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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
Pharmaceutical Policy
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📄 Primary document
OtherJul 2, 2026
Suitability Petition from Zydus Pharmaceuticals (USA) Inc.
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