Certain Other Dosage Form New Animal Drugs; Gentamicin Sulfate Intrauterine Solution
other · US Department of Health and Human Services · Rule · Published 1995-08-30 · Effective 1995-08-30 · 60 FR 45041
Document
Document number
95-21455
Federal Register citation
60 FR 45041
CFR reference
21 CFR 529
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1995-08-30
Effective date
1995-08-30
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 Macleod Pharmaceuticals, Inc. The ANADA provides for the use of a generic gentamicin solution for control of bacterial infections of the uterus (metritis) of horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.