Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin Phosphate Injection
other · Food and Drug Administration · Rule · Published 1998-02-17 · Effective 1998-02-17 · 63 FR 7701
Document
Document number
98-3897
Federal Register citation
63 FR 7701
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-02-17
Effective date
1998-02-17
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 removal of the label warnings concerning subcutaneous use of tilmicosin phosphate injection in preruminating (veal) calves. Removal of the warning is based on a tissue residue depletion study in calves less than 1 month of age.