21 C.F.R. § 520.1900

Current through July 31, 2024
Section 520.1900 - Primidone
(a)Specifications. Each tablet contains 50 or 250 milligrams of primidone.
(b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 069043 for use of 250 milligram tablets.
(2) No. 054771 for use of 50 and 250 milligram tablets.
(c)Conditions of use in dogs -
(1)Amount. Twenty-five milligrams of primidone per pound of body weight (55 milligrams per kilogram of body weight) daily.
(2)Indications for use. For the control of convulsions associated with idiopathic epilepsy, epileptiform convulsions, viral encephalitis, distemper, and hardpad disease that occurs as a clinically recognizable lesion in certain entities in dogs.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §520.1900

42 FR 61594, Dec. 6, 1977, as amended at 43 FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013; 79 FR 28827, May 20, 2014; 83 FR 48946, Sept. 28, 2018
83 FR 48946, 9/28/2018