Oral Dosage Form New Animal Drugs; Ivermectin and Praziquantel Paste
other · Food and Drug Administration · Rule · Published 2004-08-12 · Effective 2004-08-12 · 69 FR 49808
Document
Document number
04-18406
Federal Register citation
69 FR 49808
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-08-12
Effective date
2004-08-12
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 revised labeling for ivermectin and praziquantel oral paste used in horses for the treatment and control of various internal parasites.