21 C.F.R. § 520.812   Enrofloxacin tablets.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.812   Enrofloxacin tablets.

(a) Specifications. Each tablet contains either 22.7, 68.0, or 136.0 milligrams of enrofloxacin.

(b) Sponsor. See No. 000859 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Amount. 5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight.

(2) Indications for use. Dogs and cats for management of diseases associated with bacteria susceptible to enrofloxacin.

(3) Limitations. Administer orally as a single dose or divided into 2 equal doses at 12 hour intervals, daily. Administer for at least 2 to 3 days beyond cessation of clinical symptoms, for a maximum of 30 days. Safety in breeding or pregnant cats has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[54 FR 3444, Jan. 24, 1989, as amended at 55 FR 43327, Oct. 29, 1990; 62 FR 38906, July 21, 1997; 64 FR 48295, Sept. 3, 1999]

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