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U.S. Department of Health and Human Services

Animal & Veterinary

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Abbreviated New Animal Drug Approvals - March/April 2003

FDA Veterinarian Newsletter March/April 2003 Volume XVIII, No 2

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Ivy Laboratories, Division of Ivy Animal Health
(ANADA 200-346)
Trenbolone acetate, Estradiol (Component® TE-H)
Feedlot heifers. For increased rate of weight gain and improved feed efficiency.
SUBCUTANEOUS—The product Component TE-H approved under this ANADA is a generic copy of Intervet’s Revalor-H approved under NADA 140-992.
Federal Register 12/24/02

Delmarva Laboratories, Inc.
(ANADA 200-291)
AClindamycin liquid (Clinsol®)
Cats, dogs. For the treatment of various bacterial infections.
ORAL—The product Clinsol approved under this ANADA is a generic copy of Pharmacia & Upjohn’s Antirobe Aquadrops Liquid approved under NADA 135-940.
Federal Register 12/26/02

Phoenix Scientific, Inc.
(ANADA 200-176)
Praziquantel (PrazitechTM) RX
Dogs, cats. For the removal of various species of tapeworms.
INTRAMUSCULAR or SUBCUTANEOUS—The product Prazitech is a generic copy of Bayer Corp.’s Droncit 5.68% injectable solution approved under NADA 111-607.
Federal Register 12/31/02

First Priority, Inc.
(ANADA 200-340)
Ivermectin (PrivermectinTM)
Cattle. For treatment and control of various species of external and internal parasites.
TOPICAL—The product Privermectin is a generic copy of Merial Ltd.’s Ivomec pour-on for cattle approved under NADA 140-841.
Federal Register 01/27/03

Phoenix Scientific, Inc.
(ANADA 200-303)
Lincomycin Hydrochloride
Swine, broiler chickens. For the treatment of swine dysentery or the control of necrotic enteritis in chickens.
ORAL—The product Phoenix Scientific’s Lincomycin Hydrochloride Soluble Powder is a generic copy of Pharmacia & Upjohn’s LINCOMIX approved undAer NADA 111-636.
Federal Register 01/27/03

ECO LLC
(ANADA 200-348)
Ivermectin (Ecomectin)
Cattle. For treatment and control of various species of external and internal parasites.
TOPICAL—The product Ecomectin is a generic copy of Merial Limited’s Ivomec pour-on for cattle approved under NADA 140-841.
Federal Register 01/30/03

Phoenix Scientific, Inc.
(ANADA 200-313)
Levamisole (Levamisole Hydrochloride Soluble Pig Wormer)
Swine. For the treatment of various internal parasites.
ORAL—The product Phoenix Scientific’s Levamisole Hydrochloride Soluble Pig Wormer is a generic copy of Schering-Plough Animal Health’s Tramisol approved under NADA 112-049.
Federal Register 01/31/03