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NADA Number: 140-854

Proprietary Name Synanthic® Bovine Dewormer Suspension 22.5%
Synanthic® Bovine Dewormer Suspension 9.06%
Sponsor Fort Dodge Animal Health, Division of Wyeth
Sponsor Address 800 Fifth Street NW
Fort Dodge, IA    50501
USA
Ingredients Oxfendazole
Species Cattle, dairy, not lactating
Cattle, beef
Routes of Administration Per Os
Dose Form Liquid (suspension)
Drug Form Liquid (suspension)
Dispensing Status OTC
Patent Number 3929821
4002640
4080461
Exclusivity This approval is for the removal and control of the following parasites in beef cattle: Lungworms (Dictyocaulus viviparus), adults and fourth stage larvae; Stomach worms, Barberpole worms (Haemonchus contortus and H. placei), adults; Brown stomach worms (Ostertagia ostertagi) , adults, fourth stage larvae and inhibited fourth stage larvae; Small stomach worms (Trichostrongylus axei), adults; Intestinal worms, Hookworms (Bunostomum phlebotomum), adults; Small intestinal worms (Cooperia spp.), adults and fourth stage larvae; Tapeworms (Moniezia beneden i), adults; Nodular worms (Oesophagostomum radiatum), adults. The OTC product is a 9.06 percent suspension for oral administration only using appropriate dosing equipment. The Rx product is a 22.5 percent suspension for administration intra-ruminally, using the rumen injector, or orally, using appropriate dosing equipment.
Withdrawal Time Cattle: 7 days before slaughter.
Dosage Amount,
Indications
& Limitations

520.1630 Oxfendazole suspension.

Specifications: Each milliliter contains 90.6 or 225.0 milligrams oxfendazole (9.06 or 22.5 percent).

Conditions of use:

Cattle

Amount: 4.5 milligrams per kilogram of body weight (2.05 milligrams per pound).

Indications: For the removal and control of: lungworms (Dictyocaulus viviparus-adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. placei-adult), small stomach worms (Trichostrongylus axei-adult), brown stomach worms (Ostertagia ostertagi-adult, L4, inhibited L4); intestinal worms; nodular worms (Oesophagostomum radiatum-adult), hookworms (Bunostomum phlebotomum-adult), small intestinal worms (Cooperia punctata, C. oncophora, and C. mcmasteri-adult, L4), and tapeworms (Moniezia benedeni-adult).

Limitations: Administer 9.06 percent suspension orally only with a dose syringe, and 22.5 percent suspension either orally with a dose syringe or intra-ruminally with a rumen injector. Treatment may be repeated in 4 to 6 weeks. Cattle must not be slaughtered until 7 days after treatment. Do not use in lactating dairy cattle. For use of 9.06 percent suspension orally. Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism. For use of 22.5 percent suspension orally or intra-ruminally. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Tolerances

A tolerance is established for total oxfendazole residues in edible cattle tissues based on a marker residue concentration of 0.8 part per million (ppm) fenbendazole in the target liver tissue.