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: 21CFR520.1310]

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. 520.1310 Marbofloxacin.

(a) Specifications. Each tablet or chewable tablet contains 25, 50, 100, or 200 milligrams (mg) marbofloxacin.

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

(1) Nos. 017033, 054771, and 086117 for use of tablets.

(2) No. 086101 for use of chewable tablets.

(c) [Reserved]

(d) Conditions of use - (1) Amount. 1.25 mg per pound (/lb) of body weight once daily, but may be increased to 2.5 mg/lb of body weight once daily.

(2) Indications for use. For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

[64 FR 39919, July 23, 1999, as amended at 66 FR 46369, Sept. 5, 2001; 78 FR 28823, May 20, 2014; 85 FR 45307, July 28, 2020; 88 FR 27698, May 3, 2023]