Oral Dosage Form New Animal Drugs; Ivermectin Liquid
other · Food and Drug Administration · Rule · Published 2008-02-21 · Effective 2008-02-21 · 73 FR 9455
Document
Document number
E8-3266
Federal Register citation
73 FR 9455
CFR reference
21 CFR 520
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-02-21
Effective date
2008-02-21
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 IVX Animal Health, Inc. The supplemental ANADA provides revised labeling for ivermectin oral liquid used in horses.