FDA.reportPublic FDA data

Application 761152

Type
BLA
Sponsor
OMEROS CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761152Yartemleanarsoplimab-wuug351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YARTEMLEANARSOPLIMAB-WUUGINJECTIONNoNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YARTEMLEANARSOPLIMABOmeros Corporationf8ff990a-0d2e-433f-9615-b9b0974489912026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA761152

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85024ORIG 2026-02-12
84596ORIG 2025-12-30
84595ORIG 2025-12-29