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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - September/October 2001

FDA Veterinarian Newsletter September/October 2001 Volume XVI, No V

CompanyGeneric and (Brand) NamesIndicationsRoutes/Remarks

Pharmacia and Upjohn Co.

(NADA 140-338)

 

Ceftiofur (Naxcel) RxCattle. For the treatment of several bacterial diseases.

INTRAMUSCULAR AND SUBCUTANEOUS—The supplemental NADA is to add the subcutaneous route of administration.

Federal Register 06/15/01

Merial Ltd.

(NADA 136-742)

Clorsulon (Curatrem® drench)Cattle. For the treatment of liver fluke infestations.

TOPICAL—The supplemental NADA provides for establishing a tolerance of 0.1 part per

million of clorsulon as residue in muscle tissue. The Acceptable Daily Intake (ADI) for total residues of clorsulon is 8 micrograms per kilogram of body weight per day.

Federal Register 07/06/01