21 C.F.R. § 522.841 Estradiol benzoate.
Title 21 - Food and Drugs
(a) Specifications. The product consists of a vial of estradiol benzoate microspheres and a vial of diluent. (1) Each milliliter (mL) of constituted suspension contains 10 milligrams (mg) estradiol benzoate. (2) Each mL of constituted suspension contains 20 mg estradiol benzoate. (b) Sponsor. See No. 067210 in §510.600(c) of this chapter. (c) Tolerances. See §556.240 of this chapter. (d) Conditions of use. It is used by subcutaneous injection as follows: (1) Amount and indications for use—(i) Suckling beef calves. 10 mg (1 mL of product described in paragraph (a)(1) of this section or 0.5 mL of product described in paragraph (a)(2) of this section) for increased rate of weight gain. (ii) Cattle fed in confinement for slaughter. 20 mg (1 mL of product described in paragraph (a)(2) of this section) for increased rate of weight gain and improved feed efficiency. (2) Limitations. For subcutaneous injection in the ear only. Do not use in calves intended for reproduction or calves less than 30 days old. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. [68 FR 49704, Aug. 19, 2003, as amended at 71 FR 8458, Feb. 17, 2006]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.841 Estradiol benzoate.
