FDA.reportPublic FDA data

Application 125545

Type
BLA
Sponsor
HOSPIRA INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125545Retacritepoetin alfa-epbx351(k) BiosimilarRx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION2,000UNITS/MLNoNo
002RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION3,000UNITS/MLNoNo
003RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION4,000UNITS/MLNoNo
004RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION10,000UNITS/MLNoNo
005RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION40,000UNITS/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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RETACRITEPOETIN ALFA-EPBXVifor (International) Inc.e6e4dd0c-25ca-40b2-ba6b-6138a68621fe2025-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125545
ndc (product): 59353-220
ndc (product): 59353-120
ndc (product): 59353-010
RETACRITEPOETIN ALFA-EPBXPfizer Laboratories Div Pfizer Inc3af26b0d-8ad0-44e1-a538-8bdb5ab393742025-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125545

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 2 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-120RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-120RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-120RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-220RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-220RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-220RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78649SUPPL 2024-06-05
78648SUPPL 2024-06-05
78635SUPPL 2024-06-05
74025SUPPL 2023-04-20
74024SUPPL 2023-04-19
63771SUPPL2020-07-01
63765SUPPL2020-07-01
63764SUPPL2020-07-01
57298SUPPL2019-01-22
57288SUPPL2019-01-22
57287SUPPL2019-01-22
56726ORIG2018-12-13
54190ORIG2018-05-15
54187ORIG2018-05-15
54186ORIG2018-05-15