21 C.F.R. § 522.82 Aminopropazine fumarate sterile solution injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of aminopropazine fumarate sterile aqueous solution, veterinary, contains aminopropazine fumarate equivalent to 25 milligrams of aminopropazine base. (b) Sponsor. See No. 000061 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used for reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis in cats and dogs and in colic spasms in horses.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 intramuscularly or intravenously to dogs and cats at a level of 1 to 2 milligrams per pound of body weight. It is administered intramuscularly or intravenously to horses at a level of 0.25 milligrams per pound of body weight. Dosage can be repeated every 12 hours, as indicated.1 (3) Not for use in animals intended for food purposes.1 (4) For use only by or on the order of a licensed veterinarian.1 [40 FR 13858, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.82 Aminopropazine fumarate sterile solution injection.
