FDA.reportPublic FDA data

Application 761173

Type
BLA
Sponsor
FRESENIUS KABI USA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761173Stimufendpegfilgrastim-fpgk351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STIMUFENDPEGFILGRASTIM-FPGKSOLUTION; 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STIMUFENDPEGFLILGRASTIM-FPGKNORTHSTAR RX LLC1e36ee55-7f13-41db-9d49-2f7a92f3b7502025-11-30Warnings, Adverse reactionsExact identifier
application number: BLA761173
STIMUFENDPEGFLILGRASTIM-FPGKFresenius Kabi USA, LLCb44bcb82-7e60-4dab-a658-115bdf5c053c2023-10-24Warnings, Adverse reactionsExact identifier
application number: BLA761173
ndc (product): 65219-371

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65219-371STIMUFENDpegflilgrastim-fpgkFresenius Kabi USA, LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83876SUPPL 2025-10-23
83875SUPPL 2025-10-23
81768SUPPL 2025-03-28
81755SUPPL 2025-03-27
75654SUPPL 2023-10-03
75635SUPPL 2023-10-02
72620ORIG2022-11-16
72007ORIG2022-09-02
72000ORIG2022-09-02