FDA.reportPublic FDA data

Application 761091

Type
BLA
Sponsor
CELLTRION INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761091Herzumatrastuzumab-pkrb351(k) BiosimilarRx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HERZUMATRASTUZUMAB-PKRBINJECTABLE;INJECTION420MGNoNo

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
HERZUMATRASTUZUMABCephalon, Inc.ae71c003-883a-4cd8-ad50-e8cc9a54e9712025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761091
ndc (product): 63459-303
ndc (product): 63459-305

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63459-303HERZUMATRASTUZUMABCephalon, Inc.BLACurrent
63459-303HERZUMATRASTUZUMABCephalon, Inc.BLACurrent
63459-303HERZUMATRASTUZUMABCephalon, Inc.BLACurrent
63459-303HERZUMATRASTUZUMABCephalon, Inc.BLACurrent
63459-305HERZUMATRASTUZUMABCephalon, Inc.BLACurrent
63459-305HERZUMATRASTUZUMABCephalon, Inc.BLACurrent
63459-305HERZUMATRASTUZUMABCephalon, Inc.BLACurrent
63459-305HERZUMAtrastuzumabCephalon, Inc.BLACurrent
63459-305HERZUMATRASTUZUMABCephalon, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82412SUPPL 2025-06-02
82333SUPPL 2025-05-27
80218SUPPL 2024-11-14
80211SUPPL 2024-11-14
58780SUPPL2019-05-17
58779SUPPL2019-05-17
58777SUPPL2019-05-17
58776SUPPL2019-05-17
58058ORIG2019-03-21
56911ORIG2018-12-21
56747ORIG2018-12-14