21 CFR 522.2474 - Tolazoline.

§ 522.2474 Tolazoline.

(a)Specifications. Each milliliter of solution contains tolazoline hydrochloride equivalent to 100 milligrams (mg) of base activity.

(b)Sponsor. See No. 059399 in § 510.600(c) of this chapter.

(c)Conditions of use in horses -

(1)Amount. Administer slowly by intravenous injection 4 mg per kilogram of body weight or 1.8 mg per pound (4 milliliters (mL) per 100 kilograms or 4 mL per 220 pounds).

(2)Indications for use. For use in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.

(3)Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[ 79 FR 16197, Mar. 25, 2014, as amended at 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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

Title 21 published on 10-May-2017 03:43

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

  • 2017-05-10; vol. 82 # 89 - Wednesday, May 10, 2017
    1. 82 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; correcting amendments.
      This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 2017.
      21 CFR Parts 510, 520, 522, 524, and 558