Oral Dosage Form New Animal Drugs; Ivermectin Liquid
other · Food and Drug Administration · Rule · Published 2004-09-24 · Effective 2004-09-24 · 69 FR 57173
Document
Document number
04-21415
Federal Register citation
69 FR 57173
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-09-24
Effective date
2004-09-24
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 Merial Ltd. The supplemental NADA provides revised labeling, including the addition of four new species of internal parasites, for ivermectin oral liquid used in horses.