Home Applications 125387 Application 125387
Type BLA
Sponsor REGENERON PHARMACEUTICALS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125387 Eylea aflibercept 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EYLEA AFLIBERCEPT INJECTABLE; INJECTION 40MG/ML No No
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EYLEA AFLIBERCEPT Regeneron Pharmaceuticals, Inc. f96cfd69-da34-41ee-90a9-610a4655cd1c 2026-07-07 Warnings, Adverse reactions Exact identifier application number: BLA125387 ndc (product): 61755-005
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current 61755-005 EYLEA aflibercept Regeneron Pharmaceuticals, Inc. BLA Current