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U.S. Department of Health and Human Services

Animal & Veterinary

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Abbreviated New Animal Drug Approvals - July/August 2003

FDA Veterinarian Newsletter July/August 2003 Volume XVIII, No 4

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Pennfield Oil Co.
(ANADA 200-314)
Chlortetracycline/Sulfamethazine (Pennchlor S 700™)
Beef cattle.
MEDICATED FEED—The ANADA provides for the use of a fixed-combination Type A medicated article to make two-way combination drug Type C medicated feeds for beef cattle. PENNCHLOR S 700 is a generic copy of Alpharma, Inc.’s AUREO S 700 approved under NADA 35-805.
Federal Register 04/28/03

Phoenix Scientific, Inc.
(ANADA 200-322)
Butorphanol Tartrate RX
Horses. For relief of colic and postpartum pain.
INTRAVENOUS—The ANADA provides for use of Butorphanol Tartrate injection for the relief of colic and postpartum pain in adult and yearling horses. Phoenix Scientific’s Butorphanol Tartrate injection is a generic copy of Fort Dodge Animal Health’s TORBUGESIC® approved under NADA 135-780.
Federal Register 04/29/03

Phoenix Scientific, Inc.
(ANADA 200-347)
Penicillin G Potassium
Turkeys. For the treatment of erysipelas.
ORAL—The ANADA provides for use of Penicillin G Potassium, USP, in the drinking water of turkeys for the treatment of erysipelas caused by Erysipelothrix rhusiopathiae. Phoenix Scientific’s Penicillin G Potassium is a generic copy of Fort Dodge Animal Health’s Penicillin G Potassium, USP, approved under NADA 55-060.
Federal Register 05/15/03

Phoenix Scientific, Inc.
(ANADA 200-319)
Acepromazine Maleate
Dogs, cats, horses. For use as a tranquilizer.
SUBCUTANEOUS or INTRAMUSCULAR—The ANADA provides for the use of Acepromazine Maleate as a tranquilizer. Phoenix Scientific’s Acepromazine Maleate Injection is a generic copy of Fort Dodge Animal Health’s PROMACE approved under NADA 015-030.
Federal Register 06/06/03

Cross Vetpharm Group, Ltd.
(ANADA 200-350)
Pyrantel Pamoate (Exodus)
Horses and Ponies. For the removal and control of certain internal parasites.
ORAL—The ANADA provides for use of EXODUS paste for the removal and control of certain internal parasites in horses and ponies. Cross Vetpharm Group, Ltd’s EXODUS is a generic copy of Pfizer, Inc.’s STRONGID Paste approved under NADA 129-831.
Federal Register 06/10/03