Requests that the FDA declare that the proposed drug product, Desloratadine Tablets, 2.5 mg, is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is CLARINEX® (desloratadine) RediTabs®, 2.5 mg by Organon LLC, NDA #021312 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4918

Requests that the FDA declare that the proposed drug product, Desloratadine Tablets, 2.5 mg, is suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is CLARINEX® (desloratadine) RediTabs®, 2.5 mg by Organon LLC, NDA #021312

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMay 6, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	May 26, 2026	--

Keywords

CDER

Suitability Petition

Lachman Consulting Services, Inc.

Requests that the FDA declare that the proposed

drug product, Desloratadine Tablets, 2.5 mg,

is suitable for submission as an ANDA.

The listed reference drug product (RLD),

upon which this petition is based, is

Data from Regulations.gov