21 CFR § 520.1604 - Oclacitinib.
---
identifier: "/us/cfr/t21/s520.1604"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1604 - Oclacitinib."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1604"
section_name: "Oclacitinib."
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"
---
# 520.1604 Oclacitinib.
(a) *Specifications.* Each tablet or chewable tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.
(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.
(c) *Conditions of use*—(1) *Amount.* Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.
(2) *Indications for use.* For 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.
[78 FR 42007, July 15, 2013, as amended at 88 FR 55563, Aug. 16, 2023]