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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1150]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1150 Imepitoin.

(a) Specifications. Each tablet contains 100 or 400 milligrams (mg) imepitoin.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Administer orally twice daily, approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg) of body weight. Initiate therapy starting 2 days prior to the day of the expected noise event and continuing through the noise event.

(2) Indications for use. For the treatment of noise aversion in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[84 FR 12494, Apr. 2, 2019]

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