FDA.reportPublic FDA data

Application 761088

Type
BLA
Sponsor
CELLTRION INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761088Truximarituximab-abbs351(k) InterchangeableRx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRUXIMARITUXIMAB-ABBSINJECTABLE;INJECTION100MG/10ML(10MG/ML)NoNo
002TRUXIMARITUXIMAB-ABBSINJECTABLE;INJECTION500MG/50ML(10MG/ML)NoNo

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
TruximaRITUXIMAB-ABBSCephalon, Inc.9af3ddc7-4217-417a-ac89-8704edc5bc442026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761088
ndc (product): 63459-104
ndc (product): 63459-103

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 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63459-103Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-103Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-103Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-103Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-103Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-103Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-103Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-103Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-104Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-104Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-104Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-104Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-104Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-104Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-104Truximarituximab-abbsCephalon, Inc.BLACurrent
63459-104Truximarituximab-abbsCephalon, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83235SUPPL 2025-08-29
82512SUPPL 2025-06-10
70122SUPPL2022-02-08
70121SUPPL2022-02-08
70113SUPPL2022-02-08
63394SUPPL2020-06-02
63393SUPPL2020-06-02
63389SUPPL2020-06-02
61404SUPPL2019-12-23
61403SUPPL2019-12-23
61357SUPPL2019-12-19
61356SUPPL2019-12-19
61355SUPPL2019-12-19
61354SUPPL2019-12-19
58858SUPPL2019-05-31
58857SUPPL2019-05-31
58849SUPPL2019-05-31
58848SUPPL2019-05-31
58847SUPPL2019-05-31
58846SUPPL2019-05-31
57811ORIG2019-02-26
57808ORIG2019-02-25
56580ORIG2018-11-28