21 CFR §520.1604
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)Specifications. Each tablet or chewable tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate.
- (b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
- (c)Conditions of use—(1) Amount. Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy.