Oral Dosage Form New Animal Drugs; Sulfadimethoxine Soluble Powder and Oral Solution
other · Food and Drug Administration · Rule · Published 1998-11-05 · Effective 1998-11-05 · 63 FR 59713
Document
Document number
98-29612
Federal Register citation
63 FR 59713
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-11-05
Effective date
1998-11-05
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two abbreviated new animal drug applications (ANADA's) filed by Med-Pharmex, Inc. One ANADA provides for the use of sulfadimethoxine soluble powder for use in drinking water or as a drench, and the second ANADA provides for the use of the oral solution in drinking water or as a drench, for the treatment of chickens, turkeys, and dairy calves, dairy heifers, and beef cattle.