Home Applications 761378 Application 761378
Type BLA
Sponsor FORMYCON AG Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761378 Ahzantive aflibercept-mrbb 351(k) Biosimilar Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AHZANTIVE AFLIBERCEPT-MRBB INJECTABLE;INJECTION 2MG(0.05ML OF 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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AHZANTIVE AFLIBERCEPT-MRBB Valorum Biologics, LLC 289e4b90-f741-c0f6-e063-6394a90a2068 2025-10-27 Warnings, Adverse reactions Exact identifier application number: BLA761378
Documents# Document, Submission type, Date table Document Submission type Date 82033 SUPPL 2025-04-28 81627 ORIG 2025-03-18 78969 ORIG 2024-07-02 78942 ORIG 2024-07-01