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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.455 - Clomipramine.
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§ 520.455 Clomipramine tablets.
(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.
(b) SponsorSponsors. See Nos. 058198 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; 85 86 FR 1811957996, AprOct. 120, 20202021]