21 CFR Part 520 — Oral Dosage Form New Animal Drugs

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted. § 520.23 Acepromazine. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. [75 FR 10165, Mar. 5, 2010, as amended at 88 FR 84699, Dec. 6, 2023] § 520.28 Acetazolamide. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 28816, May 20, 2014] § 520.35 Afoxolaner, moxidectin, and pyrantel. (a) Specifications. (1) 9.375 milligrams (mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel (as pamoate salt); (2) 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel (as pamoate salt); (3) 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel (as pamoate salt); (4) 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel (as pamoate salt); or (5) 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel (as pamoate salt). (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Dirofilaria immitis Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocephala Toxocara canis Toxascaris leonina Ctenocephalides felis Ixodes scapularis Rhipicephalus sanguineus Dermacentor variabilis Amblyomma americanum Amblyomma maculatum Haemaphysalis longicornis Borrelia burgdorferi Ixodes scapularis (3) Limitations. [88 FR 84699, Dec. 6, 2023, as amended at 90 FR 6799, Jan. 21, 2025; 90 FR 40969, Aug. 22,2025; 91 FR 41559, July 7, 2026] § 520.38 Albendazole oral dosage forms. § 520.38a Albendazole suspension. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Cattle. (i) Amount. (ii) Indications for use. Fasciola hepatica Moniezia benedeni M. expansa Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Nematodirus spathiger N. helvetianus Cooperia punctata C. oncophora Bunostomum phlebotomum Trichostrongylus colubriformis Oesophagostomum radiatum Dictyocaulus viviparus (iii) Limitations. (2) Sheep. (i) Amount. (ii) Indications for use. Fasciola hepatica Fascioloides magna Moniezia expansa Thysanosoma actinioides Ostertagia circumcinta Marshallagia marshalli Haemonchus contortus Trichostrongylus axei Nematodirus spathiger N. filicollis Cooperia oncophora Trichostrongylus colubriformis Oesophagostomum columbianum Chabertia ovina Dictyocaulus filaria (iii) Limitations. (3) Goats. (i) Amount. (ii) Indications for use. Fasciola hepatica (iii) Limitations. [73 FR 11027, Feb. 29, 2008. Redesignated at 78 FR 66264, Nov. 5, 2013, as amended at 79 FR 28816, May 20, 2014] § 520.38b Albendazole paste. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Fasciola hepatica Moniezia benedeni, M. expansa Ostertagia ostertagi Haemonchus contortus, H. placei Trichostrongylus axei Nematodirus spathiger, N. helvetianus Cooperia punctata C. oncophora Bunostomum phlebotmum Trichostrongylus colubriformis Oesophagostomum radiatum Dictyocaulus viviparus (3) Limitations. [54 FR 51385, Dec. 15, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55658, Nov. 2, 1995. Redesignated at 78 FR 66264, Nov. 5, 2013, as amended at 79 FR 28816, May 20, 2014] § 520.43 Afoxolaner. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Ctenocephalides felis Ixodes scapularis Dermacentor variabilis Amblyomma americanum Amblyomma maculatum Rhipicephalus sanguineus Haemaphysalis longicornis Borrelia burgdorferi Ixodes scapularis (3) Limitations. [78 FR 66264, Nov. 5, 2013, as amended at 79 FR 37619, July 2, 2014; 84 FR 8972, Mar. 13, 2019; 84 FR 39182, Aug. 9, 2019; 88 FR 55563, Aug. 16, 2023; 91 FR 41559, July 7, 2026] § 520.48 Altrenogest. (a) Specifications. (b) Sponsors. (1) Nos. 000061 and 051072 for use as in paragraph (d) of this section. (2) No. 061133 for use as in paragraph (d)(1) of this section. (3) No. 053701 for use as in paragraph (d)(2) of this section. (c) Tolerances. (d) Conditions of use—(1) Horses Amount. (ii) Indications for use. (iii) Limitations. (2) Swine Amount. (ii) Indications for use. (iii) Limitations. [66 FR 47960, Sept. 17, 2001, as amended at 68 FR 62006, Oct. 31, 2003; 72 FR 9455, Feb. 21, 2008; 74 FR 61516, Nov. 25, 2009; 77 FR 32012, May 31, 2012; 80 FR 34278, June 16, 2015; 82 FR 21690, May 10, 2017; 83 FR 13635, Mar. 30, 2018; 84 FR 8972, Mar. 13, 2019; 88 FR 27698, May 3, 2023; 91 FR 20340, Apr. 16, 2026] § 520.62 Aminopentamide. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 28816, May 20, 2014] § 520.82 Aminopropazine oral dosage forms. § 520.82a Aminopropazine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 28816, May 20, 2014] § 520.82b Aminopropazine and neomycin. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 28816, May 20, 2014] § 520.88 Amoxicillin oral dosage forms. § 520.88a Amoxicillin trihydrate film-coated tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. Staphylococcus aureus, Streptococcus Escherichia coli, Proteus mirabilis, S. aureus, Streptococcus P. mirabilis. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. S. aureus, Streptococcus E. coli; S. aureus, Streptococcus E. coli, P. mirabilis; E. coli; S. aureus, Streptococcus E. coli, Pasteurella multocida. (iii) Limitations. [57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 79 FR 28816, May 20, 2014] § 520.88b Amoxicillin trihydrate for oral suspension. (a) Specifications. (b) Sponsor. (1) Conditions of use Dogs Amount. (B) Indications for use. Staphylococcus aureus, Streptococcus Escherichia coli, Proteus mirabilis; S. aureus, Streptococcus E. coli, P. mirabilis; S. aureus, Streptococcus E. coli, P. mirabilis; S. aureus, Streptococcus P. mirabilis; S. aureus, Streptococcus E. coli, P. mirabilis. (C) Limitations. (ii) Cats Amount. (B) Indications for use. Staphylococcus Streptococcus Haemophilus E. coli, Pasteurella P. mirabilis; S. aureus, Streptococcus E. coli, P. mirabilis, Corynebacterium E. coli, Proteus Staphylococcus Streptococcus Staphylococcus Streptococcus E. coli, Pasteurella multocida. (C) Limitations. (2) [Reserved] (c) Sponsors. (1) Conditions of use. Dogs Amount. (ii) Indications for use. S. aureus, Streptococcus Staphylococcus E. coli, S. aureus, Streptococcus E. coli, P. mirabilis Staphylococcus (iii) Limitations. (2) [Reserved] [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] § 520.88c Amoxicillin trihydrate oral suspension. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in swine Amount. (2) Indications for use. Escherichia coli (3) Limitations. [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] § 520.88d Amoxicillin trihydrate soluble powder. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in preruminating calves including veal calves Amount. (2) Indications for use. Escherichia coli (3) Limitations. [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] § 520.88e Amoxicillin trihydrate boluses. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Escherichia coli (3) Limitations. [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] § 520.88f Amoxicillin trihydrate tablets. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (2) Indications for use. Staphylococcus aureus, Streptococcus Staphylococcus Escherichia coli; S. aureus, Enterococcus faecalis, E. coli, Proteus mirabilis, Staphylococcus (3) Limitations. [79 FR 28817, May 20, 2014, as amended at 83 FR 64740, Dec. 18, 2018] § 520.88g Amoxicillin and clavulanate potassium tablets. (a) Specifications. (b) Sponsors. (1) No. 054771 for use of tablets and chewable tablets as in paragraph (c) of this section. (2) Nos. 017033 and 069043 for use of tablets as in paragraph (c) of this section. (3) No. 013744 for use of chewable tablets as in paragraph (c) of this section. (c) Conditions of use Dogs Amount. (ii) Indications for use. Staphylococcus aureus, Staphylococcus aureus, Staphylococcus Streptococcus E. coli. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. Staphylococcus aureus, Staphylococcus aureus, Staphylococcus Streptococcus E. coli, Pasteurella E. coli. (iii) Limitations. [57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 1998; 79 FR 28817, May 20, 2014; 80 FR 34278, June 16, 2015; 82 FR 11508, Feb. 24, 2017; 82 FR 43484, Sept. 18, 2017; 82 FR 58556, Dec. 13, 2017; 87 FR 58960, Sept. 29, 2022; 89 FR 42357, May 15, 2024] § 520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspension. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs Amount. (ii) Indications for use. Staphylococcus aureus, Staphylococcus aureus, Staphylococcus Streptococcus Escherichia coli. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. Staphylococcus aureus, Staphylococcus aureus, Staphylococcus Streptococcus Escherichia coli, Pasteurella multocida, Pasteurella E. coli. (iii) Limitations. [87 FR 17944, Mar. 29, 2022] § 520.90 Ampicillin oral dosage forms. § 520.90a Ampicillin tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Streptococcus Staphylococcus Escherichia coli, Proteus mirabilis, Pasteurella Streptococcus Staphylococcus E., coli, P. mirabilis, Enterococcus Staphylococcus Streptococcus Enterococcus E. coli. Staphylococcus Streptococcus (3) Limitations. [57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, 2014. Redesignated at 85 FR 18118, Apr. 1, 2020] § 520.90b Ampicillin capsules. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. [57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, 2014. Redesignated at 85 FR 18118, Apr. 1, 2020] § 520.90c Ampicillin boluses. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in nonruminating calves Amount. (2) Indications for use. E. coli. (3) Limitations. [57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, 1995; 79 FR 28818, May 20, 2014. Redesignated and amended at 85 FR 18118, Apr. 1, 2020] § 520.100 Amprolium. (a) Specifications. (2) Each gram of powder contains 200 mg amprolium (20 percent). (b) Sponsors. (1) Nos. 016592 and 061133 for use of products described in paragraph (a) of this section as in paragraph (d) of this section. (2) Nos. 051072 and 066104 for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section. (c) Related tolerances. (d) Conditions of use Growing chickens, turkeys, and laying hens. (i) Amount. (ii) Indications for use. (iii) Limitations. (2) Calves. (i) Indications for use and amounts Eimeria bovis E. zurnii (B) As an aid in the treatment of coccidiosis caused by E. bovis E. zurnii (ii) Limitations. [71 FR 56346, Sept. 27, 2006, as amended at 72 FR 60551, Oct. 25, 2007; 73 FR 45611, Aug. 6, 2008; 73 FR 70276, Nov. 20, 2008; 74 FR 10484, Mar. 11, 2009; 76 FR 38554, July 1, 2011; 76 FR 40808, July 12, 2011; 78 FR 23, Jan. 2, 2013; 78 FR 17596, Mar. 22, 2013; 78 FR 57058, Sept. 17, 2013; 81 FR 22523, Apr. 18, 2016; 81 FR 59133, Aug. 29, 2016; 84 FR 8972, Mar. 13, 2019; 86 FR 13184, Mar. 8, 2021; 89 FR 85426, Oct. 28, 2024] § 520.110 Apramycin sulfate soluble powder. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in swine Amount. (2) Indications for use. Escherichia coli (3) Limitations. [47 FR 15771, Apr. 13, 1982, as amended at 49 FR 19642, May 9, 1984; 53 FR 37753, Sept. 28, 1988; 79 FR 28818, May 20, 2014; 81 FR 48702, July 26, 2016; 81 FR 94989, Dec. 27, 2016] § 520.136 Atinvicitinib tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [91 FR 41559, July 7, 2026] § 520.154 Bacitracin oral dosage forms. § 520.154a Bacitracin methylenedisalicylate. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Broiler and replacement chickens Amount. (A) Indications for use. Clostridium perfringens (B) Limitations. (ii) Amount. (A) Indications for use. C. perfringens (B) Limitations. (2) Growing turkeys Amount. (ii) Indications for use. (iii) Limitations. (3) Swine Amount. (ii) Indications for use. Brachyspira hyodysenteriae. (iii) Limitations. (4) Growing quail Amount. (ii) Indications for use. Clostridium colinum (iii) Limitations. [57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 63 FR 38474, July 17, 1998; 64 FR 13068, Mar. 17, 1999; 76 FR 53050, Aug. 25, 2011; 79 FR 28818, May 20, 2014; 80 FR 34278, June 16, 2015; 88 FR 14897, Mar. 10, 2023] § 520.154b Bacitracin methylenedisalicylate and streptomycin sulfate powder. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Escherichia coli, Proteus Staphylococcus Streptococcus (3) Limitations. [71 FR 17702, Apr. 7, 2006, as amended at 79 FR 28818, May 20, 2014; 81 FR 17607, Mar. 30, 2016] § 520.154c Bacitracin zinc soluble powder. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Broiler chickens Amount. (A) Indications for use. Clostridium perfringens (B) Limitations. (ii) Amount. (A) Indications for use. Clostridium perfringens (B) Limitations. (2) Growing quail Amount. (ii) Indications for use. Clostridium (iii) Limitations. [57 FR 37322, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28818, May 20, 2014] § 520.170 Bexagliflozin. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [88 FR 16547, Mar. 20, 2023] § 520.222 Bunamidine hydrochloride. (a) Chemical name. N,N (b) Specifications. (c) Sponsor. (d) Conditions of use. Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, Dipylidium caninum Taenia taeniaeformis. (2) It is administered to cats and dogs at the rate of 25 to 50 milligrams per kilogram of body weight. The drug should be given on an empty stomach and food should not be given for 3 hours following treatment. (3) Tablets should not be crushed, mixed with food, or dissolved in liquid. Repeat treatments should not be given within 14 days. The drug should not be given to male dogs within 28 days prior to their use for breeding. Do not administer to dogs or cats having known heart conditions. (4) For use only by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 42 FR 13018, Mar. 8, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997] § 520.246 Butorphanol tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 28818, May 20, 2014] § 520.260 n (a) Specifications. n (b) Sponsors. (1) No. 023851 for capsules containing 221, 442, 884, or 1,768 mg, or 4.42 grams (g); and (2) No. 054771 for capsules containing 221 mg. (c) Conditions of use in dogs Amount. (i) Capsules containing 221 mg: Under 5 pounds, 1 capsule per 1 1/4 (ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2 1/2 (iii) Capsules containing 884 mg: (A) Under 5 pounds, 1 capsule; (B) 5 to 10 pounds, 2 capsules; (C) 10 to 20 pounds, 3 capsules; (D) 20 to 40 pounds, 4 capsules; (E) Over 40 pounds, 5 capsules. (iv) Capsules containing 1,768 mg: Dogs weighing 5 to 10 pounds, 1 capsule. (v) Capsules containing 4.42 g: Dogs weighing 40 pounds or over, 1 capsule. (2) Indications for use. Toxocara canis Toxascaris leonina Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocephala (3) Limitations. 1/2 [86 FR 10819, Feb. 23, 2021] § 520.292 Capromorelin. (a) Specifications. (1) 30 milligrams (mg) capromorelin; or (2) 20 mg capromorelin. (b) Sponsor. (c) Conditions of use Dogs. (i) Amount. (ii) Indications for use. (iii) Limitations. (2) Cats. (i) Amount. (ii) Indications for use. (iii) Limitations. [81 FR 59133, Aug. 29, 2016, as amended at 85 FR 4207, Jan. 24, 2020; 86 FR 17063, Apr. 1, 2021] § 520.301 Caramiphen ethanedisulfonate and ammonium chloride tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. [43 FR 55385, Nov. 28, 1978, as amended at 79 FR 28819, May 20, 2014. Redesignated at 80 FR 13229, Mar. 13, 2015] § 520.302 Carnidazole tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 1/2 (2) Indications for use. (3) Limitations. [54 FR 32336, Aug. 7, 1989. Redesignated at 80 FR 13229, Mar. 13, 2015] § 520.304 Carprofen. (a) Specifications. (2) Each chewable tablet contains 25, 75, or 100 mg carprofen. (3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen. (4) Each flavored tablet contains 25, 75, or 100 mg carprofen. (b) Sponsors. (1) Nos. 054771, 055529, and 082983 for use of products described in paragraphs (a)(1) and (a)(2) of this section as in paragraph (c) of this section. (2) Nos. 058198, 086101 and 086117 for use of product described in paragraph (a)(2) as in paragraph (c) of this section. (3) No. 069043 for use of product described in paragraph (a)(3) of this section as in paragraph (c) of this section. (4) No. 086101 for use of product described in paragraphs (a)(1), (a)(2), and (a)(4) of this section as in paragraph (c) of this section. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redesignated and amended at 80 FR 13229, Mar. 13, 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, Oct. 13, 2015; 82 FR 43484, Sept. 18, 2017; 84 FR 12493, Apr. 2, 2019; 85 FR 4207, Jan. 24, 2020; 86 FR 13184, Mar. 8, 2021; 86 FR 14817, Mar. 19, 2021; 86 FR 61684, Nov. 8, 2021; 88 FR 27698, May 3, 2023; 89 FR 42357, May 15, 2024; 89 FR 95103, Dec. 2, 2024; 90 FR 19625, May 9, 2025; 90 FR 40969, Aug. 22, 2025] § 520.314 Cefadroxil. (a) Specifications. (2) Each milliliter of suspension constituted from powder contains 50 mg of cefadroxil. (b) Sponsor. (c) Conditions of use in dogs and cats Amount Dogs. (ii) Cats. (2) Indications for use Dogs. Staphylococcus aureus. Escherichia coli Proteus mirabilis S. aureus. (ii) Cats. Pasteurella multocida S. aureus Staphylococcus epidermidis Streptococcus (3) Limitations. [75 FR 10165, Mar. 5, 2010, as amended at 87 FR 76421, Dec. 14, 2022] § 520.370 Cefpodoxime tablets. (a) Specifications. (2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime. (b) Sponsors. (1) Nos. 017033 and 086101 for use of product in paragraph (a)(1) of this section as in paragraph (c) of this section. (2) No. 054771 for use of products in paragraph (a) of this section as in paragraph (c) of this section. (c) Conditions of use in dogs Amount. (2) Indications for use. Staphylococcus pseudintermedius S. aureus Streptococcus canis Escherichia coli Pasteurella multocida Proteus mirabilis. (3) Limitations. [69 FR 52815, Aug. 30, 2004, as amended at 78 FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, 2014; 80 FR 13229, Mar. 13, 2015; 82 FR 12169, Mar. 1, 2017; 88 FR 16547, Mar. 20, 2023; 91 FR 5300, Feb. 6, 2026] § 520.376 Cephalexin. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. Staphylococcus pseudintermedius. (iii) Limitations. (2) [Reserved] [77 FR 47512, Aug. 9, 2012] § 520.390 Chloramphenicol oral dosage forms. § 520.390a Chloramphenicol tablets. (a) Specifications. (b) Sponsors. (1) For use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section: (i) No. 069043 for 100-, 250-, and 500-mg; and 1- and 2.5-g tablets; (ii) No. 054771 for 100-, 250-, and 500-mg tablets; (2) For use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section: (i) No. 061133 for 50-, 100-, 250-, and 500-mg; and 1-g tablets; (ii) [Reserved] (c) Conditions of use in dogs Amount. (2) Indications for use (ii) For the treatment of bacterial gastroenteritis associated with bacterial diarrhea, bacterial pulmonary infections, and bacterial infections of the urinary tract caused by susceptible organisms. (3) Limitations. [77 FR 4896, Feb. 1, 2012, as amended at 78 FR 21059, Apr. 9, 2013; 79 FR 28819, May 20, 2014; 83 FR 48944, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019] § 520.390b Chloramphenicol capsules. (a) Specifications. (b) Sponsors. (c) Special considerations. (d) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [70 FR 75398, Dec. 20, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 75 FR 55676, Sept. 14, 2010; 79 FR 28819, May 20, 2014] § 520.390c Chloramphenicol palmitate oral suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use. Dogs Amount. (2) Indications for use. (3) Limitations. [57 FR 37323, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 79 FR 28819, May 20, 2014] § 520.434 Chlorphenesin carbamate tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [44 FR 16009, Mar. 16, 1979, as amended at 79 FR 28819, May 20, 2014] § 520.441 Chlortetracycline powder. (a) Specifications. (b) Sponsors. (1) No. 069254 for use as in paragraph (d) of this section. (2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section. (3) Nos. 069043 and 076475 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) and (iii) of this section. (c) Related tolerances. (d) Conditions of use. (i) Swine Amount. ( 1 Indications for use. Escherichia coli Pasteurella Actinobacillus pleuropneumoniae Haemophilus Klebsiella ( 2) Limitations. (B) [Reserved] (ii) [Reserved] (2) Use as chlortetracycline hydrochloride in a drench or drinking water as follows: (i) Calves Amount. ( 1 E. coli Pasteurella A. pleuropneumoniae Haemophilus Klebsiella ( 2) Limitations. (B) [Reserved] (ii) [Reserved] (3) [Reserved] (4) The following uses of chlortetracycline hydrochloride or chlortetracycline bisulfate in drinking water or drench were reviewed by the National Academy of Sciences/National Research Council (NAS/NRC) and found effective: (i) Chickens Amount. ( 1 Indications for use. Mycoplasma synoviae. ( 2 Limitations. (B) Amount. ( 1 Indications for use. M. gallisepticum E. coli. ( 2 Limitations. (C) Amount. ( 1 Indications for use. Pasteurella multocida ( 2 Limitations. 2 (ii) Growing turkeys Amount. ( 1 Indications for use. M. synoviae. ( 2 Limitations. (B) Amount. ( 1 Indications for use. ( 2 Limitations. (iii) Swine Amount. (B) Indications for use. E. coli Salmonella Pasteurella Actinobacillus pleuropneumoniae Haemophilus Klebsiella (C) Limitations. (iv) Calves, beef cattle, and nonlactating dairy cattle Amount. (B) Indications for use. E. coli Salmonella Pasteurella A. pleuropneumoniae Haemophilus Klebsiella (C) Limitations. (5) Use in a drench or drinking water as follows: (i) Chickens Amount. ( 1 Indications for use. M. synoviae ( 2 Limitations. (B) Amount. ( 1 Indications for use. M. gallisepticum E. coli ( 2 Limitations. 2 (C) Amount. ( 1 Indications for use. ( 2 Limitations. 2 (ii) Growing Turkeys Amount. ( 1 Indications for use. ( 2 Limitations. (B) Amount. ( 1 Indications for use. ( 2 Limitations. 2 (iii) Swine Amount. (B) Indications for use. E. coli Salmonella Pasteurella A. pleuropneumoniae Klebsiella (C) Limitations. (iv) Calves, beef cattle, and nonlactating dairy cattle Amount. (B) Indications for use. Escherichia coli Salmonella Pasteurella Histophilus Klebsiella (C) Limitations. [57 FR 37324, Aug. 18, 1992] Editorial Note: For Federal Register www.govinfo.gov. § 520.443 Chlortetracycline tablets and boluses. (a) Specifications. (b) Sponsors. (1) No. 069043 for use of a 250-mg bolus as in paragraph (d)(1) of this section. (2) No. 016592 for use of a 25-mg tablet as in paragraph (d)(2) of this section. (3) No. 016592 for use of a 500-mg bolus as in paragraph (d)(3) of this section. (c) Related tolerances. (d) Conditions of use in calves Amount. (i) Indications for use. Escherichia coli Pasteurella Klesbsiella Haemophilus (ii) Limitations. (2) Amount. (i) Indications for use. E. coli Salmonella Pasteurella Haemophilus Klebsiella (ii) Limitations. (3) Amount. (i) Indications for use. E. coli Salmonella Pasteurella Haemophilus Klebsiella (ii) Limitations. [57 FR 37325, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002. Redesignated and amended at 76 FR 49649, Aug. 11, 2011; 78 FR 21059, Apr. 9, 2013; 81 FR 17607, Mar. 30, 2016; 88 FR 16547, Mar. 20, 2023; 88 FR 27698, May 3, 2023; 88 FR 55563, Aug. 16, 2023] § 520.445 Chlortetracycline and sulfamethazine powder. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in swine. (1) Amount. (2) Indications for use. (3) Limitations. [76 FR 49649, Aug. 11, 2011, as amended at 81 FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, 2016] § 520.446 Clindamycin capsules and tablets. (a) Specifications. (2) Each tablet contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt. (3) Each capsule contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt. (b) Sponsors. (1) Nos. 054771 and 069043 for use of capsules described in paragraph (a)(1) of this section. (2) Nos. 051311 and 086101 for use of tablets described in paragraph (a)(2) of this section. (3) No. 043806 for use of tablets described in paragraph (a)(3) of this section. (c) Conditions of use in dogs Amount. (2) Indications for use. Staphylococcus aureus S. intermedius Bacteroides fragilis Prevotella melaninogenicus Fusobacterium necrophorum Clostridium perfringens S. aureus B. fragilis P. melaninogenicus F. necrophorum C. perfringens S. aureus B. fragilis P. melaninogenicus F. necrophorum C. perfringens. (3) Limitations. [67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 28819, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016; 90 FR 40969, Aug. 22, 2025] § 520.447 Clindamycin solution. (a) Specifications. (b) Sponsors. (c) Special considerations. (d) Conditions of use Dogs Amount. (ii) Indications for use. Staphylococcus aureus S. intermedius Bacteroides fragilis Prevotella melaninogenicus Fusobacterium necrophorum Clostridium perfringens S. aureus B. fragilis P. melaninogenicus F. necrophorum C. perfringens S. aureus B. fragilis P. melaninogenicus F. necrophorum C. perfringens. (2) Cats—(i) Amount. (ii) Indications for use. Staphylococcus aureus S. intermedius Streptococcus spp. Clostridium perfringens Bacteroides fragilis S. aureus S. intermedius Streptococcus spp. C. perfringens B. fragilis. [67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013; 79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 84 FR 8972, Mar. 13, 2019] § 520.452 Clenbuterol syrup. (a) Specifications. (b) Sponsor. (c) [Reserved] (d) Conditions of use Horses Amount. (ii) Indications for use. (iii) Limitations. (2) [Reserved] [63 FR 41419, Aug. 4, 1998] § 520.455 Clomipramine. (a) Specifications. (b) Sponsors. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007; 86 FR 57996, Oct. 20, 2021; 91 FR 20340, Apr. 16, 2026] § 520.462 Clorsulon drench. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. Cattle Amount. (2) Indications for use. Fasciola hepatica (3) Limitations. [50 FR 10221, Mar. 14, 1985, as amended at 62 FR 63270, Nov. 28, 1997; 84 FR 32992, July 11, 2019; 84 FR 39183, Aug. 9, 2019] § 520.522 Cyclosporine. (a) Specifications. (2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) contains 100 mg cyclosporine. (b) Sponsors. (1) No. 058198 for use of products described in paragraph (a) as in paragraph (d) of this section. (2) No. 017033 for use of product described in paragraph (a)(1) as in paragraph (d)(1) of this section. (3) No. 051311 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(1) of this section. (4) No. 013744 for use of product described in paragraph (a)(2) as in paragraph (d) of this section. (c) [Reserved] (d) Conditions of use Dogs. (i) Amount. (ii) Indications for use. (iii) Limitations. (2) Cats. (i) Amount. (ii) Indications for use. (iii) Limitations. [68 FR 54804, Sept. 19, 2003, as amended at 76 FR 78815, Dec. 20, 2011; 84 FR 12493, Apr. 2, 2019; 86 FR 17063, Apr. 1, 2021; 88 FR 16547, Mar. 20, 2023; 88 FR 27698, May 3, 2023; 89 FR 95103, Dec. 2, 2024; 91 FR 41559, July 7, 2026] § 520.530 Cythioate oral liquid. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [49 FR 5614, Feb. 14, 1984, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, 2014; 86 FR 14818, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022] § 520.531 Cythioate tablets. (a) Specifications. (b) Sponsors. (1) No. 058198 for use of 30- and 90-mg tablets. (2) No. 054771 for use of the 30-mg tablet. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [49 FR 5615, Feb. 14, 1984, as amended at 59 FR 26942, May 25, 1994; 67 FR 78355, Dec. 24, 2002; 79 FR 28819, May 20, 2014; 86 FR 14818, Mar. 19, 2021] § 520.534 Decoquinate. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. Calves Amount. (2) Indications for use. Eimeria bovis E. zuernii. (3) Limitations. [64 FR 10103, Mar. 2, 1999, as amended at 64 FR 30386, June 8, 1999; 79 FR 28819, May 20, 2014] § 520.538 Deracoxib. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as in paragraph (d)(2)(i) of this section. (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in paragraph (d)(2)(ii) of this section. (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(iii) of this section. (2) Indications for use. (ii) For the control of postoperative pain and inflammation associated with dental surgery. (iii) For the control of postoperative pain and inflammation associated with orthopedic surgery. (3) Limitations. [67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012; 84 FR 39183, Aug. 9, 2019; 86 FR 61684, Nov. 8, 2021] § 520.540 Dexamethasone oral dosage forms. § 520.540a Dexamethasone powder. (a) Specifications. (b) Sponsor. (c) Conditions of use in cattle and horses Amount. (2) Indications for use. (3) Limitations. [79 FR 28819, May 20, 2014] § 520.540b Dexamethasone tablets and boluses. (a)(1) Specifications. (2) Sponsor. (3) Conditions of use in cattle and horses Amount. (ii) Indications for use. (iii) Limitations. (b)(1) Specifications. (2) Sponsors. (3) Conditions of use in dogs and cats Amount. (ii) Indications for use. (iii) Limitations. [40 FR 26273, June 23, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, Apr. 4, 2005; 79 FR 28819, May 20, 2014; 84 FR 8972, Mar. 13, 2019] § 520.540c Dexamethasone chewable tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014; 82 FR 11508, Feb. 24, 2017] § 520.563 Diatrizoate. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [44 FR 12993, Mar. 9, 1979, as amended at 50 FR 41489, Oct. 11, 1985; 79 FR 28820, May 20, 2014] § 520.580 Dichlorophene and toluene. (a) Specifications. (b) Sponsors. (1) Nos. 017135 and 023851 for use only as a single dose. (2) Nos. 000061, 054771, and 069043 for use in a single dose or divided-dosage regimen. (c) Required statement. (d) Conditions of use Amount. (i) Single dose: Administer 100 mg of dicholorophene and 120 mg of toluene per pound of body weight. (ii) Divided dose: Administer 100 mg of dichlorophene and 120 mg of toluene per 5 pounds of body weight (20 and 24 mg per pound) daily for 6 days. (2) Indications for use. Toxocara canis Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala Taenia pisiformis, Dipylidium caninum, Echinococcus granulosus (3) Limitations. [45 FR 10332, Feb. 15, 1980] Editorial Note: For Federal Register www.govinfo.gov. § 520.581 Dichlorophene tablets. (a) Specifications. (b) Sponsor. (c) Required statement. (d) Conditions of use. Dogs Amount. (2) Indications for use. Taenia pisiformis Dipylidium caninum (3) Limitations. [45 FR 10333, Feb. 15, 1980] § 520.596 Dichlorvos powder. (a) Specifications (2) Each milligram of powder contains 2.27 milligrams (mg) dichlorvos. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Swine (adult gilts, sows, and boars) Amount. Weight of animal in pounds Pounds of feed to Pounds of mixed Number of pigs 20-30 4 0.33 12 31-40 5 0.56 9 41-60 6 1.00 6 61-80 5 1.00 5 81-100 4 1.00 4 16 4.00 4 (ii) Indications for use. Trichuris suis Oesophagostomum Ascaris suum Ascarops strongylina (iii) Limitations. (2) Horses Amount. (ii) Indications for use. Gastrophilus intestinalis, G. nasalis Strongylus vulgaris, S. equinus, S. edentatus Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus, Triodontophorus, Poteriostomum, Gyalocephalus Oxyuris equi Parascaris equorum (iii) Limitations. [83 FR 48944, Sept. 28, 2018] § 520.598 Dichlorvos tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs, puppies, cats, and kittens Amount. (2) Indications for use Dogs and puppies: Toxocara canis Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala (ii) Cats and kittens: Toxocara cati Toxascaris leonina Ancylostoma tubaeforme Uncinaria stenocephala (3) Limitations. [83 FR 48945, Sept. 28, 2018] § 520.600 Dichlorvos capsules and pellets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Toxocara canis Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala Trichuris vulpis (3) Limitations. [83 FR 48945, Sept. 28, 2018] § 520.602 Dichlorvos gel. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Gastrophilus intestinalis G. nasalis Parascaris equorum (3) Limitations. [83 FR 48945, Sept. 28, 2018] § 520.606 Diclazuril. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Sarcocystis neurona. (3) Limitations. [72 FR 20943, Apr. 27, 2007] § 520.608 Dicloxacillin. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [57 FR 37325, Aug. 18, 1992, as amended at 79 FR 28820, May 20, 2014] § 520.620 Diethylcarbamazine oral dosage forms. § 520.622 Diethylcarbamazine citrate oral dosage forms. § 520.622a Diethylcarbamazine citrate tablets. (a) Sponsors. (2) See 054771 in § 510.600(c) of this chapter for use of 100, 200, and 300 milligram tablets for prevention of heartworm disease in dogs and as an aid in the treatment of ascarid infections in dogs. (3) See 061133 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats. (4) [Reserved] (5) See No. 000061 in § 510.600(c) of this chapter for use of 60, 120, or 180 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats. (6) See No. 069043 in § 510.600(c) of this chapter for use of 50, 100, 200, 300, or 400 milligram tablets for prevention of heartworm disease in dogs, as an aid in the control of ascarid infections in dogs, and as an aid in the treatment of ascarid infections in dogs and cats. (b) Conditions of use Dosage/indications for use. Dirofilaria immitis (ii) Three milligrams per pound of body weight daily as an aid in the control of ascarid infections ( Toxocara canis (iii) Twenty-five to 50 milligrams per pound of body weight as an aid in the treatment of ascarid infections in dogs ( Toxocara canis Toxocara canis Toxascaris leonina (2) Limitations. [46 FR 23230, Apr. 24, 1981, as amended at 46 FR 41038, Aug. 14, 1981; 46 FR 46315, Sept. 18, 1981; 46 FR 61653, Dec. 18, 1981; 47 FR 10805, Mar. 12, 1982; 47 FR 14150, Apr. 2, 1982; 50 FR 41489, Oct. 11, 1985; 50 FR 49372, Dec. 2, 1985; 53 FR 40056, Oct. 13, 1988; 53 FR 40727, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 76 FR 17777, Mar. 31, 2011; 77 FR 4896, Feb. 1, 2012; 78 FR 21059, Apr. 7, 2013; 79 FR 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019] § 520.622b Diethylcarbamazine citrate syrup. (a)(1) Specifications. (2) Sponsor. (3) Conditions of use. Dirofilaria immitis T. canis T. leonina. T. canis T. leonina T. cati (ii) For prevention of heartworm and ascarid infections in dogs, the drug may be added to the daily diet at a dosage rate of 3.0 milligrams per pound of body weight per day or given directly by mouth at the same dosage rate. For treatment of ascarid infections in dogs and cats, the drug is administered at a dosage level of 25 to 50 milligrams per pound of body weight preferably administered immediately after feeding. (iii) Older dogs should be proven negative for the presence of Dirofilaria immitis Dirofilaria immitis (iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian. (b) [Reserved] (c)(1) Specifications. (2) Sponsor. (3) Conditions of use. Toxacara canis Dirofilaria immitis (ii) The drug is administered ( a b (iii) Dogs older than 8 months of age may be infected with Dirofilaria immitis. D. immitis (iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 28265, July 9, 1976; 44 FR 3967, Jan. 19, 1979; 47 FR 14150, Apr. 2, 1982; 47 FR 35186, Aug. 13, 1982; 49 FR 33997, Aug. 28, 1984; 50 FR 41489, Oct. 11, 1985; 53 FR 47027, Oct. 18, 1988; 61 FR 34728, July 3, 1996; 62 FR 35076, June 30, 1997; 62 FR 38906, July 21, 1997; 77 FR 4897, Feb. 1, 2012; 78 FR 21059, Apr. 9, 2013; 79 FR 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018] § 520.622c Diethylcarbamazine citrate chewable tablets. (a) Specifications. (b) Sponsors. (1) [Reserved] (2) For 054771, use of 60, 120, or 180 milligram tablets as in paragraph (c)(2)(ii) of this section. (3) For 061690, use of 45 or 150 milligram tablets as in paragraph (c)(2)(iii) of this section. (4) For 061133, use of 60-, 120-, or 180-milligram tablets as in paragraph (c)(2)(i) of this section. (5) For 000061, use of 60-milligram tablets as in paragraph (c)(2)(i) of this section. (6) For 069043, use of 30, 60, 120, or 180 milligram tablets as in paragraph (c)(2)(i) of this section. (c) Conditions of use Amount. (2) Indications for use. Dirofilaria immitis Toxocara canis Toxocara canis Toxascaris leonina (ii) For prevention of infection with Dirofilaria immitis Toxocara canis Toxascaris leonina (iii) For prevention of heartworm disease ( Dirofilaria immitis (3) Limitations. [43 FR 6941, Feb. 17, 1978] Editorial Note: For Federal Register www.govinfo.gov. § 520.623 Diethylcarbamazine and oxibendazole chewable tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Dirofilaria immitis Ancylostoma caninum Trichuris vulpis Toxocara canis (3) Limitations. [50 FR 28768, July 16, 1985, as amended at 53 FR 45759, Nov. 14, 1988; 54 FR 3776, Jan. 26, 1989; 54 FR 6804, Feb. 14, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014] § 520.666 Dirlotapide. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [72 FR 263, Jan. 4, 2007, as amended at 79 FR 28820, May 20, 2014] § 520.763 Dithiazanine oral dosage forms. § 520.763a Dithiazanine tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Indications for use and amount. (i) For large roundworms ( Toxocara canis, Toxascaris leonina (ii) For hookworms ( Ancylostoma caninum, Uncinaria stenocephala Trichuris vulpis (iii) For Strongyloides ( Strongyloides canis, Strongyloides stercoralis (iv) For heartworm microfilariae ( Dirofilaria immitus (2) Limitations. [79 FR 28820, May 20, 2014, as amended at 83 FR 48945, Sept. 28, 2018] § 520.763b Dithiazanine powder. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Indications for use and amount. (i) For large roundworms ( Toxocara canis, Toxascaris leonina (ii) For hookworms ( Ancylostoma caninum, Uncinaria stenocephala Trichuris vulpis (iii) For Strongyloides ( Strongyloides canis, Strongyloides stercoralis (iv) For heartworm microfilariae ( Dirofilaria immitus (2) Limitations. [79 FR 28820, May 20, 2014, as amended at 83 FR 48945, Sept. 28, 2018] § 520.763c Dithiazanine iodide and piperazine citrate suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. 3/4 1/4 (2) Indications for use. Parascaris equorum; Strongylus vulgaris; Oxyuris equi. (3) Limitations. [47 FR 52696, Nov. 23, 1982, as amended at 48 FR 32342, July 15, 1983; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 78 FR 21059, Apr. 9, 2013; 79 FR 28820, May 20, 2014; 83 FR 48945, Sept. 28, 2018] § 520.766 Domperidone. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [75 FR 67031, Nov. 1, 2010] § 520.784 Doxylamine. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, 2014] § 520.812 Enrofloxacin. (a) Specifications. (i) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or (ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin. (2) Each chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin. (3) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin. (b) Sponsors. (1) No. 058198 for use of products described in paragraph (a) of this section. (2) Nos. 017033, 086117, and 086194 for use of product described in paragraph (a)(1)(i) of this section. (3) Nos. 055529 and 086101 for use of product described in paragraph (a)(2) of this section. (c) Conditions of use in dogs and cats Amount. (i) Dogs. (ii) Cats. (2) Indications for use. (3) Limitations. [78 FR 30197, May 22, 2013, as amended at 78 FR 52853, Aug. 27, 2013; 84 FR 8972, Mar. 13, 2019; 84 FR 53310, Oct. 7, 2019; 86 FR 13184, Mar. 8, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27698, May 3, 2023; 90 FR 40969, Aug. 22, 2025] § 520.816 Epsiprantel. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. Dipylidium caninum Taenia pisiformis. (2) Cats Amount. (ii) Indications for use. D. caninum T. taeniaeformis. (3) Limitations. [54 FR 50615, Dec. 8, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28821, May 20, 2014; 83 FR 64740, Dec. 18, 2018] § 520.823 Erythromycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Broiler and replacement chickens Amount. (ii) Indications for use. Mycoplasma gallisepticum (iii) Limitations. (2) Replacement chickens and chicken breeders Amount. (ii) Indications for use. Haemophilus gallinarum (iii) Limitations. (3) Growing turkeys Amount. (ii) Indications for use. (iii) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 79 FR 28821, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 94989, Dec. 27, 2016; 84 FR 8972, Mar. 13, 2019] § 520.852 Estriol. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [76 FR 78150, Dec. 16, 2011] § 520.863 Ethylisobutrazine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61624, Nov. 19, 1997; 79 FR 28821, May 20, 2014] § 520.903 Febantel oral dosage forms. § 520.903a Febantel paste. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Strongylus vulgaris, S. edentatus, S. equinus Parascaris equorum Oxyuris equi (3) Limitations. [79 FR 28821, May 20, 2014, as amended at 86 FR 14818, Mar. 19, 2021] § 520.903b Febantel suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Parascaris equorum Oxyuris equi Strongylus vulgaris, S. edentatus, S. equinus (3) Limitations. (d) Special considerations. (1) Combine 1 part febantel suspension with 5 parts trichlorfon liquid. (2) Allow animal to consume a portion of daily grain ration; administer mixture by stomach tube at rate of 18 milliliters per 100 pounds of body weight. [45 FR 8587, Feb. 8, 1980, as amended at 79 FR 28821, May 20, 2014; 86 FR 14818, Mar. 19, 2021] § 520.903c Febantel and praziquantel paste. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount (ii) Puppies and kittens (less than 6 months of age): 15 milligrams of febantel and 1.5 milligrams of praziquantel per kilogram of body weight (1 gram of paste per 5 pounds body weight) administered by mouth on a full stomach once daily for 3 days. (2) Indications for use. Ancylostoma caninum Uncinaria stenocephala Trichuris vulpis Toxocara canis Toxascaris leonina Dipylidium caninum Taenia pisiformis (ii) Cats and kittens: For removal of hookworms ( Ancylostoma tubaeforme Toxocara cati Dipylidium caninum Taenia taeniaeformis (3) Limitations. [50 FR 19167, May 7, 1985, as amended at 53 FR 48533, Dec. 1, 1988; 56 FR 50813, Oct. 9, 1991; 79 FR 28821, May 20, 2014. Redesignated at 85 FR 18119, Apr. 1, 2020; 86 FR 14818, Mar. 19, 2021] § 520.903d Febantel tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount Dogs and cats. (ii) Puppies and kittens fewer than 6 months of age. (2) Indications for use. Ancylostoma caninum Uncinaria stenocephala Toxocara canis Toxascaris leonina Trichuris vulpis (ii) For removal of hookworms ( Ancylostoma tubaeforme Toxocara cati (3) Limitations. [56 FR 50655, Oct. 8, 1991, as amended at 79 FR 28821, May 20, 2014. Redesignated at 85 FR 18119, Apr. 1, 2020, as amended at 86 FR 14818, Mar. 19, 2021] § 520.905 Fenbendazole oral dosage forms. § 520.905a Fenbendazole suspension. (a) Specifications. (b) Sponsors. (1) No. 000061 as in paragraph (e) of this section. (2) No. 055529 as in paragraphs (e)(2) and (4) of this section. (c) Related tolerances. (d) Special considerations. (2) Fenbendazole suspension 10 percent and approved forms of trichlorfon, when used concomitantly for treating the indications provided in paragraph (e) of this section and for treating infections of stomach bot as provided in § 520.2520, have been shown to be compatible and not to interfere with one another. (e) Conditions of use Horses Amount. (ii) Indications for use. Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus Cyathostomum Cylicocyclus Cylicostephanus Cylicodontophorus Oxyuris equi Parascaris equorum (iii) Limitations. (2) Beef and dairy cattle Amount. (ii) Indications for use. Dictyocaulus viviparus Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Bunostomum phlebotomum Nematodirus helvetianus Cooperia punctata C. oncophora Trichostrongylus colubriformis Oesophagostomum radiatum (iii) Limitations. (3) Beef cattle Amount. (ii) Indications for use. Ostertagia ostertagi, Moniezia benedeni. (iii) Limitations. (4) Goats Amount. (ii) Indications for use. Haemonchus contortus Teladorsagia circumcincta. (iii) Limitations. (5) Chickens Amount. (ii) Indications for use. Ascaridia galli A. galli Heterakis gallinarum (6) Swine, except for nursing piglets Amount. (ii) Indications for use. Metastrongylus apri, Metastrongylus pudendotectus; Ascaris suum Oesophagostomum dentatum, O. quadrispinulatum Hyostrongylus rubidus Trichuris suis Stephanurus dentatus. (iii) Limitations. [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. 24, 1978. Redesignated at 44 FR 1375, Jan. 5, 1979, and amended at 46 FR 29464, June 2, 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. 29, 2011; 80 FR 76386, Dec. 9, 2015; 81 FR 22523, Apr. 18, 2016; 86 FR 14818, Mar. 19, 2021; 86 FR 61684, Nov. 8, 2021; 87 FR 58961, Sept. 29, 2022; 91 FR 41559, July 7, 2026] § 520.905b Fenbendazole granules. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use Horses Amount. (ii) Indications for use. Strongylus edentatus, S. equinus, S. vulgaris Oxyuris equi Parascaris equorum (iii) Limitations. (2) Dogs Amount. (ii) Indications for use. Toxocara canis, Toxascaris leonina Ancylostoma caninum, Uncinaria stenocephala Trichuris vulpis Taenia pisiformis (iii) Limitations. (3) Zoo and wildlife animals Amount. (ii) Indications for use. Felidae Ursidae (A) Lion ( Panthera leo Panthera tigris Toxocara cati, Toxascaris leonina Ancylostoma (B) Cheetah ( Acinonyx jubatus Toxocara cati, Toxascaris leonina (C) Puma ( Felis concolor Panthera Panthera pardus Panthera onca Toxocara cati, Toxascaris leonina Ancylostoma Taenia hydatigena, T. krabbei, T. taeniaeformis (D) Black Bear ( Ursus americanus Baylisascaris transfuga, Toxascaris leonina Ancylostoma caninum Taenia hydatigena, T. krabbei (E) Polar Bear ( Ursus maritimus Ursus horribilis Baylisascaris transfuga, Toxascaris leonina (iii) Limitations. [44 FR 1375, Jan. 5, 1979, as amended at 47 FR 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] § 520.905c Fenbendazole paste. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Horses Indications for use and amounts. Strongylus edentatus, S. equinus, S. vulgaris Oxyuris equi (B) For treatment and control of ascarids ( Parascaris equorum (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 (D) For the control of arteritis caused by fourth-stage larvae of Strongylus vulgaris (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. (2) Beef and dairy cattle Amount. (ii) Indications for use. Dictyocaulus viviparus Ostertagia ostertagi Haemonchus contortus H. placei Trichostrongylus axei Bunostomum phlebotomum Nematodirus helvetianus Cooperia punctata C. oncophora Trichostrongylus colubriformis Oesophagostomum radiatum (iii) Limitations. [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] § 520.905d Fenbendazole powder. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Amount. (2) Indications for use. Ascaris suum Metastrongylus apri Oesophagostomum dentatum, O. quadrispinulatum Hyostrongylus rubidus Trichuris suis Stephanurus dentatus (3) Limitations. [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] § 520.928 Firocoxib tablets. (a) Specifications. (2) Each tablet contains 57 mg firocoxib. (b) Sponsors. (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, 055246, and 086101 for use of the product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Horses Amount. (ii) Indications for use. (iii) Limitations. [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; 91 FR 41559, July 7, 2026] § 520.929 Firocoxib solution. (a) Specifications. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [89 FR 42357, May 15, 2024] § 520.930 Firocoxib paste. (a) Specifications. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [71 FR 5788, Feb. 3, 2006, as amended at 84 FR 39183, Aug. 9, 2019] § 520.955 Florfenicol. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use in swine Amount. ad libitum (2) Indications for use. Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis Streptococcus suis. (3) Limitations. [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] § 520.960 Flumethasone. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount Dogs: (ii) Cats: (2) Indications for use Dogs: (ii) Dogs and cats: (3) Limitations. [44 FR 7131, Feb. 6, 1979, as amended at 61 FR 5506, Feb. 13, 1996; 79 FR 28821, May 20, 2014] § 520.970 Flunixin. (a) Specifications. (2) Each 30-g syringe of paste contains flunixin meglumine equivalent to 1,500 mg of flunixin. (b) Sponsors. (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 Amount. (2) Indications for use. (3) Limitations. [76 FR 53051, Aug. 25, 2011, as amended at 79 FR 74020, Dec. 15, 2014; 84 FR 8972, Mar. 13, 2019] § 520.980 Fluoxetine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017] § 520.998 Fluralaner chewable tablets. (a) Specifications. (2) Each chewable tablet contains 45, 100, 200, 400, or 560 mg fluralaner. (b) Sponsor. (c) Conditions of use in dogs Amount. (i) Chewable tablets described in paragraph (a)(1) of this section. Amblyomma americanum (ii) Chewable tablets described in paragraph (a)(2) of this section. (2) Indications for use Chewable tablets described in paragraph (a)(1) of this section. Ctenocephalides felis Ixodes scapularis Dermacentor variabilis Rhipicephalus sanguineus Haemaphysalis longicornis Amblyomma americanum (ii) Chewable tablets described in paragraph (a)(2) of this section. C. felis I. scapularis D. variabilis R. sanguineus H. longicornis A. americanum (3) Limitations. [86 FR 14818, Mar. 19, 2021, as amended at 88 FR 27698, May 3, 2023; 90 FR 6800, Jan. 21, 2025] § 520.999 Fluralaner oral solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in laying hens and replacement chickens Amount. (2) Indications for use. Ornithonyssus sylviarum (3) Limitations. [91 FR 5300, Feb. 6, 2026] § 520.1010 Furosemide. (a) Specifications. (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. (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. (d) Conditions of use. (1) Cattle Amount. (ii) Indications for use. (iii) Limitations. (2) Dogs Amount. (ii) Indications for use. (B) For treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency. (3) Cats Amount. (ii) Indications for use. [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] § 520.1044 Gentamicin sulfate oral dosage forms. § 520.1044a Gentamicin sulfate oral solution. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. E. coli Treponema hyodysenteriae. (3) Limitations. [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] § 520.1044b Gentamicin sulfate pig pump oral solution. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. E. coli (3) Limitations. [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] § 520.1044c Gentamicin sulfate powder. (a) Specifications. (1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin. (2) 333.3 mg gentamicin. (b) Sponsors. (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. (d) Conditions of use in swine Amount. (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. Escherichia coli Brachyspira hyodysenteriae. (3) Limitations. [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] § 520.1060 Glucose and glycine. (a) Specifications. (b) Sponsor. (c) Conditions of use in calves Amount. (i) Scouring and/or dehydrated calves. (ii) Newly purchased calves. (2) Indications for use. (3) Limitations. [79 FR 28821, May 20, 2014] § 520.1084 Grapiprant. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [81 FR 36789, June 8, 2016, as amended at 83 FR 14587, Apr. 5, 2018] § 520.1100 Griseofulvin. (a) Specifications. (2) Each bolus contains 2.5 grams griseofulvin. (3) Each tablet contains 125 or 500 milligrams griseofulvin. (b) Sponsors. (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. (d) Conditions of use Horses Amount and indications for use. Trichophyton equinum Microsporum gypseum (B) For treating ringworm infection caused by T. equinum (ii) Limitations. (2) Dogs and cats: (i) Amount. (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 according to response. Administer additional dose after the animal is free of infection. (ii) Indications for use. Trichophyton mentagrophytes, T. rubrum, T. schoenleini, T. sulphurem, T. verrucosum, T. interdigitale, Epidermophyton floccosum, Microsporum gypseum, M. canis, M. audouini. [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] § 520.1120 Haloxon oral dosage forms. § 520.1120a Haloxon drench. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Related tolerances. (e) Conditions of use in cattle Amount. 1/2 3/4 1/2 (2) Indications for use. Haemonchus, Ostertagia, Trichostrongylus, Cooperia. (3) Limitations. [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] § 520.1120b Haloxon boluses. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Haemonchus, Ostertagia, Trichostrongylus, Cooperia. (3) Limitations. [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] § 520.1136 Ilunocitinib. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [89 FR 95103, Dec. 2, 2024] § 520.1150 Imepitoin. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [84 FR 12494, Apr. 2, 2019] § 520.1156 Imidacloprid. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [80 FR 18775, Apr. 8, 2015, as amended at 86 FR 14818, Mar. 19, 2021] § 520.1157 Iodinated casein. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 1/5 (2) Indications for use. (3) Limitations. [49 FR 22469, May 30, 1984, as amended at 78 FR 28822, May 20, 2014] § 520.1158 Iodochlorhydroxyquin. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [48 FR 8054, Feb. 25, 1983, as amended at 50 FR 41489, Oct. 11, 1985; 78 FR 28822, May 20, 2014] § 520.1189 Itraconazole. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Microsporum canis (3) Limitations. [82 FR 12169, Mar. 1, 2017, as amended at 86 FR 57996, Oct. 20, 2021] § 520.1192 Ivermectin paste. (a) Specifications. (b) Sponsors. (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. (d) Special considerations. (e) Conditions of use Horses Amount. (ii) Indications for use. Strongylus vulgaris S. edentatus S. equinus Triodontophorus T. brevicauda T. serratus Craterostomum acuticaudatum Coronocyclus C. coronatus C. labiatus C. labratus Cyathostomum C. catinatum C. pateratum Cylicocyclus C. insigne C. leptostomum C. nassatus C. brevicapsulatus Cylicodontophorus Cylicostephanus C. calicatus C. goldi C. longibursatus C. minutus Petrovinema poculatum Oxyuris equi Parascaris equorum Trichostrongylus axei Habronema muscae Gasterophilus G. intestinalis G. nasalis Dictyocaulus arnfieldi Strongyloides westeri Habronema Draschia Onchocerca (iii) Limitations. (2) Cattle Amount. (ii) Indications for use. Ostertagia ostertagi O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, Nematodirus helvetianus, Bunostomum phlebotomum, Strongyloides papillosus Oesophagostomum radiatum, Trichuris ovis Dictyocaulus viviparus Hypoderma bovis, H. lineatum Linognathus vituli, Haematopinus eurysternus (iii) Limitations. [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] § 520.1193 Ivermectin tablets and chewables. (a) Specifications. (2) Each chewable contains 55 or 165 mcg ivermectin. (b) Sponsors. (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. (d) Conditions of use Dogs. (i) Amount. (ii) Indications for use. Dirofilaria immitis (2) Cats. (i) Amount. (ii) Indications for use. Dirofilaria immitis Ancylostoma tubaeforme A. braziliense. [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] § 520.1194 Ivermectin meal. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use in horses Amount. (2) Indications for use. Strongylus vulgaris S. edentatus S. equinus Triodontophorus T. brevicauda T. serratus Craterostomum acuticaudatum Coronocyclus C. coronatus C. labiatus C. labratus Cyathostomum C. catinatum C. pateratum Cylicocyclus C. insigne C. leptostomum C. nassatus C. brevicapsulatus Cylicodontophorus Cylicostephanus C. calicatus C. goldi C. longibursatus C. minutus Petrovinema poculatum Oxyuris equi Parascaris equorum Trichostrongylus axei Habronema muscae asterophilus G. intestinalis G. nasalis Dictyocaulus arnfieldi Strongyloides westeri Habronema Draschia Onchocerca Limitations. [70 FR 1817, Jan. 11, 2005, as amended at 70 FR 19262, Apr. 13, 2005] § 520.1195 Ivermectin liquid. (a) Specifications. (2) Each mL of micellar solution contains 0.8 mg ivermectin. (b) Sponsors. (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. (d) Special considerations. (e) Conditions of use Horses Amount. (ii) Indications for use. (A) Large Strongyles (adults): Strongylus vulgaris S. edentatus S. equinus Triodontophorus T. brevicauda T. serratus Craterostomum acuticaudatum Coronocyclus C. coronatus C. labiatus C. labratus Cyathostomum C. catinatum C. pateratum Cylicocyclus C. insigne C. leptostomum C. nassatus C. brevicapsulatus Cylicodontophorus Cylicostephanus C. calicatus C. goldi C. longibursatus C. minutus Petrovinema poculatum Oxyuris equi Parascaris equorum Trichostrongylus axei Habronema muscae Gasterophilus G. intestinalis G. nasalis Dictyocaulus arnfieldi Strongyloides westeri Habronema Draschia Onchocerca (B) Large Strongyles ( Strongylus equinus S. vulgaris S. endentatus Triodontophorus Cyathostomum Cylicocyclus Cylicodontophorus Cylicostephanus Oxyuris equi Parascaris equorum Trichostongylus axei Habronema muscae Gastrophilus Dictyocaulus arnfieldi Strongyloides westeri Habronema Draschia Onchocerca (iii) Limitations. (2) Sheep Amount. (ii) Indications for use. Haemonchus contortus, H. placei Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia oncophora C. curticei, Oesophagostomum columbianum, O. venulosum Nematodirus battus, N. spathiger, S. papillosus Chabertia ovina Trichuris ovis D. filaria Oestrus ovis. (iii) Limitations. [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] § 520.1196 Ivermectin and pyrantel tablets. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs Amount. (ii) Indications for use. Dirofilaria immitis Toxocara canis Toxascaris leonina, Ancylostoma caninum, A. braziliense, Uncinaria stenocephala. (iii) Limitations. (2) [Reserved] [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] § 520.1197 Ivermectin sustained-release bolus. (a) Specifications. (b) Sponsor. (c) Related tolerances. See § 556.344 of this chapter. (d) Conditions of use in ruminating calves Amount. (2) Indications. Haemonchus placei, Ostertagia ostertagi Trichostrongylus axei, T. colubriformis, Cooperia Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum radiatum; Dictyocaulus viviparus; Hypoderma Linognathus vituli, Solenopotes capillatus; Psoroptes ovis, Sarcoptes scabiei, Amblyomma americanum. (3) Limitations. [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] § 520.1198 Ivermectin and praziquantel paste. (a) Specifications. (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. (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. (d) Conditions of use in horses Amount. (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. Anoplocephala perfoliata; Strongylus vulgaris S. edentatus S. equinus, Triodontophorus T. brevicauda T. serratus, Craterostomum acuticaudatum; Coronocyclus C. coronatus, C. labiatus, C. labratus; Cyathostomum C. catinatum C. pateratum; Cylicocyclus C. insigne, C. leptostomum, C. nassatus, C. brevicapsulatus; Cylicodontophorus Cylicostephanus C. calicatus, C. goldi, C. longibursatus, C. minutus, Petrovinema poculatum; Oxyuris equi; Parascaris equorum; Trichostrongylus axei; Habronema muscae; Gasterophilus G. intestinalis G. nasalis; Dictyocaulus arnfieldi; Strongyloides westeri; Habronema Draschia Onchocerca (ii) For treatment and control of the following parasites: Tapeworms— Anoplocephala perfoliata; Strongylus vulgaris S. edentatus S. equinus, Triodontophorus Cyathostomum Cylicocyclus Cylicostephanus Cylicodontophorus Oxyuris equi; Parascaris equorum; Trichostrongylus axei; Habronema muscae; Gasterophilus Dictyocaulus arnfieldi; Strongyloides westeri; Habronema Draschia Onchocerca (iii) For treatment and control of the following parasites in horses over 5 months of age: Tapeworms— Anoplocephala perfoliata; Strongylus vulgaris S. edentatus S. equinus, Triodontophorus T. brevicauda T. serratus, Craterostomum acuticaudatum; Coronocyclus C. coronatus, C. labiatus, C. labratus; Cyathostomum C. catinatum C. pateratum; Cylicocyclus C. insigne, C. leptostomum, C. nassatus, C. brevicapsulatus; Cylicodontophorus Cylicostephanus C. calicatus, C. goldi, C. longibursatus, C. minutus, Petrovinema poculatum; Oxyuris equi; Parascaris equorum; Trichostrongylus axei; Habronema muscae; Gasterophilus G. intestinalis G. nasalis; Dictyocaulus arnfieldi; Strongyloides westeri; Habronema Draschia Onchocerca (3) Limitations. [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] § 520.1199 Ivermectin, pyrantel, and praziquantel tablets. (a) Specifications. (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. (c) Conditions of use in dogs Amount. (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. Dirofilaria immitis Toxocara canis, Toxascaris leonina Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense Dipylidium caninum, Taenia pisiformis (3) Limitations. [71 FR 65052, Nov. 7, 2006, as amended at 78 FR 28822, May 20, 2014; 83 FR 14587, Apr. 5, 2018] § 520.1200 Ivermectin, fenbendazole, and praziquantel tablets. (a) Specifications. (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. (c) Conditions of use in dogs Amount. (2) Indications for use. Toxocara canis Ancylostoma caninum Trichuris vulpis Dipylidium caninum Dirofilaria immitis (3) Limitations. [73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009] § 520.1204 Kanamycin, bismuth subcarbonate, activated attapulgite. (a) Specifications. (2) Each tablet contains 100 mg kanamycin (as the sulfate), 250 mg bismuth subcarbonate, and 500 mg activated attapulgite. (b) Sponsor. (c) Conditions of use in dogs Amount. 1/2 (2) Indications for use. (3) Limitations. [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] § 520.1242 Levamisole. § 520.1242a Levamisole powder. (a) Specifications. (b) Sponsors. (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. (d) Special considerations. (e) Conditions of use. (1) Cattle Amount. (ii) Indications for use. Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum Dictyocaulus (B) Effective against the following adult nematode infections: Stomach worms ( Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum Dictyocaulus viviparus (iii) Limitations. (2) Sheep Amount. (ii) Indications for use. Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia Dictyocaulus (B) Effective against the following adult nematode infections: Stomach worms ( Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina Dictyocaulus filaria (iii) Limitations. (3) Swine Amount. (ii) Indications for use. Ascaris suum Oesophagostomum Strongyloides ransomi Metastrongylus spp. (iii) Limitations. [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] § 520.1242b Levamisol boluses or oblets. (a) Specifications. (b) Sponsors. (c) Required labeling. (d) Related tolerances. (e) Conditions of use Cattle Amount. 1/2 1/2 (ii) Indications for use. Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum Dictyocaulus (iii) Limitations. (2) Sheep Amount. (ii) Indications for use. Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia Dictyocaulus (iii) Limitations. [78 FR 28822, May 20, 2014] § 520.1242c Levamisol and piperazine. (a) Specifications. (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. (c) Conditions of use in horses Amount. (2) Indications for use. Strongylus vulgaris, S. edentatus Cylicocercus Cylicocyclus Cylicodontophorus Cylicostephanus Cylicotetrapedon Parascaris equorum Oxyuris equi (3) Limitations. [78 FR 28823, May 20, 2014] § 520.1242d Levamisole resinate. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Amount. (2) Indications for use. Ascaris suum Oesophagostomum Metastrongylus Strongyloides ransomi Stephanurus dentatum (3) Limitations. [43 FR 18171, Apr. 28, 1978, as amended at 45 FR 3574, Jan. 18, 1980] § 520.1242e Levamisole hydrochloride effervescent tablets. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Amount. (2) Indications for use. (3) Limitations. 1/2 [45 FR 6087, Jan. 25, 1980, as amended at 67 FR 63055, Oct. 10, 2002; 78 FR 28823, May 20, 2014] § 520.1242f Levamisol gel. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum Dictyocaulus (iii) Limitations. (2) Breeding swine Amount. (ii) Conditions of use. Ascaris suum Oesophagostomum Metastrongylus Strongyloides ransomi Stephanurus dentatus (iii) Limitations. [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] § 520.1242g Levamisole resinate and famphur paste. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Related tolerances. (e) Conditions of use in cattle Amount. (2) Indications for use. Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum Dictyocaulus Hypoderma Bovicola Linognathus, Solenoptes (3) Limitations. [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] § 520.1248 Levothyroxine. (a) Specifications. (b) Sponsors. (c) Conditions of use Amount. (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. (3) Limitations. [81 FR 22523, Apr. 18, 2016, as amended at 86 FR 57996, Oct. 20, 2021] § 520.1263 Lincomycin. § 520.1263a Lincomycin tablets and syrup. (a) Specifications. (2) Each tablet contains lincomycin hydrochloride equivalent to either 25 or 50 mg lincomycin. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [78 FR 28823, May 20, 2014] § 520.1263b Lincomycin hydrochloride soluble powder. (a) Specifications. (b) Sponsors. (1) Nos. 061133 and 066104 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. (d) Conditions of use Swine Amount. (ii) Indications for use. (iii) Limitations. (2) Broiler chickens Amount. (ii) Indications for use. Clostridium perfringens (iii) Limitations. (3) Honey bees Amount. (ii) Indications for use. Paenibacillus larvae (iii) Limitations. [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; 91 FR 20340, Apr. 16, 2026; 91 FR 33071, June 3, 2026] § 520.1265 Lincomycin and spectinomycin powder. (a) Specifications. (1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate tetrahydrate. (2) Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate. (b) Sponsors. (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. (d) Conditions of use in chickens Amount. (2) Indications for use. Mycoplasma synoviae M. gallisepticum Escherichia coli M. gallisepticum (3) Limitations. [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] § 520.1284 Liothyronine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [78 FR 28823, May 20, 2014] § 520.1286 Lotilaner. (a) Specifications. (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. (c) Conditions of use Dogs Amount. (ii) Indications for use. Ctenocephalides felis Amblyomma americanum Dermacentor variabilis Ixodes scapularis Rhipicephalus sanguineus Haemaphysalis longicornis Borrelia burgdorferi Ixodes scapularis (iii) Limitations. (2) Cats Amount. (ii) Indications for use. Ctenocephalides felis Ixodes scapularis (iii) Limitations. [85 FR 18119, Apr. 1, 2020, as amended at 86 FR 61685, Nov. 8, 2021; 91 FR 20341, Apr. 16, 2026] § 520.1287 Lotilaner, moxidectin, praziquantel, and pyrantel. (a) Specifications. (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. (c) Conditions of use Amount. (2) Indications for use. Dirofilaria immitis Toxocara cani Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus Ctenocephalides felis Amblyomma americanum Dermacentor variabilis Ixodes scapularis Rhipicephalus sanguineus Haemaphysalis longicornis Borrelia burgdorferi Ixodes scapularis (3) Limitations. [90 FR 6800, Jan. 21, 2025, as amended at 90 FR 40969, Aug. 22, 2025; 91 FR 20341, Apr. 16, 2026] § 520.1288 Lufenuron tablets. (a) Specifications (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. (c) Conditions of use Dogs Amount. (ii) Indications for use (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. (2) Cats Amount. (ii) Indications for use (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. [68 FR 51905, Aug. 29, 2003] § 520.1289 Lufenuron suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. (3) Limitations. [60 FR 20402, Apr. 26, 1995, as amended at 62 FR 8371, Feb. 25, 1997] § 520.1310 Marbofloxacin. (a) Specifications. (b) Sponsors. (1) Nos. 017033, 054771, 069043, and 086117 for use of tablets. (2) No. 086101 for use of chewable tablets. (c) [Reserved] (d) Conditions of use Amount. (2) Indications for use. (3) Limitations. [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; 91 FR 41559, July 7, 2026] § 520.1315 Maropitant. (a) Specifications. (2) Each chewable tablet contains 16, 24, 60, or 160 mg maropitant as maropitant citrate. (b) Sponsors. (1) Nos. 054771, 086101, and 086117 for use of the product described in paragraph (a)(1) of this section as in paragraph (c) of this section. (2) No. 086101 for use of the product described in paragraph (a)(2) of this section as in paragraph (c) of this section. (c) Conditions of use in dogs Indications for use and amount. (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. [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; 91 FR 41559, July 7, 2026] § 520.1320 Mebendazole. (a) Specifications. (2) Each gram of paste contains 200 milligrams of mebendazole. (3) Each milliliter of suspension contains 33.3 milligrams of mebendazole. (b) Sponsor. (c) Conditions of use Horses Amount. (ii) Indications for use. Parascaris equorum Strongylus edentatus, S. equinus, S. vulgaris Oxyuris equi (iii) Limitations. (2) Dogs Amount. (ii) Indications for use. Toxocara canis Ancylostoma caninum, Uncinaria stenocephala Trichuris vulpis Taenia pisiformis (iii) Limitations. [78 FR 28823, May 20, 2014] § 520.1326 Mebendazole and trichlorfon oral dosage forms. § 520.1326a Mebendazole and trichlorfon powder. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Gastrophilus intestinalis G. nasalis Parascaris equorum Strongylus edentatus, S. equinus, S. vulgaris Oxyuris equi. (3) Limitations. [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] § 520.1326b Mebendazole and trichlorfon paste. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Gastrophilus intestinalis G. nasalis Parascaris equorum Strongylus edentatus, S. equinus, S. vulgaris Oxyuris equi (3) Limitations. [51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014] § 520.1330 Meclofenamic acid granules. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [78 FR 28824, May 20, 2014] § 520.1331 Meclofenamic acid tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [50 FR 43385, Oct. 25, 1985, as amended at 53 FR 23390, June 22, 1988; 78 FR 28824, May 20, 2014] § 520.1341 Megestrol. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (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. (3) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 78 FR 28824, May 20, 2014] § 520.1367 Meloxicam. (a) Specifications (2) Each milliliter of suspension contains 1.5 mg meloxicam. (b) Sponsors. (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 Amount. (2) Indications for use. (3) Limitations. [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] § 520.1375 Methimazole tablets. (a) Specifications. (b) Sponsors, (c) Conditions of use in cats Amount. (2) Indications for use. (3) Limitations. [74 FR 27707, June 11, 2009. Redesignated and amended at 89 FR 95103, Dec. 2, 2024; 90 FR 40970, Aug. 22, 2025] § 520.1376 Methimazole solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. (3) Limitations. [89 FR 95103, Dec. 2, 2024, as amended at 91 FR 41559, July 7, 2026] § 520.1380 Methocarbamol. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [78 FR 28824, May 20, 2014] § 520.1408 Methylprednisolone. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [78 FR 28824, May 20, 2014, as amended at 83 FR 48946, Sept. 28, 2018; 89 FR 14410, Feb. 27, 2024] § 520.1409 Methylprednisolone and aspirin. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. 1/4 (2) Indications for use. (3) Limitations. [48 FR 21566, May 13, 1983, as amended at 78 FR 28824, May 20, 2014] § 520.1422 Metoserpate hydrochloride. (a) Chemical name. o (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Amount. (i) Indications for use. (ii) Limitations. (2) Amount. (i) Indications for use. (ii) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 76 FR 17337, Mar. 29, 2011; 78 FR 28824, May 20, 2014] § 520.1425 Metronidazole. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Giardia duodenalis (3) Limitations. [89 FR 14410, Feb. 27, 2024] § 520.1430 Mibolerone. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [43 FR 15625, Apr. 14, 1978, as amended at 78 FR 28824, May 20, 2014] § 520.1441 Milbemycin. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs Amount. (ii) Indications for use. Dirofilaria immitis, Ancylostoma caninum, Toxocara canis Toxascaris leonina Trichuris vulpis (iii) Limitations. (2) Cats Amount. (ii) Indications for use. Dirofilaria immitis Toxocara cati Ancylostoma tubaeforme (iii) Limitations. [84 FR 12494, Apr. 2, 2019] § 520.1443 Milbemycin oxime and lufenuron. (a) Specifications. (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. (c) [Reserved] (d) Conditions of use Dogs Amount. (ii) Indications for use. Dirofilaria immitis, Ancylostoma caninum Toxocara canis, Toxascaris leonina Trichuris vulpis (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. (2) [Reserved] [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] § 520.1445 Milbemycin oxime and praziquantel. (a) Specifications. (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. (c) Conditions of use Dogs Amount. (ii) Indications for use. Dirofilaria immitis Toxocara canis, Toxascaris leonina Ancylostoma caninum Trichuris vulpis Taenia pisiformis, Echinococcus multilocularis, E. granulosus, Dipylidium caninum (iii) Limitations. (2) [Reserved] [77 FR 47512, Aug. 9, 2012, as amended at 82 FR 58556, Dec. 13, 2017] § 520.1447 Milbemycin oxime, lufenuron, and praziquantel tablets. (a) Specifications. (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. (c) [Reserved] (d) Conditions of use Dogs Amount. (ii) Indications for use. Dirofilaria immitis; Ctenocephalides felis Toxocara canis, Toxascaris leonina Ancylostoma caninum Trichuris vulpis Dipylidium caninum, Taenia pisiformis, Echinococcus multilocularis, E. granulosus (iii) Limitations. (2) [Reserved] [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] § 520.1450 Morantel tartrate oral dosage forms. § 520.1450a Morantel tartrate bolus. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. 1/2 1/2 (2) Indications for use. Haemonchus Ostertagia Trichostrongylus Cooperia Trichostrongylus Nematodirus Oesophagostomum radiatum (3) Limitations. [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] § 520.1450b Morantel tartrate cartridge. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. Ostertagia Trichostrongylus axei, Cooperia Oesophagostomum radiatum. (3) Limitations. [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] § 520.1450c Morantel tartrate sustained-release trilaminate cylinder/sheet. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. Ostertagia Trichostrongylus axei, Cooperia Oesophagostomum radiatum. (3) Limitations. [56 FR 13396, Apr. 2, 1991, as amended at 78 FR 28825, May 20, 2014] § 520.1451 Moxidectin tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Dirofilaria immitis (3) Limitations. [62 FR 37713, July 15, 1997, as amended at 78 FR 28825, May 20, 2014] § 520.1452 Moxidectin gel. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use in horses and ponies Amount. (2) Indications for use. Strongylus vulgaris S. edentatus Triodontophorus brevicauda T. serratus Cyathostomum C. catinatum C. pateratum Cylicocyclus. C. insigne, C. leptostomum, C. nassatus C. radiatus; Cyliocostephanus C. calicatus, C. goldi, C. longibursatus, C. minutus Coronocyclus C. coronatus, C. labiatus, C. labratus Gyalocephalus capitatus Petrovinema poculatus Parascaris equorum Oxyuris equi Trichostrongylus axei Habronema muscae Gasterophilus intestinalis G. nasalis (3) Limitations. [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] § 520.1453 Moxidectin and praziquantel gel. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use in horses and ponies Amount. (2) Indications for use. Strongylus vulgaris S. edentatus Triodontophorus brevicauda T. serratus Cyathostomum C. catinatum C. pateratum Cylicocyclus C. insigne, C. leptostomum, C. nassatus C. radiatus Cylicostephanus C. calicatus, C. goldi, C. longibursatus, C. minutus Coronocyclus C. coronatus, C. labiatus, C. labratus Gyalocephalus capitatus Petrovinema poculatus Parascaris equorum Oxyuris equi Trichostrongylus axei Habronema muscae Gasterophilus intestinalis G. nasalis Anoplocephala perfoliata (3) Limitations. [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] § 520.1454 Moxidectin solution. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use in sheep Amount. (2) Indications for use. Haemonchus contortus Teladorsagia circumcincta T. trifurcata Trichostrongylus axei T. colubriformis T. vitrinus Cooperia curticei C. oncophora Oesophagostomum columbianum O. venulosum Nematodirus battus N. filicollis N. spathiger. (3) Limitations. [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] § 520.1468 Naproxen. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [78 FR 28825, May 20, 2014] § 520.1484 Neomycin. (a) Specifications. (2) Each milliliter of solution contains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin base). (b) Sponsors. (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. (d) Special labeling considerations. (e) Conditions of use Cattle, swine, sheep, and goats Amount. (ii) Indications for use. Escherichia coli (iii) Limitations. (2) Turkeys Amount. (ii) Indications for use. E. coli (iii) Limitations. [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] § 520.1510 Nitenpyram. (a) Specifications. (b) Sponsors. (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. (d) Conditions of use Dogs Amount. (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. (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 Amount. (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. (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. [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] § 520.1604 Oclacitinib. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [78 FR 42007, July 15, 2013, as amended at 88 FR 55563, Aug. 16, 2023] § 520.1615 Omeprazole. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use in horses Amount. (ii) For prevention of gastric ulcers using the premarked syringe, one dose per day for 8 or 28 days. Each dose delivers at least 1 mg/kg of body weight. Horses over 1,200 lb body weight should receive two doses per day. (2) Indications for use. (ii) For prevention of gastric ulcers in horses. (3) Limitations. [69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9, 2019] § 520.1616 Orbifloxacin tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010] § 520.1618 Orbifloxacin suspension. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use Dogs Amount. (ii) Indications for use. Staphylococcus pseudintermedius Proteus mirabilis Escherichia coli, Enterococcus faecalis Staphylococcus pseudintermedius Staphylococcus aureus Pasteurella multocida Proteus mirabilis Pseudomonas Klebsiella pneumoniae E. coli Enterobacter Citrobacter E. faecalis Streptococcus equisimilis. (2) Cats Amount. (ii) Indications for use. S. aureus E. coli P. multocida. [75 FR 26646, May 12, 2010] § 520.1628 Oxfendazole powder and pellets. (a) Specifications Powder for suspension. (2) Pellets. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Parascaris equorum Oxyuris equi Strongylus edentatus, Strongylus vulgaris, Strongylus equinus (3) Limitations Powder for suspension. (ii) Pellets. [44 FR 35211, June 19, 1979, as amended at 46 FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014] § 520.1629 Oxfendazole paste. (a)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. Parascaris equorum Oxyuris equi Strongylus edentatus, S. vulgaris, S. equinus (iii) Limitations. (b)(1) Specifications. (2) Sponsor. (3) Related tolerances. (4) Conditions of use Amount. (ii) Indications for use. Dictyocaulus viviparus Haemonchus contortus H. placei Trichostrongylus axei Ostertagia ostertagi Oesophagostomum radiatum Bunostomum phlebotomum Cooperia punctata, C. oncophora, C. mcmasteri Moniezia benedeni (iii) Limitations. [49 FR 38250, Sept. 28, 1984, as amended at 58 FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014] § 520.1630 Oxfendazole suspension. (a) Specifications. (1) 90.6 milligrams (mg) oxfendazole (9.06 percent). (2) 225.0 mg oxfendazole (22.5 percent). (b) Sponsor. (c) Related tolerances. See (d) Special considerations. (e) Conditions of use Horses. (i) Amount. (ii) Indications for use. Parascaris equorum Oxyuris equi Strongylus edentatus, S. vulgaris, S. equinus (iii) Limitations. (2) Cattle. (i) Amount. (ii) Indications for use. Dictyocaulus viviparus Haemonchus contortus H. placei Trichostrongylus axei Ostertagia ostertagi Oesophagostomum radiatum Bunostomum phlebotomum Cooperia punctata, C. oncophora, C. surnabada Moniezia benedeni (iii) Limitations. [55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, 2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825, May 20, 2014] § 520.1631 Oxfendazole and trichlorfon paste. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Gasterophilus intestinalis, G. nasalis, Parascaris equorum Oxyuris equi Strongylus edentatus, S. vulgaris, S. equinus (3) Limitations. [50 FR 50291, Dec. 10, 1985, as amended at 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014] § 520.1638 Oxibendazole. (a) Specifications. (2) Each milliliter of suspension contains 100 mg (10 percent) oxibendazole. (b) Sponsor. (c) Special considerations. (2) Suspension product described in paragraph (a)(2) of this section shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” (d) Conditions of use in horses Amount. Strongyloides westeri Strongyloides westeri (2) Indications for use. Strongylus edentatus, S. equinus, S. vulgaris Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, Gyalocephalus Parascaris equorum Oxyuris equi Strongyloides westeri (3) Limitations. [78 FR 28825, May 20, 2014] § 520.1660 Oxytetracycline. § 520.1660a [Reserved] § 520.1660b Oxytetracycline capsules. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. Brucella bronchiseptica, Streptococcus hemolyticus, Escherichia coli, Escherichia coli, Staphylococcus aureus. (3) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 78 FR 28825, May 20, 2014; 88 FR 55563, Aug. 16, 2023] § 520.1660c Oxytetracycline tablets. (a) Specifications. (b) Sponsor. (c) Tolerances. (d) Conditions of use in beef and dairy cattle Amounts. (2) Indications for use. Salmonella typhimurium Escherichia coli Pasteurella multocida. (3) Limitations. [46 FR 32440, June 23, 1981, as amended at 50 FR 1045, Jan. 9, 1985; 63 FR 70334, Dec. 21, 1998; 70 FR 16394, Apr. 4, 2005; 78 FR 28825, May 20, 2014; 88 FR 14897, Mar. 10, 2023; 88 FR 55563, Aug. 16, 2023] § 520.1660d Oxytetracycline powder. (a) Specifications. (1) Each 18.14 grams of powder contains 1 gram of oxytetracycline hydrochloride (OTC HCl) (packets: 4, 6.4, and 16 oz.). (2) Each 4.43 grams of powder contains 1 gram of OTC HCl (packets: 4 and 16 oz.). (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.). (4) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 2.46 and 9.87 oz, 3.09 and 3.91 lb; pail: 3.09 lb). (5) Each 4.2 grams of powder contains 1 gram of OTC HCl (packets: 3.8 and 15.2 oz; pails: 4.74 and 23.7 lb). (6) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 oz.; pail: 5 lb). Each 2.73 grams of powder contains 1 gram of OTC HCl (packet: 9.87 oz). (7) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder contains 1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb). (8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC HCl. Each 677.5-gram packet (23.9 ounce) contains 512 grams of OTC HCl. (9) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and, 19.75 oz, and 3.91 lb; pails: 3.09 and 5 lb). (10) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and 19.74 oz; pails: 5 lb). (b) Sponsor. (1) No. 054771 for use of OTC HCl concentrations in paragraphs (a)(1), (a)(2), and (a)(3) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees. (2) No. 016592 for use of OTC HCl concentration in paragraph (a)(4) of this section in chickens, turkeys, and swine. (3) No. 066104 for use of OTC HCl concentration in paragraph (a)(5) of this section in turkeys and chickens. (4) No. 016592 for use of OTC HCl concentration in paragraph (a)(6) of this section in chickens, turkeys, and swine. (5) No. 061133 for use of OTC HCl concentration in paragraph (a)(7) of this section in chickens, turkeys, swine, cattle, sheep, and honeybees. (6) No. 069254 for use of OTC HCl concentrations in paragraph (a)(8) of this section in chickens, turkeys, swine, cattle, sheep, and honey bees. (7) No. 061133 for use of OTC HCl concentration in paragraph (a)(9) of this section in chickens, turkeys, and swine. (c) Related tolerances. (d) Conditions of use. (i) Chickens 1 Amount. ( 2 Indications for use. Mycoplasma synoviae ( 3 (B)( 1 Amount. ( 2 Indications for use. Mycoplasma gallisepticum E. coli Pasteurella multocida ( 3 (ii) Turkeys 1 Amount. ( 2 Indications for use. Hexamita meleagridis ( 3 (B)( 1 Amount. ( 2 Indications for use. Mycoplasma synoviae ( 3 (C)( 1 Amount. ( 2 Indications for use. ( 3 (iii) Swine Amount. (B) Indications for use. Escherichia coli Salmonella choleraesuis Pasteurella multocida Leptospira pomona (C) Limitations. (iv) Calves, beef cattle, and nonlactating dairy cattle Amount. (B) Indications for use. E. coli P. multocida (C) Withdraw 5 days prior to slaughter. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (v) Sheep Amount. (B) Indications for use. E. coli P. multocida (C) Withdraw 5 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) It is used in the food of honey bees as follows: (i) Amount. (ii) Indications for use. Paenibacillus larvae (iii) The drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975] Editorial Note: For Federal Register www.govinfo.gov. § 520.1664 Oxytetracycline and carbomycin. (a) Specifications. Streptomyces rimosus (2) Carbomycin: The antibiotic substance produced by growth of Streptomyces halstedii (b) Sponsor. (c) Special considerations. (d) Related tolerances. (e) Conditions of use. (1) Amount. (2) Indications for use. Mycoplasma gallisepticum E. coli. (3) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 78 FR 28825, May 20, 2014; 81 FR 94989, Dec. 27, 2016. Redesignated at 88 FR 55563, Aug. 16, 2023] § 520.1696 Penicillin. § 520.1696a Penicillin G powder. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use in turkeys Amount. (2) Indications for use. Erysipelothrix rhusiopathiae. (3) Limitations. [57 FR 37326, Aug. 18, 1992, as amended at 59 FR 42493, Aug. 18, 1994; 60 FR 26359, May 17, 1995; 62 FR 55160, Oct. 23, 1997; 65 FR 10705, Feb. 29, 2000; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 68 FR 26204, May 15, 2003; 69 FR 9946, Mar. 3, 2004; 69 FR 41428, July 9, 2004; 77 FR 20988, Apr. 9, 2012; 78 FR 28825, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 36789, June 8, 2016; 81 FR 94990, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019. Redesignated at 85 FR 18119, Apr. 1, 2020, as amended at 86 FR 57997, Oct. 20, 2021] § 520.1696c Penicillin V tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [57 FR 37327, Aug. 18, 1992, as amended at 59 FR 58775, Nov. 15, 1994; 78 FR 28826, May 20, 2014; 84 FR 39183, Aug. 9, 2019. Redesignated at 85 FR 18119, Apr. 1, 2020; 88 FR 27699, May 3, 2023] § 520.1705 Pergolide. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [77 FR 15960, Mar. 19, 2012, as amended at 81 FR 22523, Apr. 18, 2016; 91 FR 20341, Apr. 16, 2026] § 520.1720 Phenylbutazone oral dosage forms. § 520.1720a Phenylbutazone tablets and boluses. (a) Specifications. (b) Sponsors. (1) No. 000061 for use of 100- or 400-mg or 1-g tablets, or 2- or 4-g boluses, in dogs and horses. (2) No. 069043 for use of 100- or 200-mg or 1-g tablets in dogs and horses. (3) Nos. 054771 and 061133 for use of 100-mg or 1-g tablets in dogs and horses. (4) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses. (5) No. 058198 for use of 1-g tablets in horses. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Horses Amount. (ii) Indications for use. (iii) Limitations. [73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019; 85 FR 45307, July 28, 2020; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022] § 520.1720b Phenylbutazone granules. (a) Specifications. (b) Sponsors. (1) No. 000061 for 8-gram package. (2) No. 059320 for 1-gram package. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [78 FR 28826, May 20, 2014] § 520.1720c Phenylbutazone paste. (a) Specifications. (2) Each gram of paste contains 0.35 grams phenylbutazone. (b) Sponsors. (1) No. 000061 for use of product described in paragraph (a)(1) of this section. (2) No. 017030 for use of product described in paragraph (a)(2) of this section. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [45 FR 84762, Dec. 23, 1980, as amended at 58 FR 29777, May 24, 1993; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 68 FR 43926, July 25, 2003; 72 FR 60550, Oct. 25, 2007; 77 FR 4897, Feb. 1, 2012; 78 FR 28826, May 20, 2014; 79 FR 74020, Dec. 15, 2014] § 520.1720d Phenylbutazone gel. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [50 FR 13561, Apr. 5, 1985, as amended at 50 FR 49372, Dec. 2, 1985; 55 FR 8462, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 78 FR 28826, May 20, 2014; 84 FR 8973, Mar. 13, 2019] § 520.1720e Phenylbutazone powder. (a) Specifications. (2) Each 10 g of powder contains 1 g phenylbutazone. (b) Sponsors. (1) No. 086119 for use of product described in paragraph (a)(1) of this section. (2) No. 057699 for use of product described in paragraph (a)(2) of this section. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [72 FR 27956, May 18, 2007, as amended at 90 FR 6800, Jan. 21, 2025] § 520.1760 Phenylpropanolamine. (a) Specifications. (2) Each extended-release tablet contains 18, 38, 74, or 145 mg phenylpropanolamine hydrochloride. (b) Sponsors. (1) Nos. 055246 and 086117 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) and (3) of this section. (2) No. 055246 for use of product described in paragraph (a)(2) of this section as in paragraph (c)(1)(ii) and (c)(2) and)(3) of this section. (c) Conditions of use in dogs Amount. (i) Chewable tablet: 2 mg/kg of body weight twice daily. (ii) Extended-release tablet: 2 to 4 mg/kg of body weight once daily with food. (2) Indications for use. (3) Limitations. [77 FR 15961, Mar. 19, 2012, as amended at 84 FR 39183, Aug. 9, 2019; 89 FR 85426, Oct. 28, 2024] § 520.1780 Pimobendan tablets. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (2) Indications for use. e.g., (3) Limitations. [72 FR 27733, May 17, 2007, as amended at 79 FR 18158, Apr. 1, 2014; 87 FR 10968, Feb. 28, 2022; 89 FR 42357, May 15, 2024; 89 FR 85426, Oct. 28, 2024; 91 FR 20341, Apr. 16, 2026] § 520.1782 Pimobendan solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. i.e., (2) Indications for use. e.g., (3) Limitations. [89 FR 42357, May 15, 2024, as amended at 91 FR 41560, July 7, 2026] § 520.1802 Piperazine-carbon disulfide complex oral dosage forms. § 520.1802a Piperazine-carbon disulfide complex suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses and ponies Amount. (2) Indications for use. Parascaris equorum), Gastrophilus Strongyles Oxyuris equi (3) Limitations. [45 FR 52781, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014] § 520.1802b Piperazine-carbon disulfide complex boluses. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses and ponies Amount. (2) Indications for use. Parascaris equorum Strongylus Gastrophilus Oxyuris equi (3) Limitations. [45 FR 52782, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014] § 520.1802c Piperazine-carbon disulfide complex with phenothiazine suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses and ponies Amount. (2) Indications for use. Parascaris equorum Gastrophilus Strongylus (3) Limitations. [45 FR 52782, Aug. 8, 1980, as amended at 78 FR 28826, May 20, 2014] § 520.1803 Piperazine citrate capsules. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. Toxocara canis Toxascaris leonina (3) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 54 FR 38515, Sept. 19, 1989; 78 FR 28826, May 20, 2014] § 520.1805 Piperazine phosphate with thenium closylate tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. Number of Tablets at Each of the Two Doses Animal weight (lb) 375 mg 750 mg 2 but less than 5 1 2 5 but less than 10 1 1 2 10 or heavier 2 1 (2) Indications for use. Ancylostoma caninum, A. braziliense, Uncinaria stenocephala Toxocara canis (3) Limitations. [43 FR 32747, July 28, 1978, as amended at 47 FR 55476, Dec. 10, 1982; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 78 FR 28826, May 20, 2014] § 520.1806 Piperazine suspension. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use in dogs Indications for use. Toxocara canis Toxascaris leonina (2) Dosage. (3) Limitations. [70 FR 17319, Apr. 6, 2005] § 520.1840 Poloxalene. (a) Specifications. (b) Sponsors. (1) No. 054771 for use as in paragraphs (d)(1) and (d)(3) of this section. (2) No. 067949 for use as in paragraph (d)(2) of this section. (3) No. 066104 for use as in paragraph (d)(3) of this section. (c) Related tolerances. (d) Conditions of use. (2) For control of legume (alfalfa, clover) bloat in cattle. Administer, in molasses block containing 6.6 percent poloxalene, at the rate of 0.8 oz. of block (1.5 grams poloxalene) per 100 lbs. of body weight per day. (3) For prevention of legume (alfalfa, clover) and wheat pasture bloat in cattle. A 53-percent poloxalene top dressing on individual rations of ground feed. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily. If bloating conditions are severe, the dose is doubled. Treatment should be started 2 to 3 days before exposure to bloat-producing conditions. Repeat use of the drug if animals are exposed to bloat-producing conditions for more than 12 hours after the last treatment. Do not exceed the double dose in any 24-hour period. [40 FR 13838, Mar. 27, 1975, as amended at 40 FR 39857, Aug. 29, 1975; 42 FR 41854, Aug. 19, 1977; 50 FR 5385, Feb. 8, 1985; 54 FR 33501, Aug. 15, 1989; 56 FR 50653, Oct. 8, 1991; 58 FR 26523, May 4, 1993; 60 FR 55659, Nov. 2, 1995; 66 FR 47963, Sept. 17, 2001; 69 FR 62811, Oct. 28, 2004; 70 FR 32489, June 3, 2005; 78 FR 28826, May 20, 2014; 83 FR 48946, Sept. 28, 2018; 84 FR 32992, July 11, 2019] § 520.1855 Ponazuril. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Sarcocystis neurona. (3) Limitations. [66 FR 43774, Aug. 21, 2001, as amended at 79 FR 28827, May 20, 2014; 80 FR 34278, June 16, 2015; 80 FR 53459, Sept. 4, 2015; 84 FR 39183, Aug. 9, 2019] § 520.1858 Potassium bromide chewable tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [91 FR 41560, July 7, 2026] § 520.1860 Pradofloxacin. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, Staphylococcus pseudintermedius. (3) Limitations. [77 FR 76863, Dec. 31, 2012, as amended at 79 FR 28827, May 20, 2014; 86 FR 14819, Mar. 19, 2021] § 520.1870 Praziquantel tablets. (a) Specifications. (2) Each tablet contains 11.5 or 23 mg praziquantel. (3) Each chewable tablet contains 23 mg praziquantel. (b) Sponsors. (1) No. 058198 for use of product described in paragraph (a)(1) of this section as in paragraph (c)(1) of this section and for use of product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section. (2) Nos. 069043 and 086101 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1) of this section. (3) No. 086101 for use of product as described in paragraph (a)(3) of this section as in paragraph (c)(2) of this section. (c) Conditions of use Dogs Amount. 1/2 1/2 (ii) Indications for use Dipylidium caninum Taenia pisiformis. (B) For removal of the canine cestode Echinococcus granulosus, Echinococcus multilocularis. (iii) Limitations (B) If labeled for use as in paragraph (c)(1)(ii)(B) of this section: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats Indications for use. Dipylidium caninum Taenia taeniaeformis. (ii) Dosage. (iii) Limitations. [46 FR 60570, Dec. 11, 1981, as amended at 47 FR 26377, June 18, 1982; 55 FR 2234, Jan. 23, 1990; 58 FR 7864, Feb. 10, 1993; 58 FR 42853, Aug. 12, 1993; 68 FR 57351, Oct. 3, 2003; 69 FR 62181, Oct. 25, 2004; 78 FR 17596, Mar. 22, 2013; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022; 88 FR 27699, May 3, 2023; 91 FR 20342, Apr. 16, 2026] § 520.1871 Praziquantel and pyrantel. (a) Specifications. (2) Each chewable tablet contains 30 mg praziquantel and 30 mg pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate. (b) Sponsors. (1) See No. 058198 for use of tablets described in paragraph (a)(1) of this section for use as in paragraph (d)(1) of this section. (2) See No. 051311 for use of tablets described in paragraph (a)(2) of this section for use as in paragraph (d)(2) of this section. (c) Special considerations. (d) Conditions of use Cats Dosage. (ii) Indications for use. Dipylidium caninum Taenia taeniaeformis Ancylostoma tubaeforme Toxocara cati (iii) Limitations. (2) Dogs Amount. (ii) Indications for use. Toxocara canis Toxascaris leonina Ancylostoma caninum Ancylostoma braziliense Uncinaria stenocephala Dipylidium caninum Taenia pisiformis [58 FR 58652, Nov. 3, 1993, as amended at 72 FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, 2010; 86 FR 14819, Mar. 19, 2021] § 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets. (a) Specifications. (1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams pyrantel base, and 113.4 milligrams febantel; or (2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel base, and 340.2 milligrams febantel. (3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel base, and 680.4 mg febantel. (b) Sponsor. (c) Conditions of use Dogs Amount. Weight of animal Number of tablets per dose Kilograms Pounds Tablet no. 1 Tablet no. 2 Tablet no. 3 0.9 to 1.8 2 to 4 1/2 2.3 to 3.2 5 to 7 1 3.6 to 5.4 8 to 12 1 1/2 5.9 to 8.2 13 to 18 2 8.6 to 11.4 19 to 25 2 1/2 11.8 to 13.6 26 to 30 1 14.1 to 20.0 31 to 44 1 1/2 20.4 to 27.2 45 to 60 2 1 27.7 to 40.9 61 to 90 1 1/2 41.3 to 54.5 91 to 120 2 (ii) Indications for use. Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus Ancylostoma caninum, Uncinaria stenocephala Toxocara canis, Toxascaris leonina Trichuris vulpis Echinococcus multilocularis (iii) Limitations. (2) [Reserved] [59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, 2003; 71 FR 6677, Feb. 9, 2006; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022] § 520.1880 Prednisolone. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998; 79 FR 28827, May 20, 2014] § 520.1892 Pregabalin. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [89 FR 14410, Feb. 27, 2024] § 520.1900 Primidone. (a) Specifications. (b) Sponsors. (1) No. 069043 for use of 250 milligram tablets. (2) No. 054771 for use of 50 and 250 milligram tablets. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [42 FR 61594, Dec. 6, 1977, as amended at 43 FR 55386, Nov. 28, 1978; 46 FR 8467, Jan. 27, 1981; 46 FR 57477, Nov. 24, 1981; 53 FR 40727, Oct. 18, 1988; 56 FR 37473, Aug. 7, 1991; 62 FR 35076, June 30, 1997; 78 FR 21060, Apr. 9, 2013; 79 FR 28827, May 20, 2014; 83 FR 48946, Sept. 28, 2018] § 520.1920 Prochlorperazine and isopropamide. (a) Specifications. (1) 3.33 milligrams of prochlorperazine (as the dimaleate) and 1.67 milligrams of isopropamide (as the iodide); or (2) 10 milligrams of prochlorperazine (as the dimaleate) and 5 milligrams of isopropamide (as the iodide). (b) Sponsor. (c) Conditions of use in dogs Amount. (ii) Capsules described in paragraph (a)(2) of this section are given to dogs weighing 30 pounds and over at the rate of 1 capsule twice daily. (2) Indications for use. (3) Limitations. [79 FR 28827, May 20, 2014] § 520.1921 Prochlorperazine, isopropamide, and neomycin. (a) Specifications. (1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or (2) Capsule No. 3: 10 milligrams of prochlorperazine (as the dimaleate), 5 milligrams of isopropamide (as the iodide), and 75 milligrams of neomycin base (as the sulfate). (b) Sponsor. (c) Conditions of use in dogs Amount. Animal weight (pounds) Number of capsules per dose Capsule No. 1 Capsule No. 3 10 to 20 1 20 to 30 2 Over 30 3 1 Over 60 2 (2) Indications for use. (3) Limitations. [49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28827, May 20, 2014] § 520.1962 Promazine. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 28827, May 20, 2014] § 520.2002 Propiopromazine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 28827, May 20, 2014] § 520.2041 Pyrantel pamoate chewable tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use In dogs and puppies. Toxocara canis; Toxascaris leonina Ancylostoma caninum; Uncinaria stenocephala (ii) In puppies and adult dogs and in lactating bitches after whelping. To prevent reinfection of Toxocara canis. (3) Limitations. [52 FR 37937, Oct. 13, 1987, as amended at 57 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993; 66 FR 9650, Feb. 9, 2001; 67 FR 21996, May 2, 2002; 81 FR 22523, Apr. 18, 2016; 82 FR 12169, Mar. 1, 2017; 84 FR 8973, Mar. 13, 2019] § 520.2042 Pyrantel pamoate tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use. (1) Amount. (2) Indications for use. Toxocara canis Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala (3) Limitations. T. canis [43 FR 52700, Nov. 14, 1978, as amended at 49 FR 22073, May 25, 1984; 57 FR 48163, Oct. 22, 1992; 58 FR 44611, Aug. 24, 1993] § 520.2043 Pyrantel pamoate suspension. (a) Specifications. (2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg pyrantel base. (3) Each mL contains pyrantel pamoate equivalent to 4.54 mg pyrantel base. (b) Sponsors. (1) Nos. 054771, 058829, and 069043 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section. (2) Nos. 054771, 058198, and 058829 for use of the products described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section. (3) No. 023851 for use of the product described in paragraph (a)(3) as in paragraph (d)(2) of this section. (c) Special considerations. (d) Conditions of use Horses and ponies. (i) Amount. (ii) Indications for use. Strongylus vulgaris, S. edentatus, S. equinus Oxyuris equi Parascaris equorum (iii) Limitations. (2) Dogs. (i) Dogs and puppies Amount. (B) Indications for use. Toxocara canis Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala (C) Limitations. (ii) Dogs, puppies, and lactating bitches after whelping Amount. (B) Indications for use. T. canis. (C) Limitations. [67 FR 43248, June 27, 2002, as amended at 68 FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021] § 520.2044 Pyrantel pamoate paste. (a) Specifications (2) Each mL contains 226 mg pyrantel base (as pyrantel pamoate). (3) Each mL contains 171 mg pyrantel base (as pyrantel pamoate). (b) Sponsors. (1) No. 054771 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1)(i) and (d)(2) of this section. (2) No. 017135 for use of product described in paragraph (a)(2) of this section as in paragraph (d) of this section. (3) No. 061133 for use of product described in paragraph (a)(3) of this section as in paragraph (d)(1)(i) and (d)(2) of this section. (c) Special considerations. (d) Conditions of use. (1) Amounts and indications for use. Strongylus vulgaris S. edentatus S. equinus Oxyuris equi Parascaris equorum (ii) 6 mg/lb body weight as single oral dose for the removal and control of mature infections of tapeworms ( Anoplocephala perfoliata (2) Limitations. [70 FR 29447, May 23, 2005, as amended at 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 84 FR 8973, Mar. 13, 2019] § 520.2045 Pyrantel tartrate powder. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Horses Amount. (ii) Indications for use. Strongylus vulgaris, S. edentatus, S. equinus Trichonema Triodontophorus Oxyuris Parascaris (iii) Limitations. (2) Swine Amount. (ii) Indications for use. Ascaris suum Oesophagostomum (iii) Limitations. [79 FR 28827, May 20, 2014] § 520.2046 Pyrantel tartrate pellets. (a) Specifications. (2) Each gram of pellets contains 21.1 mg (2.11 percent) pyrantel tartrate. (b) Sponsors. (1) No. 054771 for use of products described in paragraph (a) as in paragraph (c) of this section. (2) No. 061133 for use of product described in paragraph (a)(1) as in paragraph (c) of this section. (c) Conditions of use in horses Amount. (2) Indications for use. Strongylus vulgaris, S. edentatus, S. equinus Trichonema Triodontophorus Oxyuris Parascaris (3) Limitations. [79 FR 28828, May 20, 2014, as amended at 84 FR 8973, Mar. 13, 2019] § 520.2075 Robenacoxib. (a) Specifications. (1) 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs; or (2) 6 mg robenacoxib for use in cats. (b) Sponsors. (1) No. 058198 for use of product described in paragraph (a)(1) and (a)(2) of this section as in paragraph (c)(1) and (c)(2) of this section. (2) No. 086117 for use of product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. [76 FR 18648, Apr. 5, 2011, as amended at 79 FR 10964, Feb. 27, 2014; 81 FR 59133, Aug. 29, 2016; 91 FR 20342, Apr. 16, 2026] § 520.2086 Sarolaner. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Ctenocephalides felis Amblyomma americanum Amblyomma maculatum Dermacentor variabilis Ixodes scapularis Rhipicephalus sanguineus Haemaphysalis longicornis Borrelia burgdorferi Ixodes scapularis (3) Limitations. [81 FR 22523, Apr. 18, 2016, as amended at 82 FR 12169, Mar. 1, 2017; 86 FR 61685, Nov. 8, 2021; 90 FR 6800, Jan. 21, 2025] § 520.2090 Sarolaner, moxidectin, and pyrantel. (a) Specifications. (1) 3.0 milligrams (mg) sarolaner, 0.06 mg moxidectin, and 12.5 mg pyrantel (as pamoate salt); (2) 6.0 mg sarolaner, 0.12 mg moxidectin, and 25.0 mg pyrantel (as pamoate salt); (3) 12.0 mg sarolaner, 0.24 mg moxidectin, and 50.0 mg pyrantel (as pamoate salt); (4) 24.0 mg sarolaner, 0.48 mg moxidectin, and 100 mg pyrantel (as pamoate salt); (5) 48.0 mg sarolaner, 0.96 mg moxidectin, and 200 mg pyrantel (as pamoate salt); or (6) 72.0 mg sarolaner, 1.44 mg moxidectin, and 300 mg pyrantel (as pamoate salt). (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Dirofilaria immitis Toxocara canis Toxascaris leonina Ancylostoma caninum Uncinaria stenocephala Ctenocephalides felis Dipylidium caninum Ctenocephalides felis Amblyomma americanum Amblyomma maculatum Dermacentor variabilis Ixodes scapularis Rhipicephalus sanguineus Haemaphysalis longicornis Borrelia burgdorferi Ixodes scapularis (3) Limitations. [85 FR 45307, July 28, 2020, as amended at 86 FR 57997, Oct. 20, 2021; 87 FR 17945, Mar. 29, 2022; 89 FR 95103, Dec. 2, 2024; 90 FR 6800, Jan. 21, 2025; 90 FR 40970, Aug. 22, 2025] § 520.2098 Selegiline. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amounts and indications for use. (ii) Administer 0.5 to 1.0 mg per kilogram of body weight once daily for the control of clinical signs associated with canine cognitive dysfunction syndrome. (2) Limitations. [79 FR 28828, May 20, 2014] § 520.2100 Selenium and vitamin E. (a) Specifications. (1) 2.19 milligrams (mg) sodium selenite (equivalent to 1 mg selenium) and 56.2 mg (68 I.U.) vitamin E as d-alpha tocopheryl acid succinate; or (2) 0.548 mg sodium selenite (equivalent to 0.25 mg selenium) and 14 mg (17 I.U.) vitamin E as d-alpha tocopheryl acid succinate. (b) Sponsor. (c) Conditions of use in dogs Amount. (ii) Dogs under 20 pounds: Administer 1 capsule described in paragraph (a)(2) per 5 pounds of body weight with a minimum of 1 capsule. Repeat at 3-day intervals until a satisfactory response is observed. Maintenance dosage is 1 capsule per 10 pounds of body weight every 3 to 7 days, or longer, as required. (2) Indications for use. (3) Limitations. [79 FR 28828, May 20, 2014] § 520.2123 Spectinomycin oral dosage forms. § 520.2123a Spectinomycin tablets. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [73 FR 6607, Feb. 5, 2008, as amended at 79 FR 28828, May 20, 2014; 84 FR 8973, Mar. 13, 2019] § 520.2123b Spectinomycin powder. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in chickens. (1) Indications for use and amounts. Mycoplasma synoviae (ii) As an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (2) Limitations. [73 FR 6607, Feb. 5, 2008, as amended at 81 FR 94990, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019] § 520.2123c Spectinomycin solution. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use in swine Amount. (2) Indications for use. E. coli (3) Limitations. [73 FR 6607, Feb. 5, 2008, as amended at 78 FR 17596, Mar. 22, 2013; 79 FR 28828, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, 2019; 88 FR 14897, Mar. 10, 2023] § 520.2130 Spinosad. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use Dogs Amount. (ii) Indications for use. Ctenocephalides felis (2) Cats Amount. (ii) Indications for use. C. felis [77 FR 60623, Oct. 4, 2012, as amended at 81 FR 48702, July 26, 2016; 87 FR 10968, Feb. 28, 2022; 89 FR 85426, Oct. 28, 2024] § 520.2134 Spinosad and milbemycin. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Ctenocephalides felis Dirofilaria immitis Ancylostoma caninum Toxocara canis Toxascaris leonina Trichuris vulpis (3) Limitations. [76 FR 12563, Mar. 8, 2011, as amended at 81 FR 48702, July 26, 2016] § 520.2138 Spironolactone and benazepril. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. e.g., (3) Limitations. [86 FR 14819, Mar. 19, 2021] § 520.2150 Stanozolol. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount Dogs: 1/2 (ii) Cats: 1/2 (2) Indications for use. (3) Limitations. [79 FR 28828, May 20, 2014] § 520.2158 Streptomycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Calves Amount. (ii) Indications for use. Escherichia coli Salmonella (iii) Limitations. (2) Swine Amount. (ii) Indications for use. Escherichia coli Salmonella (iii) Limitations. (3) Chickens Amount. (ii) Indications for use. (iii) Limitations. [57 FR 37327, Aug. 18, 1992, as amended at 58 FR 47211, Sept. 8, 1993; 63 FR 51821, Sept. 29, 1998. Redesignated and amended at 79 FR 28828, May 20, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13, 2015] § 520.2184 Sulfachloropyrazine. (a) Specifications. (b) Sponsor. (c) Related tolerance. (d) Conditions of use in chickens. (1) Amount. (2) Indications for use. (3) Limitations. [79 FR 28829, May 20, 2014, as amended at 81 FR 94990, Dec. 27, 2016] § 520.2200 Sulfachlorpyridazine. (a) Specifications. (2) Each milliliter (mL) of suspension contains 50 milligrams (mg) of sodium sulfachlorpyridazine. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (1) Calves Amount. (ii) Indications for use. Escherichia coli (iii) Limitations. (2) Swine Amount. (ii) Indications for use. E. coli (iii) Limitations. [75 FR 10166, Mar. 5, 2010, as amended at 79 FR 28829, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016; 88 FR 27699, May 3, 2023] § 520.2215 Sulfadiazine/pyrimethamine suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Sarcocystis neurona. (3) Limitations. [69 FR 70054, Dec. 2, 2004, as amended at 73 FR 53686, Sept. 17, 2008; 75 FR 69586, Nov. 15, 2010] § 520.2218 Sulfamerazine, sulfamethazine, and sulfaquinoxaline powder. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Chickens Amounts and indications for use. Eimeria tenella E. necatrix (B) As an aid in the control of acute fowl cholera caused by Pasteurella multocida (ii) Limitations. (2) Turkeys Amounts and indications for use. Eimeria meleagrimitis E. adenoeides (B) As an aid in the control of acute fowl cholera caused by Pasteurella multocida (ii) Limitations. [71 FR 13001, Mar. 14, 2006, as amended at 79 FR 28829, May 20, 2014; 80 FR 34278, June 16, 2015; 81 FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016; 85 FR 18119, Apr. 1, 2020] § 520.2220 Sulfadimethoxine oral dosage forms. § 520.2220a Sulfadimethoxine oral solution and soluble powder. (a) Specifications. (2) Each 107 grams of powder contains the equivalent of 94.6 grams sulfadimethoxine as sulfadimethoxine sodium. (b) Sponsors. (1) Nos. 016592, 054771, 054925, and 069043 for use of the product described in paragraph (a)(1) of this section. (2) Nos. 016592, 054771, 054925, 058829, 061133, and 066104 for use of the product described in paragraph (a)(2) of this section. (c) Related tolerances. (d) Conditions of use Broiler and replacement chickens Amount. (ii) Indications for use. (iii) Limitations. (2) Turkeys Amount. (ii) Indications for use. (iii) Limitations. (3) Cattle Amount. (ii) Indications for use. Pasteurella Fusobacterium necrophorum Sphaerophorus necrophorus (iii) Limitations. [79 FR 28829, May 20, 2014, as amended at 81 FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019; 87 FR 10968, Feb. 28, 2022] § 520.2220b Sulfadimethoxine suspension. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 28829, May 20, 2014, as amended at 88 FR 55564, Aug. 16, 2023] § 520.2220c Sulfadimethoxine tablet. (a) Specifications. (b) Sponsors. (c) [Reserved] (d) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 28829, May 20, 2014, as amended at 88 FR 55564, Aug. 16, 2023] § 520.2220d Sulfadimethoxine bolus. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Pasteurella Fusobacterium necrophorum (3) Limitations. [79 FR 28829, May 20, 2014, as amended at 88 FR 16547, Mar. 20, 2023] § 520.2220e Sulfadimethoxine extended-release bolus. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in beef cattle and non-lactating dairy cattle Amount. (2) Indications for use. Pasteurella Fusobacterium necrophorum (3) Limitations. [79 FR 28830, May 20, 2014] § 520.2220f Sulfadimethoxine and ormetoprim tablet. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications of use. Staphylococcus aureus Escherichia coli E. coli, Staphylococcus Proteus mirabilus (3) Limitations. [79 FR 28830, May 20, 2014] § 520.2240 Sulfaethoxypyridazine. § 520.2240a Sulfaethoxypyridazine solution. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Swine Amount. (ii) Indications for use. Salmonella choleraesuis (iii) Limitations. (2) Cattle Amount. (ii) Indications for use. (iii) Limitations. [79 FR 28830, May 20, 2014] § 520.2240b Sulfaethoxypyridazine tablets. (a) Specifications. (2) Each extended-release tablet contains 5 grams sulfaethoxypyridazine. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle 2.5- or 15-gram tablets Amount. (ii) Indications for use. (iii) Limitations. (2) 15-gram extended-release tablets Amount. (ii) Indications for use. E. coli, Streptococci, Staphylococci, Sphaerophorus necrophorus Pasteurella (iii) Limitations. [79 FR 28830, May 20, 2014] § 520.2260 Sulfamethazine oral dosage forms. § 520.2260a Sulfamethazine oblets and boluses. (a) Specifications. (1) 2.5, 5, or 15 grams sulfamethazine. (2) 5 grams sulfamethazine. (b) Sponsors. (1) No. 016592 for use of products described in paragraph (a)(1) of this section. (2) No. 054771 for use of product described in paragraph (a)(2) of this section. (c) Related tolerances. (d) Conditions of use. (i) Amount. (ii) Indications for use Beef cattle and nonlactating dairy cattle. Pasteurella Escherichia coli Fusobacterium necrophorum Fusobacterium necrophorum Streptococcus Streptococcus Eimeria bovis E. zurnii (B) Horses. Pasteurella Streptococcus Escherichia coli (iii) Limitations. (2) Boluses described in paragraph (a)(2) of this section: (i) Amount. (ii) Indications for use Ruminating beef and dairy calves. Escherichia coli; Fusobacterium necrophorum; Pasteurella Eimeria bovis E. zurnii. (B) [Reserved] (iii) Limitations. [87 FR 58961, Sept. 29, 2022, as amended at 88 FR 14897, Mar. 10, 2023; 88 FR 16547, Mar. 20, 2023] § 520.2260b Sulfamethazine sustained-release boluses. (a) Related tolerances. (b) [Reserved] (c)(1) Sponsor. (2) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. (d)(1) Sponsor. (2) Conditions of use Amount. (ii) Indications for use. Pasteurella E. coli, Fusobacterium necrophorum, Streptococcus (iii) Limitations. (e) [Reserved] (f)(1) Sponsor. (2) Conditions of use Amount. (ii) Indications for use. Pasteurella E. coli Fusobacterium necrophorum (iii) Limitations. (g)(1) Sponsor. (2) Conditions of use Amount. (ii) Indications for use. Pasteurella Pasteurell Fusobacterium necrophorum Escherichia coli Eimeria bovis E. zurnii Streptococcus (iii) Limitations. [46 FR 36132, July 14, 1981, as amended at 48 FR 18803, Apr. 26, 1983; 48 FR 32760, July 19, 1983; 49 FR 29057, July 18, 1984; 50 FR 49372, Dec. 2, 1985; 51 FR 30212, Aug. 25, 1986; 53 FR 40727, Oct. 18, 1988; 54 FR 14341, Apr. 11, 1989; 55 FR 8462, Mar. 8, 1990; 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 35076, June 30, 1997; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 70 FR 8290, Feb. 18, 2005; 78 FR 17596, Mar. 22, 2013; 79 FR 28830, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 84 FR 8973, Mar. 13, 2019; 85 FR 18119, Apr. 1, 2020; 86 FR 14819, Mar. 19, 2021; 87 FR 10969, Feb. 28, 2022; 88 FR 55564, Aug. 16, 2023] § 520.2260c Sulfamethazine sustained-release tablets. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. Pasteurella Escherichia coli; Fusobacterium necrophorum. (3) Limitations. [48 FR 26763, June 10, 1983, as amended at 56 FR 50653, Oct. 8, 1991; 59 FR 22754, May 3, 1994; 61 FR 4875, Feb. 9, 1996; 79 FR 28830, May 20, 2014] § 520.2261 Sulfamethazine sodium oral dosage forms. § 520.2261a Sulfamethazine solution. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. (i) Beef and nonlactating dairy cattle. Pasteurella Escherichia coli Fusobacterium necrophorum Fusobacterium necrophorum Streptococcus Streptococcus (ii) Swine. Escherichia coli Pasteurella (iii) Chickens and turkeys. Avibacterium paragallinarum Eimeria tenella, Eimeria necatrix Pasteurella multocida Salmonella Eimeria meleagrimitis, Eimeria adenoeides (3) Limitations. [47 FR 25322, June 11, 1982, as amended at 47 FR 25735, June 15, 1982; 67 FR 78355, Dec. 24, 2002; 70 FR 32489, June 3, 2005; 74 FR 36112, July 22, 2009; 75 FR 10166, Mar. 5, 2010; 76 FR 17337, Mar. 29, 2011; 79 FR 28831, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 36789, June 8, 2016; 81 FR 94990, Dec. 27, 2016] § 520.2261b Sulfamethazine powder. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use Chickens Amount. (ii) Indications for use. Avibacterium paragallinarum Eimeria tenella, E. necatrix Pasteurella multocida Salmonella (iii) Limitations. (2) Turkeys Amount. (ii) Indications for use. E. meleagrimitis E. adenoeides (iii) Limitations. (3) Swine Amount. (ii) Indications for use. E. coli Pasteurella (iii) Limitations. (4) Cattle Amount. (ii) Indications for use in beef and nonlactating dairy cattle. Pasteurella E. coli Fusobacterium necrophorum F. necrophorum Streptococcus Streptococcus (iii) Limitations. [71 FR 70303, Dec. 4, 2006, as amended at 75 FR 10166, Mar. 5, 2010; 79 FR 28831, May 20, 2014; 80 FR 61296, Oct. 13, 2015; 81 FR 17607, Mar. 30, 2016; 81 FR 94990, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019] § 520.2280 Sulfamethizole and methenamine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 50 FR 13561, Apr. 5, 1985; 79 FR 28831, May 20, 2014] § 520.2325 Sulfaquinoxaline oral dosage forms. § 520.2325a Sulfaquinoxaline powder and solution. (a) Sponsor. (1) To No. 016592 for use of a 25-percent sulfaquinoxaline soluble powder and a 20-percent sulfaquinoxaline sodium solution as provided for in paragraph (c) of this section. (2) To Nos. 016592 and 054771 for use of a 31.92-percent sulfaquinoxaline solution (sodium and potassium salts) as provided for in paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii) of this section. (3) No. 054771 for use of a 28.62-percent sulfaquinoxaline sodium solution as provided in paragraphs (c)(1), (c)(2), and (c)(3) of this section. (b) Related tolerances. (c) Conditions of use. (1) Chickens. Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti. (ii) Administer at the 0.04 percent level for 2 or 3 days, skip 3 days then administer at the 0.025 percent level for 2 more days. If bloody droppings appear, repeat treatment at the 0.025 percent level for 2 more days. Do not change litter unless absolutely necessary. Do not give flushing mashes. (2) Turkeys. Eimeria meleagrimitis E. adenoeides. (ii) Administer at the 0.025 percent level for 2 days, skip 3 days, give for 2 days, skip 3 days and give for 2 more days. Repeat if necessary. Do not change litter unless absolutely necessary. Do not give flushing mashes. (3) Chickens and turkeys. Pasteurella multocida Salmonella gallinarum (ii) Administer at the 0.04 percent level for 2 or 3 days. Move birds to clean ground. If disease recurs, repeat treatment. If cholera has become established as the respiratory or chronic form, use feed medicated with sulfaquinoxaline. Poultry which have survived typhoid outbreaks should not be kept for laying house replacements or breeders unless tests show they are not carriers. (4) Cattle and calves. Eimeria bovis E. zurnii. (ii) Administer at the 0.015-percent level for 3 to 5 days in drinking water medicated with sulfaquinoxaline solution. (iii) In lieu of treatment as provided in paragraph (c)(4)(ii) of this section, administer 1 teaspoon of 25 percent sulfaquinoxaline soluble powder per day for each 125 pounds of body weight for 3 to 5 days in drinking water. (d) Limitations. [48 FR 3964, Jan. 28, 1983, as amended at 48 FR 26762, June 10, 1983; 55 FR 29843, July 23, 1990; 59 FR 28769, June 3, 1994; 59 FR 33197, June 28, 1994; 61 FR 24443, May 15, 1996; 61 FR 63711, Dec. 2, 1996; 62 FR 37712, July 15, 1997; 65 FR 10705, Feb. 29, 2000; 69 FR 41427, July 9, 2004; 69 FR 60547, Oct. 12, 2004; 74 FR 36112, July 22, 2009; 78 FR 17596, Mar. 22, 2013; 79 FR 28831, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 36789, June 8, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 94990, Dec. 27, 2016; 87 FR 58962, Sept. 29, 2022] § 520.2325b Sulfaquinoxaline drench. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Eimeria bovis E. zuernii. (3) Limitations. [79 FR 28831, May 20, 2014, as amended at 82 FR 12169, Mar. 1, 2017; 84 FR 32992, July 11, 2019; 84 FR 53310, Oct. 7, 2019] § 520.2330 Sulfisoxazole tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [43 FR 60895, Dec. 29, 1978, as amended at 79 FR 28831, May 20, 2014; 87 FR 76421, Dec. 14, 2022] § 520.2335 Telmisartan. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [83 FR 64740, Dec. 18, 2018] § 520.2340 Tepoxalin. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [68 FR 34795, June 11, 2003] § 520.2345 Tetracycline. § 520.2345a Tetracycline capsules. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. E. coli Staphylococcus E. coli. (3) Limitations. [70 FR 50182, Aug. 26, 2005, as amended at 73 FR 18442, Apr. 4, 2008; 79 FR 28831, May 20, 2014] § 520.2345b Tetracycline tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use. Dogs Amount. (2) Indications for use. E. coli Staphylococcus E. coli. (3) Limitations. [57 FR 37327, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] § 520.2345c Tetracycline boluses. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. Calves Amount. (i) Indications for use. E. coli Pasteurella Hemophilus Klebsiella (ii) Limitations. (2) Amount. (i) Indications for use. E. coli, (ii) Limitations. [57 FR 37328, Aug. 18, 1992, as amended at 67 FR 78355, Dec. 24, 2002; 79 FR 28831, May 20, 2014; 81 FR 67151, Sept. 30, 2016] § 520.2345d Tetracycline powder. (a) Specifications. (b) Sponsors. (1) No. 054771: 25 grams per pound as in paragraphs (d)(3) and (d)(4) of this section. (2) No. 066104: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section. (3) Nos. 016592 and 054771: 25, 102.4, and 324 grams per pound as in paragraph (d) of this section. (4) Nos. 016592, 054925, 061133, and 076475: 324 grams per pound as in paragraph (d) of this section. (5) No. 016592: 25 grams per pound as in paragraphs (d)(1) and (d)(2) of this section. (c) Related tolerances. (d) Conditions of use. (1) Calves Amount. (ii) Indications for use. Escherichia coli Pasteurella Actinobacillus pleuropneumoniae (Haemophilus Klebsiella (iii) Limitations. (2) Swine Amount. (ii) Indications for use. E. coli Pasteurella A. pleuropneumoniae (Haemophilus Klebsiella (iii) Limitations. (3) Chickens Amount. (ii) Indications for use. Mycoplasma gallisepticum E. coli M. synoviae (iii) Limitations. (4) Turkeys Amount. (ii) Indications for use. M. synoviae (iii) Limitations. [59 FR 17693, Apr. 14, 1994, as amended at 59 FR 19133, Apr. 22, 1994; 62 FR 5319, Feb. 5, 1997; 62 FR 35076, June 30, 1997; 62 FR 46668, Sept. 4, 1997; 62 FR 55160, Oct. 23, 1997; 64 FR 37673, July 13, 1999; 67 FR 78355, Dec. 24, 2002; 70 FR 16934, Apr. 4, 2005; 70 FR 67353, Nov. 7, 2005; 71 FR 13542, Mar. 16, 2006; 75 FR 10166, Mar. 5, 2010; 75 FR 12981, Mar. 18, 2010; 76 FR 17338, Mar. 29, 2011; 77 FR 20988, Apr. 9, 2012; 78 FR 21060, Apr. 9, 2013; 79 FR 28831, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 81 FR 22523, Apr. 18, 2016; 81 FR 94990, Dec. 27, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019; 91 FR 20342, Apr. 16, 2026 § 520.2345e Tetracycline solution. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. Escherichia coli Staphylococcus E. coli. (iii) Limitations. (2) Dogs and cats Amount. (ii) Indications for use. E. coli Staphylococcus E. coli. (iii) Limitations. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] § 520.2345f Tetracycline phosphate complex and sodium novobiocin capsules. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Staphylococcus Escherichia coli. (3) Limitations. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] § 520.2345g Tetracycline hydrochloride and sodium novobiocin tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Staphylococcus Escherichia coli. (3) Limitations. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28831, May 20, 2014] § 520.2345h Tetracycline hydrochloride, sodium novobiocin, and prednisolone tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Staphylococcus Escherichia coli, (3) Limitations. [57 FR 37329, Aug. 18, 1992, as amended at 79 FR 28832, May 20, 2014] § 520.2362 Thenium closylate. (a) Specifications. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Ancylostoma caninum Uncinaria stenocephala (3) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 41 FR 53477, Dec. 7, 1976; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 79 FR 28832, May 20, 2014] § 520.2382 Thiabendazole and triclorfon. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Gasterophilus Strongylus Cyathostomum, Cylicobrachytus, Craterostomum, Oesophagodontus, Poteriostomum Oxyuris Strongyloides Parascaris (3) Limitations. [40 FR 23071, May 28, 1975, as amended at 48 FR 48229, Oct. 18, 1983; 79 FR 28832, May 20, 2014. Redesignated at 84 FR 39183, Aug. 9, 2019. Redesignated at 88 FR 27699, May 3, 2023] § 520.2455 Tiamulin. (a) Specifications. (2) Each milliliter (mL) of solution contains 125 mg (12.5 percent) tiamulin hydrogen fumarate. (3) Each mL of solution contains 123 mg (12.3 percent) tiamulin hydrogen fumarate. (b) Sponsors. (1) No. 058198 for products described in paragraph (a) of this section. (2) No. 066104 for products described in paragraphs (a)(1) and (3) of this section. (3) Nos. 016592, 051072, 051311, and 061133 for product described in paragraph (a)(2) of this section. (c) Related tolerances. (d) Conditions of use in swine Amounts and indications for use. (i) 3.5 mg per (/) lb of body weight daily for treatment of swine dysentery associated with Brachyspira hyodysenteriae (ii) 10.5 mg/lb of body weight daily for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae (2) Limitations. [70 FR 75017, Dec. 19, 2005, as amended at 74 FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, Mar. 22, 2013; 80 FR 13229, Mar. 13, 2015; 85 FR 18119, Apr. 1, 2020; 87 FR 17945, Mar. 29, 2022; 87 FR 58962, Sept. 29, 2022; 90 FR 40970, Aug. 22, 2025] § 520.2471 Tilmicosin. (a) Specifications. (b) Sponsors. (c) Tolerances. (d) Conditions of use in swine Amount. (2) Indications for use. Pasteurella multocida Haemophilus parasuis (ii) For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae (3) Limitations. [79 FR 18158, Apr. 1, 2014, as amended at 81 FR 17608, Mar. 30, 2016; 81 FR 48702, July 26, 2016; 87 FR 58962, Sept. 29, 2022] § 520.2473 Tioxidazole oral dosage forms. § 520.2473a Tioxidazole granules. (a) Specifications. (b) Sponsor. (c) Conditions of use Horses Amount. (ii) Indications for use. Strongylus edentatus, S. equinus, S. vulgaris Parascaris equorum Oxyuris equi Triodontophorus (iii) Limitations. (2) [Reserved] [50 FR 52772, Dec. 26, 1985; 51 FR 2693, Jan. 21, 1986, as amended at 52 FR 7832, Mar. 13, 1987] § 520.2473b Tioxidazole paste. (a) Specifications. (b) Sponsor. (c) Conditions of use Horses Amount. (ii) Indications for use. Strongylus edentatus, S. equinus, S. vulgaris Parascaris equorum Oxyuris equi Triodontophorus (iii) Limitations. (2) [Reserved] [52 FR 43059, Nov. 9, 1987] § 520.2475 Toceranib. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) [Reserved] [74 FR 28875, June 18, 2009, as amended at 79 FR 28832, May 20, 2014] § 520.2520 Trichlorfon oral dosage forms. § 520.2520a Trichlorfon and atropine. (a) Specifications. (2) For atropine: Atropine N.F. (b) Sponsor. (c) Conditions of use in mice Amount. (2) Indications for use. Syphacia obvelata (3) Limitations. [79 FR 28832, May 20, 2014] § 520.2520b Trichlorfon boluses. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Gastrophilus nasalis, Gastrophilus intestinalis Strongylus vulgaris Parascaris equorum Oxyuris equi (3) Limitations. [45 FR 48127, July 18, 1980. Redesignated and amended at 79 FR 28833, May 20, 2014] § 520.2520c Trichlorfon granules. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Gastrophilus nasalis, Gastrophilus intestinalis Parascaris equorum Oxyuris equi (3) Limitations. [45 FR 48128, July 18, 1980. Redesignated and amended at 79 FR 28833, May 20, 2014] § 520.2520d Trichlorfon, phenothiazine, and piperazine. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. Gastrophilus nasalis, Gastrophilus intestinalis Strongylus vulgaris Parascaris equorum Oxyuris equi (3) Limitations. [48 FR 2757, Jan. 21, 1983. Redesignated and amended at 79 FR 28833, May 20, 2014; 85 FR 4208, Jan. 24, 2020] Editorial Note: At 79 FR 28833, May 20, 2014, § 520.2520d was amended in part by redesignating paragraph (e) as (c). This action could not be performed because paragraph (e) did not exist. § 520.2582 Triflupromazine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 28833, May 20, 2014] § 520.2598 Trilostane. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [74 FR 21767, May 11, 2009, as amended at 74 FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, 2015; 87 FR 58962, Sept. 29, 2022; 89 FR 85426, Oct. 28, 2024] § 520.2604 Trimeprazine and prednisolone tablets. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. 1/2 (2) Indications for use. (3) Limitations. [79 FR 28833, May 20, 2014, as amended at 87 FR 10969, Feb. 28, 2022; 89 FR 85426, Oct. 28, 2024] § 520.2605 Trimeprazine and prednisolone capsules. (a) Specifications. (1) 3.75 milligrams (mg) trimeprazine in sustained released form (as trimeprazine tartrate) and 1 mg prednisolone (Capsule No. 1); or (2) 7.5 mg trimeprazine in sustained release form (as trimeprazine tartrate) and 2 mg prednisolone (Capsule No. 2). (b) Sponsor. (c) Conditions of use in dogs Amount. (i) For dogs weighing up to 10 pounds: one Capsule No. 1; (ii) For dogs weighing 11 to 20 pounds, one Capsule No. 2 or two Capsule No. 1; (iii) For dogs weighing 21 to 40 pounds, two Capsule No. 2 or four Capsule No. 1; and (iv) For dogs weighing over 40 pounds, three Capsule No. 2 or six Capsule No. 1. After 4 days, the dosage is reduced to approximately 1/2 (2) Indications for use. (3) Limitations. [79 FR 28833, May 20, 2014] § 520.2610 Trimethoprim and sulfadiazine tablets. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 28833, May 20, 2014] § 520.2611 Trimethoprim and sulfadiazine paste. (a) Specifications. (b) Sponsors. (1) No. 054771 for product administered as in paragraph (c)(1)(i) of this section. (2) No. 000061 for product administered as in paragraph (c)(1)(ii) of this section. (c) Conditions of use in horses Amount. (i) 5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight per day. (ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfadiazine) per 110 pounds (50 kilograms) of body weight per day. (2) Indications for use. (3) Limitations. [71 FR 30802, May 31, 2006, as amended at 79 FR 28834, May 20, 2014] § 520.2612 Trimethoprim and sulfadiazine suspension. (a) Specifications. (1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or (2) 400 mg combined active ingredients (67 mg trimethoprim and 333 mg sulfadiazine). (b) Sponsors. (1) No. 000061 for use of product described in paragraph (a)(1) for use as in paragraph (c)(1) of this section. (2) No. 051072 for use of product described in paragraph (a)(2) for use as in paragraph (c)(2) of this section. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Horses Amount. (ii) Indications for use. Streptococcus equi zooepidemicus. (iii) Limitations. [78 FR 63872, Oct. 25, 2013, as amended at 85 FR 4208, Jan. 24, 2020] § 520.2613 Trimethoprim and sulfadiazine powder. (a) Specifications. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [58 FR 36135, July 6, 1993, as amended at 64 FR 68289, Dec. 7, 1999; 79 FR 28834, May 20, 2014; 79 FR 64116, Oct. 28, 2014] § 520.2640 Tylosin. (a) Specifications. (1) 100 grams (g) tylosin base, or (2) 256 g tylosin base. (b) Sponsors. (1) Nos. 016592 and 058198 for use of the 100-g container as in paragraph (e) of this section (2) No. 061133 for use of the 100-or 256-g container as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section. (3) No. 061133 for use of a 100-g container as in paragraphs (e)(1)(i)(B) and (e)(1)(ii) of this section. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Chickens Amounts and indications for use. Mycoplasma gallisepticum M. gallisepticum Mycoplasma synoviae (B) Administer 851 to 1,419 mg/gallon (225 to 375 ppm) for 5 days for the control of mortality caused by necrotic enteritis associated with Clostridium perfringens (ii) Limitations. (2) Turkeys Amount. (ii) Indications for use. Mycoplasma gallisepticum. (iii) Limitations. (3) Swine Amount. (ii) Indications for use. Brachyspira hyodysenteriae Lawsonia intracellularis (B) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae. (iii) Limitations. c (4) Honey bees Amount. (ii) Indications for use. Paenibacillus larvae (iii) Limitations. [40 FR 13838, Mar. 27, 1975, as amended at 50 FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, May 9, 2003; 70 FR 69439, Nov. 16, 2005; 73 FR 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010; 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 34278, June 16, 2015; 83 FR 14587, Apr. 5, 2018; 84 FR 8973, Mar. 13, 2019; 84 FR 32992, July 11, 2019; 87 FR 76421, Dec. 14, 2022; 88 FR 16547, Mar. 20, 2023] § 520.2645 Tylvalosin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in swine Amount. (2) Indications for use. Lawsonia intracellularis Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, Mycoplasma hyopneumoniae (3) Limitations. [77 FR 55415, Sept. 10, 2012, as amended at 83 FR 13635, Mar. 30, 2018; 86 FR 57997, Oct. 20, 2021; 89 FR 14410, Feb. 27, 2024] § 520.2654 Velagliflozin. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [88 FR 84700, Dec. 6, 2023] § 520.2700 Verdinexor tablets. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [91 FR 20342, Apr. 16, 2026, as amended at 91 FR 41560, July 7, 2026]

21 CFR Part 520 — Oral Dosage Form New Animal Drugs

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