cfr_sections
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317 rows where part_number = 520 and title_number = 21 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:6.0.1.1.11.0.1.1 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.23 Acepromazine. | FDA | [75 FR 10165, Mar. 5, 2010, as amended at 88 FR 84699, Dec. 6, 2023] | (a) Specifications. Each tablet contains 10 or 25 milligrams (mg) acepromazine maleate. (b) Sponsors. See Nos. 000010 and 086117 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. 0.25 to 1.0 mg per pound (/lb) body weight orally. (ii) Indications for use. As an aid in tranquilization and as a preanesthetic agent. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. 0.5 to 1.0 mg/lb body weight orally. (ii) Indications for use. As a tranquilizer. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.10 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.82 Aminopropazine oral dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.11.0.1.100 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.905c Fenbendazole paste. | FDA | [72 FR 24185, May 2, 2007, as amended at 74 FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, 2011; 86 FR 57996, Oct. 20, 2021; 87 FR 10968, Feb. 28, 2022] | (a) Specifications. Each gram of paste contains 100 milligrams (mg) fenbendazole (10 percent). (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.275 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use —(1) Horses —(i) Indications for use and amounts. (A) For the treatment and control of large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, and pinworms ( Oxyuris equi ). For large strongyles, small strongyles, and pinworms, the recommended dose is 5 mg/kg (2.3 mg/lb). (B) For treatment and control of ascarids ( Parascaris equorum ). For ascarids, the recommended dose is 10 mg/kg (4.6 mg/lb). (C) For treatment and control of hypobiotic (encysted early third-stage), late third-stage, and fourth-stage cyathostome larvae, as well as fourth-stage Strongylus vulgaris larvae, the recommended dose is 10 mg/kg (4.6 mg/lb) daily for 5 consecutive days. (D) For the control of arteritis caused by fourth-stage larvae of Strongylus vulgaris in horses. (E) Fenbendazole paste 10 percent may be used concomitantly with approved forms of trichlorfon for the indications provided in paragraph (e)(1)(i)(A) of this section and for treating infections of stomach bots as provided in § 520.2520. (ii) Limitations. Do not use in horses intended for human consumption. (2) Beef and dairy cattle —(i) Amount. Administer orally 2.3 mg/lb (5 mg/kg) body weight. (ii) Indications for use. For the treatment and control of: Lungworms: Adult ( Dictyocaulus viviparus ); Stomach worms: Adult brown stomach worms ( Ostertagia ostertagi ), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus ), fourth-stage larvae barberpole worms ( H. placei ), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei ); Intestinal worms (adult and fourth-stage larvae): Hookworms ( Bunostomum phlebotomum ), thread-necked intestinal worms ( Nematodirus helvetianus ), small intestina… | |||||
| 21:21:6.0.1.1.11.0.1.101 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.905d Fenbendazole powder. | FDA | [49 FR 18090, Apr. 27, 1984, as amended at 49 FR 20485, May 15, 1984; 66 FR 47960, Sept. 17, 2001; 70 FR 32489, June 3, 2005; 74 FR 61516, Nov. 25, 2009; 83 FR 48945, Oct. 9, 2018] | (a) Specifications. Each 2-ounce packet contains 2.27 grams (4 percent) fenbendazole. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.275 of this chapter. (d) Conditions of use. It is administered to swine as follows: (1) Amount. 3 milligrams fenbendazole per kilogram body weight per day (1.36 milligrams per pound per day). (2) Indications for use. For removal and control of large roundworms ( Ascaris suum ); lungworms ( Metastrongylus apri ); nodular worms ( Oesophagostomum dentatum, O. quadrispinulatum ); small stomach worms ( Hyostrongylus rubidus ); whipworms ( Trichuris suis ); and kidneyworms ( Stephanurus dentatus — mature and immature). (3) Limitations. Thoroughly mix the contents of the packet(s) with swine ration and administer according to label directions. Feed as sole ration for 3 consecutive days. Can be fed to pregnant sows. No prior withdrawal of feed or water is necessary. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. | |||||
| 21:21:6.0.1.1.11.0.1.102 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.928 Firocoxib tablets. | FDA | [69 FR 51171, Aug. 18, 2004, as amended at 73 FR 2808, Jan. 16, 2008; 73 FR 64885, Oct. 31, 2008; 81 FR 67151, Sept. 30, 2016; 87 FR 58961, Sept. 29, 2022; 88 FR 14897, Mar. 10, 2023; 88 FR 55563, Aug. 16, 2023; 88 FR 84700, Dec. 6, 2023; 89 FR 42357, May 15, 2024] | (a) Specifications. (1) Each chewable tablet contains 57 or 227 milligrams (mg) firocoxib. (2) Each tablet contains 57 mg firocoxib. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) Nos. 000010, 013744, 055246, 055529, and 086101 for use of products described in paragraph (a)(1) as in paragraph (c)(1) of this section; and (2) Nos. 000010 and 055246 for use of the product described in paragraph (a)(2) as in paragraph (c)(2) of this section. (c) Conditions of use —(1) Dogs —(i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. Administer approximately 2 hours before soft tissue or orthopedic surgery. (ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses —(i) Amount. Administer one 57-mg tablet to horses weighing 800 to 1,300 lb once daily for up to 14 days. (ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.103 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.929 Firocoxib solution. | FDA | [89 FR 42357, May 15, 2024] | (a) Specifications. Each milliliter of solution contains 9 milligram (mg) firocoxib. (b) Sponsors. See No. 051072 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. Administer 0.1 mg per kilogram (0.045 mg per pound) of body weight once daily for up to 14 days. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.104 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.930 Firocoxib paste. | FDA | [71 FR 5788, Feb. 3, 2006, as amended at 84 FR 39183, Aug. 9, 2019] | (a) Specifications. Each milligram (mg) of paste contains 0.82 mg firocoxib. (b) Sponsors. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. 0.1 mg per kilogram (0.045 mg per pound) body weight daily for up to 14 days. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.105 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.955 Florfenicol. | FDA | [67 FR 78357, Dec. 24, 2002, as amended at 72 FR 262, Jan. 4, 2007; 78 FR 52854, Aug. 27, 2013; 82 FR 12169, Mar. 1, 2017] | (a) Specifications. Each milliliter (mL) contains 23 milligrams (mg) florfenicol. (b) Sponsors. See Nos. 000061, 054925, and 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.283 of this chapter. (d) Conditions of use in swine —(1) Amount. Administer in drinking water ad libitum at 400 mg per gallon (100 parts per million (ppm)) for 5 consecutive days. (2) Indications for use. For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis. (3) Limitations. Do not slaughter within 16 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.106 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.960 Flumethasone. | FDA | [44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014] | (a) Specifications. Each tablet contains 0.0625 milligram of flumethasone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount —(i) Dogs: Administer orally from 0.0625 to 0.25 milligram daily in divided doses. (ii) Cats: Administer orally from 0.03125 to 0.125 milligram daily in divided doses. (2) Indications for use —(i) Dogs: It is used for musculoskeletal conditions due to inflammation of muscles or joints and accessory structures, where permanent structural changes do not exist, such as arthritis, the disc syndrome, and myositis. (ii) Dogs and cats: It is used in certain acute and chronic dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.107 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.970 Flunixin. | FDA | [76 FR 53051, Aug. 25, 2011, as amended at 79 FR 74020, Dec. 15, 2014; 84 FR 8972, Mar. 13, 2019] | (a) Specifications. (1) Each 10-gram (g) packet of granules contains flunixin meglumine equivalent to 250 milligrams (mg) of flunixin. (2) Each 30-g syringe of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section. (1) No. 000061 for use of products described in paragraph (a). (2) No. 061133 for use of the product described in paragraph (a)(2). (c) Conditions of use in horses —(1) Amount. 0.5 mg per pound of body weight per day for up to 5 days. (2) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.108 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.980 Fluoxetine. | FDA | [72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017] | (a) Specifications. Each chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride. (b) Sponsor. See No. 055246 in § 510.600 of this chapter. (c) Conditions of use in dogs —(1) Amount. 1 to 2 mg per kilogram body weight once daily. (2) Indications for use. For the treatment of canine separation anxiety in conjunction with a behavior modification plan. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.109 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.998 Fluralaner chewable tablets. | FDA | [86 FR 14818, Mar. 19, 2021, as amended at 88 FR 27698, May 3, 2023; 90 FR 6800, Jan. 21, 2025] | (a) Specifications. (1) Each chewable tablet contains 112.5, 250, 500, 1,000, or 1,400 milligrams (mg) fluralaner. (2) Each chewable tablet contains 45, 100, 200, 400, or 560 mg fluralaner. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer orally as a single dose with food: (i) Chewable tablets described in paragraph (a)(1) of this section. Administer every 12 weeks, an appropriate combination of tablets to provide a minimum dose of 11.4 mg per pound (lb) (25 mg per kilogram (kg)) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks. (ii) Chewable tablets described in paragraph (a)(2) of this section. Administer monthly, an appropriate combination of tablets to provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight. (2) Indications for use —(i) Chewable tablets described in paragraph (a)(1) of this section. Kills adult fleas; for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations ( Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater; and for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lbs or greater. (ii) Chewable tablets described in paragraph (a)(2) of this section. Kills adult fleas; for the treatment and prevention of flea infestations ( C. felis ), and the treatment and control of tick infestations ( I. scapularis (black-legged tick), D. variabilis (American dog tick), R. sanguineus (brown dog tick), and H. longicornis (Asian longhorned tick)) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 4.4 lb or greater; and for the t… | |||||
| 21:21:6.0.1.1.11.0.1.11 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.82a Aminopropazine. | FDA | [79 FR 28816, May 20, 2014] | (a) Specifications. Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats —(1) Amount. Administer orally at a dosage of 1 to 2 milligrams per pound of body weight, repeated every 12 hours as indicated. (2) Indications for use. For reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.110 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.999 Fluralaner oral solution. | FDA | [91 FR 5300, Feb. 6, 2026] | (a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) fluralaner. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in laying hens and replacement chickens —(1) Amount. Administer orally to chickens via the drinking water as 2 single doses, spaced 7 days apart, with each dose consumed over a period of 6 to 24 hours. Each dose is 0.5 mg fluralaner/kilogram (kg) (0.227 mg/pound (mg/lb)) body weight, equivalent to 0.05 mL fluralaner oral solution/kg body weight (0.023 mL/lb). (2) Indications for use. For the treatment and control of northern fowl mites ( Ornithonyssus sylviarum ). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Chickens must not be slaughtered for human consumption for 11 days after the last treatment. No egg discard is required when used according to the labeling. | |||||
| 21:21:6.0.1.1.11.0.1.111 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1010 Furosemide. | FDA | [66 FR 47960, Sept. 17, 2001, as amended at 69 FR 74419, Dec. 14, 2004; 70 FR 50182, Aug. 26, 2005; 70 FR 76396, Dec. 27, 2005; 74 FR 61516, Nov. 25, 2009; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016; 91 FR 5300, Feb. 6, 2026] | (a) Specifications. (1) Each tablet contains 12.5 or 50 milligrams (mg) furosemide. (2) Each bolus contains 2 grams (g) furosemide. (3) Each packet of powder contains 2 g furosemide. (4) Each milliliter of syrup contains 10 mg furosemide. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use of dosage forms and strengths listed in paragraph (a) of this section for uses as in paragraph (d) of this section. (1) Nos. 000010 and 086117 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section. (2) No. 000061 for tablets in paragraph (a)(1) of this section for conditions of use in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(3) of this section; for boluses in paragraph (a)(2) of this section and powder in paragraph (a)(3) of this section for conditions of use in paragraph (d)(1) of this section; and for syrup in paragraph (a)(4) of this section for conditions of use in paragraphs (d)(2)(i) and (d)(2)(ii)(A). (3) Nos. 058829 and 069043 for use of syrup in paragraph (a)(4) of this section for conditions of use in paragraph (d)(2)(i) and (d)(2)(ii)(A) of this section. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use. It is used as follows: (1) Cattle —(i) Amount. 1 to 2 mg per pound (/lb) body weight using powder, or one 2-g bolus per animal, per day. (ii) Indications for use. For treatment of physiological parturient edema of the mammary gland and associated structures. (iii) Limitations. Treatment not to exceed 48 hours post-parturition. Milk taken during treatment and for 48 hours after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment. (2) Dogs —(i) Amount. 1 to 2 mg/lb body weight, once or twice daily. (ii) Indications for use. (A) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency a… | |||||
| 21:21:6.0.1.1.11.0.1.112 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1044 Gentamicin sulfate oral dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.11.0.1.113 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1044a Gentamicin sulfate oral solution. | FDA | [48 FR 10302, Mar. 11, 1983. Redesignated at 49 FR 572, Jan. 5, 1984, and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006; 81 FR 94989, Dec. 27, 2016; 88 FR 84700, Dec. 6, 2023] | (a) Specifications. Each milliliter of aqueous solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.300 of this chapter. (d) Conditions of use —(1) Amount. Colibacillosis: 1 milliliter per 2 gallons of drinking water for 3 consecutive days, to provide 0.5 milligram/pound/day; swine dysentery: 1 milliliter per 1 gallon of drinking water for 3 consecutive days, to provide 1.0 milligram/pound/day. (2) Indications for use. In weanling swine for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin, and in swine for control and treatment of swine dysentery associated with Treponema hyodysenteriae. (3) Limitations. Do not slaughter treated swine for food for at least 3 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.114 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1044b Gentamicin sulfate pig pump oral solution. | FDA | [49 FR 572, Jan. 5, 1984, as amended at 52 FR 7832, Mar. 13, 1987; 62 FR 29011, May 29, 1997; 78 FR 17596, Mar. 22, 2013; 81 FR 22523, Apr. 18, 2016; 88 FR 27698, May 3, 2023] | (a) Specifications. Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 4.35 milligrams of gentamicin. (b) Sponsor. See Nos. 000061 and 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.300 of this chapter. (d) Conditions of use —(1) Amount. Administer 1.15 milliliters of pig pump oral solution (5 milligrams of gentamicin) orally per pig one time. (2) Indications for use. In neonatal swine 1 to 3 days of age for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin. (3) Limitations. For use in neonatal swine only. Do not slaughter treated swine for food for at least 14 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.115 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1044c Gentamicin sulfate powder. | FDA | [77 FR 4226, Jan. 27, 2012, as amended at 81 FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019; 87 FR 10968, Feb. 28, 2022] | (a) Specifications. Each gram of powder contains gentamicin sulfate equivalent to: (1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin. (2) 333.3 mg gentamicin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section as follows: (1) No. 000061 for products described in paragraph (a)(1) of this section. (2) Nos. 016592 and 061133 for product described in paragraph (a)(2) of this section. (c) Related tolerances. See § 556.300 of this chapter. (d) Conditions of use in swine —(1) Amount. Administer in drinking water for 3 consecutive days as follows: (i) For colibacillosis: Gentamicin sulfate equivalent to 25 mg of gentamicin per gallon of drinking water to provide 0.5 mg per pound of body weight per day; (ii) For swine dysentery: Gentamicin sulfate equivalent to 50 mg of gentamicin per gallon of drinking water to provide 1 mg per pound of body weight per day. Treatment may be repeated if dysentery recurs. (2) Indications for use. For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for control and treatment of swine dysentery associated with Brachyspira hyodysenteriae. (3) Limitations. Withdrawal period: 10 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.116 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1060 Glucose and glycine. | FDA | [79 FR 28821, May 20, 2014] | (a) Specifications. Each packet of powder contains 8.82 grams sodium chloride, 4.20 grams potassium phosphate, 0.5 gram citric acid anhydrous, 0.12 gram potassium citrate, 6.36 grams aminoacetic acid (glycine), and 44.0 grams glucose. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in calves —(1) Amount. Dissolve each packet in 2 quarts of warm water and administer to each calf as follows: (i) Scouring and/or dehydrated calves. Feed 2 quarts of solution, twice daily for 2 days (four feedings). No milk or milk replacer should be fed during this period. For the next four feedings (days 3 and 4), use 1 quart of solution together with 1 quart of milk replacer. Thereafter, feed as normal. (ii) Newly purchased calves. Feed 2 quarts of solution instead of milk as the first feed upon arrival. For the next scheduled feeding, use 1 quart of solution mixed together with 1 quart of milk or milk replacer. Thereafter, feed as normal. (2) Indications for use. For control of dehydration associated with diarrhea (scours); and as an early treatment at the first signs of scouring. It may also be used as followup treatment following intravenous fluid therapy. (3) Limitations. The product should not be used in animals with severe dehydration (down, comatose, or in a state of shock). Such animals need intravenous therapy. A veterinarian should be consulted in severely scouring calves. The product is not nutritionally complete if administered by itself for long periods of time. It should not be administered beyond the recommended treatment period without the addition of milk or milk replacer. | |||||
| 21:21:6.0.1.1.11.0.1.117 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1084 Grapiprant. | FDA | [81 FR 36789, June 8, 2016, as amended at 83 FR 14587, Apr. 5, 2018] | (a) Specifications. Each tablet contains 20, 60, or 100 milligrams (mg) grapiprant. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer 0.9 mg/lb (2 mg/kg) once daily by mouth. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.118 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1100 Griseofulvin. | FDA | [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, July 19, 1989; 71 FR 38073, July 5, 2006; 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, 2014; 84 FR 8972, Mar. 13, 2019] | (a) Specifications. (1) The powder complies with U.S.P. for griseofulvin, microsize. (2) Each bolus contains 2.5 grams griseofulvin. (3) Each tablet contains 125 or 500 milligrams griseofulvin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (1) No. 000061 for use of products described in paragraph (a) for use as in paragraph (d) of this section. (2) No. 061133 for use of the powder described in paragraph (a)(1) for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use —(1) Horses —(i) Amount and indications for use. (A) For equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum , administer soluble powder described in paragraph (a)(1) of this section daily as a drench or as a top dressing on feed for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams. (B) For treating ringworm infection caused by T. equinum , administer boluses described in paragraph (a)(2) of this section daily for not less than 10 days as follows: adults, 1 bolus; yearlings, one-half to 1 bolus; and foals, one-half bolus. (ii) Limitations. Do not use in horses intended for human consumption. (2) Dogs and cats: (i) Amount. 125- and 500-milligram tablets administered orally as follows: (A) Daily (single or divided) dose as follows: For animals weighing up to 6 pounds: 62.5 milligrams; for animals weighing 6 to 18 pounds: 125 milligrams; for animals weighing 18 to 36 pounds: 250 milligrams; for animals weighing 36 to 48 pounds: 375 milligrams; for animal weighing 48 to 75 pounds: 500 milligrams. (B) Weekly (single) dose: If experience indicates that treatment is more effective for the drug given in large doses, administer at intervals of 7 to 10 days, a dose equal to 10 milligrams/pound of body weight × body weight × number of days between treatments. Dosage should be adjusted accor… | |||||
| 21:21:6.0.1.1.11.0.1.119 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1120 Haloxon oral dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.11.0.1.12 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.82b Aminopropazine and neomycin. | FDA | [79 FR 28816, May 20, 2014] | (a) Specifications. Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base and neomycin sulfate equivalent to 50 milligrams (mg) of neomycin base. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer orally at a dosage of 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated. (2) Indications for use. For control of bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.120 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1120a Haloxon drench. | FDA | [40 FR 13838, Mar. 27, 1975, as amended at 45 FR 10333, Feb. 15, 1980; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 78 FR 28822, May 20, 2014] | (a) Specifications. Each packet contains 141.5 grams haloxon. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Special considerations. Do not use any drug, insecticide, pesticide, or other chemical having cholinesterase-inhibiting activity either simultaneously or within a few days before or after treatment with haloxon. (d) Related tolerances. See § 556.310 of this chapter. (e) Conditions of use in cattle —(1) Amount. Dissolve each packet in 32 fluid ounces of water and administer as follows: For animals weighing up to 100 pounds: 1/2 fluid ounce; for animals weighing 100 to 150 pounds: 3/4 fluid ounce; for animals weighing 150 to 200 pounds: 1 fluid ounce; for animals weighing 200 to 300 pounds: 1 1/2 fluid ounces; for animals weighing 300 to 450 pounds: 2 fluid ounces; for animals weighing 450 to 700 pounds: 3 fluid ounces; for animals weighing 700 to 1,000 pounds: 4 fluid ounces; for animals weighing 1,000 to 1,200 pounds: 5 fluid ounces; for animals weighing over 1,200 pounds: 6 fluid ounces. Retreat in 3 to 4 weeks. (2) Indications for use. For control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia. (3) Limitations. Do not treat dairy animals of breeding age. Do not treat within 1 week of slaughter. | |||||
| 21:21:6.0.1.1.11.0.1.121 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1120b Haloxon boluses. | FDA | [40 FR 13838, Mar. 27, 1975, as amended at 44 FR 61591, Oct. 29, 1979; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28822, May 20, 2014] | (a) Specifications. Each bolus contains 10.1 grams of haloxon. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.310 of this chapter. (d) Conditions of use in cattle —(1) Amount. Administered one bolus per 500 pounds body weight (35 to 50 milligrams per kilogram of body weight). Retreat in 3 to 4 weeks. (2) Indications for use. For control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia. (3) Limitations. Do not treat dairy animals of breeding age or older. Do not treat within 1 week of slaughter. | |||||
| 21:21:6.0.1.1.11.0.1.122 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1136 Ilunocitinib. | FDA | [89 FR 95103, Dec. 2, 2024] | (a) Specifications. Each tablet contains 4.8, 6.4, 8.5, and 15 milligrams (mg) ilunocitinib. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food. (2) Indications for use. For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.123 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1150 Imepitoin. | FDA | [84 FR 12494, Apr. 2, 2019] | (a) Specifications. Each tablet contains 100 or 400 milligrams (mg) imepitoin. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer orally twice daily, approximately 12 hours apart, at a dose of 13.6 mg per pound (30 mg/kg) of body weight. Initiate therapy starting 2 days prior to the day of the expected noise event and continuing through the noise event. (2) Indications for use. For the treatment of noise aversion in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.124 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1156 Imidacloprid. | FDA | [80 FR 18775, Apr. 8, 2015, as amended at 86 FR 14818, Mar. 19, 2021] | (a) Specifications. Each chewable tablet contains 7.5 or 37.5 milligrams (mg) imidacloprid. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer daily one 7.5-mg chewable tablet to dogs weighing 4 to 22 pounds (lb) or one 37.5-mg chewable table to dogs weighing 23 to 110 lb. (2) Indications for use. Kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 lb or greater. (3) Limitations. Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 lb. Do not give more than one tablet a day. | |||||
| 21:21:6.0.1.1.11.0.1.125 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1157 Iodinated casein. | FDA | [49 FR 22469, May 30, 1984, as amended at 78 FR 28822, May 20, 2014] | (a) Specifications. Each 1-gram tablet contains 25 milligrams of iodinated casein. (b) Sponsor. See No. 017762 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. 1/5 to 1 tablet per 10 pounds of body weight (equivalent to 0.5 to 2.5 milligrams of iodinated casein per pound of body weight). (2) Indications for use. For dogs for apparent decreased thyroid activity where the signs are alopecia, scaliness of the skin surface, loss of hair, seborrhea, thickening of the skin, hyperpigmentation, and lethargy. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.126 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1158 Iodochlorhydroxyquin. | FDA | [48 FR 8054, Feb. 25, 1983, as amended at 50 FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, 2014] | (a) Specifications. Each bolus contains 10 grams of iodochlorhydroxyquin. (b) Sponsor. See No. 054771 in § 510.600 (c) of this chapter. (c) Conditions of use —(1) Amount. 1 bolus (10 grams) daily for a 1,000-pound horse. (2) Indications for use. For treatment of equine diarrhea. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.127 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1189 Itraconazole. | FDA | [82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021] | (a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) of itraconazole. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer 5 mg/kilogram (kg) (0.5 mL/kg) of body weight once daily on alternating weeks for 3 treatment cycles. (2) Indications for use. For the treatment of dermatophytosis caused by Microsporum canis in cats. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.128 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1192 Ivermectin paste. | FDA | [49 FR 22275, May 29, 1984, as amended at 50 FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, 2005; 71 FR 40010, July 14, 2006; 71 FR 67298, Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013; 84 FR 8972, Mar. 13, 2019; 84 FR 39183, Aug. 9, 2019; 86 FR 14818, Mar. 19, 2021] | (a) Specifications. Each milligram (mg) of paste contains 0.0187 mg (1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section: (1) No. 000010 for use of a 1.87 percent paste as in (e)(1) of this section and a 0.153 percent paste for use as in paragraph (e)(2) of this section. (2) Nos. 051311, 054925, 058198, and 061133 for use of a 1.87 percent paste for use as in paragraph (e)(1) of this section. (c) Related tolerances. See § 556.344 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use —(1) Horses —(i) Amount. 200 micrograms per kilogram (91 micrograms per pound) of body weight. (ii) Indications for use. For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus , Triodontophorus spp. Including T. brevicauda and T. serratus , and Craterostomum acuticaudatum ; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. Including C. coronatus , C. labiatus , and C. labratus , Cyathostomum spp. Including C. catinatum and C. pateratum , Cylicocyclus spp. Including C. insigne , C. leptostomum , C. nassatus , and C. brevicapsulatus , Cylicodontophorus spp., Cylicostephanus spp. Including C. calicatus , C. goldi , C. longibursatus , and C. minutus , and Petrovinema poculatum ; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth-stage larvae): Oxyuris equi ; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum ; Hairworms (adults): Trichostrongylus axei ; Large mouth Stomach Worms (adults): Habronema muscae ; Bots (oral and gastric stages): Gasterophilus spp. Including G. intestinalis and G. nasalis ; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi ; Intestinal Threadworms (adults): Strongyloides westeri ;… | |||||
| 21:21:6.0.1.1.11.0.1.129 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1193 Ivermectin tablets and chewables. | FDA | [67 FR 11230, Mar. 13, 2002, as amended at 67 FR 21996, May 2, 2002; 69 FR 43735, July 22, 2004; 81 FR 17607, Mar. 30, 2016; 84 FR 39183, Aug. 9, 2019] | (a) Specifications. (1) Each tablet or chewable contains 68, 136, or 272 micrograms (mcg) ivermectin. (2) Each chewable contains 55 or 165 mcg ivermectin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 000010 for use of tablets or chewables described in paragraph (a)(1) as in paragraph (d)(1) and chewables described in paragraph (a)(2) as in paragraph (d)(2) of this section. (2) Nos. 051311 and 069043 for use of tablets described in paragraph (a)(1) as in paragraph (d)(1) of this section. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use —(1) Dogs. For use in dogs 6 weeks of age and older as follows: (i) Amount. 6.0 mcg per kilogram (kg) of body weight (2.72 mcg per pound (lb)), minimum. Up to 25 lb, 68 mcg; 26 to 50 lb, 136 mcg; 51 to 100 lb, 272 mcg; over 100 lb, a combination of the appropriate tablets. Administer at monthly dosing intervals. (ii) Indications for use. To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection. (2) Cats. For use in cats 6 weeks of age and older as follows: (i) Amount. Up to 2.3 kilograms (up to 5 lb), 55 mcg; 2.3 to 6.8 kilograms (5 to 15 lb), 165 mcg; over 6.8 kilograms (15 lb), a combination of the appropriate chewables (recommended minimum dose of 24 mcg/kg of body weight (10.9 mcg/lb)). Administer once a month. (ii) Indications for use. To prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae Dirofilaria immitis for a month (30 days) after infection, and for removal and control of adult and immature (L4) hookworms Ancylostoma tubaeforme and A. braziliense. | |||||
| 21:21:6.0.1.1.11.0.1.13 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.88 Amoxicillin oral dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.11.0.1.130 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1194 Ivermectin meal. | FDA | [70 FR 1817, Jan. 11, 2005, as amended at 70 FR 19262, Apr. 13, 2005] | (a) Specifications. Each gram of meal contains 6 milligrams ivermectin (0.6 percent). (b) Sponsor. See No. 017135 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use in horses —(1) Amount. Administer 136 micrograms (mcg) ivermectin per pound (/lb) body weight (300 mcg/kilogram) as a single dose on approximately 2 lb grain or sweet feed. (2) Indications for use. For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus , Triodontophorus spp. Including T. brevicauda and T. serratus , and Craterostomum acuticaudatum ; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. Including C. coronatus , C. labiatus , and C. labratus , Cyathostomum spp. Including C. catinatum and C. pateratum , Cylicocyclus spp. Including C. insigne , C. leptostomum , C. nassatus , and C. brevicapsulatus , Cylicodontophorus spp., Cylicostephanus spp. Including C. calicatus , C. goldi , C. longibursatus , and C. minutus , and Petrovinema poculatum ; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi ; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum ; Hairworms (adults): Trichostrongylus axei ; Large Mouth Stomach Worms (adults): Habronema muscae ; Bots (oral and gastric stages): G asterophilus spp. Including G. intestinalis and G. nasalis ; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi ; Intestinal Threadworms (adults): Strongyloides westeri ; Summer Sores caused by Habronema and Draschia spp. Cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp. Limitations. Do not use in horses intended for human consumption. | |||||
| 21:21:6.0.1.1.11.0.1.131 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1195 Ivermectin liquid. | FDA | [67 FR 50597, Aug. 5, 2002, as amended at 69 FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, Feb. 27, 2014; 84 FR 39183, Aug. 9, 2019; 86 FR 14818, Mar. 19, 2021; 88 FR 27698, May 3, 2023; 88 FR 84700, Dec. 6, 2023] | (a) Specifications. (1) Each milliliter (mL) contains 10 milligrams (mg) ivermectin. (2) Each mL of micellar solution contains 0.8 mg ivermectin. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) Nos. 058005 and 058198 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section. (2) No. 058829 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section. (3) Nos. 000010 and 058829 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section. (c) Related tolerances. See § 556.344 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use —(1) Horses —(i) Amount. 200 micrograms (mcg) per kilogram (/kg) of body weight as a single dose by stomach tube or as an oral drench. (ii) Indications for use. For treatment and control of: (A) Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus , Triodontophorus spp. Including T. brevicauda and T. serratus , and Craterostomum acuticaudatum ; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. Including C. coronatus , C. labiatus , and C. labratus , Cyathostomum spp. Including C. catinatum and C. pateratum , Cylicocyclus spp. Including C. insigne , C. leptostomum , C. nassatus , and C. brevicapsulatus , Cylicodontophorus spp., Cylicostephanus spp. Including C. calicatus , C. goldi , C. longibursatus , and C. minutus , and Petrovinema poculatum ; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi ; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum ; Hairworms (adults): Trichostrongylus axei ; Large mouth Stomach Worms (adults): Habronema muscae ; Bots (oral and … | |||||
| 21:21:6.0.1.1.11.0.1.132 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1196 Ivermectin and pyrantel tablets. | FDA | [58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014; 84 FR 39183, Aug. 9, 2019; 88 FR 16547, Mar. 20, 2023; 89 FR 42357, May 15, 2024] | (a) Specifications. Each chewable tablet contains either 68 micrograms (µg) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 µg and 114 mg, or 272 µg and 227 mg, respectively. (b) Sponsors. See Nos. 000010, 051311, and 053701 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer a minimum of 6 µg of ivermectin and 5 mg of pyrantel per kilogram (2.72 µg and 2.27 mg per pound) of body weight monthly. (ii) Indications for use. To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for up to a month (30 days) after infection and treatment and control of adult roundworms Toxocara canis and Toxascaris leonina, and adult hookworms Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] | |||||
| 21:21:6.0.1.1.11.0.1.133 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1197 Ivermectin sustained-release bolus. | FDA | [61 FR 67452, Dec. 23, 1996, as amended at 62 FR 63270, Nov. 28, 1997; 65 FR 45876, July 26, 2000; 84 FR 39183, Aug. 9, 2019] | (a) Specifications. Each sustained-release bolus contains 1.72 grams of ivermectin. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.344 of this chapter. (d) Conditions of use in ruminating calves —(1) Amount. Administer one bolus per calf weighing at least 275 pounds (lb) (125 kilograms (kg)) and not more than 660 lb (300 kg) on the day of administration. (2) Indications. For treatment and control, throughout the grazing season (approximately 130 days), of gastrointestinal roundworms Haemonchus placei, Ostertagia ostertagi (including inhibited fourth-stage larvae), Trichostrongylus axei, T. colubriformis, Cooperia spp., Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum radiatum; lungworms Dictyocaulus viviparus; grubs Hypoderma spp.; sucking lice Linognathus vituli, Solenopotes capillatus; mange mites Psoroptes ovis, Sarcoptes scabiei, and ticks Amblyomma americanum. (3) Limitations. The bolus was specifically designed for use in cattle; do not use in other animal species. Calves must be ruminating and older than 12 weeks of age. Do not administer to calves weighing less than 275 lb (125 kg). Do not administer a damaged bolus. Because a milk withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter cattle within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. | |||||
| 21:21:6.0.1.1.11.0.1.134 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1198 Ivermectin and praziquantel paste. | FDA | [68 FR 55309, Sept. 25, 2003, as amended at 69 FR 49808, Aug. 12, 2004; 70 FR 65835, Nov. 1, 2005; 79 FR 37619, July 2, 2014; 84 FR 39183, Aug. 9, 2019; 89 FR 42357, May 15, 2024] | (a) Specifications. Each milligram (mg) of paste contains: (1) 0.0155 mg (1.55 percent) ivermectin and 0.0775 mg (7.75 percent) praziquantel. (2) 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) praziquantel. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.— (1) No. 000010 for use of product described in paragraph (a)(1) of this section as in paragraphs (d)(1)(i), (d)(2)(i) and (d)(3) of this section. (2) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii), (d)(2)(ii), and (d)(3) of this section. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use in horses —(1) Amount. (i) 200 micrograms (mcg) per kilogram (/kg) ivermectin (91 mcg per pound (/lb)) and 1 mg/kg praziquantel (454 mcg/lb) body weight. (ii) 200 mcg/kg ivermectin (91 mcg/lb) and 1.5 mg/kg praziquantel (681 mcg/lb) body weight. (iii) 200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel (1.14 mg/lb). (2) Indications for use. (i) For treatment and control of the following parasites: Tapeworms— Anoplocephala perfoliata; Large Strongyles (adults)— Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. Including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)— Coronocyclus spp. Including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp. Including C. catinatum and C. pateratum; Cylicocyclus spp. Including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. Including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)— Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)— Para… | |||||
| 21:21:6.0.1.1.11.0.1.135 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1199 Ivermectin, pyrantel, and praziquantel tablets. | FDA | [71 FR 65052, Nov. 7, 2006, as amended at 78 FR 28822, May 20, 2014; 83 FR 14587, Apr. 5, 2018] | (a) Specifications. Each chewable tablet or soft chewable tablet contains: (1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel; (2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel; (3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or (4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer monthly according to body weight as follows: (i) 6 to 12 lb: one tablet as described in paragraph (a)(1) of this section. (ii) 12.1 to 25 lb: one tablet as described in paragraph (a)(2) of this section. (iii) 25.1 to 50 lb: one tablet as described in paragraph (a)(3) of this section. (iv) 50.1 to 100 lb: one tablet as described in paragraph (a)(4) of this section. (v) Greater than 100 lb: use the appropriate combination of tablets. (2) Indications for use. To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis ) for 1 month (30 days) after infection and for the treatment and control of roundworm ( Toxocara canis, Toxascaris leonina ), hookworm ( Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense ) and tapeworm ( Dipylidium caninum, Taenia pisiformis ) infections. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.136 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1200 Ivermectin, fenbendazole, and praziquantel tablets. | FDA | [73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009] | (a) Specifications. Each chewable tablet contains either: (1) 68 micrograms (µg) ivermectin, 1.134 grams fenbendazole, and 57 milligrams (mg) praziquantel; or (2) 27 µg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer tablets to provide 6 µg per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel. (2) Indications for use. For the treatment and control of adult Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the prevention of heartworm disease caused by Dirofilaria immitis in adult dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.137 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1204 Kanamycin, bismuth subcarbonate, activated | FDA | [40 FR 13838, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 56 FR 8710, Mar. 1, 1991; 64 FR 403, Jan. 5, 1999; 71 FR 43968, Aug. 3, 2006; 78 FR 28822, May 20, 2014] | (a) Specifications. (1) Each 5 milliliters (mL) of suspension contains 100 milligrams (mg) kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite (aluminum magnesium silicate). (2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. 5 mL of suspension or 1 tablet per 20 pounds body weight every 8 hours. Maximum dose: 5 mL of suspension or 3 tablets every 8 hours. Dogs under 10 pounds: 2.5 mL of suspension or 1/2 tablet every 8 hours. A recommended initial loading dose should be twice the amount of a single dose. (2) Indications for use. For the treatment of bacterial enteritis caused by organisms susceptible to kanamycin and the symptomatic relief of the associated diarrhea. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.138 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1242 Levamisole. | FDA | |||||||
| 21:21:6.0.1.1.11.0.1.139 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1242a Levamisole powder. | FDA | [69 FR 9753, Mar. 2, 2004, as amended at 69 FR 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, 2014; 84 FR 8972, Mar. 13, 2019; 87 FR 58961, Sept. 29, 2022] | (a) Specifications. Each package of powder contains 9.075, 11.7, 18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride. (b) Sponsors. See sponsors in § 510.600(c) for use as follows: (1) No. 000061 for use of 46.8- and 544.5-g packages as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section; for 11.7-, 46.8-, and 544.5-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for an 18.15-g package as in paragraph (e)(3) of this section. (2) No. 054771 for use of a 46.8-g package as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section; for 11.7- and 46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in paragraph (e)(3) of this section. (3) No. 016592 for use of 46.8- and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section. (4) No. 061133 for use of 46.8-, 362.7-, and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-g package as in paragraph (e)(3) of this section. (c) Related tolerances. See § 556.350 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use. It is used as an anthelmintic as follows: (1) Cattle —(i) Amount. 8 milligrams per kilogram (mg/kg) body weight as a drench. (ii) Indications for use. (A) Effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ); intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ); and lungworms ( Dictyocaulus ). (B) Effective against the following adult nematode infections: Stomach worms ( Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei ); intestinal worms ( T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oeso… | |||||
| 21:21:6.0.1.1.11.0.1.14 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.88a Amoxicillin trihydrate film-coated tablets. | FDA | [57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28816, May 20, 2014] | (a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days. (ii) Indications for use. Treatment of infections of the respiratory tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), gastrointestinal tract (bacterial gastroenteritis), and soft tissues (abscesses, lacerations, wounds), caused by susceptible strains of Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days. (ii) Indications for use. Treatment of infections caused by susceptible organisms as follows: upper respiratory tract due to S. aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, and wounds) due to S. aureus, Streptococcus spp., E. coli, and Pasteurella multocida. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.140 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1242b Levamisol boluses or oblets. | FDA | [78 FR 28822, May 20, 2014] | (a) Specifications. Each bolus contains 2.19 grams levamisol hydrochloride. Each oblet contains 0.184 grams levamisol hydrochloride. (b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter. (c) Required labeling. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (d) Related tolerances. See § 556.350 of this chapter. (e) Conditions of use —(1) Cattle —(i) Amount. Administer orally 2.19-gram boluses as a single dose as follows: 250 to 450 pounds, 1/2 bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, 1 1/2 boluses. (ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ), and lungworms ( Dictyocaulus ). (iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Consult veterinarian before using in severely debilitated animals. (2) Sheep —(i) Amount. Administer orally one 0.184-gram oblet for each 50 pounds of body weight. (ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia ), and lungworms ( Dictyocaulus ). (iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 72 hours of treatment. Consult a veterinarian before using in severely debilitated animals. | |||||
| 21:21:6.0.1.1.11.0.1.141 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1242c Levamisol and piperazine. | FDA | [78 FR 28823, May 20, 2014] | (a) Specifications. (1) Each ounce of solution contains 0.36 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 3.98 grams of piperazine base. (2) A soluble powder which when constituted with water contains in each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 5.0 grams of piperazine base. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfection occurs, re-treat animals at 6- to 8-week intervals. (2) Indications for use. An anthelmintic effective against infections of large strongyles ( Strongylus vulgaris, S. edentatus ), small strongyles ( Cylicocercus spp., Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp.), ascarids ( Parascaris equorum ), and pinworms ( Oxyuris equi ). (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.142 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1242d Levamisole resinate. | FDA | [43 FR 18171, Apr. 28, 1978, as amended at 45 FR 3574, Jan. 18, 1980] | (a) Specifications. The drug is levamisole adsorbed on a resin, in a concentration equivalent to 10 percent levamisole hydrochloride. Each 2.05-ounce (58.1 gram) packet contains levamisole equivalent to 5.806 grams of levamisole hydrochloride. (b) Sponsor. See No. 043781 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of this chapter. (d) Conditions of use. In swine it is used as follows: (1) Amount. The equivalent of 8 milligrams per kilogram of body weight, as a single dose, mixed in the animal's ration. (2) Indications for use. For the removal of and control of the following nematode infections: large roundworms ( Ascaris suum ), nodular worms ( Oesophagostomum spp.), lungworms ( Metastrongylus spp.), intestinal threadworms ( Strongyloides ransomi ), and swine kidney worms ( Stephanurus dentatum ). (3) Limitations. For pigs from weaning to market weight, mix one 58.1-gram packet of levamisole resinate containing the equivalent of 10-percent levamisole hydrochloride in 40 pounds of feed and administer 1 pound of medicated feed per 40 pounds of body weight as sole ration. For breeding swine, mix 1 packet of the 10-percent resinate in 16 pounds of feed and administer 1 pound of medicated feed per 100 pounds of body weight as sole ration. Administer as single doses. Withhold regular feed overnight and administer medicated feed the following morning. Do not withhold water during fasting. Do not treat within 72 hours of slaughter. Salivation or muzzle foam may be observed. The reaction will disappear a short time after feeding. If pigs are infected with mature lungworms, coughing and vomiting may be observed. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. | |||||
| 21:21:6.0.1.1.11.0.1.143 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1242e Levamisole hydrochloride effervescent tablets. | FDA | [45 FR 6087, Jan. 25, 1980, as amended at 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014] | (a) Specifications. Each tablet contains 907 milligrams of levamisole hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of this chapter. (d) Conditions of use. It is used for swine as follows: (1) Amount. The equivalent of 8 milligrams of levamisole hydrochloride per kilogram of body weight, as a single dose. (2) Indications for use. See § 520.1242a(f)(3)(ii). (3) Limitations. Withholding water from pigs before treatment is not necessary. Add one tablet for each 2 1/2 gallons of water; mix thoroughly. Allow 1 gallon of medicated water for each 100 pounds body weight of pigs to be treated. No other source of water should be offered. After pigs have consumed medicated water, resume use of regular water. Pigs maintained under conditions of constant worm exposure may require re-treatment within 4 to 5 weeks. Consult your veterinarian before administering to sick swine. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Do not administer within 72 hours of slaughter for food. | |||||
| 21:21:6.0.1.1.11.0.1.144 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1242f Levamisol gel. | FDA | [47 FR 22517, May 25, 1982; 47 FR 30242, July 13, 1982, as amended at 48 FR 11429, Mar. 18, 1983; 51 FR 29215, Aug. 15, 1986; 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014] | (a) Specifications. Each gram of gel contains 115 milligrams (11.5 percent) levamisol hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.350 of this chapter. (d) Conditions of use —(1) Cattle —(i) Amount. Eight milligrams of levamisole hydrochloride per kilogram of body weight, as a single oral dose. (ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ), and lungworms ( Dictyocaulus ). (iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment; do not administer to cattle within 6 days of slaughter for food; do not administer to dairy animals of breeding age; consult veterinarian before using in severely debilitated animals. (2) Breeding swine —(i) Amount. Eight milligrams per kilogram of body weight (3.6 milligrams per pound) as a single oral dose. (ii) Conditions of use. For treating breeding swine infected with the following nematodes: Large roundworms ( Ascaris suum ), nodular worms ( Oesophagostomum spp.), lungworms ( Metastrongylus spp.), intestinal threadworms ( Strongyloides ransomi ), and kidney worms ( Stephanurus dentatus ). (iii) Limitations. May require retreatment in 4 to 5 weeks. Do not use within 11 days of slaughter for food. Consult your veterinarian for assistance before using in severely debilitated animals and in the diagnosis, treatment, and control of parasitism. | |||||
| 21:21:6.0.1.1.11.0.1.145 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1242g Levamisole resinate and famphur paste. | FDA | [53 FR 23757, June 24, 1988, as amended at 54 FR 1353, Jan. 13, 1989; 57 FR 7652, Mar. 4, 1992; 62 FR 55160, Oct. 23, 1997; 62 FR 61625, Nov. 19, 1997; 78 FR 28823, May 20, 2014] | (a) Specifications. The drug is a paste containing 11.6 percent levamisole resinate (50 percent potency) and 23.6 percent famphur. (b) Sponsor. See 000061 in § 510.600(c) of this chapter. (c) Special considerations. Do not use any cholinesterase-inhibiting drugs, pesticides, insecticides, or chemicals on cattle simultaneously or within a few days before or after treatment with this product. (d) Related tolerances. See §§ 556.273 and 556.350 of this chapter. (e) Conditions of use in cattle —(1) Amount. 8 milligrams of levamisole hydrochloride (equivalent) and 30 milligrams of famphur activity per kilogram of body weight. (2) Indications for use. For treatment of cattle infected with the following parasites: Stomach worms ( Haemonchus, Trichostrongylus, Ostertagia ), intestinal worms ( Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ), lungworms ( Dictyocaulus ), cattle grubs ( Hypoderma ), biting lice ( Bovicola ), and sucking lice ( Linognathus, Solenoptes ). (3) Limitations. Drug is not effective against lice eggs. Conditions of constant helminth and ectoparasitic exposure may require retreatment within 2 to 4 weeks after first treatment. Do not administer to cattle within 19 days of slaughter. Do not administer to dairy animals of breeding age. Do not use in calves less than 3 months old, or in debilitated animals. Do not treat Brahman bulls. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. | |||||
| 21:21:6.0.1.1.11.0.1.146 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1248 Levothyroxine. | FDA | [81 FR 22523, Apr. 18, 2016, as amended at 86 FR 57996, Oct. 20, 2021] | (a) Specifications. Each tablet contains 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, or 1.0 milligrams (mg) levothyroxine sodium. (b) Sponsors. See Nos. 059051 and 061690 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer by mouth as follows: (i) No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/kilogram (kg)) as a single dose every 24 hours or as a divided dose every 12 hours. (ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily. (2) Indications for use. For replacement therapy for diminished thyroid function in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.147 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1263 Lincomycin. | FDA | |||||||
| 21:21:6.0.1.1.11.0.1.148 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1263a Lincomycin tablets and syrup. | FDA | [78 FR 28823, May 20, 2014] | (a) Specifications. (1) Each ounce of syrup contains lincomycin hydrochloride equivalent to either 25 or 50 milligrams (mg) lincomycin. (2) Each tablet contains lincomycin hydrochloride equivalent to either 25 or 50 mg lincomycin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats —(1) Amount. Administer orally 10 mg per pound of body weight every 12 hours, or 7 mg per pound of body weight every 8 hours, for up to 12 days. (2) Indications for use. For infections caused by gram-positive organisms which are sensitive to its action, particularly streptococci and staphylococci. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.149 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1263b Lincomycin powder. | FDA | [48 FR 3966, Jan. 28, 1983, as amended at 55 FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; 78 FR 28823, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019. Redesignated at 85 FR 18119, Apr. 1, 2020, as amended at 88 FR 16547, Mar. 20, 2023; 88 FR 84700, Dec. 6, 2023] | (a) Specifications. Each gram of soluble powder contains lincomycin hydrochloride equivalent to 0.4 grams of lincomycin. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows: (1) Nos. 054771 and 061133 for use as in paragraph (d) of this section. (2) Nos. 016592 and 076475 for use as in paragraphs (d)(1) and (2) of this section. (c) Tolerances. See § 556.360 of this chapter. (d) Conditions of use —(1) Swine —(i) Amount. 250 milligrams per gallon of drinking water to provide 3.8 milligrams per pound of body weight per day. (ii) Indications for use. For the treatment of swine dysentery (bloody scours). (iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Do not use for more than 10 days. If clinical signs of disease have not improved within 6 days, discontinue treatment and reevaluate diagnosis. The safety of lincomycin has not been demonstrated in pregnant swine or swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Chickens —(i) Amount. 64 milligrams per gallon of drinking water. (ii) Indications for use. For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens. (iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Administer for 7 consecutive days. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Not for use in layer and breeder chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Honey bees —(i) Amount. Mix 100 milligrams lincomycin with 20 grams confectioners'/powdered sugar and dust over the top bars of the brood chamber once weekly for 3 weeks. (ii) Indications for use. For the control of American foulbrood ( Paenibacillus larvae ). (iii) Limitations. The drug should be fed early in the spring o… | |||||
| 21:21:6.0.1.1.11.0.1.15 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.88b Amoxicillin trihydrate for oral suspension. | FDA | [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003; 79 FR 28816, May 20, 2014; 81 FR 17607, Mar. 30, 2016] | (a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (1) Conditions of use —(i) Dogs —(A) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days. (B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract (bacterial gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis. (C) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (ii) Cats —(A) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days. (B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: upper respiratory tract due to Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida. (C) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] (c) Sponsors. See Nos. 000856 and 051311 in § 510.60… | |||||
| 21:21:6.0.1.1.11.0.1.150 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1265 Lincomycin and spectinomycin powder. | FDA | [69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823, May 20, 2014; 81 FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019] | (a) Specifications. The following salts of lincomycin and spectinomycin are present in a soluble powder in the ratio of 1 to 2 on the basis of equivalency of lincomycin base to equivalency of spectinomycin base: (1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate tetrahydrate. (2) Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (1) No. 054771 for use of product described in paragraph (a)(1) of this section. (2) Nos. 016592, 061133, and 066104 for use of product described in paragraph (a)(2) of this section. (c) Tolerances. See §§ 556.360 and 556.600 of this chapter. (d) Conditions of use in chickens —(1) Amount. 2 grams of antibiotic activity per gallon of drinking water; administer as the sole source of water for the first 5 to 7 days of life. (2) Indications for use. As an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.151 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1284 Liothyronine. | FDA | [78 FR 28823, May 20, 2014] | (a) Specifications. Each tablet contains 60 or 120 micrograms (µg) liothyronine as the sodium salt. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer orally to dogs at levels up to 12.8 µg per kilogram (/kg) of body weight per day. Dosage should be adjusted according to the severity of the condition and the response of the patient. Dosage at the total replacement level (12.8 µg/kg of body weight) should be considered for initiating therapy and then titrated downward for optimum maintenance effect. Twice daily administration is recommended. (2) Indications for use. For treatment of hypothyroidism in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.152 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1286 Lotilaner. | FDA | [85 FR 18119, Apr. 1, 2020, as amended at 86 FR 61685, Nov. 8, 2021] | (a) Specifications. Each chewable tablet contains: (1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner; or (2) For use in cats: 12 or 48 mg lotilaner. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg). (ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations ( Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age or older and weighing 4.4 pounds or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. Administer orally once a month at the recommended minimum dosage of 2.7 mg/lb (6 mg/kg). (ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations ( Ctenocephalides felis ) for 1 month in cats and kittens 8 weeks of age and older, and weighing 2.0 pounds or greater; and for the treatment and control of Ixodes scapularis (black-legged tick) for 1 month in cats and kittens 6 months of age and older, and weighing 2.0 pounds or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.153 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel. | FDA | [90 FR 6800, Jan. 21, 2025, as amended at 90 FR 40969, Aug. 22, 2025] | (a) Specifications. Each chewable tablet contains: (1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg praziquantel, and 14.25 mg pyrantel (as pamoate salt); (2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, and 28.5 mg pyrantel (as pamoate salt); (3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 57 mg pyrantel (as pamoate salt); (4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 114 mg pyrantel (as pamoate salt); or (5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 228 mg pyrantel (as pamoate salt). (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt). (2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ), hookworm (fourth stage larvae, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala ), and tapeworm ( Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations ( Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.154 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1288 Lufenuron tablets. | FDA | [68 FR 51905, Aug. 29, 2003] | (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. | |||||
| 21:21:6.0.1.1.11.0.1.155 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1289 Lufenuron suspension. | FDA | [60 FR 20402, Apr. 26, 1995, as amended at 62 FR 8371, Feb. 25, 1997] | (a) Specifications. Each individual dose pack contains either 135 or 270 milligrams of lufenuron. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use in cats —(1) Amount. Minimum of 13.6 milligrams per pound of body weight (30 milligrams per kilogram). Recommended dose of 135 milligrams for up to 10 pounds of body weight or 270 milligrams for 11 to 20 pounds. Cats over 20 pounds are provided the appropriate combination of packs. (2) Indications for use. For control of flea populations. (3) Limitations. For oral use in cats 6 weeks of age or older, once a month, mixed with food. Administer in conjunction with a full meal to ensure adequate absorption. Treat all cats in the household to ensure maximum benefits. Because the drug has no affect on adult fleas, the concurrent use of insecticides that kill adults may be necessary depending on the severity of the infestation. | |||||
| 21:21:6.0.1.1.11.0.1.156 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1310 Marbofloxacin. | FDA | [64 FR 39919, July 23, 1999, as amended at 66 FR 46369, Sept. 5, 2001; 78 FR 28823, May 20, 2014; 85 FR 45307, July 28, 2020; 88 FR 27698, May 3, 2023] | (a) Specifications. Each tablet or chewable tablet contains 25, 50, 100, or 200 milligrams (mg) marbofloxacin. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section: (1) Nos. 017033, 054771, and 086117 for use of tablets. (2) No. 086101 for use of chewable tablets. (c) [Reserved] (d) Conditions of use —(1) Amount. 1.25 mg per pound (/lb) of body weight once daily, but may be increased to 2.5 mg/lb of body weight once daily. (2) Indications for use. For the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals. | |||||
| 21:21:6.0.1.1.11.0.1.157 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1315 Maropitant. | FDA | [72 FR 9243, Mar. 1, 2007, as amended at 78 FR 28823, May 20, 2014; 80 FR 53459, Sept. 4, 2015; 88 FR 27699, May 3, 2023; 89 FR 85426, Oct. 28, 2024] | (a) Specifications. Each tablet contains 16, 24, 60, or 160 milligrams (mg) maropitant as maropitant citrate. (b) Sponsors. See Nos. 054771, 086101, and 086117 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Indications for use and amount. (i) For prevention of acute vomiting in dogs 2 to 7 months of age, administer a minimum dose of 2.0 mg per kilogram (/kg) body weight once daily for up to 5 consecutive days. (ii) For prevention of acute vomiting in dogs 7 months of age and older, administer a minimum dose of 2.0 mg/kg body weight once daily until resolution of acute vomiting. (iii) For prevention of vomiting due to motion sickness in dogs 4 months of age and older, administer a minimum of 8.0 mg/kg body weight once daily for up to 2 consecutive days. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.158 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1320 Mebendazole. | FDA | [78 FR 28823, May 20, 2014] | (a) Specifications. (1) Each gram of powder contains either 40 or 166.7 milligrams of mebendazole. (2) Each gram of paste contains 200 milligrams of mebendazole. (3) Each milliliter of suspension contains 33.3 milligrams of mebendazole. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Horses —(i) Amount. 1 gram of mebendazole per 250 pounds of body weight per dose, as an oral powder, paste or suspension. (ii) Indications for use. For treatment of infections caused by large roundworms ( Parascaris equorum ); large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ); small strongyles; and mature and immature (4th larval stage) pinworms ( Oxyuris equi ). (iii) Limitations. The drug is compatible with carbon disulfide. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Dogs —(i) Amount. Administer 100 milligrams of mebendazole per 10 pounds of body weight, once daily for 3 days, as an oral powder by mixing with a small quantity of food, preferably before the regular meal. (ii) Indications for use. The drug is used for treatment of infections of roundworms ( Toxocara canis ), hookworms ( Ancylostoma caninum, Uncinaria stenocephala ), whipworms ( Trichuris vulpis ), and tapeworms ( Taenia pisiformis ). (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.159 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1326 Mebendazole and trichlorfon oral dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.11.0.1.16 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.88c Amoxicillin trihydrate oral suspension. | FDA | [57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28817, May 20, 2014; 85 FR 18118, Apr. 1, 2020] | (a) Specifications. Each 0.8-milliliter dose contains amoxicillin trihydrate equivalent to 40 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of this chapter. (d) Conditions of use in swine —(1) Amount. Administer 40 mg orally twice a day using a dosing pump. Treat animals for 48 hours after all symptoms have subsided but not beyond 5 days. (2) Indications for use. Treatment of baby pigs under 10 pounds for porcine colibacillosis caused by Escherichia coli susceptible to amoxicillin. (3) Limitations. Do not slaughter during treatment or for 15 days after latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.160 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1326a Mebendazole and trichlorfon powder. | FDA | [45 FR 10759, Feb. 19, 1980, as amended at 46 FR 52330, Oct. 27, 1981. Redesignated at 51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] | (a) Specifications. Each gram of powder contains 83.3 milligrams of mebendazole and 375.0 milligrams of trichlorofon. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorofon per kilogram of body weight. (2) Indications for use. It is used in horses for the treatment of infections of bots ( Gastrophilus intestinalis and G. nasalis ), large roundworms ( Parascaris equorum ), large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, and pinworms ( Oxyuris equi. ) (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.161 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1326b Mebendazole and trichlorfon paste. | FDA | [51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] | (a) Specifications. Each gram of paste contains 100 milligrams of mebendazole and 454 milligrams of trichlorfon. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorfon per kilogram of body weight. (2) Indications for use. It is used in horses for treatment of infections of bots ( Gastrophilus intestinalis and G. nasalis ), large roundworms ( Parascaris equorum ), large strongyles ( Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, and pinworms ( Oxyuris equi ). (3) Limitations. Do not administer more than once every 30 days. Do not treat sick or debilitated animals, foals under 4 months of age, or mares in the last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not administer simultaneously or within a few days before or after treatment with, or exposure to, cholinesterase-inhibiting drugs, pesticides, or chemicals. Do not administer intravenous anesthetics, especially muscle relaxants, concurrently. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. | |||||
| 21:21:6.0.1.1.11.0.1.162 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1330 Meclofenamic acid granules. | FDA | [78 FR 28824, May 20, 2014] | (a) Specifications. Each gram of granules contains 5 milligrams (5 percent) meclofenamic acid. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. Administer 1 milligram per pound of body weight (1 gram per 1000 pounds) once daily for 5 to 7 days by addition to the daily grain ration. (2) Indications for use. For the treatment of acute or chronic inflammatory diseases involving the musculoskeletal system. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.163 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1331 Meclofenamic acid tablets. | FDA | [50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988; 78 FR 28824, May 20, 2014] | (a) Specifications. Each tablet contains either 10 or 20 milligrams of meclofenamic acid. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. 1.1 milligrams per kilogram (0.5 milligram per pound) daily for 5 to 7 days. (2) Indications for use. For the relief of signs and symptoms of chronic inflammatory disease involving the musculoskeletal system. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.164 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1341 Megestrol. | FDA | [40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 78 FR 28824, May 20, 2014] | (a) Specifications. Each tablet contains 5 or 20 milligrams of megestrol acetate. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer orally, intact, or crushed and mixed with food as follows: (i) For the postponement of estrus by proestrus treatment: 1 milligram per pound of body weight per day for 8 days. (ii) For the postponement of estrus by anestrus treatment: 0.25 milligram per pound of body weight per day for 32 days. (iii) For alleviation of false pregnancy: 1 milligram per pound of body weight per day for 8 days. (2) Indications for use. For the postponement of estrus and the alleviation of false pregnancy in female dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.165 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1367 Meloxicam. | FDA | [68 FR 42968, July 21, 2003, as amended at 69 FR 69523, Nov. 30, 2004. Redesignated and amended at 78 FR 57058, Sept. 17, 2013; 80 FR 53459, Sept. 4, 2015; 91 FR 5301, Feb. 6, 2026] | (a) Specifications —(1) Each milliliter of suspension contains 0.5 milligrams (mg) meloxicam. (2) Each milliliter of suspension contains 1.5 mg meloxicam. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section: (1) Nos. 000010 and 069043 for use of the products described in paragraph (a) of this section; and (2) Nos. 013744, 055529, and 086101 for use of the product described in paragraph (a)(2) of this section. (c) Conditions of use in dogs —(1) Amount. Administer orally as a single dose at 0.09 mg per pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) on the first day of treatment. For all treatments after day 1, administer 0.045 mg/lb (0.1 mg/kg) body weight once daily. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.166 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1375 Methimazole tablets. | FDA | [74 FR 27707, June 11, 2009. Redesignated and amended at 89 FR 95103, Dec. 2, 2024; 90 FR 40970, Aug. 22, 2025] | (a) Specifications. Each tablet contains 2.5 or 5 milligrams (mg) methimazole. (b) Sponsors, See Nos. 043264 and 086101in § 510.600 of this chapter. (c) Conditions of use in cats —(1) Amount. The starting dose is 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 (TT4) levels and clinical response. Dose adjustments should be made in 2.5 mg increments. The maximum total dosage is 20 mg per day divided, not to exceed 10 mg as a single administration. (2) Indications for use. For the treatment of hyperthyroidism. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.167 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1376 Methimazole solution. | FDA | [89 FR 95103, Dec. 2, 2024] | (a) Specifications. Each milliliter of solution contains 5 milligrams (mg) methimazole. (b) Sponsor. See No. 055529 in § 510.600(c) of this chapter. (c) Conditions of use in cats —(1) Amount. Administer a starting dose of 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 (TT4) levels and clinical response. Dose adjustments should be made in 2.5 mg increments with a maximum dosage of 20 mg per day divided, not to exceed 10 mg as a single dose. (2) Indications for use. For the treatment of hyperthyroidism. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.168 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1380 Methocarbamol. | FDA | [78 FR 28824, May 20, 2014] | (a) Specifications. Each tablet contains 500 milligrams (mg) of methocarbamol. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats —(1) Amount. Administer 60 mg per pound of body weight in two or three equally divided doses, followed each following day by 30 to 60 mg per pound of body weight, usually not to exceed 14 to 21 days. (2) Indications for use. As an adjunct to therapy for acute inflammatory and traumatic conditions of the skeletal muscles in order to reduce muscular spasms. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.169 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1408 Methylprednisolone. | FDA | [78 FR 28824, May 20, 2014, as amended at 83 FR 48946, Sept. 28, 2018; 89 FR 14410, Feb. 27, 2024] | (a) Specifications. Each tablet contains 1, 2, or 4 milligrams (mg) of methylprednisolone. (b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats —(1) Amount. 5 to 15 pounds (lbs): 2 mg; 15 to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 mg. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. (2) Indications for use. As an anti-inflammatory agent. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.17 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.88d Amoxicillin trihydrate soluble powder. | FDA | [57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, Apr. 8, 1993, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 5525, Feb. 6, 1997; 79 FR 28817, May 20, 2014] | (a) Specifications. Each gram of powder contains amoxicillin trihydrate equivalent to 115.4 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of this chapter. (d) Conditions of use in preruminating calves including veal calves —(1) Amount. Administer 400 mg per 100 pounds of body weight twice daily by drench or in milk. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. (2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves. (3) Limitations. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian | |||||
| 21:21:6.0.1.1.11.0.1.170 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1409 Methylprednisolone and aspirin. | FDA | [48 FR 21566, May 13, 1983, as amended at 78 FR 28824, May 20, 2014] | (a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Under 15 pounds, 1/4 to 1 tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and over, 2 tablets daily. Administer total daily dose in divided doses 6 to 10 hours apart, with a light feeding. When response is attained, dosage should be gradually reduced until maintenance level is achieved. (2) Indications for use. As an anti-inflammatory and analgesic agent. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.171 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1422 Metoserpate hydrochloride. | FDA | [40 FR 13838, Mar. 27, 1975, as amended at 76 FR 17337, Mar. 29, 2011; 78 FR 28824, May 20, 2014] | (a) Chemical name. Methyl- o -methyl-18-epireserpate hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.410 of this chapter. (d) Conditions of use. It is used in drinking water for replacement chickens as follows: (1) Amount. 568.5 milligrams per gallon (0.015 percent). (i) Indications for use. As a tranquilizer for flock treatment of chickens prior to handling. (ii) Limitations. To be used one time as a treatment for replacement chickens up to 16 weeks of age; usual drinking water should be withheld prior to treatment to provide adequate consumption of medicated drinking water; not for use in laying chickens; chickens slaughtered within 72 hours following treatment must not be used for food. (2) Amount. 2 to 4 milligrams per 2.2 pounds of body weight. (i) Indications for use. As an aid in control of hysteria. (ii) Limitations. To be used as a treatment for replacement chickens up to 16 weeks of age; usual drinking water should be withheld prior to treatment to provide adequate consumption of medicated drinking water; the drug should be administered at a dosage level of 4 milligrams per 2.2 pounds of body weight followed by 2 treatments at 4-day intervals of 2 milligrams per 2.2 pounds of body weight; not for use in laying chickens; chickens slaughtered within 72 hours following treatment must not be used for food. | |||||
| 21:21:6.0.1.1.11.0.1.172 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1425 Metronidazole. | FDA | [89 FR 14410, Feb. 27, 2024] | (a) Specifications. Each milliliter of suspension contains 125 milligrams (mg) metronidazole. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer 25 mg per kilogram (11.3 mg per pound) of body weight twice daily for 5 consecutive days. (2) Indications for use. For the treatment of Giardia duodenalis infection in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.173 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1430 Mibolerone. | FDA | [43 FR 15625, Apr. 14, 1978, as amended at 78 FR 28824, May 20, 2014] | (a) Specifications. Each milliliter contains 100 micrograms of mibolerone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. 30 micrograms for animals weighing 1 to 25 pounds; 60 micrograms for animals weighing 26 to 50 pounds; 120 micrograms for animals weighing 51 to 100 pounds; 180 micrograms for animals weighing over 100 pounds, German Shepherds, or German Shepherd mix. Administer daily, orally or in a small amount of food, at least 30 days before expected initiation of heat, and continue daily as long as desired, but not for more than 24 months. (2) Indications for use. For the prevention of estrus (heat) in adult female dogs not intended primarily for breeding purposes. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.174 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1441 Milbemycin. | FDA | [84 FR 12494, Apr. 2, 2019] | (a) Specifications. Each flavored tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams (mg) of milbemycin oxime. (b) Sponsors. See Nos. 013744 and 058198 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. For hookworm, roundworm, and whipworm, administer 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)). For heartworm, administer 0.05 mg/lb of body weight (0.1 mg/kg). Administer once a month. (ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis, control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and Toxascaris leonina and whipworm infections caused by Trichuris vulpis in dogs and puppies 4 weeks of age or greater and 2 pounds body weight or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. Administer 0.91 mg/lb of body weight (2.0 mg/kg) once a month. (ii) Indications for use. For prevention of heartworm disease caused by Dirofilaria immitis and the removal of adult Toxocara cati (roundworm) and Ancylostoma tubaeforme (hookworm) infections in cats 6 weeks of age or greater and 1.5 pounds body weight or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.175 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1443 Milbemycin oxime and lufenuron. | FDA | [62 FR 28629, May 27, 1997, as amended at 63 FR 41190, Aug. 3, 1998; 68 FR 51905, Aug. 29, 2003. Redesignated at 77 FR 47512, Aug. 9, 2012, as amended at 80 FR 18776, Apr. 8, 2015; 86 FR 13184, Mar. 8, 2021] | (a) Specifications. (1) Tablets containing: 2.3 milligrams (mg) milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 mg lufenuron. (2) Flavored tablets containing: 2.3 mg milbemycin oxime and 46 mg lufenuron, 5.75 mg milbemycin oxime and 115 mg lufenuron, 11.5 mg milbemycin oxime and 230 mg lufenuron, or 23 mg milbemycin oxime and 460 mg lufenuron. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use —(1) Dogs —(i) Amount. 0.5 mg milbemycin oxime and 10 mg lufenuron per kilogram of body weight, once a month. (ii) Indications for use. (A) For use in dogs and puppies for the prevention of heartworm disease caused by Dirofilaria immitis, for prevention and control of flea populations, for control of adult Ancylostoma caninum (hookworm), and for removal and control of adult Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis (whipworm) infections. (B) The concurrent use of flavored milbemycin oxime and lufenuron tablets described in paragraph (a)(2) of this section as in paragraph (d)(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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] | |||||
| 21:21:6.0.1.1.11.0.1.176 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1445 Milbemycin oxime and praziquantel. | FDA | [77 FR 47512, Aug. 9, 2012, as amended at 82 FR 58556, Dec. 13, 2017] | (a) Specifications. Each chewable tablet contains: (1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel; (2) 5.75 mg milbemycin oxime and 57 mg praziquantel; (3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or (4) 23 mg milbemycin oxime and 228 mg praziquantel. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel. (ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm ( Toxocara canis, Toxascaris leonina ), adult hookworm ( Ancylostoma caninum ), adult whipworm ( Trichuris vulpis ), and adult tapeworm ( Taenia pisiformis, Echinococcus multilocularis, E. granulosus, and Dipylidium caninum ) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] | |||||
| 21:21:6.0.1.1.11.0.1.177 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets. | FDA | [77 FR 4225, Jan. 27, 2012, as amended at 80 FR 18776, Apr. 8, 2015; 83 FR 13635, Mar. 30, 2018; 86 FR 13184, Mar. 8, 2021] | (a) Specifications. Each tablet contains: (1) 2.3 milligrams (mg) milbemycin oxime, 46 mg lufenuron, and 22.8 mg praziquantel; (2) 5.75 mg milbemycin oxime, 115 mg lufenuron, and 57 mg praziquantel; (3) 11.5 mg milbemycin oxime, 230 mg lufenuron, and 114 mg praziquantel; or (4) 23 mg milbemycin oxime, 460 mg lufenuron, and 228 mg praziquantel. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use —(1) Dogs —(i) Amount. 0.5 mg milbemycin oxime, 10 mg lufenuron, and 5 mg of praziquantel per kilogram of body weight, once a month. (ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis; for the prevention and control of flea populations ( Ctenocephalides felis ); and for the treatment and control of adult roundworm ( Toxocara canis, Toxascaris leonina ), adult hookworm ( Ancylostoma caninum ), adult whipworm ( Trichuris vulpis ), and adult tapeworm ( Dipylidium caninum, Taenia pisiformis, Echinococcus multilocularis, and E. granulosus ) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] | |||||
| 21:21:6.0.1.1.11.0.1.178 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1450 Morantel tartrate oral dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.11.0.1.179 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1450a Morantel tartrate bolus. | FDA | [46 FR 50949, Oct. 16, 1981. Redesignated at 49 FR 47831, Dec. 7, 1984, and amended at 51 FR 9005, Mar. 17, 1986; 78 FR 28825, May 20, 2014] | (a) Specifications. Each bolus contains 2.2 grams morantel tartrate equivalent to 1.3 grams of morantel base. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.425 of this chapter. (d) Conditions of use —(1) Amount. One bolus per 500 pounds of body weight (4.4 milligrams per pound of body weight) as a single oral dose. Boluses may be divided in half for more accurate dosing as follows: up to 325 pounds, 1/2 bolus; 326 to 600 pounds, 1 bolus; 601 to 900 pounds, 1 1/2 boluses; and 901 to 1,200 pounds, 2 boluses. (2) Indications for use. For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms ( Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine ( Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine ( Oesophagostomum radiatum ). (3) Limitations. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. Do not treat within 14 days of slaughter. | |||||
| 21:21:6.0.1.1.11.0.1.18 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.88e Amoxicillin trihydrate boluses. | FDA | [57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 62 FR 5526, Feb. 6, 1997; 79 FR 28817, May 20, 2014] | (a) Specifications. Each bolus contains amoxicillin trihydrate equivalent to 400 milligrams (mg) amoxicillin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.38 of this chapter. (d) Conditions of use in cattle —(1) Amount. Administer 400 mg per 100 pounds of body weight twice daily. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. (2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves. (3) Limitations. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.180 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1450b Morantel tartrate cartridge. | FDA | [49 FR 47831, Dec. 7, 1984, as amended at 51 FR 23415, June 27, 1986; 51 FR 41081, Nov. 13, 1986; 78 FR 28825, May 20, 2014] | (a) Specifications. The drug product consists of a stainless-steel cylinder having both ends closed with polyethylene diffusing discs and containing a morantel tartrate paste. The paste contains 22.7 grams of morantel tartrate equivalent to 13.5 grams of morantel base. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.425 of this chapter. (d) Conditions of use —(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season. (2) Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum. (3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 106 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. | |||||
| 21:21:6.0.1.1.11.0.1.181 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1450c Morantel tartrate sustained-release trilaminate cylinder/sheet. | FDA | [56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014] | (a) Specifications. The drug product consists of a trilaminated, perforated, plastic sheet formed into a cylinder having plastic plugs in its ends. The core lamina contains 19.8 grams of morantel tartrate equivalent to 11.8 grams of morantel base. (b) Sponsor. See 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.425 of this chapter. (d) Conditions of use —(1) Amount. Grazing cattle: Administer 1 cartridge to each animal at the start of the grazing season. (2) Indications for use. For control of the adult stage of the following gastrointestinal nematode infections in weaned calves and yearling cattle weighing a minimum of 200 pounds: Ostertagia spp., Trichostrongylus axei, Cooperia spp., and Oesophagostomum radiatum. (3) Limitations. Administer orally with the dosing gun to all cattle that will be grazing the same pasture. Effectiveness of the drug product is dependent upon continuous control of the gastrointestinal parasites for approximately 90 days following administration. Therefore, treated cattle should not be moved to pastures grazed in the same grazing season/calendar year by untreated cattle. Do not administer to cattle within 102 days of slaughter. Consult your veterinarian before administering to severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. | |||||
| 21:21:6.0.1.1.11.0.1.182 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1451 Moxidectin tablets. | FDA | [62 FR 37713, July 15, 1997, as amended at 78 FR 28825, May 20, 2014] | (a) Specifications. Each tablet contains 30, 68, or 136 micrograms of moxidectin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. 3 micrograms per kilogram (1.36 micrograms per pound) of body weight. (2) Indications for use. To prevent infection by the canine heartworm Dirofilaria immitis and the subsequent development of canine heartworm disease. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.183 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1452 Moxidectin gel. | FDA | [62 FR 42902, Aug. 11, 1997, as amended at 64 FR 66105, Nov. 24, 1999; 68 FR 51445, Aug. 27, 2003; 69 FR 24959, May 5, 2004; 70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014] | (a) Specifications. Each milliliter of gel contains 20 milligrams (2 percent) moxidectin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use in horses and ponies —(1) Amount. 0.4 milligram moxidectin per kilogram (2.2 pounds) of body weight. (2) Indications for use. For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): Cyathostomum spp., including C. catinatum and C. pateratum ; Cylicocyclus. spp., including C. insigne, C. leptostomum, C. nassatus , and C. radiatus; Cyliocostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus ; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus ; Gyalocephalus capitatus ; and Petrovinema poculatus ; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); and horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars). One dose also suppresses strongyle egg production for 84 days. (3) Limitations. Do not use in horses intended for human consumption. | |||||
| 21:21:6.0.1.1.11.0.1.184 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1453 Moxidectin and praziquantel gel. | FDA | [68 FR 51446, Aug. 27, 2003, as amended at 69 FR 21956, Apr. 23, 2004; 70 FR 75017, Dec. 19, 2005; 78 FR 28825, May 20, 2014] | (a) Specifications. Each milliliter of gel contains 20 milligrams (mg) (2.0 percent) moxidectin and 125 mg (12.5 percent) praziquantel. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations. See § 500.25 of this chapter. (d) Conditions of use in horses and ponies —(1) Amount. Administer by mouth as a single dose: 0.4 mg moxidectin per kilogram and 2.5 mg praziquantel per kilogram (2.2 pounds) body weight. (2) Indications for use. For the treatment and control of large strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), and T. serratus (adults); small strongyles (adults): ( Cyathostomum spp., including C. catinatum and C. pateratum ; Cylicocyclus spp., including C. insigne, C. leptostomum, C. nassatus , and C. radiatus ; Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus ; Coronocyclus spp., including C. coronatus, C. labiatus, and C. labratus ; Gyalocephalus capitatus ; and Petrovinema poculatus ; small strongyles: undifferentiated lumenal larvae; encysted cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris equi (adults and L4 larval stages); hairworms: Trichostrongylus axei (adults); large-mouth stomach worms: Habronema muscae (adults); horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. nasalis (3rd instars); and tapeworms: Anoplocephala perfoliata (adults). One dose also suppresses strongyle egg production for 84 days. (3) Limitations. Do not use in horses intended for human consumption. | |||||
| 21:21:6.0.1.1.11.0.1.185 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1454 Moxidectin solution. | FDA | [70 FR 76163, Dec. 23, 2005, as amended at 76 FR 48714, Aug. 9, 2011; 82 FR 21690, May 10, 2017; 86 FR 14818, Mar. 19, 2021] | (a) Specifications. Each milliliter (mL) of solution contains 1 milligram (mg) moxidectin. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.426 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use in sheep —(1) Amount. Administer 1 mL per 11 pounds body weight (1 mL per 5 kilograms) by mouth. (2) Indications for use. For the treatment and control of the adult and L4 larval stages of Haemonchus contortus , Teladorsagia circumcincta , T. trifurcata , Trichostrongylus axei , T. colubriformis , T. vitrinus , Cooperia curticei , C. oncophora , Oesophagostomum columbianum , O. venulosum , Nematodirus battus , N. filicollis , and N. spathiger. (3) Limitations. Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption. | |||||
| 21:21:6.0.1.1.11.0.1.186 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1468 Naproxen. | FDA | [78 FR 28825, May 20, 2014] | (a) Specifications. Each gram of granules contains 500 milligrams (mg) (50 percent) naproxen. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. 10 mg per kilogram of body weight twice daily top dressed on feed for up to 14 consecutive days. (2) Indications for use. For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.187 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1484 Neomycin. | FDA | [71 FR 56866, Sept. 28, 2006, as amended at 71 FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, 2013; 78 FR 28825, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019; 88 FR 55563, Aug. 16, 2023; 88 FR 84700, Dec. 6, 2023] | (a) Specifications. (1) Each ounce of powder contains 20.3 grams (g) neomycin sulfate (equivalent to 14.2 g neomycin base). (2) Each milliliter of solution contains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin base). (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section. (1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section. (2) Nos. 016592, 054771, 058005, and 061133 for use of product described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of this section. (3) Nos. 016592, 054771, and 058005 for use of product described in paragraph (a)(2) as in paragraph (e)(1) of this section. (c) Related tolerances. See § 556.430 of this chapter. (d) Special labeling considerations. Labeling shall bear the following warning statements: “A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.” (e) Conditions of use —(1) Cattle, swine, sheep, and goats —(i) Amount. 10 mg per pound (/lb) of body weight per day (22 mg per kilogram (/kg)) in divided doses for a maximum of 14 days. (ii) Indications for use. For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate. (iii) Limitations. Discontinue treatment prior to slaughter as follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Turkeys —(i) Amount. 10 mg/lb of body weight per day (22 mg/kg) for 5 days. (ii) Indications for use. For the control of mortality associated with E. coli susceptible to neomycin sulfate in growing turkeys. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.11.0.1.188 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1510 Nitenpyram. | FDA | [68 FR 51906, Aug. 29, 2003, as amended at 80 FR 18776, Apr. 8, 2015; 86 FR 13184, Mar. 8, 2021; 86 FR 57997, Oct. 20, 2021] | (a) Specifications. Each tablet contains 11.4 or 57 milligrams (mg) nitenpyram. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter: (1) No. 021091 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of this section. (2) No. 000061 for use as in paragraphs (d)(1)(i)(B) and (d)(1)(ii)(B) of this section. (c) Special considerations. The concurrent use of nitenpyram tablets and flavored milbemycin/lufenuron tablets as in paragraph (d)(1)(ii)(B) of this section shall be by or on the order of a licensed veterinarian. (d) Conditions of use —(1) Dogs —(i) Amount. (A) One 11.4-mg tablet for dogs weighing less than 25 pounds (lb) or one 57-mg tablet for dogs weighing more than 25 lb, as needed, for use as in paragraph (d)(1)(ii)(A) of this section. (B) One 11.4-mg tablet for dogs weighing less than 25 lb or one 57 mg tablet for dogs weighing more than 25 lbs, once or twice weekly, for use as in paragraph (d)(1)(ii)(B) of this section. (ii) Indications for use. (A) For the treatment of flea infestations on dogs and puppies 4 weeks of age and older and 2 lbs of body weight or greater. (B) The concurrent use of nitenpyram tablets as in paragraph (d)(1)(i)(B) of this section with either flavored lufenuron tablets as in § 520.1288(c)(1) of this chapter or flavored milbemycin and lufenuron tablets as in § 520.1443(d)(1) is indicated to kill adult fleas and prevent flea eggs from hatching. (2) Cats —(i) Amount. (A) One 11.4-mg tablet, as needed, for use as in paragraph (d)(2)(ii)(A) of this section. (B) One 11.4-mg tablet, once or twice weekly, for use as in paragraph (d)(2)(ii)(B) of this section. (ii) Indications for use. (A) For the treatment of flea infestations on cats and kittens 4 weeks of age and older and 2 lbs of body weight or greater. (B) The concurrent use of nitenpyram tablets as in paragraph (d)(2)(i)(B) of this section with flavored lufenuron tablets as in § 520.1288(c)(2) of this chapter is indicated to kill adult fleas and prevent flea eggs from hatching. | |||||
| 21:21:6.0.1.1.11.0.1.189 | 21 | Food and Drugs | I | E | 520 | PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS | § 520.1604 Oclacitinib. | FDA | [78 FR 42007, July 15, 2013, as amended at 88 FR 55563, Aug. 16, 2023] | (a) Specifications. Each tablet or chewable tablet contains 3.6, 5.4, or 16 milligrams (mg) of oclacitinib as oclacitinib maleate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer orally 0.18 to 0.27 mg/per pound of body weight (0.4 to 0.6 mg/kg body weight) twice daily for up to 14 days; then administered once daily for maintenance therapy. (2) Indications for use. For control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
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