21 C.F.R. § 520.1468 Naproxen granules.
Title 21 - Food and Drugs
(a) Specifications. Naproxen granules contain 50 percent naproxen. (b) Sponsor. No. 000856 in §510.600(c) of this chapter. (c) Conditions of use—(1) Horses. The drug is used 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. (2)(i) For oral maintenance therapy following initial intravenous dosage, administer 10 milligrams naproxen per kilogram of animal body weight twice daily as top dressing in the animal's feed for up to 14 consecutive days. The initial intravenous dosage is 5 milligrams per kilogram of body weight. (ii) For oral dosage only, administer 10 milligrams naproxen per kilogram of animal body weight twice daily as a top dressing in the animal's feed for up to 14 consecutive days. (3) Not for use in horses intended for food. (4) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [41 FR 14188, Apr. 2, 1976, as amended at 51 FR 24525, July 7, 1986; 61 FR 5506, Feb. 13, 1996]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1468 Naproxen granules.
