Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter E - Animal Drugs, Feeds, and Related Products |
Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.1189 - Itraconazole.
Latest version.
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§ 520.1189 Itraconazole.
(a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) of itraconazole.
(b) Sponsor. See No. 058198 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]