Requests that the FDA declare that the drug products Benztropine Tablets, 1.5 mg and 3 mg, are suitable for consideration in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7927

Requests that the FDA declare that the drug products Benztropine Tablets, 1.5 mg and 3 mg, are suitable for consideration in an Abbreviated New Drug Application.

Documents

Comments

Key Dates

Comment Period OpensJul 20, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Jul 30, 2026	--

Keywords

CDER

Suitability Petition

Hyman Phelps and McNamara PC

declare that the drug products

Benztropine Tablets

1.5 mg and 3 mg

are suitable for consideration

in an Abbreviated New Drug Application

Data from Regulations.gov