[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.82b]

[Page 98]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.82b  Aminopropazine fumarate, neomycin sulfate tablets.

    (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 Sec. 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\
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    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec. 514.111 of this chapter, but may require 
bioequivalency and safety information.
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    (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]