Request that the FDA determine that the drug product, Amantadine Extended-Release Capsules, 274 mg, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-6646

Request that the FDA determine that the drug product, Amantadine Extended-Release Capsules, 274 mg, is suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 2, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Buchanan Ingersoll & Rooney PC	Apr 30, 2026	--

Keywords

CDER

Suitability Petition

Buchanan Ingersoll & Rooney PC

determine that the drug product

Amantadine Extended-Release Capsules

274 mg, is suitable for submission as an ANDA

reference listed drug product (RLD)

New Drug Application (NDA)

Data from Regulations.gov