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Code · CFR · Title 21 — Food and Drugs · Part 520 — Oral Dosage Form New Animal Drugs · § 520.2044

§ 520.2044. Pyrantel pamoate paste.

253 words·~1 min read·/us/cfr/t21/s§ 520.2044·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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. 054771 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. 017135 for use of product described in paragraph (a)(2) of this section as in paragraph
(d)of this section.
(3)No. 061133 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. Do not use in horses intended for human consumption. [70 FR 29447, May 23, 2005, as amended at 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 84 FR 8973, Mar. 13, 2019]
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§ 520.2044
Pyrantel pamoate paste.
Fed. Reg.×3
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