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U.S. Department of Health and Human Services

Animal & Veterinary

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ABBREVIATED NEW ANIMAL DRUG APPROVALS

FDA Veterinarian Newsletter January/February 1998 Volume XIII, No I

Company Generic and (Brand) Names Indications Routes/Remarks
Med-Pharmex, Inc. (ANADA 200-196)Miconazole Nitrate Lotion and SprayDog and Cats. For use as a topical antifungal agent to treat certain infections.TOPICAL: ANADA 200-196 is a generic copy of Mallinckrodt Veterinary¹s Conofite ’ miconazole nitrate 1 percent lotion and spray -- NADA 95-184. Federal Register 10/23/97.
ALPHARMA, Inc. (ANADA 200-223)Bacitracin ZincCattle, Broiler Chickens, Turkeys, Pheasants, Growing Quail, and Growing and Finishing Swine for increased rate of weight gain and improved feed efficiency and for Laying Chickens for improved feed efficiency and increased egg production.ORAL: ANADA 200-223 is a generic copy of Hoffmann-LaRoche¹s NADA 46-920. Federal Register 10/23/97.
ALPHARMA, Inc. (ANADA 200-207)Clopidol and Bacitracin Zinc with Roxarsone.Broiler Chickens. For prevention of coccidiosis, improved feed efficiency, improved pigmentation, and increased rate of weight gain.MEDICATED FEED: ANADA 200-207 is a generic copy of Rhone-Poulenc, Inc.¹s NADA 44-016. Federal Register 11/21/97.
ALPHARMA, Inc. (ANADA 200-218)Clopidol and Bacitracin ZincBroiler Chickens. For prevention of coccidiosis, improved feed efficiency, and increased rate of weight gain.MEDICATED FEED: ANADA 200-218 is a generic copy of Rhone-Poulenc, Inc.¹s NADA 49-934. Federal Register 11/20/97.
ALPHARMA, Inc. (ANADA 200-211)Monensin and Bacitracin Zinc with RoxarsoneBroiler Chickens. For prevention of coccidiosis, and increased weight gain or for prevention of coccidiosis and improved feed efficiency, and improved pigmentation.MEDICATED FEED: ANADA 200-211 is a generic copy of Hoffmann-LaRoche¹s NADA 123-154. Federal Register 11/20/97.
ALPHARMA, Inc. (ANADA 200-205)Amprolium plus ethopabate and Bacitracin ZincBroiler and Replacement Chickens. For prevention of coccidiosis in broiler and replacement chickens and improved feed efficiency in broiler chickens.MEDICATED FEED: ANADA 200-205 is a generic copy of Hoffmann-LaRoche¹s NADA 114-794. Federal Register 11/19/97.
ALPHARMA, Inc. (ANADA 200-203)Carbarsone and Bacitracin ZincTurkeys. For prevention of blackhead, increased rate of weight gain, and improved feed efficiency.MEDICATED FEED: ANADA 200-203 is a generic copy of Hoffmann-LaRoche¹s NADA 136-484. Federal Register 11/14/97.
ALPHARMA, Inc. (ANADAs 200-204 and 210)Salinomycin and Bacitracin ZincBroiler Chickens. For prevention of coccidiosis and increased rate of weight gain.MEDICATED FEED: ANADA 200-204 is a generic copy of Hoffmann-LaRoche Inc.¹s NADA 139-235 and ANADA 200-210 is a generic copy of Hoechst-Roussel Vet¹s ANADA 200-089. Federal Register 11/13/97.
ALPHARMA, Inc. (ANADA 200-214)Amprolium plus Ethopabate with Bacitracin Zinc and RoxarsoneBroiler Chickens. For prevention of coccidiosis and improved feed efficiency or improved feed efficiency and improved pigmentation.MEDICATED FEED: ANADA 200-214 is a generic copy of Hoffmann-LaRoche Inc.¹s NADA 105-758. Federal Register 11/12/97.
Phoenix Scientific, Inc. (ANADA 200-236)Chlortetracycline Hydrochloride Soluble PowderSwine, Chickens and Turkeys. In swine, for control and treatment of certain diseases caused by pathogens susceptible to chlortetracycline. In chickens and turkeys, for control of certain diseases caused by pathogens susceptible to chlortetracycline.ORAL (in Drinking Water): ANADA 200-236 is a generic copy of ADM Animal Health and Nutrition Div.¹s Chlortet TM Soluble-O, NADA 65-256. Federal Register 11/12/97.