Requests that FDA consider a change in strength from RLD from 10 mg and 20 mg to 5 mg is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4665

Requests that FDA consider a change in strength from RLD from 10 mg and 20 mg to 5 mg is suitable for submission as an ANDA

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensApr 28, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	May 18, 2026	--

Keywords

CDER

Suitability Petition

Lachman Consulting Services, Inc.

consider a change in strength from RLD

from 10 mg and 20 mg to 5 mg is

suitable for submission as an ANDA

OPEN

Data from Regulations.gov