Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic Solution
other · Food and Drug Administration · Rule · Published 2010-09-08 · Effective 2010-09-08 · 75 FR 54492
Document
Document number
2010-22276
Federal Register citation
75 FR 54492
CFR reference
21 CFR 524
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-09-08
Effective date
2010-09-08
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to codify the conditions of use of an approved new animal drug application (NADA) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and Cosmetic Act and to improve the accuracy of the regulations.