Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol Tartrate
other · Food and Drug Administration · Rule · Published 1998-12-02 · Effective 1998-12-02 · 63 FR 66431
Document
Document number
98-32022
Federal Register citation
63 FR 66431
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-12-02
Effective date
1998-12-02
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Intervet, Inc. The ANADA provides for use of butorphanol tartrate injection for horses for the relief of pain associated with colic and postpartum pain in adult horses and yearlings.