Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate Ophthalmic Ointment
other · Food and Drug Administration · Rule · Published 2004-08-05 · Effective 2004-08-05 · 69 FR 47363
Document
Document number
04-17891
Federal Register citation
69 FR 47363
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-08-05
Effective date
2004-08-05
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 Altana Inc. The ANADA provides for veterinary prescription use of gentamicin sulfate ophthalmic ointment on dogs and cats for topical treatment of conjunctivitis caused by susceptible bacteria.