Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin Phosphate Injection
other · US Department of Health and Human Services · Rule · Published 1997-02-06 · Effective 1997-02-06 · 62 FR 5526
Document
Document number
97-3016
Federal Register citation
62 FR 5526
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1997-02-06
Effective date
1997-02-06
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 Elanco Animal Health, a Division of Eli Lilly and Co. The supplemental NADA provides for subcutaneous use of tilmicosin phosphate injection for the control of respiratory disease in cattle at high risk of developing bovine respiratory disease (BRD) associated with Pasteurella haemolytica.