21 CFR § 520.455 - Clomipramine.

---
identifier: "/us/cfr/t21/s520.455"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.455 - Clomipramine."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.455"
section_name: "Clomipramine."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.455 Clomipramine.

(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.

[64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007; 86 FR 57996, Oct. 20, 2021]