21 C.F.R. § 520.455 Clomipramine hydrochloride tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains 20, 40, or 80 milligrams of clomipramine hydrochloride. (b) Sponsor. See No. 058198 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]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.455 Clomipramine hydrochloride tablets.
