Requests that the FDA determine and declare that Dexchlorpheniramine Maleate Tablets 1 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7181

Requests that the FDA determine and declare that Dexchlorpheniramine Maleate Tablets 1 mg is suitable for submission in an Abbreviated New Drug Application (ANDA)

Documents

Comments

Description

Open

Key Dates

Comment Period OpensJun 29, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Senores Pharmaceuticals, Inc.	Jul 28, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals, Inc.

Requests that the FDA determine and declare that

Dexchlorpheniramine Maleate Tablets 1 mg is

suitable for submission in an

Abbreviated New Drug Application (ANDA)

The Reference Listed Drug (RLD) upon which

Data from Regulations.gov