CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 22, 2024.

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: 21CFR520.1616]

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. 520.1616 Orbifloxacin tablets.

(a) Specifications. Each tablet contains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats - (1) Amount. 2.5 to 7.5 mg per kilogram body weight once daily.

(2) Indications for use. For management of diseases associated with bacteria susceptible to orbifloxacin.

(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.

[71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010]