← FDA DRUG APPROVALS

FDA BLA · BLA761416

ZIIHERA

zanidatamab-hrii

Sponsor: JAZZ PHARMS

APPLICATION
BLA761416
TYPE
BLA
ORIGINAL APPROVAL
2024-11-20
LATEST ACTION
2024-11-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZIIHERAPrescription
ZANIDATAMAB-HRII 300MG · INJECTABLE · INJECTION

Approval history

2024-11-20Type 1 - New Molecular Entity · Original · priorityLabelAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →