Ophthalmic and Topical Dosage Form New Animal Drugs; Copper Naphthenate Solution
other · Food and Drug Administration · Rule · Published 2003-09-29 · Effective 2003-09-29 · 68 FR 55825
Document
Document number
03-24495
Federal Register citation
68 FR 55825
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-09-29
Effective date
2003-09-29
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for topical use of copper naphthenate solution on horses and ponies as an aid in treating thrush caused by organisms susceptible to copper naphthenate.