Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection
other · Food and Drug Administration · Rule · Published 2003-09-19 · Effective 2003-09-19 · 68 FR 54804
Document
Document number
03-23891
Federal Register citation
68 FR 54804
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-09-19
Effective date
2003-09-19
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a hybrid new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The NADA provides for the prescription and over-the-counter use of a 300 milligram per milliliter (mg/mL) oxytetracycline injectable solution for the treatment of various bacterial diseases of cattle and swine, and for the control of respiratory disease in cattle at high risk of developing bovine respiratory disease (BRD).