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  1. Approved Animal Drug Products (Green Book)

Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal Drugs

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A Freedom of Information (FOI) Summary provides the public with the key information that FDA used to determine that a New Animal Drug Application (NADA), an Abbreviated New Animal Drug Application (ANADA), or a Conditional New Animal Drug Application (CNADA) met the requirements for approval or conditional approval. Under federal law,1 FDA must release this information after the agency approves or conditionally approves the application.

For an NADA, the FOI Summary describes the information that the drug company submitted to FDA to support that a brand name animal drug is safe and effective for its intended use.

For an ANADA, the FOI Summary describes the information that the drug company submitted to FDA to support that a generic animal drug is bioequivalent to the already-approved brand name animal drug. Broadly, bioequivalence means that the generic copy is absorbed by and performs the same way in the animal’s body as the brand name drug, which has already been shown to be safe and effective for its intended use.

For a CNADA, the FOI Summary describes the information that the drug company submitted to FDA to support that a brand name animal drug is safe and has a reasonable expectation of effectiveness for its intended use. 

For a drug for a food-producing species, the FOI Summary also summarizes the human food safety information that the company submitted to FDA to demonstrate that food products made from treated animals are safe for people to eat.

Location of FOI Summaries

FOI Summaries are arranged by application number in Animal Drugs @ FDA. If the application number is less than 200-000, then the animal drug is a brand name drug with either an approved NADA or a conditionally approved CNADA. A number over 200-000 indicates the animal drug is a generic drug with an approved ANADA.

The FOI Summary includes:

  • General information about the approved or conditionally approved animal drug;
  • The specific intended use of the drug (called the “indication”) and its dosage form. The drug’s dosage form is its physical form when it comes out of the manufacturing facility. There are several types of dosage forms, including oral and injectable;
  • An explanation of the drug's dosage regimen. The dosage regimen includes how much of the drug to give (the dose), how often to give it (the frequency), how long to give it (the duration), and how to give it (the route of administration). Various routes of administration include injecting the drug under the skin, into muscle, or into a vein, giving the drug by mouth, or applying the drug topically to the skin; and
  • The agency's overall conclusions about the drug’s safety and effectiveness.

Most recent FOI Summaries include an Executive Summary that provides a brief overview of the scientific basis for the approval or conditional approval followed by a more detailed description.

If the FOI Summary is not electronically available

To obtain a copy of an FOI Summary that is not electronically available, please submit a written Freedom of Information Act (FOIA) request. Visit the "How to Make a FOIA Request" webpage for more information. FDA cannot accept FOIA requests by e-mail.

1 Title 21 of the Code of Federal Regulations, Part 514.11(e)

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