21 CFR § 520.1189 - Itraconazole.

---
identifier: "/us/cfr/t21/s520.1189"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1189 - Itraconazole."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1189"
section_name: "Itraconazole."
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"
---


# 520.1189 Itraconazole.

(a) *Specifications.* Each milliliter (mL) of solution contains 10 milligrams (mg) of itraconazole.

(b) *Sponsor.* See No. 051311 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer 5 mg/kilogram (kg) (0.5 mL/kg) of body weight once daily on alternating weeks for 3 treatment cycles.

(2) *Indications for use.* For the treatment of dermatophytosis caused by *Microsporum canis* in cats.

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

[82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021]