Oral Dosage Form New Animal Drugs; Trimethoprim and Sulfadiazine Oral Paste
other · Food and Drug Administration · Rule · Published 2006-05-31 · Effective 2006-05-31 · 71 FR 30802
Document
Document number
E6-8303
Federal Register citation
71 FR 30802
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-05-31
Effective date
2006-05-31
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 Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine oral paste, administered to horses as a systemic antibacterial.