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U.S. Department of Health and Human Services

Animal & Veterinary

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ABBREVIATED NEW ANIMAL DRUG APPROVALS - November/December 1998

FDA Veterinarian Newsletter November/December 1998 Volume XIII, No VI

CompanyGeneric and (Brand) NamesIndicationsRoutes/Remarks
Phoenix Scientific, Inc. (ANADA 200-254)Iron Hydrogenated Dextran Inj.Baby pigs. For treatment or prevention of iron deficiency anemia.

INTRAMUSCULAR:
ANADA is a generic copy of Boehringer Ingelheim Vetmedica, Inc.'s NADA 106-772.

Federal Register 8/19/98.

Phoenix Scientific, Inc. (ANADA 200-219)Ivermectin Topical Solution (pour-on)Cattle. For treatment and control of worms, grubs, lice mites, and flies.

TOPICAL:
ANADA is a generic copy of Merial, Ltd' s NADA 140-841 Ivomec pour-on for cattle.

Federal Register 8/19/98.

Phoenix Scientific, Inc. (ANADA 200-248)Pyrantel Pamoate SuspensionDogs. For removal of large roundworms and hookworms and to prevent reinfections of Toxocara canis in puppies and adult dogs.

ORAL:
A NADA is a generic copy of Pfizer, Inc.'s NADA 100-237 (Nemex and Nemex-2).

Federal Register 8/28/98.

Contemporary Products, Inc. (ANADA 200-197)Streptomycin Oral SolutionChickens, swine, calves. For treatment of nonspecific infectious enteritis in chickens and treatment of bacterial enteritis in swine and calves

ORAL:
A NADA is a generic copy of Veterinary Services, Inc.'s NADA 65-252.

Federal Register 9/29/98.

Lloyd, Inc. (ANADA 200-055)

Ketamine Hydrochloride Inj. (VetaKet Rx)

 

Cats and subhuman primates. In cats for restraint or as an anesthetic and in subhuman primates for restraint.

INTRAMUSCULAR:
ANADA is a generic copy of Fort Dodge Animal Health’s NADA 45-290 (Vetalar).

Federal Register 9/29/98.

Phoenix Scientific, Inc. (ANADA 200-256)Iron Dextran Inj.Baby Pigs. For prevention or treatment of iron deficiency anemia

INTRAMUSCULAR:
ANADA is a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s NADA 134-708.

Federal Register 10/6/98.