Requests that the FDA declare that Mexiletine Hydrochloride Capsules 100 mg, 300 mg and 400 mg, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-P-0431

Requests that the FDA declare that Mexiletine Hydrochloride Capsules 100 mg, 300 mg and 400 mg, is suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensJan 16, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Senores Pharmaceuticals, Inc.	Jul 6, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals, Inc

declare that Mexiletine Hydrochloride

Capsules 100 mg, 300 mg and 400 mg,

is suitable for submission as an ANDA

Approved Drug Products with

Therapeutic Equivalence Evaluations

Data from Regulations.gov