Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol
other · Food and Drug Administration · Rule · Published 2004-02-13 · Effective 2004-02-13 · 69 FR 7115
Document
Document number
04-3134
Federal Register citation
69 FR 7115
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-02-13
Effective date
2004-02-13
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for the addition of tylosin tartrate to an approved subcutaneous implant containing trenbolone and estradiol used for increased rate of weight gain and improved feed efficiency in feedlot steers.