Implantation or Injectable Dosage Form New Animal Drugs; N-Butylscopolammonium Bromide
other · Food and Drug Administration · Rule · Published 2004-06-25 · Effective 2004-06-25 · 69 FR 35512
Document
Document number
04-14438
Federal Register citation
69 FR 35512
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-06-25
Effective date
2004-06-25
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 a solution of N- butylscopolammonium bromide by intravenous injection for the control of abdominal pain (colic) associated with spasmodic colic, flatulent colic, and simple impactions in horses.