21 C.F.R. § 522.522   Danofloxacin.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.522   Danofloxacin.

(a) Specifications. Each milliliter of solution contains 180 milligrams (mg) danofloxacin as the mesylate salt.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.169 of this chapter.

(d) Conditions of use in cattle—(1) Amount. 6 mg per kilogram of body weight by subcutaneous injection. Treatment should be repeated approximately 48 hours following the first injection.

(2) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia (Pasteurella) haemolytica and Pasteurella multocida.

(3) Limitations. Animals intended for human consumption should not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

[67 FR 78972, Dec. 27, 2002]

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