Home Applications 761134 Application 761134
Type BLA
Sponsor EVIVE BIOTECHNOLOGY Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761134 Ryzneuta efbemalenograstim alfa-vuxw 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RYZNEUTA EFBEMALENOGRASTIM ALFA-VUXW INJECTABLE;INJECTION 20MG/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 RYZNEUTA EFBEMALENOGRASTIM ALFA-VUXW Acrotech Biopharma Inc 290ed754-758c-9cae-e063-6294a90ae68b 2026-05-19 Warnings, Adverse reactions Exact identifier application number: BLA761134
Documents# Document, Submission type, Date table Document Submission type Date 76753 ORIG 2023-12-08 76620 ORIG 2023-11-17 76606 ORIG 2023-11-17