Implantation or Injectable Dosage Form New Animal Drugs; Estradiol
other · Food and Drug Administration · Rule · Published 2004-11-22 · Effective 2004-11-22 · 69 FR 67818
Document
Document number
04-25877
Federal Register citation
69 FR 67818
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-11-22
Effective date
2004-11-22
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental NADA provides for the addition of statements to labeling of subcutaneous implants containing estradiol warning against the use of these products in calves to be processed for veal.