Requests that the FDA declare that the drug product Buspirone Tablets, 20 mg, is suitable for consideration in an Abbreviated New Drug Application (“ANDA”). | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-2302

Requests that the FDA declare that the drug product Buspirone Tablets, 20 mg, is suitable for consideration in an Abbreviated New Drug Application (“ANDA”).

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMar 5, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Mar 23, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

declare that the drug product Buspirone Tablets,

20 mg, is suitable for consideration in an

Abbreviated New Drug Application (“ANDA”).

OPEN

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