FDA Approved Animal Drug Products, 1998

摘要

On November 16, 1988, the President of the United States signed into law theGeneric Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions, the Act extends eligibility for submission of Abbreviated New Animal Drug Applications (ANADAs) to all animal drug products approved for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. The Act also requires that each sponsor of an approved animal drug product submit to the FDA certain information regarding patents held for the animal drug or its method of use. The Act requires that this information, as well as a list of all animal drug products approved for safety and effectiveness, be made available to the public. This list must be updated monthly under the provisions of the Act. This publication, which is known as the 'Green Book', was first published in January of 1989. Updates have been added monthly since then. The list is published in its entirety each January. There are eight sections in the publication. The first lists approved drug products; sorted by tradename and by NADA number. The second section lists active ingredients and each approved product containing that active ingredient. Sections I and II will not contain voluntary withdrawn products. The third section lists patent information as provided by the sponsors of approved animal drug products. Products voluntarily withdrawn will appear in this section if they have unexpired patents.