21 CFR 520.1616
§ 520.1616 Orbifloxacin tablets.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 520.1616, § 520.1616 Orbifloxacin tablets, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87248
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.