Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Topical Spray
other · US Department of Health and Human Services · Rule · Published 1997-03-06 · 62 FR 10220
Document
Document number
97-5453
Federal Register citation
62 FR 10220
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1997-03-06
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 Med-Pharmex, Inc. The ANADA provides for use of gentamicin topical spray in dogs for the treatment of infected superficial lesions caused by bacteria susceptible to gentamicin.