Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole Nitrate Cream; Miconazole Nitrate Lotion; Miconazole Nitrate Spray
other · Food and Drug Administration · Rule · Published 2005-12-09 · Effective 2005-12-09 · 70 FR 73137
Document
Document number
05-23811
Federal Register citation
70 FR 73137
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2005-12-09
Effective date
2005-12-09
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 miconazole nitrate as a spray or lotion on dogs and cats for the treatment of certain fungal infections.