Certain Other Dosage Form New Animal Drugs; Gentamicin Sulfate Intrauterine Solution
other · Food and Drug Administration · Rule · Published 1997-01-06 · Effective 1997-01-06 · 62 FR 611
Document
Document number
97-185
Federal Register citation
62 FR 611
CFR reference
21 CFR 529
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-01-06
Effective date
1997-01-06
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 Phoenix Pharmaceutical, Inc. The ANADA provides for the use of a generic gentamicin sulfate intrauterine solution for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.