Oral Dosage Form New Animal Drugs; Ivermectin Paste; Technical Amendment
other · Food and Drug Administration · Rule · Published 2003-07-22 · Effective 2003-07-22 · 68 FR 43293
Document
Document number
03-18163
Federal Register citation
68 FR 43293
CFR reference
21 CFR 520
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-07-22
Effective date
2003-07-22
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 for the addition of several new species of internal parasites to product labeling for ivermectin paste for horses. This action is being taken to ensure accuracy and clarity in the agency's regulations.