Injectable or Implantable Dosage Form New Animal Drugs; Estradiol Benzoate
other · Food and Drug Administration · Rule · Published 2003-08-19 · Effective 2003-08-19 · 68 FR 49703
Document
Document number
03-21113
Federal Register citation
68 FR 49703
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-08-19
Effective date
2003-08-19
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two new animal drug applications (NADAs) filed by PR Pharmaceuticals, Inc. The NADAs provide for subcutaneous injection, in the ear only, of a suspension implant of estradiol benzoate microspheres for increased rate of weight gain in suckling beef calves, and for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter.