21 C.F.R. § 520.980
Fluoxetine.
Cite as 21 C.F.R. § 520.980 (2026)
(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.
[72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017]
- Cross-references to the CFR
- 510.600