CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 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: 21CFR520.804]

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. 520.804 Enalapril.

(a) Specifications. Each tablet contains 1.0, 2.5, 5.0, 10, or 20 milligrams (mg) of enalapril maleate.

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

(c) Conditions of use in dogs - (1) Amount. Administer orally 0.5 to 1.0 mg of enalapril maleate per kilogram of body weight per day.

(2) Indications for use. For the treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.

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

[79 FR 28821, May 20, 2014, as amended at 80 FR 34278, June 16, 2015; 84 FR 39183, Aug. 9, 2019]