21 CFR 524.1448
§ 524.1448 Mirtazapine transdermal ointment.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1448, § 524.1448 Mirtazapine transdermal ointment, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87627
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Full text
(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 body weight gain in cats with a history of weight loss.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.