Requests that the FDA declare that the drug product Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, is suitable for consideration in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-5194

Requests that the FDA declare that the drug product Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, is suitable for consideration in an Abbreviated New Drug Application.

Documents

Comments

Key Dates

Comment Period OpensMay 11, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Attachment 4	May 11, 2026	--

Keywords

CDER

Suitability Petition

Hyman Phelps and McNamara PC

declare that the drug product

Naltrexone Hydrochloride Oral Suspension 5 mg mL

is suitable for consideration

in an Abbreviated New Drug Application

OPEN

Data from Regulations.gov