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                Approved Animal Drug Products (Green Book)

Approved Animal Drug Products (Green Book)

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


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          Approved Animal Drug Products (Green Book)
          Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal DrugsApproved 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 a summary of 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 the safety and effectiveness of a brand name animal drug for its intended use.

For an ANADA, the FOI Summary describes the information that the drug company submitted to FDA to prove 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 the safety and reasonable expectation of effectiveness of a brand name animal drug 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 drug’s indications for use, dosage form, and route of administration;
	An explanation of the dosage regimen; and
	The agency's conclusions.Most recent FOI Summaries begin with 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 via e-mail.

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

                                                                                  Content current as of:
      01/02/2024Approved Animal Drug Products (Green Book)

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


                        Drug Labels
 
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