Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate
other · Food and Drug Administration · Rule · Published 2004-12-02 · Effective 2004-12-02 · 69 FR 70055
Document
Document number
04-26552
Federal Register citation
69 FR 70055
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-12-02
Effective date
2004-12-02
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) and an abbreviated supplemental new animal drug application (ANADA) filed by Intervet, Inc., and Ivy Laboratories, Division of Ivy Animal Health, Inc., respectively. The supplemental NADA and ANADA provide for the addition of statements to labeling of subcutaneous implants containing trenbolone acetate warning against the use of these products in calves to be processed for veal.