21 CFR § 520.1136 - Ilunocitinib.

---
identifier: "/us/cfr/t21/s520.1136"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1136 - Ilunocitinib."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1136"
section_name: "Ilunocitinib."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1136 Ilunocitinib.

(a) *Specifications.* Each tablet contains 4.8, 6.4, 8.5, and 15 milligrams (mg) ilunocitinib.

(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food.

(2) *Indications for use.* For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[89 FR 95103, Dec. 2, 2024]