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U.S. Department of Health and Human Services

Animal & Veterinary

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Supplemental Abbreviated New Animal Drug Approvals - November/December 2003

FDA Veterinarian Newsletter November/December 2003 Volume XVIII, No 6

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Ivy Laboratories, Division of Ivy Animal Health, Inc.
(ANADA 200-221)
Trenbolone acetate and Estradiol (Component® TE-IS)
Feedlot Steers. For increased rate of weight gain and improved feed efficiency.
EAR IMPLANTATION-The supplement provides for an additional dose of trenbolone acetate and estradiol implant for use in steers fed in confinement for slaughter. Ivy Laboratories' Component TE-IS is a generic copy of Intervet, Inc.'s Revalor-IS, approved under NADA 140-897.
Federal Register 09/23/03

Ivy Laboratories, Division of Ivy Animal Health, Inc.
(ANADA 200-346)
Trenbolone acetate, Estradiol (Component® TE-IH)
Feedlot heifers. For increased rate of weight gain.
EAR IMPLANTATION-The supplement provides for an additional dose of trenbolone acetate and estradiol implant for use in heifers fed in confinement for slaughter. Ivy Laboratories' Component TE-IH is a generic copy of Intervet, Inc.'s Revalor-IH, approved under NADA 140-992.
Federal Register 09/23/03

Phoenix Scientific, Inc.
(ANADA 200-246)
Pyrantel pamoate (Anthelban V)
Horses and ponies. For removal and control of certain internal parasites.
ORAL-The supplemental ANADA provides for over-the-counter marketing status for pyrantel pamoate suspension, when labeled for oral administration rather than stomach tube, a veterinary prescription procedure. Phoenix Scientific, Inc.'s Pyrantel Pamoate Equine Anthelmintic Suspension is a generic copy of Pfizer, Inc.'s Pamoban horse wormer, approved under NADA 91-739.
Federal Register 09/23/03