Approved Animal Drug Products (Green Book)

Metadata Updated: June 20, 2020

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.

Access & Use Information

Public: This dataset is intended for public access and use. License: No license information was provided. If this work was prepared by an officer or employee of the United States government as part of that person's official duties it is considered a U.S. Government Work.

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Metadata Created Date June 20, 2020
Metadata Updated Date June 20, 2020
Data Update Frequency R/P1Y

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Additional Metadata

Resource Type Dataset
Metadata Created Date June 20, 2020
Metadata Updated Date June 20, 2020
Publisher U.S. Food and Drug Administration
Unique Identifier ee7073db-55c0-46b0-b831-1c659fe7137d
Maintainer Email
Public Access Level public
Data Update Frequency R/P1Y
Bureau Code 009:10
Metadata Context
Metadata Catalog ID
Schema Version
Catalog Describedby
Harvest Object Id 4daf1ce8-469c-45f4-82ca-4b8ec15d06d4
Harvest Source Id 15c538b5-31a0-474e-8ba5-c85ee421cb4d
Harvest Source Title
Data First Published 2019-02-28
Homepage URL
Data Last Modified R/P1Y
Program Code 009:004
Source Datajson Identifier True
Source Hash 9cd8e2d6e92aadebef8ca238b89fa507a4a5fe89
Source Schema Version 1.1

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