FDA.reportPublic FDA data

Application 761164

Type
BLA
Sponsor
BIOVERATIV THERAPEUTICS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761164Enjaymosutimlimab-jome351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENJAYMOSUTIMLIMAB-JOMEINJECTABLE;INJECTION1,100MG/22ML(50MG/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
EnjaymoSUTIMLIMAB-JOMERecordati Rare Diseases, Inc.0a25363a-7781-d9f8-cb1c-be22987bf03b2026-03-02Warnings, Adverse reactionsExact identifier
application number: BLA761164

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
80203-347EnjaymosutimlimabBioverativ U.S. LLC.BLACurrent
80203-347Enjaymosutimlimab-jomeBioverativ U.S. LLC.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77437SUPPL 2024-02-09
77436SUPPL 2024-02-09
77435SUPPL 2024-02-09
73298SUPPL2023-01-26
73297SUPPL2023-01-26
73296SUPPL2023-01-26
72426SUPPL2022-10-20
70401ORIG2022-03-04
70193ORIG2022-02-18
70095ORIG2022-02-04
70094ORIG2022-02-04