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21 C.F.R. § 520.2345a   Tetracycline hydrochloride capsules.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.2345a   Tetracycline hydrochloride capsules.

(a) Specifications. Each capsule contains 50, 100, 125, 250, or 500 milligrams (mg) tetracycline hydrochloride.

(b) Sponsor. See sponsors in §510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) No. 000009: 250 mg per capsule.

(2) No. 000069: 125, 250, or 500 mg per capsule.

(3) No. 000185: 50, 100, 250, or 500 mg per capsule.

(c) Conditions of use in dogs—(1) Amount. 25 mg per pound of body weight per day in divided doses every 6 hours.

(2) Indications for use. For treatment of infections caused by organisms sensitive to tetracycline hydrochloride, such as bacterial gastroenteritis due to E. coli and urinary tract infections due to Staphylococcus spp. and E. coli.

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

[70 FR 50182, Aug. 26, 2005]

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