Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Injection
other · Food and Drug Administration · Rule · Published 2007-08-02 · Effective 2007-08-02 · 72 FR 42290
Document
Document number
E7-14950
Federal Register citation
72 FR 42290
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-08-02
Effective date
2007-08-02
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 Norbrook Laboratories, Ltd. The ANADA provides for use of an oxytetracycline hydrochloride injectable solution in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves for the treatment of various bacterial diseases.