Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole Nitrate Lotion and Spray
other · Food and Drug Administration · Rule · Published 1997-10-23 · Effective 1997-10-23 · 62 FR 55161
Document
Document number
97-28014
Federal Register citation
62 FR 55161
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-10-23
Effective date
1997-10-23
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 miconazole nitrate lotion and spray as topical antifungal agents to treat certain infections of dogs and cats.