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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2020.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2020]
[CITE: 21CFR520.370]



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. 520.370 Cefpodoxime tablets.

(a) Specifications. (1) Each tablet contains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime.

(2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as follows:

(1) No. 026637 for use of product in paragraph (a)(1) of this section as in paragraph (c) of this section.

(2) No. 054771 for use of products in paragraph (a) of this section as in paragraph (c) of this section.

(c) Conditions of use in dogs - (1) Amount. 5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

(2) Indications for use. For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , S. aureus , Streptococcus canis (group G, beta-hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis.

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

[69 FR 52815, Aug. 30, 2004, as amended at 78 FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, 2014; 80 FR 13229, Mar. 13, 2015; 82 FR 12169, Mar. 1, 2017]

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