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Ziihera

zanidatamab-hrii

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Ziihera

Proper name

zanidatamab-hrii

Licence type

351(a)

BLA number

761416

Applicant

Jazz Pharmaceuticals Ireland Limited

Center

CDER

Presentations

1

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
300MG	For Injection	Intravenous	Single-Dose Vial	Rx	November 20, 2024

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 20, 1931

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity