(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]