Requests that the FDA declare that the drug product, Dexmethylphenidate Hydrochloride Tablets 7.5 mg is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7183

Requests that the FDA declare that the drug product, Dexmethylphenidate Hydrochloride Tablets 7.5 mg is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Key Dates

Comment Period OpensJun 29, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Attachment 3 - Draft Package Insert	Jul 21, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals Inc

declare that the drug product

Dexmethylphenidate Hydrochloride Tablets 7 5 mg

is suitable for submission

in an Abbreviated New Drug Application

OPEN

Data from Regulations.gov