21 C.F.R. § 520.2044 Pyrantel pamoate paste.
Title 21 - Food and Drugs
(a) Specifications—(1) Each milliliter (mL) contains 180 milligrams (mg) pyrantel base (as pyrantel pamoate). (2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate). (3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate). (b) Sponsors. See sponsors in §510.600(c) of this chapter. (1) No. 000069 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1)(i) and (d)(2) of this section. (2) No. 059130 for use of product described in paragraph (a)(2) of this section as in paragraph (d) of this section. (3) No. 061623 for use of product described in paragraph (a)(3) of this section as in paragraph (d)(1)(i) and (d)(2) of this section. (c) Special considerations. See §500.25 of this chapter. (d) Conditions of use. It is used in horses and ponies as follows: (1) Amounts and indications for use—(i) 3 mg per pound (/lb) body weight as single oral dose for removal and control of infections from the following mature parasites: large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Parascaris equorum). (ii) 6 mg/lb body weight as single oral dose for the removal and control of mature infections of tapeworms (Anoplocephala perfoliata). (2) Limitations. Not for use in horses intended for food. [70 FR 29447, May 23, 2005]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2044 Pyrantel pamoate paste.
