Approved Animal Drug Products (Green Book)

On November 16, 1988, the President of the United States signed into law the Generic 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.

[
  "009:10"
]

[
  "009:004"
]

[
  "FDA"
]