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Code · CFR · Title 21 — Food and Drugs · Part 520 — Oral Dosage Form New Animal Drugs · § 520.1248

§ 520.1248. Levothyroxine.

129 words·~1 min read·/us/cfr/t21/s§ 520.1248·

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