Requests that the FDA determine that the drug product, ivermectin (1.0%) oral liquid, is suitable for submission in an ANADA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-7371

Requests that the FDA determine that the drug product, ivermectin (1.0%) oral liquid, is suitable for submission in an ANADA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 29, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CVM to Argenta	Apr 29, 2026	--

Keywords

CVM

Suitability Petition

Argenta

Requests that the FDA determine that the

drug product, ivermectin (1.0%) oral liquid, is

suitable for submission in an ANADA

The pioneer drug product is EQVALAN (ivermectin)

Paste 1.87% for horses, sponsored by

Data from Regulations.gov