---
kind: "section"
citation: "21 C.F.R. § 520.2075"
title: "21"
number: "520.2075"
heading: "Robenacoxib."
url: "https://uscodex.org/cfr/21/520.2075"
---

# §520.2075. Robenacoxib.

- (a) **Specifications.** Each tablet contains:
  - (1) 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs; or
  - (2) 6 mg robenacoxib for use in cats.
- (b) **Sponsors.** See sponsors in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
  - (1) **No.** 058198 for use of product described in paragraph [(a)(1)](#a-1) and [(a)(2)](#a-2) of this section as in paragraph [(c)(1)](#c-1) and [(c)(2)](#c-2) of this section.
  - (2) **No.** 086117 for use of product described in [paragraph (a)(2)](#a-2) of this section as in [paragraph (c)(2)](#c-2) of this section.
- (c) **Conditions of use—**
  - (1) **Dogs—**
    - (i) **Amount.** Administer 0.91 mg/lb (2 mg/kg) orally, once daily, for a maximum of 3 days.
    - (ii) **Indications for use.** For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
    - (iii) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.
  - (2) **Cats—**
    - (i) **Amount.** Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days.
    - (ii) **Indications for use.** For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days.
    - (iii) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[76 FR 18648, Apr. 5, 2011, as amended at 79 FR 10964, Feb. 27, 2014; 81 FR 59133, Aug. 29, 2016; 91 FR 20342, Apr. 16, 2026]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[76 FR 18648, Apr. 5, 2011, as amended at 79 FR 10964, Feb. 27, 2014; 81 FR 59133, Aug. 29, 2016; 91 FR 20342, Apr. 16, 2026]