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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: 21CFR520.538]



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. 520.538 Deracoxib.

(a) Specifications. Each tablet contains 12, 25, 50, 75, or 100 milligrams (mg) deracoxib.

(b) Sponsor. See Nos. 013744 and 058198 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use in dogs - (1) Amount. Administer orally as needed, as a single daily dose based on body weight:

(i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as in paragraph (d)(2)(i) of this section.

(ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in paragraph (d)(2)(ii) of this section.

(iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(iii) of this section.

(2) Indications for use. (i) For the control of pain and inflammation associated with osteoarthritis.

(ii) For the control of postoperative pain and inflammation associated with dental surgery.

(iii) For the control of postoperative pain and inflammation associated with orthopedic surgery.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012; 84 FR 39183, Aug. 9, 2019]

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