21 C.F.R. § 520.1315

Current through October 31, 2024
Section 520.1315 - Maropitant
(a)Specifications. Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate.
(b)Sponsors. See Nos. 054771, 086101, and 086117 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs -
(1)Indications for use and amount.
(i) For prevention of acute vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days.
(ii) For prevention of acute vomiting in dogs 7 months of age and older, administer a minimum dose of 2.0 mg/kg body weight once daily until resolution of acute vomiting.
(iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days.
(2)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §520.1315

72 FR 9243 , Mar. 1, 2007, as amended at 78 FR 28823 , May 20, 2014; 80 FR 53459 , Sept. 4, 2015; 88 FR 27699 , May 3, 2023; 89 FR 85426 , Oct. 28, 2024
88 FR 27699 , 5/3/2023; 89 FR 85426 , 10/28/2024