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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 2019.

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, 2019]
[CITE: 21CFR520.2612]



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. 520.2612 Trimethoprim and sulfadiazine suspension.

(a) Specifications. Each milliliter (mL) of suspension contains:

(1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or

(2) 400 mg combined active ingredients (67 mg trimethoprim and 333 mg sulfadiazine).

(b) Sponsors. See sponsor numbers in 510.600 of this chapter:

(1) No. 000061 for use of product described in paragraph (a)(1) for use as in paragraph (c)(1) of this section.

(2) No. 051072 for use of product described in paragraph (a)(2) for use as in paragraph (c)(2) of this section.

(c) Conditions of use --(1) Dogs --(i) Amount. Administer 1 mL (10 mg trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight once daily, or one-half the recommended daily dose every 12 hours, for up to 14 consecutive days.

(ii) Indications for use. The drug is used in dogs where systemic antibacterial action against sensitive organisms is required, either alone or as an adjunct to surgery or debridement with associated infection. The drug is indicated where control of bacterial infection is required during the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, wound infections, and abscesses.

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

(2) Horses --(i) Amount. Administer 24 mg combined active ingredients per kilogram of body weight (2.7 mL/100 lb) twice daily for 10 days.

(ii) Indications for use. For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[78 FR 63872, Oct. 25, 2013]

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