Approved Animal Drug Products (Green Book)

Metadata Updated: April 30, 2021

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: See this page for license information.

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Dates

Metadata Created Date November 10, 2020
Metadata Updated Date April 30, 2021
Data Update Frequency R/P1Y

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date April 30, 2021
Publisher U.S. Food and Drug Administration
Unique Identifier Unknown
Maintainer
Identifier ee7073db-55c0-46b0-b831-1c659fe7137d
Data First Published 2021-02-25
Data Last Modified 2021-03-12
Public Access Level public
Data Update Frequency R/P1Y
Bureau Code 009:10
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Homepage URL http://www.accessdata.fda.gov/scripts/animaldrugsatfda/index.cfm
License http://opendefinition.org/licenses/odc-odbl/
Program Code 009:004
Source Datajson Identifier True
Source Hash 222c0a011fc196879e2f7661084ff16068a9f9e9
Source Schema Version 1.1

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