Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray
other · Food and Drug Administration · Rule · Published 2007-02-08 · Effective 2007-02-08 · 72 FR 5929
Document
Document number
E7-2121
Federal Register citation
72 FR 5929
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-02-08
Effective date
2007-02-08
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 First Priority, Inc. The ANADA provides for topical use of a gentamicin sulfate and betamethasone valerate topical spray on dogs for the treatment of infected superficial lesions.