Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution
other · Food and Drug Administration · Rule · Published 2008-03-20 · Effective 2008-03-20 · 73 FR 14926
Document
Document number
E8-5598
Federal Register citation
73 FR 14926
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-03-20
Effective date
2008-03-20
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 Norbrook Laboratories, Ltd. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for 300 milligrams per milliliter (mg/mL) strength oxytetracycline injectable solution.