CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.1616—Orbifloxacin tablets.

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.

Code of Federal Regulations

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