Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin
other · Food and Drug Administration · Rule · Published 2005-07-12 · Effective 2005-07-12 · 70 FR 39918
Document
Document number
05-13586
Federal Register citation
70 FR 39918
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2005-07-12
Effective date
2005-07-12
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of tulathromycin solution in cattle and in swine, by injection, for the management of respiratory disease. FDA is also amending the regulations to add the acceptable daily intake for total residues of tulathromycin and tolerances for residues of tulathromycin in edible tissues of cattle and swine.