ORAL DOSAGE FORM NEW ANIMAL DRUGS

• Citation: 21 CFR Part 520
• Sections: 285

§ 520.23 Acepromazine.

(a) Specifications. Each tablet contains 10 or 25 milligrams (mg) acepromazine maleate.

(b) Sponsors. See Nos. 000010 and 086117 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Dogs —(i) Amount. 0.25 to 1.0 mg per pound (/lb) body weight orally.

(ii) Indications for use. As an aid in tranquilization and as a preanesthetic agent.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats —(i) Amount. 0.5 to 1.0 mg/lb body weight orally.

(ii) Indications for use. As a tranquilizer.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.28 Acetazolamide.

(a) Specifications. A powder containing acetazolamide sodium, USP equivalent to 25 percent acetazolamide activity.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. Administer orally at a dosage of 5 to 15 milligrams per pound of body weight daily.

(2) Indications for use. As an aid in the treatment of mild congestive heart failure and for rapid reduction of intraocular pressure.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.35 Afoxolaner, moxidectin, and pyrantel.

(a) Specifications. Each chewable tablet contains:

(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. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Amount. Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel. For heartworm disease prevention, give once monthly for at least 6 months after last exposure to mosquitoes.

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), and Haemaphysalis longicornis (longhorned tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.38a Albendazole suspension.

(a) Specifications. Each milliliter of suspension contains 45.5 milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.

(b) Sponsor. See No. 054771 in § 510.600 of this chapter.

(c) Related tolerances. See § 556.34 of this chapter.

(d) Special considerations. See § 500.25 of this chapter.

(e) Conditions of use —(1) Cattle. Administer 11.36 percent suspension:

(i) Amount. 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For removal and control of adult liver flukes ( Fasciola hepatica ); heads and segments of tapeworms ( Moniezia benedeni and M. expansa ); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae ( Ostertagia ostertagi ), barberpole worm ( Haemonchus contortus and H. placei ), small stomach worm ( Trichostrongylus axei )); adult and 4th stage larvae of intestinal worms (thread-necked intestinal worm ( Nematodirus spathiger and N. helvetianus ), small intestinal worm ( Cooperia punctata and C. oncophora )); adult stages of intestinal worms (hookworm ( Bunostomum phlebotomum ), bankrupt worm ( Trichostrongylus colubriformis ), nodular worm ( Oesophagostomum radiatum )); adult and 4th stage larvae of lungworms ( Dictyocaulus viviparus ).

(iii) Limitations. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls.

(2) Sheep. Administer 4.45 or 11.36 percent suspension:

(i) Amount. 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For removal and control of adult liver flukes ( Fasciola hepatica and Fascioloides magna ); heads and segments of common tapeworms ( Moniezia expansa ) and fringed tapeworm ( Thysanosoma actinioides ); adult and fourth stage larvae of stomach worms (brown stomach worm ( Ostertagia circumcinta and Marshallagia marshalli ), barberpole worm ( Haemonchus contortus ), small stomach worm ( Trichostrongylus axei )); adult and fourth stage larvae of intestinal worms (thread-necked intestinal worm ( Nematodirus spathiger and N. filicollis ), Cooper's worm ( Cooperia oncophora ), bankrupt worm ( Trichostrongylus colubriformis ), nodular worm ( Oesophagostomum columbianum ), and large-mouth bowel worm ( Chabertia ovina )); adult and larval stages of lungworms ( Dictyocaulus filaria ).

(iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to ewes during first 30 days of pregnancy or for 30 days after removal of rams.

(3) Goats. Administer 11.36 percent suspension:

(i) Amount. 4.54 mg/lb body weight (10 mg/kg) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For the treatment of adult liver flukes ( Fasciola hepatica ) in nonlactating goats.

(iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to does during the first 30 days of pregnancy or for 30 days after removal of bucks.

§ 520.38b Albendazole paste.

(a) Specifications. The product contains 30 percent albendazole.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.34 of this chapter.

(d) Conditions of use in cattle —(1) Amount. Equivalent to 4.54 milligrams per 1 pound of body weight (10 milligrams per kilogram).

(2) Indications for use. For removal and control of the following internal parasites of cattle: adult liver flukes ( Fasciola hepatica ); heads and segments of tapeworms ( Moniezia benedeni, M. expansa ); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae ( Ostertagia ostertagi ); barberpole worm ( Haemonchus contortus, H. placei ); small stomach worm ( Trichostrongylus axei )); adult and 4th stages larvae of intestinal worms (thread-necked intestinal worm ( Nematodirus spathiger, N. helvetianus ); small intestinal worm ( Cooperia punctata and C. oncophora )); adult stages of intestinal worms (hookworm ( Bunostomum phlebotmum ); bankrupt worm ( Trichostrongylus colubriformis ), nodular worm ( Oesophagostomum radiatum )); adult and 4th stage larvae of lungworms ( Dictyocaulus viviparus ).

(3) Limitations. Administer as a single oral dose. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age. Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

§ 520.43 Afoxolaner.

(a) Specifications. Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Amount. Administer orally once a month at a minimum dosage of 1.14 mg/pound (2.5 mg/kilogram).

(2) Indications for use. Kills adult fleas and for the treatment and prevention of flea infestations ( Ctenocephalides felis ); and the treatment and control of Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), Amblyomma americanum (lone star tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.48 Altrenogest.

(a) Specifications. Each milliliter (mL) of solution contains 2.2 milligrams (mg) altrenogest.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter:

(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. 013744 for use as in paragraph (d)(2) of this section.

(c) Tolerances. See § 556.36 of this chapter.

(d) Conditions of use—(1) Horses —(i) Amount. 1.0 mL per 110 pounds body weight (0.044 mg/kg) daily for 15 consecutive days.

(ii) Indications for use. For suppression of estrus in mares.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Swine —(i) Amount. Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days by top-dressing on a portion of each gilt's daily feed.

(ii) Indications for use. For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.

(iii) Limitations. Do not use in gilts having a previous or current history of uterine inflammation (i.e., acute, subacute or chronic endometritis). Gilts must not be slaughtered for human consumption for 21 days after the last treatment.

§ 520.62 Aminopentamide.

(a) Specifications. Each tablet contains 0.2 milligram (mg) aminopentamide hydrogen sulphate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats —(1) Amount. Administer orally every 8 to 12 hours as follows: For animals weighing up to 10 pounds (lbs): 0.1 mg; for animals weighing 11 to 20 lbs: 0.2 mg; for animals weighing 21 to 50 lbs: 0.3 mg; for animals weighing 51 to 100 lbs: 0.4 mg; for animal weighing over 100 lbs: 0.5 mg. Dosage may be gradually increased up to a maximum of five times the suggested dosage. Oral administration of tablets may be preceded by subcutaneous or intramuscular use of the injectable form of the drug.

(2) Indications for use. For the treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.82a Aminopropazine.

(a) Specifications. Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats —(1) Amount. Administer orally at a dosage of 1 to 2 milligrams per pound of body weight, repeated every 12 hours as indicated.

(2) Indications for use. For reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.82b Aminopropazine and neomycin.

(a) Specifications. Each tablet contains aminopropazine fumarate equivalent to 25 percent aminopropazine base and neomycin sulfate equivalent to 50 milligrams (mg) of neomycin base.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. Administer orally at a dosage of 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated.

(2) Indications for use. For control of bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.88a Amoxicillin trihydrate film-coated tablets.

(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Dogs —(i) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days.

(ii) Indications for use. Treatment of infections of the respiratory tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), gastrointestinal tract (bacterial gastroenteritis), and soft tissues (abscesses, lacerations, wounds), caused by susceptible strains of Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats —(i) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days.

(ii) Indications for use. Treatment of infections caused by susceptible organisms as follows: upper respiratory tract due to S. aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, and wounds) due to S. aureus, Streptococcus spp., E. coli, and Pasteurella multocida.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.88b Amoxicillin trihydrate for oral suspension.

(a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(1) Conditions of use —(i) Dogs —(A) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days.

(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract (bacterial gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis.

(C) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(ii) Cats —(A) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days.

(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: upper respiratory tract due to Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida.

(C) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

(c) Sponsors. See Nos. 000856 and 051311 in § 510.600(c) of this chapter.

(1) Conditions of use. Dogs —(i) Amount. Administer orally 5 mg/lb of body weight, twice a day for 5 to 7 days.

(ii) Indications for use. Treatment of bacterial dermatitis due to S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus spp.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

§ 520.88c Amoxicillin trihydrate oral suspension.

(a) Specifications. Each 0.8-milliliter dose contains amoxicillin trihydrate equivalent to 40 milligrams (mg) amoxicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.38 of this chapter.

(d) Conditions of use in swine —(1) Amount. Administer 40 mg orally twice a day using a dosing pump. Treat animals for 48 hours after all symptoms have subsided but not beyond 5 days.

(2) Indications for use. Treatment of baby pigs under 10 pounds for porcine colibacillosis caused by Escherichia coli susceptible to amoxicillin.

(3) Limitations. Do not slaughter during treatment or for 15 days after latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.88d Amoxicillin trihydrate soluble powder.

(a) Specifications. Each gram of powder contains amoxicillin trihydrate equivalent to 115.4 milligrams (mg) amoxicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.38 of this chapter.

(d) Conditions of use in preruminating calves including veal calves —(1) Amount. Administer 400 mg per 100 pounds of body weight twice daily by drench or in milk. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days.

(2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves.

(3) Limitations. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian

§ 520.88e Amoxicillin trihydrate boluses.

(a) Specifications. Each bolus contains amoxicillin trihydrate equivalent to 400 milligrams (mg) amoxicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.38 of this chapter.

(d) Conditions of use in cattle —(1) Amount. Administer 400 mg per 100 pounds of body weight twice daily. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days.

(2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves.

(3) Limitations. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.88f Amoxicillin trihydrate tablets.

(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 200, or 400 milligrams (mg) amoxicillin.

(b) Sponsors. See Nos. 051311 and 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. Administer 5 mg per pound of body weight twice daily for 5 to 7 days or 48 hours after all symptoms have subsided.

(2) Indications for use. For treatment of bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and Escherichia coli; and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Enterococcus faecalis, E. coli, Proteus mirabilis, and Staphylococcus spp.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.88g Amoxicillin and clavulanate potassium tablets.

(a) Specifications. Each tablet or chewable tablet contains amoxicillin and clavulanate potassium equivalent to 50 milligrams (mg) amoxicillin and 12.5 mg clavulanic acid, 100 mg amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter:

(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 —(1) Dogs —(i) Amount. 6.25 milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days.

(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and E. coli. Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats —(i) Amount. 62.5 milligrams (50 milligrams amoxicillin and 12.5 milligrams clavulanic acid) twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days.

(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspension.

(a) Specifications. When constituted, each milliliter (mL) of suspension contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg clavulanic acid.

(b) Sponsors. See Nos. 017033, 054771, and 069043 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Dogs —(i) Amount. 6.25 mg/lb (1 mL/10 lb of body weight) twice a day. Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5 to 7 days or for 48 hours after all signs have subsided. If no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21 days; the maximum duration of treatment should not exceed 30 days.

(ii) Indications for use. Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats —(i) Amount. 62.5 mg (1 mL) twice daily. Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5 to 7 days or 48 hours after all symptoms have subsided, not to exceed 30 days. If no response is seen after 3 days of treatment, therapy should be discontinued and the case reevaluated. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days.

(ii) Indications for use. Treatment of skin and soft tissue infections, such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: Beta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., Escherichia coli, Pasteurella multocida, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.90a Ampicillin tablets.

(a) Specifications. Each tablet contains ampicillin trihydrate equivalent to 50 or 100 milligrams of ampicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. 5 milligrams per pound of body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be continued 36 to 48 hours after all symptoms have subsided. If no improvement is seen within 5 days, stop treatment, reevaluate diagnosis, and change therapy.

(2) Indications for use. Oral treatment of infections caused by susceptible organisms as follows: Upper respiratory infections, tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary tract infections (cystitis) due to Streptococcus spp., Staphylococcus spp., E., coli, P. mirabilis, and Enterococcus spp.; gastrointestinal infections due to Staphylococcus spp., Streptococcus spp., Enterococcus spp., and E. coli. ; infections associated with abscesses, lacerations, and wounds caused by Staphylococcus spp., and Streptococcus spp.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.90b Ampicillin capsules.

(a) Specifications. Each capsule contains ampicillin trihydrate equivalent to 125, 250, or 500 milligrams of ampicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Dogs —(i) Amount. 5 to 10 milligrams per pound of body weight two or three times daily. In severe or acute conditions, 10 milligrams per pound of body weight, three times daily. Administer 1 to 2 hours prior to feeding.

(ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (tracheobronchitis and tonsillitis); urinary tract infections (cystitis); bacterial gastroenteritis; generalized infections (septicemia) associated with abscesses, lacerations, and wounds; and bacterial dermatitis.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats —(i) Amount. 10 to 30 milligrams per pound of body weight or three times daily. Administer 1 to 2 hours prior to feeding.

(ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (bacterial pneumonia); urinary tract infections (cystitis); and generalized infections (septicemia) associated with abscesses, lacerations, and wounds.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.90c Ampicillin boluses.

(a) Specifications. Each bolus contains ampicillin trihydrate equivalent to 400 milligrams of ampicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.40 of this chapter.

(d) Conditions of use in nonruminating calves —(1) Amount. 5 milligrams per pound of body weight twice daily not to exceed 4 days.

(2) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) caused by E. coli.

(3) Limitations. Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.100 Amprolium.

(a) Specifications. (1) Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution).

(2) Each gram of powder contains 200 mg amprolium (20 percent).

(b) Sponsors. See sponsors in 510.600(c) of this chapter.

(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. See § 556.50 of this chapter.

(d) Conditions of use —(1) Growing chickens, turkeys, and laying hens. It is used in drinking water as follows:

(i) Amount. Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

(ii) Indications for use. For the treatment of coccidiosis.

(iii) Limitations. Use as the sole source of amprolium.

(2) Calves. Administer concentrate solution or soluble powder as a drench or in drinking water as follows:

(i) Indications for use and amounts —(A) As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii , administer 5 mg per kilogram (mg/kg) body weight for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard.

(B) As an aid in the treatment of coccidiosis caused by E. bovis and E. zurnii , administer 10 mg/kg body weight for 5 days.

(ii) Limitations. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Use as the sole source of amprolium.

§ 520.110 Apramycin sulfate soluble powder.

(a) Specifications. A water soluble powder used to make a medicated drinking water containing apramycin sulfate equivalent to 0.375 gram of apramycin activity per gallon of drinking water.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.52 of this chapter.

(d) Conditions of use in swine —(1) Amount. Administer in drinking water at the rate of 12.5 milligrams of apramycin per kilogram (5.7 milligrams per pound) of body weight per day for 7 days.

(2) Indications for use. For the control of porcine colibacillosis (weanling pig scours) caused by strains of Escherichia coli sensitive to apramycin.

(3) Limitations. Do not slaughter treated swine for 28 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.154a Bacitracin methylenedisalicylate.

(a) Specifications. Each pound of soluble powder contains the equivalent of 50 grams of bacitracin activity for use as in paragraph (d)(1) or (d)(2) of this section, or the equivalent of 200 grams of bacitracin activity for use as in paragraph (d) of this section.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.70 of this chapter.

(d) Conditions of use —(1) Broiler and replacement chickens —(i) Amount. 100 mg per gal in drinking water.

(A) Indications for use. Aid in the prevention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin methylenedisalicylate.

(B) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water.

(ii) Amount. 200 to 400 mg per gal in drinking water. Administer continuously 5 to 7 days or as long as clinical signs persist, then reduce to prevention levels (100 mg/gal).

(A) Indications for use. Treatment of necrotic enteritis caused by C. perfringens susceptible to bacitracin methylenedisalicylate.

(B) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water.

(2) Growing turkeys —(i) Amount. 400 milligrams (mg) per gallon (gal) in drinking water.

(ii) Indications for use. Aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate.

(iii) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water.

(3) Swine —(i) Amount. 1 gram per gallon in drinking water.

(ii) Indications for use. Treatment of swine dysentery associated with Brachyspira hyodysenteriae. Administer continuously for 7 days or until signs of dysentery disappear.

(iii) Limitations. Prepare a fresh solution daily. Use as the sole source of drinking water. Treatment not to exceed 14 days. Not to be given to swine that weigh more than 250 pounds.

(4) Growing quail —(i) Amount. 400 mg per gal in drinking water.

(ii) Indications for use. For prevention of ulcerative enteritis due to Clostridium colinum susceptible to bacitracin methylenedisalicylate.

(iii) Limitations. Prepare fresh solution daily. Use as sole source of drinking water.

§ 520.154b Bacitracin methylenedisalicylate and streptomycin sulfate powder.

(a) Specifications. Each gram of powder contains 200 units bacitracin methylenedisalicylate and streptomycin sulfate equivalent to 20 milligrams of streptomycin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. Administer 1 level teaspoonful per 10 pounds of body weight three times daily, mixed in a small quantity of liquid or feed.

(2) Indications for use. For the treatment of bacterial enteritis caused by pathogens susceptible to bacitracin and streptomycin such as Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus spp., and for the symptomatic treatment of associated diarrhea.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.154c Bacitracin zinc soluble powder.

(a) Specifications. Each pound contains the equivalent of not less than 5 grams of bacitracin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.70 of this chapter.

(d) Conditions of use —(1) Broiler chickens —(i) Amount. 100 milligrams per gallon in drinking water.

(A) Indications for use. Prevention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin zinc.

(B) Limitations. Prepare a fresh solution daily.

(ii) Amount. 200 to 400 milligrams per gallon in drinking water.

(A) Indications for use. Control of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin zinc.

(B) Limitations. Prepare a fresh solution daily.

(2) Growing quail —(i) Amount. 500 milligrams per gallon in drinking water for 5 days followed by 165 milligrams per gallon in drinking water for 10 days.

(ii) Indications for use. Control of ulcerative enteritis caused by Clostridium spp. Susceptible to bacitracin zinc.

(iii) Limitations. Prepare a fresh solution daily.

§ 520.170 Bexagliflozin.

(a) Specifications. Each tablet contains 15 milligrams bexagliflozin.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Amount. Administer one tablet by mouth to cats 6.6 lb (3.0 kg) or greater once daily, at approximately the same time each day, with or without food, and regardless of blood glucose level.

(2) Indications for use. To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.222 Bunamidine hydrochloride.

(a) Chemical name. N,N -Dibutyl-4-(hexyloxy)-1-naphthamidine hydrochloride.

(b) Specifications. The drug is an oral tablet containing 100, 200, or 400 milligrams of bunamidine hydrochloride.

(c) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(d) Conditions of use. (1) The drug is intended for oral administration to dogs for the treatment of the tapeworms Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus, and to cats for the treatment of the tapeworms Dipylidium caninum and 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.

§ 520.246 Butorphanol tablets.

(a) Specifications. Each tablet contains butorphanol tartrate equivalent to 1, 5, or 10 milligrams (mg) butorphanol base.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. Administer 0.25 mg butorphanol base per pound of body weight. Repeat at intervals of 6 to 12 hours as required. Treatment should not normally be required for longer than 7 days.

(2) Indications for use. For the relief of chronic nonproductive cough associated with tracheobronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.260 n -Butyl chloride.

(a) Specifications. Each capsule contains 221, 442, 884, or 1,768 milligrams (mg); or 4.42 grams of n -butyl chloride.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter:

(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 —(1) Amount. Administer capsules orally based on body weight as follows:

(i) Capsules containing 221 mg: Under 5 pounds, 1 capsule per 1

1/4 pounds of body weight.

(ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2

1/2 pounds of body weight.

(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. For the removal of ascarids ( Toxocara canis and Toxascaris leonina ) and hookworms ( Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala ) from dogs.

(3) Limitations. Dogs should not be fed for 18 to 24 hours before being given the drug. Administration of the drug should be followed in

1/2 to 1 hour with a mild cathartic. Normal feeding may be resumed 4 to 8 hours after treatment. Animals subject to reinfection may be retreated in 2 weeks. A veterinarian should be consulted before using in severely debilitated dogs.

§ 520.292 Capromorelin.

(a) Specifications. Each milliliter of solution contains:

(1) 30 milligrams (mg) capromorelin; or

(2) 20 mg capromorelin.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Dogs. Use product described in paragraph (a)(1) of this section as follows:

(i) Amount. Administer 3 mg/kg once daily by mouth.

(ii) Indications for use. For appetite stimulation in dogs.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats. Use product described in paragraph (a)(2) of this section as follows:

(i) Amount. Administer 2 mg/kg once daily by mouth.

(ii) Indications for use. For management of weight loss in cats with chronic kidney disease.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.301 Caramiphen ethanedisulfonate and ammonium chloride tablets.

(a) Specifications. Each tablet contains 10 milligrams of 5st caramiphen ethanedisulfonate and 80 milligrams of ammonium chloride.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. One tablet per 15 to 30 pounds of body weight every 4 to 6 hours.

(2) Indications for use. For relief of cough.

§ 520.302 Carnidazole tablets.

(a) Specifications. Each tablet contains 10 milligrams of carnidazole.

(b) Sponsor. See 053923 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Amount. Adult pigeons: 1 tablet (10 milligrams); newly weaned pigeons:

1/2 tablet (5 milligrams).

(2) Indications for use. For treating trichomoniasis (canker) in ornamental and homing pigeons.

(3) Limitations. Not for use in pigeons intended for human food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism or when severely ill birds do not respond to treatment.

§ 520.304 Carprofen.

(a) Specifications. (1) Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.

(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. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.

(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 —(1) Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.

(2) Indications for use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.

(3) Limitations. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.314 Cefadroxil.

(a) Specifications. (1) Each tablet contains 50, 100, or 200 milligrams (mg) or 1 gram of cefadroxil.

(2) Each milliliter of suspension constituted from powder contains 50 mg of cefadroxil.

(b) Sponsor. See No. 042791 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats —(1) Amount —(i) Dogs. Administer 10 mg per pound (/lb) body weight twice daily orally.

(ii) Cats. Administer 10 mg/lb body weight once daily orally.

(2) Indications for use —(i) Dogs. For the treatment of skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections, and abscesses due to susceptible strains of Staphylococcus aureus. For the treatment of genitourinary tract infections (cystitis) due to susceptible strains of Escherichia coli , Proteus mirabilis , and S. aureus.

(ii) Cats. For the treatment of skin and soft tissue infections including abscesses, wound infections, cellulitis, and dermatitis caused by susceptible strains of Pasteurella multocida , S. aureus , Staphylococcus epidermidis , and Streptococcus spp.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.370 Cefpodoxime tablets.

(a) Specifications. (1) Each tablet contains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime.

(2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as follows:

(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 —(1) Amount. 5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

(2) Indications for use. For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius , S. aureus , Streptococcus canis (group G, beta-hemolytic), Escherichia coli , Pasteurella multocida , and Proteus mirabilis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.376 Cephalexin.

(a) Specifications. Each chewable tablet contains 75, 150, 300, or 600 milligrams (mg) cephalexin.

(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Dogs —(i) Amount. Administer 22 mg per kilogram of body weight twice daily for 28 days.

(ii) Indications for use. For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

§ 520.390a Chloramphenicol tablets.

(a) Specifications. Each tablet contains 50, 100, 250, or 500 milligrams (mg); 1 or 2.5 grams (g) of chloramphenicol.

(b) Sponsors. See § 510.600(c) of this chapter:

(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 —(1) Amount. Administer 25 mg per pound of body weight by mouth every 6 hours.

(2) Indications for use —(i) For the treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.

(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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

§ 520.390b Chloramphenicol capsules.

(a) Specifications. Each capsule contains 50, 100, 250, or 500 milligrams (mg) chloramphenicol.

(b) Sponsors. See Nos. 050057 and 054771 in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(c) Special considerations. Federal law prohibits the extralabel use of this product in food-producing animals.

(d) Conditions of use in dogs —(1) Amount. 25 mg per pound of body weight every 6 hours.

(2) Indications for use. For treatment of bacterial pulmonary infections, bacterial infections of the urinary tract, bacterial enteritis, and bacterial infections associated with canine distemper caused by susceptible organisms.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.390c Chloramphenicol palmitate oral suspension.

(a) Specifications. Each milliliter contains chloramphenicol palmitate equivalent to 30 milligrams of chloramphenicol.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use. Dogs —(1) Amount. 25 milligrams per pound of body weight every 6 hours. If no response is obtained in 3 to 5 days, discontinue use and reevaluate diagnosis.

(2) Indications for use. Treatment of bacterial pulmonary infections, infections of the urinary tract, enteritis, and infections associated with canine distemper that are caused by organisms susceptible to chloramphenicol.

(3) Limitations. Not for use in animals that are raised for food production. Must not be used in meat-, egg-, or milk-producing animals. The length of time that residues persist in milk or tissues has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.434 Chlorphenesin carbamate tablets.

(a) Specifications. Each tablet contains 400 milligrams of chlorphenesin carbamate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs —(1) Amount. 50 milligrams per pound of body weight on first day; 25 milligrams per pound of body weight each following day. Divide total daily dose into 2 or 3 equal doses—administer at 12- or 8-hour intervals.

(2) Indications for use. For use as an adjunct to therapy of acute inflammatory and traumatic conditions of skeletal muscles. The drug provides relief of the signs of discomfort associated with myositis, muscle sprains, traumatic injuries, stifle injuries—especially when administered before or after surgery—and invertebral disc syndrome (can be used concurrently with adrenal corticosteroids).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.441 Chlortetracycline powder.

(a) Specifications. Chlortetracycline powder contains not less than 15 milligrams per gram chlortetracycline hydrochloride, or chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline hydrochloride.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(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. See § 556.150 of this chapter.

(d) Conditions of use. (1) Use as chlortetracycline hydrochloride in drinking water as follows:

(i) Swine —(A) Amount. Ten milligrams per pound of body weight daily in divided doses.

( 1 ) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae ( Haemophilus spp.), and Klebsiella spp.

( 2) Limitations. Prepare a fresh solution twice daily; as sole source of chlortetracycline; administer for not more than 5 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) [Reserved]

(ii) [Reserved]

(2) Use as chlortetracycline hydrochloride in a drench or drinking water as follows:

(i) Calves —(A) Amount. Ten milligrams per pound of body weight daily in divided doses.

( 1 ) Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia (shipping fever) associated with Pasteurella spp., A. pleuropneumoniae ( Haemophilus spp.), and Klebsiella spp.

( 2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; administer for not more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(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 —(A) Amount. 200 to 400 milligrams per gallon.

( 1 ) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae.

( 2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Amount. 400 to 800 milligrams per gallon.

( 1 ) Indications for use. Control of chronic respiratory disease and air-sac infections caused by M. gallisepticum and E. coli.

( 2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(C) Amount. One thousand milligrams per gallon.

( 1 ) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

( 2 ) Limitations. See paragraph (d)(4)(i)(A)( 2 ) of this section.

(ii) Growing turkeys —(A) Amount. 400 milligrams per gallon.

( 1 ) Indications for use. Control of infectious synovitis caused by M. synoviae.

( 2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Amount. 25 milligrams per pound of body weight daily.

( 1 ) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).

( 2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iii) Swine —(A) Amount. 10 milligrams per pound body weight daily in divided doses.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. And bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae ( Haemophilus spp.), and Klebsiella spp.

(C) Limitations. Prepare fresh solution daily as the sole source of chlortetracycline. Do not use for more than 5 days. For Nos. 066104, 069043, 069254, and 076475: Do not slaughter animals for food within 5 days of treatment. For No. 069254: Do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iv) Calves, beef cattle, and nonlactating dairy cattle —(A) Amount. 10 milligrams per pound daily in divided doses.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. And bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., A. pleuropneumoniae ( Haemophilus spp.), and Klebsiella spp.

(C) Limitations. Prepare fresh solution daily; use as a drench; as sole source of chlortetracycline; do not use for more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not use in lactating cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(5) Use in a drench or drinking water as follows:

(i) Chickens —(A) Amount. 200 to 400 mg/gal, for 7 to 14 days.

( 1 ) Indications for use. Control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline.

( 2 ) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 14 consecutive days; do not use in laying chickens; do not administer to chickens within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Amount. 400 to 800 mg/gal, for 7 to 14 days.

( 1 ) Indications for use. Control of chronic respiratory disease (CRD) and air-sac infections caused by M. gallisepticum and E. coli susceptible to chlortetracycline.

( 2 ) Limitations. As in paragraph (d)(5)(i)(A)( 2 ) of this section.

(C) Amount. One thousand mg/gal, for 7 to 14 days.

( 1 ) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

( 2 ) Limitations. As in paragraph (d)(5)(i)(A)( 2 ) of this section.

(ii) Growing Turkeys —(A) Amount. 400 mg/gal, for 7 to 14 days.

( 1 ) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

( 2 ) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 14 consecutive days; do not administer to growing turkeys within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Amount. 25 mg/lb body weight daily, for 7 to 14 days.

( 1 ) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.

( 2 ) Limitations. As in paragraph (d)(5)(ii)(A)( 2 ) of this section.

(iii) Swine —(A) Amount. 10 mg/lb body weight daily, for 3 to 5 days.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae , and Klebsiella spp. Susceptible to chlortetracycline.

(C) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to swine within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iv) Calves, beef cattle, and nonlactating dairy cattle —(A) Amount. 10 mg/lb body weight daily in divided doses, for 3 to 5 days.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. Susceptible to chlortetracycline.

(C) Limitations. Prepare fresh solution daily; use as a drench; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to cattle within 24 hours of slaughter; do not use in lactating dairy cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.443 Chlortetracycline tablets and boluses.

(a) Specifications. Each tablet contains 25 milligrams (mg) chlortetracycline hydrochloride; each bolus contains 250 or 500 mg chlortetracycline hydrochloride.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(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. See § 556.150 of this chapter.

(d) Conditions of use in calves —(1) Amount. One 250 milligram bolus per 50 pounds of body weight twice a day for 3 to 5 days.

(i) Indications for use. Treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Klesbsiella spp., and Haemophilus spp.

(ii) Limitations. Administer bolus directly by mouth or crush and dissolve in milk or water for drenching or bucket feeding. Do not use for more than 5 days. Do not administer within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Amount. One 25 milligram tablet for each 5 pounds of body weight every 12 hours daily for 3 to 5 days.

(i) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. And bacterial pneumonia associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.

(ii) Limitations. Administer tablet directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; when feeding milk or milk replacer, administration 1 hour before or 2 hours after feeding; do not administer within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Amount. One 500 milligram bolus per 100 pounds of body weight twice a day for 3 to 5 days.

(i) Indications for use. Treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.

(ii) Limitations. Do not use for more than 5 days. Do not administer within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.445 Chlortetracycline and sulfamethazine powder.

(a) Specifications. Each pound of soluble powder contains chlortetracycline bisulfate equivalent to 102.4 grams (g) of chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent to 102.4 g of sulfamethazine.

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 556.150 and 556.670 of this chapter.

(d) Conditions of use in swine. Administer in drinking water as follows:

(1) Amount. 250 milligrams (mg) of chlortetracycline and 250 mg of sulfamethazine per gallon.

(2) Indications for use. For the prevention and treatment of bacterial enteritis; as an aid in the reduction of the incidence of cervical abscesses; and as an aid in the maintenance of weight gains in the presence of bacterial enteritis and atrophic rhinitis.

(3) Limitations. Use as the sole source of chlortetracycline and sulfonamide. Not to be used for more than 28 consecutive days. Withdraw 15 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.446 Clindamycin capsules and tablets.

(a) Specifications. (1) Each capsule contains the equivalent of 25, 75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.

(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. See sponsors in § 510.600(c) of this chapter as follows:

(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 —(1) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.

(2) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum , and Clostridium perfringens , dental infections due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens , and osteomyelitis due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.447 Clindamycin solution.

(a) Specifications. Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.

(b) Sponsors. See Nos. 051311, 054771, 058829, 061133, and 069043 in § 510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use —(1) Dogs —(i) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum , and Clostridium perfringens ; dental infections due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens ; and osteomyelitis due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens.

(2) Cats—(i) Amount. 5.0 to 15.0 mg/lb body weight every 24 hours for a maximum of 14 days.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of Staphylococcus aureus , S. intermedius , Streptococcus spp. ; deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis ; and dental infections due to susceptible strains of S. aureus , S. intermedius , Streptococcus spp. , C. perfringens , and B. fragilis.

§ 520.452 Clenbuterol syrup.

(a) Specifications. Each milliliter contains 72.5 micrograms of clenbuterol hydrochloride.

(b) Sponsor. See 000010 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use —(1) Horses —(i) Amount. Administer orally twice a day (b.i.d.). Initial dose is 0.5 milliliter per 100 pounds body weight (0.8 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1 milliliter per 100 pounds (1.6 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 1.5 milliliters per 100 pounds (2.4 micrograms per kilogram) for 3 days (6 treatments). If no improvement, administer 2.0 milliliters per 100 pounds (3.2 micrograms per kilogram) for 3 days (6 treatments). If no improvement, horse is nonresponder to clenbuterol and treatment should be discontinued.

(ii) Indications for use. Indicated for the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).

(iii) Limitations. Treat at effective dose for 30 days. At the end of the 30-day treatment period, drug should be withdrawn. If signs return, the 30-day treatment period may be repeated. If repeating treatment, the step-wise dosage schedule should be repeated. The effect of this drug on breeding stallions and brood mares has not been determined. Treatment starting with dosages higher than the initial dose is not recommended. Federal law prohibits the extralabel use of this drug in food animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

§ 520.455 Clomipramine.

(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.

(b) Sponsors. See Nos. 051311 and 086039 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Amount. 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.

(2) Indications for use. For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§ 520.462 Clorsulon drench.

(a) Specifications. The drug is a suspension containing 8.5 percent clorsulon (85 milligrams per milliliter).

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.163 of this chapter.

(d) Conditions of use. Cattle —(1) Amount. One-quarter fluid ounce per 200 pounds of body weight (7 milligrams per kilogram or 3.2 milligrams per pound of body weight).

(2) Indications for use. For the treatment of immature and adult liver fluke ( Fasciola hepatica ) infestations in cattle.

(3) Limitations. Using dose syringe, deposit drench over back of tongue. Do not treat cattle within 8 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

§ 520.522 Cyclosporine.

(a) Specifications. (1) Each cyclosporine capsule, USP (MODIFIED) contains 10, 25, 50, or 100 milligrams (mg) cyclosporine.

(2) Each milliliter of cyclosporine oral solution, USP (MODIFIED) contains 100 mg cyclosporine.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(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 —(1) Dogs. Use capsules described in paragraph (a)(1) of this section as follow:

(i) Amount. Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.

(ii) Indications for use. For the control of atopic dermatitis in dogs weighing at least 4 pounds.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats. Use the solution described in paragraph (a)(2) of this section as follow:

(i) Amount. Administer 7 mg/kg of body weight orally as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or twice weekly to maintain the desired therapeutic effect.

(ii) Indications for use. For the control of feline allergic dermatitis as manifested by excoriations (including facial and neck), miliary dermatitis, eosinophilic plaques, and self-induced alopecia in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.