CFR - Code of Federal Regulations Title 21

The information on this page is current as of Oct 17, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.2098]

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. 520.2098 Selegiline.

(a) Specifications. Each tablet contains 2, 5, 10, 15, or 30 milligrams (mg) selegiline hydrochloride.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amounts and indications for use. (i) Administer 1 mg per kilogram (0.45 mg per pound) of body weight once daily for control of clinical signs associated with uncomplicated pituitary-dependent hyperadrenocorticism in dogs.

(ii) Administer 0.5 to 1.0 mg per kilogram of body weight once daily for the control of clinical signs associated with canine cognitive dysfunction syndrome.

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

[79 FR 28828, May 20, 2014]