Requests that FDA declare that Metformin HCl for Extended-Release Oral Suspension, 500 mg and 750 mg (unit-dose sachets), are suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-P-4535

Requests that FDA declare that Metformin HCl for Extended-Release Oral Suspension, 500 mg and 750 mg (unit-dose sachets), are suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensApr 23, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter	Jul 21, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that Metformin HCl for

Extended- Release Oral Suspension,

500 mg and 750 mg (unit-dose sachets), are

suitable for submission as an ANDA

As designated in FDA’s Approved Drug Products

Data from Regulations.gov