FDA.reportPublic FDA data

Application 761136

Type
BLA
Sponsor
CELGENE CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761136Reblozylluspatercept-aamt351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REBLOZYLLUSPATERCEPT-AAMTPOWDER;SUBCUTANEOUS25MG/VIALNoNo
002REBLOZYLLUSPATERCEPT-AAMTPOWDER;SUBCUTANEOUS75MG/VIALNoNo

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
ReblozylLUSPATERCEPTCelgene Corporation82f4d266-3f52-41eb-86ba-0abf3cf468e82026-02-27Warnings, Adverse reactionsExact identifier
application number: BLA761136
ndc (product): 59572-775
ndc (product): 59572-711

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59572-711LuspaterceptLuspaterceptCelgeneBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgeneBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgeneBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgeneBLACurrent
59572-775LuspaterceptLuspaterceptCelgeneBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgeneBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgeneBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgeneBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85281SUPPL 2026-03-06
85214SUPPL 2026-03-03
78505SUPPL 2024-05-20
78492SUPPL 2024-05-17
75318SUPPL 2023-08-29
75314SUPPL 2023-08-29
71535SUPPL2022-07-11
71531SUPPL2022-07-11
64881ORIG2020-10-08
62444ORIG2020-04-06
62441ORIG2020-04-06
61346ORIG2019-12-19
60817ORIG2019-11-12
60799ORIG2019-11-08