21 C.F.R. § 520.1189

Current through September 30, 2024
Section 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.

21 C.F.R. §520.1189

82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021
82 FR 12169, 3/1/2017; as amended at 86 FR 57996, 10/20/2021