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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 Oct 01, 2021.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.622a]



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. 520.622a Diethylcarbamazine citrate tablets.

(a) Sponsors. (1) [Reserved]

(2) See 054771 in § 510.600(c) of this chapter for use of 100, 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the treatment of ascarid infections in dogs.

(3) See 061133 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.

(4) [Reserved]

(5) See No. 000061 in § 510.600(c) of this chapter for use of 60, 120, or 180 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.

(6) See No. 069043 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats.

(b) Conditions of use - (1) Dosage/indications for use. (i) Three milligrams per pound of body weight daily for prevention of heartworm disease (Dirofilaria immitis ) in dogs.

(ii) Three milligrams per pound of body weight daily as an aid in the control of ascarid infections (Toxocara canis ) in dogs.

(iii) Twenty-five to 50 milligrams per pound of body weight as an aid in the treatment of ascarid infections in dogs (Toxocara canis ) and cats (Toxocara canis and Toxascaris leonina ).

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

[46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, 2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019]

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