21 C.F.R. § 520.980

Current through September 30, 2024
Section 520.980 - Fluoxetine
(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.

21 C.F.R. §520.980

72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017
82 FR 21690, 5/10/2017