Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray
other · Food and Drug Administration · Rule · Published 2012-01-25 · Effective 2012-01-25 · 77 FR 3598
Document
Document number
2012-1501
Federal Register citation
77 FR 3598
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-01-25
Effective date
2012-01-25
HHS docket
Docket No. FDA-2011-N-0003
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for the veterinary prescription use of gentamicin sulfate and betamethasone valerate topical spray in dogs.