Oral Dosage Form New Animal Drugs; Sulfadimethoxine Oral Solution
other · US Department of Health and Human Services · Rule · Published 1997-02-25 · Effective 1997-02-25 · 62 FR 8370
Document
Document number
97-4515
Federal Register citation
62 FR 8370
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1997-02-25
Effective date
1997-02-25
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 Fermenta Animal Health. The ANADA provides for use of sulfadimethoxine oral solution to prepare medicated drinking water for animals to treat bacterial infections sensitive to sulfadimethoxine.