Requests that the FDA to declare that the proposed drug product Desloratadine Tablets, 2.5 mg is suitable for consideration in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5583

Requests that the FDA to declare that the proposed drug product Desloratadine Tablets, 2.5 mg is suitable for consideration in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 24, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Lachman Consulting Services, Inc.	Apr 27, 2026	--

Keywords

CDER

Suitability Petition

Lachman Consulting Services Inc

to declare that the proposed

drug product Desloratadine Tablets

2 5 mg is suitable for consideration

in an Abbreviated New Drug Application

CLOSED

Data from Regulations.gov