GroundRules
21 CFR 520.980: Fluoxetine.
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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON