Requests that FDA declare that Methimazole Oral Solution, 1 mg/mL, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

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FDA

FDA-2025-P-4047

Requests that FDA declare that Methimazole Oral Solution, 1 mg/mL, is suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Comment Period OpensSep 19, 2025

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.	Mar 3, 2026	--

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Methimazole Oral Solution, 1 mg/mL, is

suitable for submission as an ANDA

the Reference Listed Drug (RLD)

upon which this petition is based is