Implantation or Injectable Dosage Form New Animal Drugs; Atipamezole
other · Food and Drug Administration · Rule · Published 2007-01-04 · Effective 2007-01-04 · 72 FR 264
Document
Document number
E6-22515
Federal Register citation
72 FR 264
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 a supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA adds a claim for reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride to labeling for atipamezole hydrochloride injectable solution for dogs.