Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol
other · Food and Drug Administration · Rule · Published 2004-11-24 · Effective 2004-11-24 · 69 FR 68253
Document
Document number
04-25978
Federal Register citation
69 FR 68253
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-11-24
Effective date
2004-11-24
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Intervet Inc.; three supplemental abbreviated new animal drug applications (ANADAs) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc.; and a supplemental ANADA filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADAs and ANADAs provide for the addition of statements to labeling of subcutaneous implants containing trenbolone acetate and estradiol warning against the use of these products in calves to be processed for veal.