21 C.F.R. § 520.2240b   Sulfaethoxypyridazine tablets.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.2240b   Sulfaethoxypyridazine tablets.

(a) Chemical name. N′-(6-Ethoxy-3-pyridazinyl) sulfanilamide.

(b) Specifications. Melting point range of 180 °C to 186 °C.

(c) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(d) Related tolerances. See §556.650 of this chapter.

(e) Conditions of use. It is used for cattle as follows:

(1) Amount. 2.5 or 15 grams per tablet.

(i) Indications for use. Treatment of respiratory infections (pneumonia, shipping fever), foot rot, calf scours; as adjunctive therapy in septicemia accompanying mastitis and metritis.

(ii) Limitations. Administer 25 milligrams per pound of animal weight per day for 4 days; do not treat within 16 days of slaughter; as sole source of sulfonamide; milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food; for use only by or on the order of a licensed veterinarian.

(2) Amount. 15-gram controlled release tablets.

(i) Indications for use. Treatment of foot rot and respiratory infections (shipping fever and pneumonia) caused by sulfonamide-susceptible pathogens (E. coli, streptococci, staphylococci, Sphaerophorus necrophorus and Gram-negative rods including Pasteurella); for use prophylactically in cattle during periods of stress for reducing losses due to sulfonamide sensitive disease conditions.

(ii) Limitations. Administer 100 milligrams per pound of body weight; do not treat within 16 days of slaughter; as sole source of sulfonamide; not for use in lactating dairy cows; Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13838, Mar. 27, 1975, as amended at 67 FR 78355, Dec. 24, 2002]

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