[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: 21CFR522.44]

[Page 215]
 
                        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. 522.44  Sterile sodium acetazolamide.

    (a) Specifications. Sterile sodium acetazolamide contains 
acetazolamide sodium complying with United States Pharmacopeia as a 
sterile powder with directions for reconstituting the product with 
sterile distilled water to furnish a product having a concentration of 
100 milligrams acetazolamide activity per milliliter.
    (b) Sponsor. See No. 010042 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is used as an aid in the treatment of 
dogs with mild congestive heart failure and for rapid reduction of 
intraocular pressure.\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 intraperitoneally to dogs 
at a level of 5 to 15 milligrams per pound of body weight daily 
preferably administered in two or more divided doses.\1\
    (3) For use only by or on the order of a licensed veterinarian.\1\

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