Requests that FDA determine whether GLUMETZA (METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 500MG and 1G), approved under New Drug Application (“NDA”) number N021748, held by SANTARUS INC, has been voluntarily withdrawn for reasons of safety or effectiveness | Federal Regulations · Congress.wiki

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FDA

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FDA-2026-P-3798

Requests that FDA determine whether GLUMETZA (METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE 500MG and 1G), approved under New Drug Application (“NDA”) number N021748, held by SANTARUS INC, has been voluntarily withdrawn for reasons of safety or effectiveness

Documents

Comments

Description

Open

Key Dates

Comment Period OpensApr 7, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Citizen Petition from Senores Pharmaceuticals, Inc.	Apr 7, 2026	--

Keywords

CDER

Citizen Petition

Senores Pharmaceuticals, Inc.

Requests that FDA determine whether

GLUMETZA (METFORMIN HYDROCHLORIDE TABLET,

EXTENDED RELEASE 500MG and 1G), approved under

New Drug Application (“NDA”) number N021748,

held by SANTARUS INC, has been voluntarily

Data from Regulations.gov