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NADA Number: 141-220

Proprietary Name Cydectin® Injectable Solution for Beef and Nonlactating Dairy Cattle
Sponsor Fort Dodge Animal Health, Division of Wyeth
Sponsor Address 800 Fifth Street NW
Fort Dodge, IA    50501
USA
Ingredients Moxidectin
Species Cattle, beef
Cattle, dairy, excluding female breeding age animals
Routes of Administration Subcutaneous (cattle)
Dose Form Liquid (solution)
Drug Form Liquid (solution)
Dispensing Status OTC
Patent Number 4916154
5965603
Exclusivity Granted for for use of moxidectin injectable solution for beef and nonlactating dairy cattle for the treatment and control of various internal and external parasites.
Exclusivity is granted based on a supplemental approval describing the treatment and control of an additional three species (Cooperia pectinata - Adult, Cooperia spatulata - Adult, Nematodirus helvetianus - Adult) of internal parasites and an additional three life stages (Trichostrongylus colubriformis - Adult, Ostertagia ostertagi - L4, Trichostrongylus axei -L4) of previously approved internal parasites.
Withdrawal Time Cattle:21 days before slaughter. Not for use in female dairy cattle of breeding age.
Dosage Amount,
Indications
& Limitations

522.1450 Moxidectin solution.

Specifications: Each milliliter of solution contains 10 milligrams (mg) moxidectin.

Conditions of use:

Beef and nonlactating dairy cattle

Amount: 0.2 mg/kilogram body weight (0.2 mg/2.2 pound) as a single subcutaneous injection.

Indications: For treatment and control of gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage larvae, and inhibited larvae), Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-stage larvae), T. colubriformis (adults and fourth-stage larvae), Cooperia oncophora (adults), C. pectinata (adults), C. punctata (adults and fourth-stage larvae), C. spatulata (adults), C. surnabad (adults and fourth-stage larvae), Nematodirus helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); grubs: Hypoderma bovis and H. lineatum; mites: Psoroptes ovis (P. communis var. bovis); lice: Linognathus vituli and Solenopotes capillatus; for protection of cattle from reinfection with D. viviparus and O. radiatum for 42 days after treatment, with H. placei for 35 days after treatment, and with O. ostertagi and T. axei for 14 days after treatment.

Limitations: Do not slaughter cattle within 21 days of treatment. Because a withholding time for milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal.

Tolerances

The tolerance for parent moxidectin (the marker residue) in edible tissues of cattle is 200 parts per billion (ppb) in liver (the target tissue) and 50 ppb in muscle. The tolerance for parent moxidectin is 40 ppb in milk.