Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, Clotrimazole Ointment
other · Food and Drug Administration · Rule · Published 2006-09-28 · Effective 2006-09-28 · 71 FR 56867
Document
Document number
E6-15888
Federal Register citation
71 FR 56867
CFR reference
21 CFR 524
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-09-28
Effective date
2006-09-28
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides for a new container size, a 40-gram dropper bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be administered for the treatment of acute and chronic canine otitis externa.