21 C.F.R. § 520.2482 Triamcinolone acetonide oral powder.
Title 21 - Food and Drugs
(a) Specifications. Each 15 grams of triamcinolone acetonide oral powder contains 10 milligrams of triamcinolone acetonide. (b) Sponsor. See No. 053501 in §510.600(c) of this chapter. (c) NAS/NRC status. The conditions of use specified in this section are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information. (d) Conditions of use. (1) The drug is used as an anti-inflammatory agent for horses. (2) It is administered at a dosage of 0.005 to 0.01 milligram triamcinolone acetonide per pound of body weight twice daily, sprinkled (top-dressed) on a small portion of feed. Treatment may be initiated with a single dose of sterile triamcinolone acetonide suspension USP followed after 3 or 4 days with the use of triamcinolone acetonide oral powder. (3) The labeling shall comply with the requirements of §510.410 of this chapter. (4) Not for use in horses intended for food. (5) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [41 FR 24884, June 21, 1976, as amended at 50 FR 41489, Oct. 11, 1985; 51 FR 26002, July 18, 1986]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2482 Triamcinolone acetonide oral powder.
