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NADA Number: 113-232

Proprietary Name Liquamycin® LA-200®
Terramycin LA-200® (Rx)
Sponsor Pfizer, Inc.
Sponsor Address 235 East 42d St.
New York, NY    10017
USA
Ingredients Oxytetracycline
Species Cattle, dairy, not lactating
Swine, sows with litters or about to farrow
Cattle, no use class stated or implied
Swine, no use class stated or implied
Routes of Administration Intravenous (cattle)
Intramuscular
Subcutaneous (cattle)
Dose Form Liquid (solution)
Drug Form Liquid (solution)
Pfizer, Inc. Has Pioneered:                   Agrimycin® - 200
    Agri Laboratories, Ltd.
                  Bio-Mycin® 200 Injectable Solution
    Boehringer Ingelheim Vetmedica, Inc.
                  Oxy-Tet® 200 Injectable Solution
    Boehringer Ingelheim Vetmedica, Inc.
                  Oxyshot® LA
    Cross Vetpharm Group Ltd.
                  Tetroxy® - LA
    Cross Vetpharm Group Ltd.
                  Oxytetracycline Injection
    Norbrook Laboratories Ltd.
                  Oxytetracycline Injection 300 mg/ml (OTC)
    Norbrook Laboratories Ltd.
                  Tetradure™ 300 (Rx)
    Norbrook Laboratories Ltd.
                  Oxytetracycline 200
    Pennfield Oil Co.
                  Pennox™ 200
    Pennfield Oil Co.
                  Geomycin 200
    Pliva, d. d.
                  Maxim-200® Injection
    Teva Animal Health, Inc.
                  Oxytetracycline Hydrochloride Injection 200mg
    Teva Animal Health, Inc.
Dispensing Status RX, OTC
Patent Number 4018889
Exclusivity Granted for use in a new species (lactating dairy cattle).
Granted for product labeling to include a subcutaneous route of administration in cattle. Also revise label to include new species pre-ruminating (veal) calves.
Withdrawal Time Cattle: 28 days before slaughter. Swine: 28 days before slaughter
Dosage Amount,
Indications
& Limitations

522.1660a Oxytetracycline injection 200 milligrams/milliliter

Special considerations: When labeled for the treatment of anaplasmosis or anthrax, labeling shall also bear the following: ``Federal law restricts this drug to use by or on the order of a licensed veterinarian.'

Conditions of use:

Cattle (beef,dairy excluding lactating animals, and calves, including preruminating veal calves)

Amount: 3 to 5 milligrams of oxytetracycline per pound of body weight per day.

Indications: For treatment of pneumonia and shipping fever complex associated with Pasteurella species and Haemophilus species, foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, wound infections and acute metritis caused by Staphylococcus species and Streptococcus species, and anthrax caused by Bacillus anthracis.

Limitations: Administer intramuscularly, subcutaneously, or intravenously. Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration in cattle may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals.

Amount: 5 milligrams per pound of body weight per day.

Indications: For treatment of anaplasmosis, severe foot-rot and advanced cases of other indicated diseases.

Amount: 9 milligrams per pound of body weight intramuscularly or subcutaneously as a single dose.

Limitations: Administer intramuscularly or intravenously . Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration in cattle may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Not for use in lactating dairy animals.

Swine

Amount: 3 to 5 milligrams of oxytetracycline per pound of body weight per day.

Indications: For treatment of bacterial enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona.

Limitations: Administer intramuscularly. Do not inject more than 5 mL per site in adult swine. Discontinue treatment at least 28 days prior to slaughter.

Amount: 9 milligrams per pound of body weight as a single dosage

Indications: Where re-treatment for pneumonia is impractical.

Limitations: Administer intramuscularly. Do not inject more than 5 mL per site in adult swine. Discontinue treatment at least 28 days prior to slaughter.

Sows:

Amount: 3 milligrams per pound of body weight intramuscularly once.

Indications: As an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by E. coli.

Limitations: Administer intramuscularly. Do not inject more than 5 mL per site in adult swine. Discontinue treatment at least 28 days prior to slaughter.

Tolerances

Beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish and lobster. Tolerances are established for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues and milk as follows: a. 2 parts per million (ppm) in muscle b. 6 ppm in liver c. 12 ppm in fat and kidney d. 0.3 ppm in milk.