21 C.F.R. § 520.455

Current through May 31, 2024
Section 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.

21 C.F.R. §520.455

64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007; 86 FR 57996, Oct. 20, 2021
85 FR 18119, 4/1/2020; 86 FR 57996, 10/20/2021