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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: 21CFR520.1200]



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. 520.1200 Ivermectin, fenbendazole, and praziquantel tablets.

(a) Specifications. Each chewable tablet contains either:

(1) 68 micrograms ([micro]g) ivermectin, 1.134 grams fenbendazole, and 57 milligrams (mg) praziquantel; or

(2) 27 [micro]g ivermectin, 454 mg fenbendazole, and 23 mg praziquantel.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer tablets to provide 6 [micro]g per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel.

(2) Indications for use. For the treatment and control of adult Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the prevention of heartworm disease caused by Dirofilaria immitis in adult dogs.

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

[73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009]

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