Oral Dosage Form New Animal Drugs; Ivermectin Paste
other · Food and Drug Administration · Rule · Published 2006-11-21 · Effective 2006-11-21 · 71 FR 67298
Document
Document number
E6-19616
Federal Register citation
71 FR 67298
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-11-21
Effective date
2006-11-21
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Virbac AH, Inc. The supplemental ANADA provides revised labeling for oral use of generic ivermectin paste in horses that conforms to the pioneer product label.