Oral Dosage Form New Animal Drugs; Sulfadiazine/Pyrimethamine Suspension
other · Food and Drug Administration · Rule · Published 2008-09-17 · Effective 2008-09-17 · 73 FR 53685
Document
Document number
E8-21625
Federal Register citation
73 FR 53685
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-09-17
Effective date
2008-09-17
HHS docket
Docket No. FDA-2008-N-0039
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 Animal Health Pharmaceuticals, LLC. The supplemental NADA provides for a revised human food safety warning on labeling for an oral suspension of sulfadiazine and pyrimethamine used for the treatment of equine protozoal myeloencephalitis (EPM).