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Electronic Code of Federal Regulations

e-CFR data is current as of January 16, 2020

Title 21Chapter ISubchapter EPart 522 → §522.2473


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


§522.2473   Tiludronate.

(a) Specifications. Each vial of powder contains 500 milligrams (mg) tiludronate disodium. Each milliliter of constituted solution contains 20 mg tiludronate disodium.

(b) Sponsor. See No. 061133 in §510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer a single dose of 1 mg per kilogram (0.45 mg/pound) of body weight by intravenous infusion.

(2) Indication for use. For the control of clinical signs associated with navicular syndrome.

(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 18159, Apr. 1, 2014, as amended at 82 FR 21691, May 10, 2017; 84 FR 8974, Mar. 13, 2019]

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