ANADA Number: 200-420 |
|
| Proprietary Name |
Ceftiofur Sodium Sterile Powder |
|---|---|
| Sponsor |
Cephazone Pharma, LLC |
| Ingredients |
CEFTIOFUR SODIUM |
| Dose Form |
POWDER-STERILE |
| Drug Form |
POWDER/CRYSTAL |
| Dispensing Status |
RX |
| Withdrawal Time |
4 days following last treatment for cattle and swine. Neither pre-slaughter drug withdrawal interval nor a milk discard time is required for sheep & goats. |
|
Dosage Amount, Indications & Limitations |
Cattle Ceftiofur Sodium Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. Ceftiofur Sodium Sterile Powder is also indicated for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Swine Ceftiofur Sodium Sterile Powder is indicated for treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis. Sheep Ceftiofur Sodium Sterile Powder is indicated for treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida. Goat Ceftiofur Sodium Sterile Powder is indicated for treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida. Horses Ceftiofur Sodium Sterile Powder is indicated for treatment of respiratory infections in horses associated with Streptococcus zooepidemicus. Dogs Ceftiofur Sodium Sterile Powder is indicated for treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis. Day-Old Chicks Ceftiofur Sodium Sterile Powder is indicated for the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks. Day-Old Turkey Poults Ceftiofur Sodium Sterile Powder is indicated for the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.
|
| Tolerances |
A tolerance is established for negligible residues of hydrocortisone (as hydrocortisone sodium succinate or hydrocortisone acetate) in milk at 10 parts per billion. |
Ceftiofur Sodium Sterile Powder
Muricin
ANADA Number: 200-418 |
|
| Proprietary Name |
Muricin™ |
|---|---|
| Sponsor |
Nycomed US, Inc. |
| Sponsor Address |
60 Baylis Rd Melville, NY 11747 |
| Ingredients |
Mupirocin |
| Species |
Dog, no use class stated or implied |
| Routes of Administration |
Topical |
| Dose Form |
Ointment |
| Drug Form |
Ointment |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1465 Mupirocin ointment. Specifications Each gram contains 20 milligrams of mupirocin. Conditions of use Dogs Amount Apply twice daily. Indications Topical treatment of bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius. Limitations. Treatment should not exceed 30 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
Gentamicin Sulfate Topical Spray
ANADA Number: 200-415 |
|
| Proprietary Name |
Gentamicin Sulfate Topical Spray |
|---|---|
| Sponsor |
First Priority, Inc. |
| Sponsor Address |
1585 Todd Farm Dr. Elgin, IL 60123 |
| Ingredients |
Gentamicin Sulfate Betamethasone Valerate |
| Species |
Dog, no use class stated or implied |
| Routes of Administration |
Topical |
| Dose Form |
Spray |
| Drug Form |
Spray |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1044f Gentamicin sulfate betamethasone valerate topical spray. Specifications: Each milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram of gentamicin base and betamethasone valerate equivalent to 0.284 milligram of betamethasone. Conditions of use: Dogs Amount: Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. The drug should be administered with two spray actuations 2 to 4 times daily for 7 days. Indications: The drug is used in dogs in the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin. Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
| Tolerances |
A tolerance of 0.1 part per million is established for negligible residues of gentamicin sulfate in the uncooked edible tissues of chickens and turkeys. Tolerances are established for total residues of gentamicin in edible tissues of swine as follows: 0.1 part per million in muscle, 0.3 part per million in liver, and 0.4 part per million in fat and kidney. |
Lincomycin Spectinomycin Water Soluble Powder
ANADA Number: 200-407 |
|
| Proprietary Name |
Lincomycin-Spectinomycin Water Soluble Powder |
|---|---|
| Sponsor |
Agri Laboratories, Ltd. |
| Sponsor Address |
P.O. Box 3103 St. Joseph, MO 64503 |
| Ingredients |
Lincomycin Hydrochloride Spectinomycin dihydrochloride pentahydrate |
| Species |
Chicken, up to 7 days old |
| Routes of Administration |
Per Os |
| Dose Form |
Liquid (solution) |
| Drug Form |
Powder |
| Dispensing Status |
OTC |
| Withdrawal Time |
Zero hours |
|
Dosage Amount, Indications & Limitations |
520.1265 Lincomycin and spectinomycin soluble powder. Specifications: The following salts of lincomycin and spectinomycin are present in a soluble powder in the ratio of 1 to 2 on the basis of equivalency of lincomycin base to equivalency of spectinomycin base: Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate. Conditions of use: Chickens (up to 7 days old) Amount: Administered the drinking water at a level of 2 grams of antibiotic activity per gallon of water as the sole source of water for the first 5 to 7 days of life. Indications: It is administered in the drinking water of chickens up to 7 days of age as an aid in the control of airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin. Limitations: No limitations are included in the CFR for this species when using this product in this amount. |
| Tolerances |
A tolerance for residues of lincomycin in chickens is not required. Tolerances for lincomycin in swine of 0.6 part per million in liver and 0.1 part per million in muscle are established. |
Clindamycin Hydrochloride Oral Drops
ANADA Number: 200-398 |
|
| Proprietary Name |
Clindamycin Hydrochloride Oral Drops |
|---|---|
| Sponsor |
First Priority, Inc. |
| Sponsor Address |
1585 Todd Farm Dr. Elgin, IL 60123 |
| Ingredients |
Clindamycin Hydrochloride |
| Species |
Cat, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Liquid (solution) |
| Drug Form |
Liquid (solution) |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
520.447 Clindamycin hydrochloride liquid. Specifications: Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt. Conditions of use: Dogs Amount: Wounds, abscesses, and dental infections: 2.5 to 15 milligrams per pound of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 milligrams per pound of body weight every 12 hours for a minimum of 28 days. Indications: 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 ecrophorum, 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. Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cats Amount: 5.0 to 15.0 milligrams per pound of body weight every 24 hours for a maximum of 14 days. Indications: For the treatment of skin infections (wounds and abscesses) due to susceptible strains of S. aureus, S. intermedius, Streptococcus species, 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 species, C. perfringens, and B. fragilis. Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
Vetprofen
ANADA Number: 200-397 |
|
| Proprietary Name |
Vetprofen™ |
|---|---|
| Sponsor |
Belcher Pharmaceuticals, Inc. |
| Sponsor Address |
12393 Belcher Road |
| Ingredients |
Carprofen |
| Species |
Dog, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Caplet |
| Drug Form |
Caplet |
| Dispensing Status |
RX |
| Withdrawal Time |
Withdrawal times do not apply to the species listed for this product. |
|
Dosage Amount, Indications & Limitations |
520.309 Carprofen Specifications: Each caplet or chewable tablet contains 25, 75, or 100 milligrams (mg) carprofen. Conditions of use: Dogs Amount: 2 milligram per pound of body weight once daily or 1 milligram per pound twice daily. Indications: For the control of postoperative pain associated with soft tissue and orthopedic surgery. For the relief of pain and inflammation associated with osteoarthritis. Limitations: For the control of postoperative pain, administer approximately 2 hours before the procedure. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
Gentamicin Piglet Injection
ANADA Number: 200-394 |
|
| Proprietary Name |
Gentamicin Piglet Injection |
|---|---|
| Sponsor |
Sparhawk Laboratories, Inc. |
| Sponsor Address |
12340 Santa Fe Trail Drive Lenexa, KS 66215 |
| Ingredients |
Gentamicin Sulfate |
| Species |
Swine, 1 to 3 days old |
| Routes of Administration |
Intramuscular |
| Dose Form |
Liquid (solution) |
| Drug Form |
Liquid (solution) |
| Dispensing Status |
OTC |
| Withdrawal Time |
Swine: 40 days before slaughter. |
|
Dosage Amount, Indications & Limitations |
522.1044 Gentamicin sulfate injection. Specifications: Each milliliter of sterile aqueous solution contains the equivalent of 5 milligrams of gentamicin. Conditions of use: Swine Amount: 5 milligrams of gentamicin as a single intramuscular dose using 5 milligram-per-milliliter solution. Indications: In piglets up to 3 days old for treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin. Limitations: For single intramuscular dose in pigs up to 3 days of age only. Do not slaughter treated animals for food for at least 40 days following treatment. |
| Tolerances |
A tolerance of 0.1 part per million is established for negligible residues of gentamicin sulfate in the uncooked edible tissues of chickens and turkeys. Tolerances are established for total residues of gentamicin in edible tissues of swine as follows: 0.1 part per million in muscle, 0.3 part per million in liver, and 0.4 part per million in fat and kidney. |
Griseofulvin Powder
ANADA Number: 200-391 |
|
| Proprietary Name |
Griseofulvin Powder |
|---|---|
| Sponsor |
Teva Animal Health, Inc. |
| Sponsor Address |
3915 South 48th Street Ter. St. Joseph, MO 64506 |
| Ingredients |
Griseofulvin |
| Species |
Horse, yearling Horse, foals Horse, adults |
| Routes of Administration |
Per Os |
| Dose Form |
Top dressing in feed Liquid |
| Drug Form |
Powder |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
Specifications: Complies with U.S.P. for griseofulvin microsize. Conditions of use: Horses Amount: 2.5 grams griseofulvin per 15 gram container. Administer 2.5 grams to adults for not less than 10 days a daily dose. Administer 1.25 to 2.5 grams to yearlings for not less than 10 days a daily dose. Administer 1.25 grams to foals for not less than 10 days a daily dose. Indications: As a soluble powder for horses, it is administered as a drench or as a top dressing on feed. It is used for equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum. Limitations: Do not use in horses intended for human consumption. For use only by or on the order of a licensed veterinarian. |
Ivermectin Paste 1.87 %
ANADA Number: 200-390 |
|
| Proprietary Name |
Ivermectin Paste 1.87 % |
|---|---|
| Sponsor |
Med-Pharmex, Inc. |
| Sponsor Address |
2727 Thompson Creek Rd. Pomona, CA 91767-1861 |
| Ingredients |
Ivermectin |
| Species |
Horse, not for meat production |
| Routes of Administration |
Per Os |
| Dose Form |
Paste |
| Drug Form |
Paste |
| Dispensing Status |
OTC |
| Withdrawal Time |
Withdrawal times do not apply to the species listed for this product. |
|
Dosage Amount, Indications & Limitations |
520.1192 Ivermectin paste. Specifications: Paste contains 1.87 percent ivermectin. Conditions of use: Horses Amount: 200 micrograms per kilogram (91 micrograms per pound) of body weight. Indications: For treatment and control of: Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults), Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri;Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp. Limitations: For oral use only. Do not use in horses intended for human consumption. |
| Tolerances |
A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in liver (target tissue) as follows: a. In cattle 100 parts per billion. b. In swine 20 parts per billion. c. In sheep 30 parts per billion. d. In reindeer 15 parts per billion. e. In American bison 15 parts per billion. Muscle residues are not indicative of the safety of other edible tissues. A tolerance is established for 22,23-dihydroavermectin B1a (marker residue) in muscle as follows: a. Swine 20 parts per billion b. Cattle 10 parts per billion |
Amprolium 9.6% Oral Solution
ANADA Number: 200-389 |
|
| Proprietary Name |
Amprolium 9.6% Oral Solution |
|---|---|
| Sponsor |
Teva Animal Health, Inc. |
| Sponsor Address |
3915 South 48th Street Ter. St. Joseph, MO 64506 |
| Ingredients |
Amprolium |
| Species |
Cattle, calves |
| Routes of Administration |
Per Os |
| Dose Form |
Liquid |
| Dispensing Status |
OTC |
| Withdrawal Time |
Cattle: 1 day before slaughter. |
|
Dosage Amount, Indications & Limitations |
520.100 Amprolium Specifications: Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution). Conditions of use: Cattle (calves) Indications: As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii. Amount: Administer 5 mg per kilogram (mg/kg) body weight in drinking water for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard. Indications: As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zurnii. Amount: Administer 10 mg/kg body weight in drinking water for 5 days. 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. |
| Tolerances |
Tolerances are established as follows for residues of amprolium (1-(4-amino-2-n- propyl-5-pyrimidinylmethyl)-2-picolinium chloride hydrochloride): a. In chickens and turkeys (edible tissues): (1) 1 part per million in uncooked liver and kidney. (2) 0.5 part per million in uncooked muscle tissue. b. In chicken and turkey eggs: (1) 8 parts per million in egg yolks. (2) 4 parts per million in whole eggs. c. In calves (edible tissues): (1) 2.0 parts per million in uncooked fat. (2) 0.5 part per million in uncooked muscle tissue, liver, and kidney. d. In pheasants (edible tissues): (1) 1 part per million in uncooked liver. (2) 0.5 part per million in uncooked muscle. |
