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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.2075]



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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.2075 Robenacoxib.

(a) Specifications. Each tablet contains 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.

(b) Sponsors. See No. 058198 in § 510.600(c) of this chapter.

(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.

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

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