CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.2098—Selegiline hydrochloride tablets.

520.2098—Selegiline hydrochloride tablets.

(a) Specifications. Each tablet contains either 2, 5, 10, 15, or 30 milligrams of selegiline hydrochloride.
(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use—Dogs— (1) Dosage. 1 milligram per kilogram (0.45 milligram per pound) of body weight.
(i) Indications for use. For control of clinical signs associated with uncomplicated pituitary-dependent hyperadrenocorticism in dogs.
(ii) Limitations. Administer orally once daily. If no improvement in clinical signs or physical examination findings after 2 months of therapy, increase dose to a maximum of 2 milligrams per kilogram once daily. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dosage. 0.5 to 1.0 milligram per kilogram of body weight once daily.
(i) Indications for use. For the control of clinical signs associated with canine cognitive dysfunction syndrome.
(ii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[62 FR 34632, June 27, 1997; 62 FR 55159, Oct. 23, 1997, as amended at 63 FR 29551, June 1, 1998; 64 FR 2122, Jan. 13, 1999]