21 CFR §520.1189
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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.