-06
77270SUPPL 2024-01-23
68204SUPPL2021-07-27
68196SUPPL2021-07-27
59566SUPPL2019-08-02
59550SUPPL2019-08-02
47295SUPPL2017-02-23
47271SUPPL2017-02-21
18934SUPPL2016-03-04
9783SUPPL2016-03-04
44818ORIG2015-04-20
22823ORIG2015-04-20
77403ORIG 2015-03-06
39990ORIG2015-03-06
9782ORIG2015-03-06
54061ORIG1900-01-01
51105ORIG1900-01-01
51104ORIG1900-01-01
51103ORIG1900-01-01
51102ORIG1900-01-01
51100ORIG1900-01-01