FDA.reportPublic FDA data

Application 761355

Type
BLA
Sponsor
REGENERON PHARMACEUTICALS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761355Eylea HDaflibercept351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EYLEA HDAFLIBERCEPTINJECTABLE;INJECTION8MG(0.07ML;114.3MG/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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EYLEA HDAFLIBERCEPTRegeneron Pharmaceuticals, Inc86d8848b-111b-4da9-8957-7cccef1b8f662026-04-06Warnings, Adverse reactionsExact identifier
application number: BLA761355

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85640SUPPL 2026-04-06
85639SUPPL 2026-04-06
84251SUPPL 2025-11-21
84240SUPPL 2025-11-20
79867SUPPL 2024-10-11
79861SUPPL 2024-10-11
78157ORIG 2024-04-18
76860SUPPL 2023-12-15
76847SUPPL 2023-12-15
75247ORIG 2023-08-22
75220ORIG 2023-08-22