Requests that the FDA to declare that the proposed drug products Liothyronine Sodium Tablets, 10 mcg, 15 mcg, and 20 mcg are suitable for consideration in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5491

Requests that the FDA to declare that the proposed drug products Liothyronine Sodium Tablets, 10 mcg, 15 mcg, and 20 mcg are suitable for consideration in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 20, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Lachman Consulting Services, Inc.	Mar 10, 2026	--

Keywords

CDER

Suitability Petition

Lachman Consulting Services Inc

declare that the proposed drug products

Liothyronine Sodium Tablets

10 mcg, 15 mcg and 20 mcg

are suitable for consideration

in an Abbreviated New Drug Application

Data from Regulations.gov