21 CFR 522.44 - Sterile sodium acetazolamide.

§ 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

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 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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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2015-06-16; vol. 80 # 115 - Tuesday, June 16, 2015
    1. 80 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective June 16, 2015.
      21 CFR Parts 510, 520, 522, 526, and 528