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U.S. Department of Health and Human Services

Animal & Veterinary

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Supplemental New Animal Drug Approvals - January/February 2002

FDA Veterinarian Newsletter January/February 2002 Volume XVII, No 1

CompanyGeneric and (Brand) NamesIndicationsRoutes/Remarks
Schering-Plough Animal Health Corp.
(NADA140-951)
 
Diclazuril
(ClinacoxTM)
 
Turkeys. For prevention of coccidiosis.
 

MEDICATED FEED—The supplemental NADA provides for use of the approved diclazuril Type A medicated article to make Type B and Type C medicated turkey feeds used for prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. melagrimitis. Also, the NADA establishes tolerances for diclazuril residues in turkey liver at 3 ppm, muscle at 0.5 ppm, and skin with adherent fat at 1 ppm.

Federal Register 12/04/01
 

Pfizer, Inc.
(NADA 141-053)
 
Carprofen
(Rimadyl® Caplets) Rx
 
Dogs. For the relief of pain and inflammation associated with osteoarthritis.
 

ORAL—The supplement provides for a once daily, 2 mg/lb dosage of carprofen, by oral caplet.

Federal Register 12/05/01
 

MoorMan's, Inc.
(NADA 115-581)
 
Monensin
(MoorMan's Mintrate Blonde Block RU and MoorMan's Mintrate Red Block RU)
 
Cattle. For prevention and control of coccidiosis.
 

MEDICATED FEED—The supplement provides for use of approved monensin Type A medicated

articles to make free-choice, medicated feed blocks used for prevention and control of coccidiosis

caused by Eimeria bovis and E. zuernii in pasture cattle.

Federal Register 12/07/01