21 CFR 520.1189

§ 520.1189 Itraconazole.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 520.1189, § 520.1189 Itraconazole, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87184
Permanent ID: ys:prov:87184@1
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.