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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: 21CFR520.2598]



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. 520.2598 Trilostane.

(a) Specifications. Each capsule contains 5, 10, 30, 60, or 120 milligrams (mg) trilostane.

(b) Sponsor. See No. 043264 in § 510.600 of this chapter.

(c) Conditions of use in dogs - (1) Amount. The starting dose is 1.0 to 3.0 milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.

(2) Indications for use. For treatment of pituitary-dependent hyperadrenocorticism. For treatment of hyperadrenocorticism due to adrenocortical tumor.

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

[74 FR 21767, May 11, 2009, as amended at 74 FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, 2015]

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