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: 21CFR520.763a]

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. 520.763a Dithiazanine tablets.

(a) Specifications. Each tablet contains 10, 50, 100, or 200 milligrams (mg) dithiazanine iodide.

(b) Sponsor. See No. 069043 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Indications for use and amount. Administer orally immediately after feeding as follows:

(i) For large roundworms (Toxocara canis, Toxascaris leonina ): 10 mg per pound (/lb) of body weight for 3 to 5 days;

(ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala ) and whipworms (Trichuris vulpis ): 10 mg/lb of body weight for 7 days;

(iii) For Strongyloides (Strongyloides canis, Strongyloides stercoralis ): 10 mg/lb of body weight for 10 to 12 days;

(iv) For heartworm microfilariae (Dirofilaria immitus ): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should follow 6 weeks after therapy for adult worms.

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

[79 FR 28820, May 20, 2014, as amended at 83 FR 48945, Sept. 28, 2018]