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U.S. Department of Health and Human Services

Animal & Veterinary

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ABBREVIATED NEW ANIMAL DRUG APPROVALS - September/October 1998

FDA Veterinarian Newsletter September/October 1998 Volume XIII, No V

CompanyGeneric and (Brand) NamesIndicationsRoutes/Remarks
Med-Pharmex, Inc. (ANADA 200-229)Gentamicin Sulfate, Betamethasone Valerate, and Clotrimazole. (Tri-Otic ointment)Dogs. For treatment of acute and chronic otitis externa associated with yeast and/or bacteria susceptible to gentamicin.TOPICAL: ANADA is a generic copy of Schering-Plough Animal Health Corp. NADA 140-896. (OTOMAX) Federal Register 6/11/98.
Phoenix Scientific, Inc. (ANADA 200-202)Ivermectin Oral Liquid (Phoenectin Liquid) RxHorses. For treatment and control of parasites and parasitic conditionsORAL: ANADA is a generic copy of Merial Ltd.’s NADA 140-439 (Eqvalan liquid). Federal Register 7/17/98.

Phoenix Scientific, Inc. (ANADA 200-246)
Pyrantel Pamoate Suspension
Horses and ponies. For removal and control of mature infections of large & small strongyles, pinworms, large round-worms.
ORAL: ANADA is a generic copy of Pfizer, Inc.’s NADA 91-739 (Strongid T). Federal Register 7/24/98
G.C. Hanford Manufacturing Co. (ANADA 200-180)Ampicillin Trihydrate Sterile Powder RxCats, dogs, cattle and calves including veal. For treatment of respiratory, skin, urinary tract, gastrointestinal, soft-tissue, and postsurgical infections of dogs and cats, and intramuscular use for the treatment respiratory infections in cattle and calves.SUBCUTANEOUS or INTRAMUSCULAR: ANADA 200-180 is a generic copy of Fort Dodge Animal Health’s NADA 55-030 (Polyflex). Federal Register 8/4/98.