Code of Federal Regulations · Section
§ 520.455 — Clomipramine
21 C.F.R. § 520.455
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(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.
(b) Sponsors. See Nos. 051311 and 086039 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.
Authorizing Statute
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New animal drugs21 U.S.C. § 360b