Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin
other · Food and Drug Administration · Rule · Published 2004-01-06 · Effective 2004-01-06 · 69 FR 501
Document
Document number
04-130
Federal Register citation
69 FR 501
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-01-06
Effective date
2004-01-06
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 for topical use of ivermectin on cattle to control infections and prevent reinfection with certain species of external and internal parasites.