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. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7337

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.

Documents

Comments

Key Dates

Comment Period OpensJul 2, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Zydus Pharmaceuticals (USA) Inc.	Jul 20, 2026	--

Keywords

CDER

suitability petition

Zydus Pharmaceuticals USA Inc

determine that the proposed drug product

Zanubrutinib Tablets

80 mg and 320 mg

are suitable for consideration

in an Abbreviated New Drug Application

Data from Regulations.gov