Oral Dosage Form New Animal Drugs; Nitazoxanide Paste
other · Food and Drug Administration · Rule · Published 2004-01-06 · Effective 2004-01-06 · 69 FR 499
Document
Document number
04-129
Federal Register citation
69 FR 499
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-01-06
Effective date
2004-01-06
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by IDEXX Pharmaceuticals, Inc. The NADA provides for veterinary prescription use of an nitazoxanide oral paste for the treatment of equine protozoal myeloencephalitis (EPM).