Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin Sulfate Injection
other · US Department of Health and Human Services · Rule · Published 1995-06-07 · Effective 1995-06-07 · 60 FR 29985
Document
Document number
95-13828
Federal Register citation
60 FR 29985
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1995-06-07
Effective date
1995-06-07
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 Sanofi Animal Health, Inc. The ANADA provides for use of gentamicin sultate injection in day-old chickens for the prevention of early mortality caused by Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.