Oral Dosage Form New Animal Drugs; Sulfadiazine/Pyrimethamine Suspension
other · Food and Drug Administration · Rule · Published 2004-12-02 · Effective 2004-12-02 · 69 FR 70053
Document
Document number
04-26528
Federal Register citation
69 FR 70053
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-12-02
Effective date
2004-12-02
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 Animal Health Pharmaceuticals, LLC. The NADA provides for veterinary prescription use of an oral suspension of sulfadiazine and pyrimethamine for the treatment of equine protozoal myeloencephalitis (EPM).