subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.980"
section_subject: "Fluoxetine."
cfr_reference: "21 CFR 520.980"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Each chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride.
(b)Sponsor. See No. 055246 in § 510.600 of this chapter.
(c)Conditions of use in dogs—(1) Amount. 1 to 2 mg per kilogram body weight once daily.
(2)Indications for use. For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.