• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

Supplemental Abbreviated New Animal Drug Approvals - September/October 2003

FDA Veterinarian Newsletter September/October 2003 Volume XVIII, No 5

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Ivy Laboratories
Division of Ivy Animal Health, Inc.
(ANADA 200-346)
Trenbolone Acetate, Estradiol
(Component® TE-H)
Feedlot heifers. For increased rate of weight gain and improved feed efficiency.
SUBCUTANEOUS—The supplement provides for the addition of tylosin tartrate to an approved subcutaneous implant containing trenbolone and estradiol.
Federal Register 07/17/03

Cross Vetpharm Group Ltd.
(ANADA 200-144)
Oxytetracycline Hydrochloride (Tetroxy®)
Swine.
ORAL—The supplement provides for a new pouch size of oxytetracycline hydrochloride soluble powder used to make medicated drinking water for swine.
Federal Register 07/21/03

Delmarva Laboratories, Inc.
(ANADA 200-071)
Pentobarbital Sodium and Phenytoin Sodium (Euthasol™) RX
Dogs and others. For humane, painless, and rapid euthanasia.
SUBCUTANEOUS OR INTRAMUSCULAR—The supplement adds an environmental warning statement to product labeling.
Federal Register 07/21/03

Ivy Laboratories
Division of Ivy Animal Health, Inc.
(ANADA 200-346)
Trenbolone, Estradiol
(Component® TE-200)
Feedlot steers. For increased rate of weight gain and improved feed efficiency.
SUBCUTANEOUS—The supplemental ANADA provides for an additional dose of trembolone acetate and estradiol implant.
Federal Register 08/15/03