21 C.F.R. § 520.645 Difloxacin.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains 11.4, 45.4, or 136 milligrams (mg) of difloxacin hydrochloride. (b) Sponsor. See No. 000856 in §510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(1) Dogs—(i) Amount. 5 to 10 mg per kilogram (2.3 to 4.6 mg/pound) of body weight. (ii) Indications for use. For management of diseases in dogs associated with bacteria susceptible to difloxacin. (iii) Limitations. Use once a day for 2 to 3 days beyond cessation of clinical signs of disease up to a maximum of 30 days. 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]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.645 Difloxacin.
