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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1448


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. 086078 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]

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