Requests that the FDA declare that the drug products Ivermectin Tablets, 9 mg, 12 mg, and 15 mg, are suitable for consideration in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-3664

Requests that the FDA declare that the drug products Ivermectin Tablets, 9 mg, 12 mg, and 15 mg, are suitable for consideration in an Abbreviated New Drug Application.

Documents

Comments

Key Dates

Comment Period OpensApr 3, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Apr 22, 2026	--

Keywords

CDER

Suitability Petition

Hyman Phelps and McNamara PC

declare

that the drug products Ivermectin Tablets

9 mg 12 mg and 15 mg

are suitable for consideration

in an Abbreviated New Drug Application

Data from Regulations.gov