CFR - Code of Federal Regulations Title 21

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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: 21CFR520.376]

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. 520.376 Cephalexin.

(a) Specifications. Each chewable tablet contains 75, 150, 300, or 600 milligrams (mg) cephalexin.

(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Dogs - (i) Amount. Administer 22 mg per kilogram of body weight twice daily for 28 days.

(ii) Indications for use. For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.

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

(2) [Reserved]

[77 FR 47512, Aug. 9, 2012]