GroundRules
21 CFR 524.1448: Mirtazapine transdermal ointment.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON