21 CFR 522.1885 - Prednisolone tertiary butylacetate.

§ 522.1885 Prednisolone tertiary butylacetate.

(a)Specifications. Each milliliter of suspension contains 20 milligrams (mg) of prednisolone tertiary butylacetate.

(b)Sponsor. See No. 050604 in § 510.600(c) of this chapter.

(c)Conditions of use -

(1)Amount -

(i)Horses: Administer by intramuscular injection 100 to 300 mg or by intrasynovial injection at a dosage level of 50 to 100 mg. Retreatment of horses in 24 to 48 hours may be necessary, depending on the general condition of the animal and the severity and duration of the disease.

(ii)Dogs and cats: Administer by intramuscular injection 1 mg per 5 pounds of body weight or intrasynovially at a dosage level of 10 to 20 mg.

(2)Indications for use. It is used as an anti-inflammatory agent in horses, dogs, and cats.

(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 16194, Mar. 25, 2014]

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

Title 21 published on 19-May-2018 03:57

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

  • 2018-04-05; vol. 83 # 66 - Thursday, April 5, 2018
    1. 83 FR 14584 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 5, 2018.
      21 CFR Parts 510, 520, 522, 526, and 558