21 C.F.R. § 520.1288 Lufenuron tablets.
Title 21 - Food and Drugs
(a) Specifications—(1) Tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A), (c)(1)(iii), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section. (2) Flavored tablets containing 45, 90, 204.9, or 409.8 milligrams (mg) lufenuron for use as in paragraphs (c)(1)(i), (c)(1)(ii)(A) or (c)(1)(ii)(B), and (c)(1)(iii) of this section. (3) Flavored tablets containing 90 or 204.9 mg lufenuron for use as in paragraphs (c)(2)(i), (c)(2)(ii)(A) or (c)(2)(ii)(B), and (c)(2)(iii) of this section. (4) Flavored tablets containing 135 or 270 mg lufenuron for use as in paragraphs (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section. (b) Sponsor. See No. 058198 in §510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Minimum of 10 mg lufenuron per kilogram (4.5 mg per pound (lb)) of body weight, once a month. (ii) Indications for use—(A) For the prevention and control of flea populations. (B) The concurrent use of flavored lufenuron tablets described in paragraph (a)(2) of this section as in paragraph (c)(1)(ii)(A) of this section with nitenpyram tablets as in §520.1510(d)(1) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching. (iii) Limitations. For use in dogs and puppies 4 weeks of age and older. (2) Cats—(i) Amount. Minimum of 30 mg lufenuron per kilogram (13.6 mg/lb) of body weight, once a month. (ii) Indications for use—(A) For the control of flea populations. (B) The concurrent use of flavored lufenuron tablets described in paragraph (a)(3) of this section as in paragraph (c)(2)(ii)(A) of this section with nitenpyram tablets as in §520.1510(d)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching. (iii) Limitations. For use in cats and kittens 4 weeks of age and older. [68 FR 51905, Aug. 29, 2003]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1288 Lufenuron tablets.
