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: 21CFR520.2220c]

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. 520.2220c Sulfadimethoxine tablet.

(a) Specifications. Each tablet contains 125, 250, or 500 milligrams (mg) sulfadimethoxine.

(b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use in dogs and cats - (1) Amount. Administer orally 25 mg per pound of body weight, followed by 12.5 mg per pound of body weight daily until the animal is free of clinical signs for 48 hours.

(2) Indications for use. For the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and cats and enteritis associated with coccidiosis in dogs.

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

[79 FR 28829, May 20, 2014, as amended at 88 FR 55564, Aug. 16, 2023]