Oral Dosage Form New Animal Drugs; Sulfadimethoxine Soluble Powder
other · Food and Drug Administration · Rule · Published 2005-12-09 · Effective 2005-12-09 · 70 FR 73136
Document
Document number
05-23813
Federal Register citation
70 FR 73136
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2005-12-09
Effective date
2005-12-09
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the oral use of sulfadimethoxine soluble powder to create a solution administered as a drench to cattle or in the drinking water of chickens, turkeys, or cattle for the treatment of coccidiosis or various bacterial diseases.