Ophthalmic and Topical Dosage Form New Animal Drugs; Doramectin
other · Food and Drug Administration · Rule · Published 2004-08-10 · Effective 2004-08-10 · 69 FR 48391
Document
Document number
04-18165
Federal Register citation
69 FR 48391
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-08-10
Effective date
2004-08-10
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 Pfizer, Inc. The supplemental NADA provides for an increased period of protection from reinfection with three species of internal parasites following topical administration of doramectin solution on cattle.