Requests that the FDA declare that the drug product Metformin Hydrochloride Tablets, 375 mg, is suitable for consideration in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-6625

Requests that the FDA declare that the drug product Metformin Hydrochloride Tablets, 375 mg, is suitable for consideration in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 3, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter	Jun 16, 2026	--

Keywords

CDER

Suitability Petition

Hyman Phelps and McNamara PC

declare that the drug product

Metformin Hydrochloride Tablets 375 mg

is suitable for consideration

in an Abbreviated New Drug Application

CLOSED

Data from Regulations.gov