Requests that the FDA declare that an ANDA may be submitted for Probenecid Tablets USP, 250 mg, a strength that differs from the currently approved RLD, BENEMID (Probenecid) Tablets, 500 mg, NDA #007898, held by Merck and Co Inc. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-5431

Requests that the FDA declare that an ANDA may be submitted for Probenecid Tablets USP, 250 mg, a strength that differs from the currently approved RLD, BENEMID (Probenecid) Tablets, 500 mg, NDA #007898, held by Merck and Co Inc.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 16, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response	Apr 8, 2026	--

Keywords

CDER

Suitability Petition

Rising Pharma Holdings Inc

declare that an ANDA

may be submitted for Probenecid Tablets USP

250 mg

a strength

that differs from the currently approved RLD

Data from Regulations.gov