21 CFR § 520.1616 - Orbifloxacin tablets.

---
identifier: "/us/cfr/t21/s520.1616"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1616 - Orbifloxacin tablets."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1616"
section_name: "Orbifloxacin tablets."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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]