Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine
other · Food and Drug Administration · Rule · Published 2007-01-04 · Effective 2007-01-04 · 72 FR 263
Document
Document number
E6-22508
Federal Register citation
72 FR 263
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-01-04
Effective date
2007-01-04
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative, analgesic, and preanesthetic in dogs.