Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin and Clorsulon Injection
other · Food and Drug Administration · Rule · Published 2004-06-07 · Effective 2004-06-07 · 69 FR 31734
Document
Document number
04-12717
Federal Register citation
69 FR 31734
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-06-07
Effective date
2004-06-07
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 following administration of an ivermectin and clorsulon injectable solution to cattle.