Application 761078

Type
BLA
Sponsor
EMD SERONO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BAVENCIOAVELUMABINJECTABLE;INTRAVENOUS20MG/MLYesNo

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
BAVENCIOAVELUMABEMD Serono, Inc.5cd725a1-2fa4-408a-a651-57a7b84b21182025-06-13Warnings, Adverse reactionsName fallback
brand name: BAVENCIO
generic name: AVELUMAB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54474ORIG2018-06-08
48326ORIG2017-05-09
48324ORIG2017-05-09
48323ORIG2017-05-09