21 CFR § 520.2340
Tepoxalin
June 25, 2020
(a) Specifications. Each tablet contains 30, 50, 100, or 200 milligrams (mg) tepoxalin.
(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. 10 mg per kilogram (/kg) daily; or 20 mg/kg on the initial day of treatment, followed by 10 mg/kg daily.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[68 FR 34795, June 11, 2003]