Oral Dosage Form New Animal Drugs; Omeprazole Paste
other · Food and Drug Administration · Rule · Published 2004-03-22 · Effective 2004-03-22 · 69 FR 13219
Document
Document number
04-6248
Federal Register citation
69 FR 13219
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-03-22
Effective date
2004-03-22
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 Merial Ltd. The NADA provides for oral administration of omeprazole paste to horses for the prevention of gastric ulcers.