Implantation or Injectable Dosage Form New Animal Drugs; Dexamethasone Injection
other · Food and Drug Administration · Rule · Published 2003-10-02 · Effective 2003-10-02 · 68 FR 56765
Document
Document number
03-24928
Federal Register citation
68 FR 56765
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-10-02
Effective date
2003-10-02
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 Veterinary Laboratories, Inc. The ANADA provides for the use of dexamethasone injectable solution for the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses.