(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]