21 C.F.R. § 522.1720 Phenylbutazone injection.
Title 21 - Food and Drugs
(a) Specifications. The drug contains 100 or 200 milligrams of phenylbutazone in each milliliter of sterile aqueous solution. (b) Sponsors. (1) Approval for use of the 200 milligrams per milliliter drug in dogs and horses: See sponsor Nos. 000061, 000856, 059130, and 061623 in §510.600(c) of this chapter. (2) Approval for use of the 200 milligrams per milliliter drug for use in horses: See sponsor Nos. 000010 and 058005 in §510.600(c) of this chapter. (3) Approval for use of the 100 milligrams per milliliter drug in dogs and horses: See sponsor No. 000856 in §510.600(c) of this chapter. (c) Conditions of use for dogs. (1) It is used for the relief of inflammatory conditions associated with the musculoskeletal system. (2) It is administered intravenously at a dosage level of 10 milligrams per pound of body weight daily in 3 divided doses, not to exceed 800 milligrams daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow. (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use for horses. (1) It is used for the relief of inflammatory conditions associated with the musculoskeletal system. (2) It is administered intravenously at a dosage level of 1 to 2 grams per 1,000 pounds of body weight daily in 3 divided doses, not to exceed 4 grams daily. Limit intravenous administration to not more than 5 successive days. (3) Not for use in animals intended for food. (4) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975] Editorial Note: For
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1720 Phenylbutazone injection.
