FDA.reportPublic FDA data

Application 761216

Type
BLA
Sponsor
COHERUS BIOSCIENCES INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761216Yusimryadalimumab-aqvh351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YUSIMRYADALIMUMAB-AQVHINJECTABLE;INJECTION40MGNoNo

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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YUSIMRYADALIMUMAB-AQVHMeitheal Pharmaceuticals Inc.4cab600d-6950-409f-a6d8-d447da22cd952025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761216
YUSIMRYADALIMUMAB-AQVHCoherus BioSciences Inccd0e7af2-7704-49ce-bde9-f645294b67882025-05-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761216

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84142SUPPL 2025-11-13
84141SUPPL 2025-11-12
75468SUPPL 2023-09-15
75463SUPPL 2023-09-14
75449SUPPL 2023-09-14
73933SUPPL 2023-04-03
73929SUPPL 2023-04-03
73628SUPPL 2023-02-28
73621SUPPL 2023-02-28
69894ORIG2022-01-18
69725ORIG2021-12-21
69640ORIG2021-12-20
69641ORIG2021-12-19