Requests that they FDA declare that the drug product Buspirone HCl Oral Solution, 2 mg/mL, is suitable for consideration in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-6524

Requests that they FDA declare that the drug product Buspirone HCl Oral Solution, 2 mg/mL, is suitable for consideration in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensNov 28, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter	Jun 5, 2026	--

Keywords

CDER

Suitability Petition

Hyman Phelps and McNamara PC

declare that the drug product

Buspirone HCl Oral Solution 2 mg mL

is suitable for consideration

in an Abbreviated New Drug Application

CLOSED

Data from Regulations.gov