21 C.F.R. § 520.82b Aminopropazine fumarate, neomycin sulfate tablets.
Title 21 - Food and Drugs
(a) Specifications. The drug is in tablet form. Each tablet contains both aminopropazine fumarate equivalent to 25 milligrams of aminopropazine base and neomycin sulfate equivalent to 50 milligrams of neomycin base. (b) Sponsor. See No. 000061 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs to control bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions.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 at a dosage level of one to two tablets per 10 pounds of body weight twice daily for 3 days.1 (3) 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
§ 520.82b Aminopropazine fumarate, neomycin sulfate tablets.
