Home Applications 761298 Application 761298
Type BLA
Sponsor AMGEN INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761298 Pavblu aflibercept-ayyh 351(k) Biosimilar Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PAVBLU AFLIBERCEPT-AYYH INJECTABLE;INJECTION 2 mg (0.05 mL of 40 mg/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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAVBLU AFLIBERCEPT-AYYH Amgen, Inc c61062f3-80ec-4a20-8c28-46e468592a06 2026-05-10 Warnings, Adverse reactions Exact identifier application number: BLA761298
Documents# Document, Submission type, Date table Document Submission type Date 85797 SUPPL 2026-05-01 85779 SUPPL 2026-04-30 81690 ORIG 2025-03-24 79774 ORIG 2024-09-30 79467 ORIG 2024-08-26