21 CFR § 520.1084 - Grapiprant.

---
identifier: "/us/cfr/t21/s520.1084"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1084 - Grapiprant."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1084"
section_name: "Grapiprant."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1084 Grapiprant.

(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]