CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.1367]

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. 520.1367 Meloxicam.

(a) Specifications - (1) Each milliliter of suspension contains 0.5 milligrams (mg) meloxicam.

(2) Each milliliter of suspension contains 1.5 mg meloxicam.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section:

(1) No. 000010 for use of the products described in paragraph (a) of this section; and

(2) Nos. 013744 and 055529 for use of the product described in paragraph (a)(2) of this section.

(c) Conditions of use in dogs - (1) Amount. Administer orally as a single dose at 0.09 mg per pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) on the first day of treatment. For all treatment after day 1, administer 0.045 mg/lb (0.1 mg/kg) body weight once daily.

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

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

[68 FR 42968, July 21, 2003, as amended at 69 FR 69523, Nov. 30, 2004. Redesignated and amended at 78 FR 57058, Sept. 17, 2013; 80 FR 53459, Sept. 4, 2015]