Requests that FDA declare that Labetalol Hydrochloride Tablets, 50 mg and 150 mg, are suitable for submission as an ANDA | Federal Regulations · Congress.wiki

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FDA

FDA-2025-P-7056

Requests that FDA declare that Labetalol Hydrochloride Tablets, 50 mg and 150 mg, are suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 15, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Suitability Petition Amendment from Hyman, Phelps & McNamara, P.C.	Jul 2, 2026	--

Keywords

CDER

Suitability Petition

Hyman, Phelps & McNamara, P.C.

Requests that FDA declare that

Labetalol Hydrochloride Tablets,

50 mg and 150 mg, are suitable for

submission as an ANDA

the Reference Listed Drug (“RLD”) upon which

Data from Regulations.gov