Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin
other · Food and Drug Administration · Rule · Published 2010-03-02 · Effective 2010-03-02 · 75 FR 9333
Document
Document number
2010-4206
Federal Register citation
75 FR 9333
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-03-02
Effective date
2010-03-02
HHS docket
Docket No. FDA-2010-N-0002
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 & Co. The supplemental NADA provides a dose range for use of an injectable solution of tilmicosin phosphate for treatment of respiratory disease in cattle and additional pathogens for which this therapy is effective.