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NADA Number: 130-736

Proprietary Name Coban®
Sponsor Elanco Animal Health, A Division of Eli Lilly & Co.
Sponsor Address Lilly Corporate Center

Indianapolis, IN    46285
USA
Ingredients Monensin Sodium
Species (Class) QUAIL (Bobwhite quail, growing)
TURKEYS (Turkey, no use class stated or implied)
Routes of Administration Per Os
Dosage Form Medicated feed
Dispensing Status OTC
Patent Number (Expiration Date) 3839557 (No Expiration Date)
3995027 (No Expiration Date)
4061755 (No Expiration Date)
4075323 (No Expiration Date)
4083962 (No Expiration Date)
4218438 (No Expiration Date)
4333919 (No Expiration Date)
4366168 (No Expiration Date)
4405609 (No Expiration Date)
4468380 (No Expiration Date)
Exclusivity This supplemental approval provides for a change in treatment regime from a ten week period to a continuous feeding for growing turkeys at the same range of 54 to 90 grams per ton. The drug is indicated for the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis.
Dosage Amount,
Indications
& Limitations

558.355 Monensin.

Specifications: Monensin as the base or the sodium salt, contains a minimum of 90 percent monensin activity derived from monensin A and a minimum of 95 percent derived from monensin A plus B. Approvals for Type A medicated articles containing 45 or 60 grams per pound.

Conditions of use:

Turkeys

Amount: Monensin, 54 to 90 grams per ton of feed.

Indications: For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis.

Limitations: Feed continuously as the sole ration to growing turkeys from 1 day of age as monensin sodium. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Do not allow horses or other equines access to formulations containing monensin. Ingestion of monensin by equines has been fatal.

Labeling. The labeling of all formulations containing monensin intended for use in turkeys shall bear the following caution statements: Do not allow horses or other equines access to formulations containing monensin. Ingestion of monensin by equines has been fatal.

Bobwhite quail

Amount: Monensin, 73 grams per ton of feed.

Indications: For the prevention of coccidiosis in growing bobwhite quail caused by Eimeria dispersa and E. Lettyae.

Limitations: Feed continuously as the sole ration. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Do not allow horses or other equines access to formulations containing monensin. Ingestion of monensin by equines has been fatal.

Labeling. The labeling of all formulations containing monensin intended for use in quail shall bear the following caution statements: Do not allow horses or other equines access to formulations containing monensin. Ingestion of monensin by equines has been fatal.

Tolerances

Monensin Sodium: A tolerance of 0.10 part per million (ppm) in cattle liver, 0.05 ppm in muscle, kidney, and fate.

A tolerance of 0.05 ppm in goats edible tissue.

A tolerance for residue of monensin in chickens, turkeys and quail is not needed.

A tolerance for residues of monensin in milk is not needed.