FDA.reportPublic FDA data

Application 761065

Type
BLA
Sponsor
TAIMED BIOLOGICS USA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761065Trogarzoibalizumab-uiyk351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TROGARZOIBALIZUMAB-UIYKINJECTABLE;INJECTION150MG/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
TROGARZOIBALIZUMABTheratechnologies Inc.c548ad82-9d1f-4d16-95b6-4e6106badf432026-01-07Warnings, Adverse reactionsExact identifier
application number: BLA761065
ndc (product): 62064-122

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent
62064-122TROGARZOibalizumabTheratechnologies Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76783SUPPL 2023-12-13
76778SUPPL 2023-12-13
72266SUPPL2022-10-07
67171SUPPL2021-04-26
67167SUPPL2021-04-23
62659SUPPL2020-04-24
62609SUPPL2020-04-20
54394SUPPL2018-05-31
54387SUPPL2018-05-31
53561ORIG2018-03-30
52850ORIG2018-03-07
52849ORIG2018-03-07