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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.645 - Difloxacin.
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§ 520.645 Difloxacin.
(a) Specifications. Each tablet contains 11.4, 45.4, or 136 milligrams (mg) of difloxacin hydrochloride.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) [Reserved]
(d) Conditions of use -
(i) Amount. Administer 5 to 10 mg per kilogram (2.3 to 4.6 mg per pound) of body weight orally once a day for 2 to 3 days beyond cessation of clinical signs of disease up to a maximum of 30 days.
(ii) Indications for use. For management of diseases in dogs associated with bacteria susceptible to difloxacin.
(iii) Limitations. Federal law prohibits the extra-label use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[63 FR 8123, Feb. 18, 1998, as amended at 75 FR 10165, Mar. 5, 2010]