21 C.F.R. § 520.863 Ethylisobutrazine hydrochloride tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains either 10 milligrams or 50 milligrams of ethylisobutrazine hydrochloride. (b) Sponsor. See No. 000061 in §510.600(c) of this chapter. (c) Conditions of use. (1) It is administered orally to dogs as a tranquilizer.1 1 These conditions are NAS/NRC reviewed and deemed 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. (2) It is administered once daily at a dosage level of 2 to 5 milligrams of ethylisobutrazine hydrochloride per pound of body weight.1 (3) It is not to be used in conjunction with organophosphates and/or procaine hydrochloride because phenothiazine may potentiate the toxicity of organophosphates and the activity of procaine hydrochloride.1 (4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1 [40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.863 Ethylisobutrazine hydrochloride tablets.
