Request that the FDA declare that the drug products Metformin HCl Capsules, 250 mg, 500 mg, and 625 mg, are suitable for consideration in an Abbreviated New Drug Application (ANDA) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-5991

Request that the FDA declare that the drug products Metformin HCl Capsules, 250 mg, 500 mg, and 625 mg, are suitable for consideration in an Abbreviated New Drug Application (ANDA)

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMay 27, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Jul 8, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

declare that the drug products

Metformin HCl Capsules, 250 mg, 500 mg,

and 625 mg, are suitable for consideration

in an Abbreviated New Drug Application (ANDA)

Approved Drug Products with

Data from Regulations.gov