21 C.F.R. § 520.980

Fluoxetine.

Last amended: 2017Year: 2026Length: 101 wordsSubsections: 3Official source

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
21 C.F.R. § 520.980: Fluoxetine. | Justis AI