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Title 21 → Chapter I → Subchapter E → Part 524 → §524.1448

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Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

§524.1448 Mirtazapine transdermal ointment.

(a) Specifications. Each gram of ointment contains 20 milligrams (mg) mirtazapine.

(b) Sponsor. See No. 043264 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer topically by applying a 1.5 inch ribbon of ointment (approximately 2 mg) on the inner pinna of the cat's ear once daily for 14 days. Alternate the daily application of ointment between the left and right inner pinna of the ears.

(2) Indications for use. For the management of weight loss in cats.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[83 FR 64740, Dec. 18, 2018, as amended at 85 FR 45308, July 28, 2020]

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