Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol Benzoate
other · Food and Drug Administration · Rule · Published 1999-04-15 · Effective 1999-04-15 · 64 FR 18573
Document
Document number
99-9458
Federal Register citation
64 FR 18573
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1999-04-15
Effective date
1999-04-15
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 Fort Dodge Animal Health. The supplemental NADA provides for use of a trenbolone acetate-estradiol benzoate implant in steers fed in confinement for slaughter for increased rate of weight gain. At this time, FDA is also amending the regulation for trenbolone tolerances to establish an acceptable daily intake (ADI) for the drug.