Ophthalmic and Topical Dosage Form New Animal Drugs; Doramectin
other · Food and Drug Administration · Rule · Published 2005-07-26 · Effective 2006-07-26 · 70 FR 43046
Document
Document number
05-14630
Federal Register citation
70 FR 43046
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2005-07-26
Effective date
2006-07-26
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 a period of protection from reinfestation with two species of external parasites following topical administration of doramectin solution on cattle.