FDA.reportPublic FDA data

Application 761100

Type
BLA
Sponsor
SAMSUNG BIOEPIS CO LTD

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761100Ontruzanttrastuzumab-dttb351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONTRUZANTTRASTUZUMAB-DTTBINJECTABLE;INJECTION150MGNoNo
002ONTRUZANTTRASTUZUMAB-DTTBPOWDER;IV (INFUSION)420MGNoNo

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
OntruzantTRASTUZUMABOrganon LLCce2a2492-85e3-4b0a-872a-047f44e4203d2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761100
ndc (product): 78206-147
ndc (product): 78206-148

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-5033OntruzanttrastuzumabMerck Sharp & Dohme Corp.BLACurrent
0006-5033OntruzanttrastuzumabMerck Sharp & Dohme Corp.BLACurrent
0006-5034OntruzantOntruzantMerck Sharp & Dohme Corp.BLACurrent
0006-5034OntruzantOntruzantMerck Sharp & Dohme Corp.BLACurrent
78206-147OntruzanttrastuzumabOrganon LLCBLACurrent
78206-148OntruzantOntruzantOrganon LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84370SUPPL 2025-12-09
81493SUPPL 2025-03-07
81444SUPPL 2025-03-07
70106SUPPL2022-02-07
70103SUPPL2022-02-07
57314ORIG2019-03-07
57908ORIG2019-03-05
57246ORIG2019-01-18