FDA.reportPublic FDA data

Application 761172

Type
BLA
Sponsor
RIDGEBACK BIOTHERAPEUTICS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761172Ebangaansuvimab-zykl351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EBANGAANSUVIMAB-ZYKLPOWDER;IV (INFUSION)400MG/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
EbangaANSUVIMABEmergent BioDefense Operations Lansing LLCde220c8f-ffcb-4522-a6a2-c7d6ce5de1b52026-08-13Warnings, Adverse reactionsExact identifier
application number: BLA761172

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
80673-777EBANGAANSUVIMABRidgeback Biotherapeutics, LPBLACurrent
80673-777EBANGAANSUVIMABRidgeback Biotherapeutics, LPBLACurrent
80673-777EBANGAANSUVIMABRidgeback Biotherapeutics, LPBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85142SUPPL 2026-02-24
85074SUPPL 2026-02-19
80769SUPPL 2024-12-27
80760SUPPL 2024-12-27
71120SUPPL2022-05-20
71110SUPPL2022-05-20
69794SUPPL2021-12-28
69516SUPPL2021-12-08
65897ORIG2021-01-12
65695ORIG2020-12-22
65650ORIG2020-12-21