Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Injection
other · US Department of Health and Human Services · Rule · Published 1995-09-20 · Effective 1995-09-20 · 60 FR 48650
Document
Document number
95-23250
Federal Register citation
60 FR 48650
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1995-09-20
Effective date
1995-09-20
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 Phoenix Pharmaceutical, Inc. The ANADA provides for intravenous use of oxytetracycline hydrochloride injection in cattle for treatment of certain diseases caused by pathogens sensitive to oxytetracycline. EFFECTIVE DATE: September 20, 1995. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center For Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1643.