Fluoxetine.
21 C.F.R. § 520.980
in effectEffective: 2024-07-01(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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026
