Certain Other Dosage Form New Animal Drugs; Detomidine
other · Food and Drug Administration · Rule · Published 2010-04-23 · Effective 2010-04-23 · 75 FR 21162
Document
Document number
2010-9371
Federal Register citation
75 FR 21162
CFR reference
21 CFR 529
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-04-23
Effective date
2010-04-23
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation and restraint of horses.