Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-6538

Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons.

Documents

Comments

Key Dates

Comment Period OpensJun 8, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Citizen Petition from Newcastle Bioscience LLC	Jun 8, 2026	--

Keywords

CDER

Newcastle Bioscience

Citizen Petition

determine

whether Namenda Memantine Hydrochloride

5 mg and 10 mg Tablets

NDA 021487

has been voluntarily withdrawn

from sale for safety or efficacy reasons

Data from Regulations.gov