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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 522 → §522.842


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.842   Estradiol benzoate and testosterone propionate.

(a) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (c) of this section.

(1) No. 054771 for use as in paragraph (c)(1)(i), (c)(2), and (c)(3) of this section.

(2) No. 058198 for use as in paragraph (c) of this section.

(b) Related tolerances. See §§556.240 and 556.710 of this chapter.

(c) Conditions of use. For implantation in heifers as follows:

(1) Amount. (i) 20 milligrams (mg) estradiol benzoate and 200 mg testosterone propionate (one implant consisting of 8 pellets, each pellet containing 2.5 mg estradiol benzoate and 25 mg testosterone propionate) per implant dose.

(ii) 20 mg estradiol benzoate and 200 mg testosterone propionate (one implant consisting of 9 pellets, each of 8 pellets containing 2.5 mg estradiol benzoate and 25 mg testosterone propionate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose.

(2) Indications for use. For increased rate of weight gain and improved feed efficiency.

(3) Limitations. For heifers weighing 400 pounds or more; for subcutaneous ear implantation, one dose per animal; not for use in dairy or beef replacement heifers. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[69 FR 68252, Nov. 24, 2004, as amended at 77 FR 31723, May 30, 2012; 79 FR 16187, Mar. 25, 2014; 81 FR 48702, July 26, 2016]

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