Implantation and Injectable Dosage Form New Animal Drugs; Ivermectin Injection
other · Food and Drug Administration · Rule · Published 2004-09-02 · Effective 2004-09-02 · 69 FR 53617
Document
Document number
04-19984
Federal Register citation
69 FR 53617
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-09-02
Effective date
2004-09-02
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 an increased period of protection from reinfection with three species of internal parasites of cattle following administration of ivermectin solution by subcutaneous injection.