§520.1248. Levothyroxine.

21 C.F.R. § 520.1248

(a)

Specifications. Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium.

(b)

Sponsors. See Nos. 059051 and 061690 in § 510.600(c) of this chapter.

(c)

Conditions of use—

(1)

Amount. Administer by mouth as follows:

(i)

No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/kilogram (kg)) as a single dose every 24 hours or as a divided dose every 12 hours.

(ii)

No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily.

(2)

Indications for use. For replacement therapy for diminished thyroid function in dogs.

(3)

Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Notes, amendments, and revision history

[81 FR 22523, Apr. 18, 2016, as amended at 86 FR 57996, Oct. 20, 2021]

Authority: 21 U.S.C. 360b.

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

[81 FR 22523, Apr. 18, 2016, as amended at 86 FR 57996, Oct. 20, 2021]