[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.82]

[Page 218]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.82  Aminopropazine fumarate sterile solution injection.

    (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 Sec.  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\
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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 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]