Home Applications 761416 Application 761416
Type BLA
Sponsor JAZZ PHARMS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761416 Ziihera zanidatamab-hrii 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZIIHERA ZANIDATAMAB-HRII INJECTABLE;INJECTION 300MG 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 ZIIHERA ZANIDATAMAB-HRII Jazz Pharmaceuticals, Inc. ae5d9425-fae5-4541-a158-150998343348 2025-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761416
Documents# Document, Submission type, Date table Document Submission type Date 80557 ORIG 2024-12-12 80553 ORIG 2024-12-11 80261 ORIG 2024-11-21