Title 21

SECTION 520.812

520.812 Enrofloxacin.

§ 520.812 Enrofloxacin.

(a) Specifications - (1) Each tablet contains:

(i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or

(ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.

(2) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section.

(1) Nos. 000859 and 026637 for use of product described in paragraph (a)(1)(i) of this section.

(2) No. 058198 for use of product described in paragraph (a)(1)(ii) of this section.

(3) No. 000859 for use of product described in paragraph (a)(2) of this section.

(c) Conditions of use in dogs and cats - (1) Amount. Administer orally as a single, daily dose or divided into two equal doses at 12-hour intervals.

(i) Dogs. 5 to 20 mg per kilogram (/kg) (2.27 to 9.07 mg per pound (/lb)) of body weight.

(ii) Cats. 5 mg/kg (2.27 mg/lb) of body weight.

(2) Indications for use. For the management of diseases associated with bacteria susceptible to enrofloxacin.

(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.

[78 FR 30197, May 22, 2013, as amended at 78 FR 52853, Aug. 27, 2013; 84 FR 8972, Mar. 13, 2019; 84 FR 53310, Oct. 7, 2019]

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