GroundRules
21 CFR 522.2473: Tiludronate.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON