21 CFR § 520.1084
Grapiprant
June 25, 2020
(a) Specifications. Each tablet contains 20, 60, or 100 milligrams (mg) grapiprant.
(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. Administer 0.9 mg/lb (2 mg/kg) once daily by mouth.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[81 FR 36789, June 8, 2016, as amended at 83 FR 14587, Apr. 5, 2018]