21 CFR 520.1604
§ 520.1604 Oclacitinib.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 520.1604, § 520.1604 Oclacitinib, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87246
- Permanent ID
ys:prov:87246@1- SHA-256
685c09bfcd45cbf452cd00f72548e51b59f254ccf50ea973fac7d1ddd0886409
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
(2) Indications for use. For control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.