Requests that the FDA determine that the proposed drug product, Zanubrutinib Tablets, 80 mg and 320 mg, are suitable for consideration in an Abbreviated New Drug Application.
🏛 Food and Drug Administration (FDA)FDA-2026-P-7337
Documents
5
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0
all analyzed
Comment status
Open
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In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
- Supporting & Related Material· Jul 2, 2026
- Supporting & Related Material· Jul 2, 2026
- Supporting & Related Material· Jul 2, 2026
