21 CFR 520.455
§ 520.455 Clomipramine.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 520.455, § 520.455 Clomipramine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87111
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Full text
(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.
(b) Sponsors. See Nos. 051311, 086039, and 086101 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.
(2) Indications for use. For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 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.