Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin Sulfate Injection
other · Food and Drug Administration · Rule · Published 1998-12-10 · Effective 1998-12-10 · 63 FR 68182
Document
Document number
98-32741
Federal Register citation
63 FR 68182
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-12-10
Effective date
1998-12-10
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for use of gentamicin sulfate injection in the neck of 1 to 3-day-old turkey poults for prevention of early mortality due to susceptible Arizona paracolon infections.