(a) Specifications. Each 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 b
CFR 21-520.1604-2013 history
2013CFR 21-520.1604-2013 Food and drugs. Part520:Oral dosage form new animal drugs. Section520.1604:Oclacitinib.