Request that the FDA determine, pursuant to 21 CFR 314.161, whether the Reference Listed Drug (RLD) ADLARITY (Donepezil Hydrochloride Transdermal System), 5 mg/day and 10 mg/day, NDA 212304, held by Corium, LLC, was withdrawn from sale for reasons of safety or effectiveness | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7916

Request that the FDA determine, pursuant to 21 CFR 314.161, whether the Reference Listed Drug (RLD) ADLARITY (Donepezil Hydrochloride Transdermal System), 5 mg/day and 10 mg/day, NDA 212304, held by Corium, LLC, was withdrawn from sale for reasons of safety or effectiveness

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensJul 17, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Annexure-I	Jul 17, 2026	--

Keywords

CDER

Citizen Petition

Pilnova Pharma Inc.

determine, pursuant to 21 CFR 314.161

whether the Reference Listed Drug

(RLD) ADLARITY

(Donepezil Hydrochloride Transdermal System)

5 mg/day and 10 mg/day

Data from Regulations.gov