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Electronic Code of Federal Regulations

e-CFR data is current as of December 3, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1468


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1468   Naproxen for injection.

(a) Specifications. The drug is a lyophilized powder which is reconstituted with sterile water for injection to form a 10 percent sterile aqueous solution (100 milligrams per milliliter).

(b) Sponsor. See 054771 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Dosage. Five milligrams per kilogram of body weight intravenously followed by maintenance oral therapy of 10 milligrams per kilogram of body weight twice daily for up to 14 consecutive days.

(2) Indications for use. For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system of the horse.

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

[46 FR 26763, May 15, 1981. Redesignated and amended at 51 FR 24525, July 7, 1986; 61 FR 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014]

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