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CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2009]
[CITE: 21CFR522.44]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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 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

(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

1These 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.

 
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