StacksVerified U.S. regulatory reference

21 CFR §520.455

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.
  2. (b)Sponsors. See Nos. 051311 and 086039 in § 510.600(c) of this chapter.
  3. (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.
    1. (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.
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.