Oral Dosage Form New Animal Drugs; Gentamicin Sulfate Oral Solution
other · Food and Drug Administration · Rule · Published 1997-06-25 · Effective 1997-06-25 · 62 FR 34168
Document
Document number
97-16686
Federal Register citation
62 FR 34168
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-06-25
Effective date
1997-06-25
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 Med-Pharmex, Inc. The ANADA provides for the use of gentamicin sulfate oral solution for the control and treatment of colibacillosis in weanling swine and for the control and treatment of swine dysentery caused by Treponema hyodysenteriae.