Implantation or Injectable Dosage Form New Animal Drugs; Romifidine
other · Food and Drug Administration · Rule · Published 2004-08-05 · Effective 2004-08-05 · 69 FR 47362
Document
Document number
04-17876
Federal Register citation
69 FR 47362
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-08-05
Effective date
2004-08-05
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 Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of romifidine hydrochloride injectable solution in horses as a sedative and analgesic, and as a preanesthetic agent.