Home Applications 761473 Application 761473
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 761473 Nufymco ranibizumab-leyk 351(k) Interchangeable Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NUFYMCO RANIBIZUMAB-LEYK INJECTION 6MG/ML No No 002 NUFYMCO RANIBIZUMAB-LEYK INJECTION 10MG/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 NUFYMCO RANIBIZUMAB-LEYK Zydus Pharmaceuticals USA Inc. 05ed75bc-ae21-480b-9be4-cbc51689dd8a 2026-06-04 Warnings, Adverse reactions Exact identifier application number: BLA761473
Documents# Document, Submission type, Date table Document Submission type Date 84475 ORIG 2025-12-19